Beigene Ltd (ONC) 2018 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Q4 2018 BeiGene Earnings Conference Call.

女士們、先生們，美好的一天，歡迎參加百濟神州 2018 年第四季財報電話會議。

(Operator Instructions)

（操作員說明）

I would now like to introduce your host for today's conference, Dr. Howard Liang, Chief Financial Officer and Chief Strategy Officer.

現在我想介紹一下今天會議的主持人，財務長兼首席策略長梁博士。

Dr. Liang, you may begin.

梁醫生，您可以開始了。

Thanks very much.

非常感謝。

Good evening and good morning.

晚上好，早安。

Welcome to our 2018 Fourth Quarter and Annual Results Conference Call.

歡迎參加我們的 2018 年第四季和年度業績電話會議。

At the next slide, as a reminder, we'll be making forward-looking statements during today's events, and our business carries certain risks.

在下一張投影片中，作為提醒，我們將在今天的活動中做出前瞻性陳述，我們的業務存在一定的風險。

Some of these are discussed in our filings with the SEC and Hong Kong Stock Exchange.

我們向美國證券交易委員會和香港證券交易所提交的文件中討論了其中一些問題。

Next slide.

下一張投影片。

The agenda for today's presentation will start with the opening remarks by our Founder, CEO and Chairman, John Oyler; followed by commercial operation highlights by Dr. Xiaobin Wu, our General Manager of China and President of the company; Dr. Eric Hedrick, our Chief Adviser, will provide an update on our clinical programs on our -- for our clinical assets and I'll take you through our full year and fourth quarter financial results before Q&A.

今天演講的議程將從我們的創辦人、執行長兼董事長 John Oyler 的開場白開始；隨後由中國區總經理兼公司總裁吳曉斌博士介紹商業營運亮點；我們的首席顧問 Eric Hedrick 博士將提供有關我們臨床資產的臨床計劃的最新信息，我將在問答前向您介紹我們全年和第四季度的財務業績。

So with that, I would like to turn it over to John.

因此，我想把它交給約翰。

Great.

偉大的。

Good morning, everyone, and thank you for joining us for our first annual results review.

大家早安，感謝您參加我們的第一次年度業績審查。

The year of 2018 was the year of unparallel growth and advancement at BeiGene in all areas.

2018年是百濟神州在各個領域取得無與倫比的成長和進步的一年。

We have enrolled more than 2,000 patients in our clinical programs this year and reported exciting data and initiated regulatory filings based on those results.

今年，我們已招募了 2,000 多名患者參加我們的臨床項目，報告了令人興奮的數據，並根據這些結果啟動了監管備案。

During the last year, we've also strengthened our team, which included bringing in our President and GM, Dr. Wu Xiaobin; and the recent appointment of Chief Medical Officer and Immuno-Oncology, Dr. Yong Ben.

去年，我們也加強了我們的團隊，包括引進了總裁兼總經理吳曉斌博士；以及最近任命 Yong Ben 博士為首席醫療官和免疫腫瘤學。

And we've also grown the team to over 2,200 people.

我們的團隊規模也擴大到 2,200 多人。

We built significant capabilities in our clinical, commercial and manufacturing groups, always with the utmost commitment to patients and to quality.

我們在臨床、商業和製造團隊中建立了強大的能力，始終對患者和品質做出最大的承諾。

And we've continued to expand our research capabilities.

我們繼續擴大我們的研究能力。

We believe that BeiGene has now become uniquely positioned to integrate and leverage the opportunities created by newly introduced China reimbursement and clinical trial reforms.

我們相信，百濟神州目前已處於獨特的地位，可以整合和利用中國新推出的報銷和臨床試驗改革所創造的機會。

Specifically, we're well positioned to continue to execute the broad development of tislelizumab with our partner Celgene or independently.

具體來說，我們處於有利地位，可以繼續與我們的合作夥伴 Celgene 或獨立地進行 tislelizumab 的廣泛開發。

We continue to make good progress with our broad program, and we're announcing a couple of enrollment completions today.

我們的廣泛計劃繼續取得良好進展，今天我們宣布了一些註冊完成情況。

We've also grown dramatically our product-related revenue.

我們的產品相關收入也大幅成長。

Our commercial products are performing very well.

我們的商業產品表現非常好。

We're now preparing for the potential approvals in China of our 2 internally discovered and developed products for potentially 3 indications in 2019.

我們現在正在準備 2019 年我們的 2 個內部發現和開發的產品在中國獲得潛在的 3 個適應症的批准。

We believe that BeiGene is very well positioned for what we believe is likely to be a highly transformational year.

我們相信，百濟神州已經做好了充分準備，迎接我們認為可能是高度轉型的一年。

Next slide, please.

請下一張投影片。

Slide 6 provides some of the details of our 2018 accomplishments that I just mentioned.

幻燈片 6 提供了我剛才提到的 2018 年成就的一些細節。

The compelling clinical data reported here for both tisle and zanu warrant your attention.

這裡報告的 tisle 和 zanu 令人信服的臨床數據值得您關注。

We're very excited when we see the potential of these drug candidates to help people.

當我們看到這些候選藥物幫助人們的潛力時，我們感到非常興奮。

Slide 7. I would also like to highlight the expansion of our manufacturing capabilities.

投影片 7。

As you can see on this slide, we have added highly experienced leaders for our manufacturing operations.

正如您在這張投影片中所看到的，我們為我們的製造業務增加了經驗豐富的領導者。

We're committed to and investing heavily in building truly world-class-level manufacturing.

我們致力於並大力投資建立真正的世界級水準的製造業。

We're working with exceptional partners such as BI and Catalent, and we're building our own world-class facilities.

我們正在與 BI 和 Catalent 等傑出合作夥伴合作，並且正在建立我們自己的世界一流設施。

We're always committed to ensuring patients across the globe receive product of the highest quality.

我們始終致力於確保全球患者獲得最高品質的產品。

There's no shortcuts to be taken here.

這裡沒有捷徑可走。

Next slide, please.

請下一張投影片。

All of this has been done in support of our vision to build a transformational, leading global biotech company that's strongly entrenched in China, with a commitment to the highest global standards.

所有這一切都是為了支持我們的願景，即建立一家在中國根深蒂固的變革型全球領先生物技術公司，並致力於實現全球最高標準。

In 2019, we will continue to work towards this end by the following.

2019年，我們將繼續為此努力。

First, we're going to try to realize our 2 near-term commercial opportunities that we have in our BTK inhibitor globally and our PD-1 inhibitor, which are currently focused for us in Asia but we may regain global rights in the near future.

首先，我們將努力實現我們在全球 BTK 抑制劑和 PD-1 抑制劑方面擁有的 2 個近期商業機會，目前我們主要集中在亞洲，但我們可能會在不久的將來重新獲得全球權利。

Secondly, by continuing to strengthen our overall capabilities, especially in global clinical development, our commercial footprint, manufacturing; and third, capturing the opportunities created and enabled by the recent significant regulatory reforms in China and continuing to leverage them to expand our existing portfolio.

其次，透過持續加強我們的整體能力，特別是在全球臨床開發、我們的商業足跡、製造方面；第三，抓住中國近期重大監管改革所創造和實現的機遇，並繼續利用它們來擴大我們現有的投資組合。

BeiGene is certainly a new and a different type of organization.

百濟神州無疑是一個新的、不同類型的組織。

We're pursuing a truly global model that differentiates us from other local Chinese companies and from big multinational pharma, and we're doing so by leveraging our strong clinical resources and commercial capabilities in China.

我們正在追求真正的全球模式，使我們有別於其他中國本土公司和大型跨國製藥公司，我們正在透過利用我們在中國強大的臨床資源和商業能力來實現這一目標。

Next slide, please.

請下一張投影片。

We believe that we're part of a once-in-a-lifetime opportunity that will positively and fundamentally change how drugs are developed globally and in the future.

我們相信，我們是千載難逢的機會的一部分，它將積極地從根本上改變全球和未來的藥物開發方式。

BeiGene was created with this opportunity in mind, and it is indelibly imprinted in our DNA.

百濟神州正是抓住這個機會而創建的，它已不可磨滅地烙印在我們的 DNA 中。

We have grown into a unique and different company and a true leader at the forefront of this opportunity, having built a clinical organization of over 800 that is a world leader in running China-inclusive global trials and executing at the highest global standards and with great efficiency.

我們已經成長為一家獨特且與眾不同的公司，也是抓住這一機會的真正領導者，我們建立了一個擁有800 多人的臨床組織，在進行包括中國在內的全球試驗並按照全球最高標準和卓越執行力方面處於世界領先地位。

We have initiated 6 of these global pivotal studies and have 21 pivotal or potential registration-enabling studies up and running, over 50 studies ongoing or planned.

我們已經啟動了其中 6 項全球關鍵研究，並有 21 項關鍵或潛在的註冊支持研究正在啟動和運行，超過 50 項研究正在進行或計劃中。

It's truly remarkable.

這確實很了不起。

Slide 10, please.

請投影片 10。

We are also actively engaged in establishing collaborations to enter other compelling drug candidates to leverage our capabilities to help accelerate their global programs.

我們也積極參與建立合作，以進入其他引人注目的候選藥物，並利用我們的能力幫助加速他們的全球計畫。

We've expanded our portfolio by in-licensing regional rights to Sitra from Mirati and 2 new bispecific antibodies therapeutics from Zymeworks that we're quite excited about.

我們透過從 Mirati 獲得 Sitra 的區域權利以及從 Zymeworks 獲得兩種新的雙特異性抗體療法的區域權利來擴大我們的產品組合，對此我們感到非常興奮。

We will continue to look for the highest-quality opportunities to add other compelling therapies for patients through our business development and also to complement our internal research.

我們將繼續尋找最高品質的機會，透過我們的業務發展為患者添加其他引人注目的療法，並補充我們的內部研究。

Next slide, which is 11.

下一張投影片，即 11。

The confluence of China with regard to global clinical trial development and the introduction of reimbursement in China enable new, improved models for our industry.

中國與全球臨床試驗發展的融合以及報銷在中國的引入為我們的行業帶來了新的、改進的模式。

This is a model that recognizes the unique opportunity that China represents; and will expand access to high-quality, innovative medicines globally.

這是一個認識到中國所代表的獨特機會的模式；並將在全球範圍內擴大獲得高品質創新藥物的機會。

BeiGene is different, and it was built fit for this opportunity.

百濟神州是不同的，它是為了抓住這個機會而建立的。

We're on the forefront of pursuing this truly global model; and committed to never sacrificing our quality, innovation or science.

我們處於追求這種真正的全球模式的最前線；並致力於永不犧牲我們的品質、創新或科學。

And with that brief introduction to BeiGene and review of 2018, I'd like to turn the podium over to Dr. Wu Xiaobin, our General Manager of China and the President of BeiGene.

在簡單介紹百濟神州和回顧 2018 年之後，我想請我們的中國區總經理、百濟神州總裁吳曉斌博士講台。

Thank you.

謝謝。

So thank you, John.

謝謝你，約翰。

Hello, everyone.

大家好。

Thank you for joining us today.

感謝您今天加入我們。

Next slide, 13.

下一張投影片，13。

China is a country with larger population.

中國是一個人口較多的國家。

And combined with regulatory reform, reimbursement and a high incidence of cancer, this has resulted in reordering of the world's largest ESCC product to market by revenue, and such, China is now the second largest market behind the United States.

再加上監管改革、報銷和高癌症發病率，這導致全球收入最大的 ESCC 產品重新上市，中國目前已成為僅次於美國的第二大市場。

If we look at the majority of the market share, excluding TCM, it is still dominated by generic product today.

如果我們看一下除中藥外的大部分市場份額，今天仍然由仿製藥佔據主導地位。

Top-selling brands in China are quite different from those in United States.

中國最暢銷的品牌與美國的品牌有很大不同。

You can see the slide, on the right side.

您可以在右側看到幻燈片。

So next page, Slide 14.

下一頁，投影片 14。

From the hospital market channel, which makes 80% of the entire pharmaceutical market, the overall pharma market continue to grow.

從佔整個醫藥市場80%的醫院市場管道來看，整體醫藥市場持續成長。

And we see the growth driver is therapeutical treatment medicine, which has strong, consecutive growth in the past 3 years.

我們看到成長動力是治療藥物，在過去三年中持續強勁成長。

The growth of the overall market slowing down over the past years; and traditional Chinese medicine, auxiliary that's advanced drug are now in declining.

過去幾年整體市場成長放緩；而中藥、輔助這種高級藥物現在都在下降。

In contrast to that, the therapeutical category is growing substantially faster.

相比之下，治療類別的成長速度要快得多。

The market is shifting toward evidence-based medicine and now therapeutical treatment.

市場正在轉向實證醫學，現在轉向治療性治療。

This market accounts almost 60% of the entire market by value.

以價值計算，該市場幾乎佔整個市場的 60%。

So next slide, 15.

下一張投影片是 15。

Within the large Chinese pharmaceutical market, oncology is one of the largest TAs, accounting for nearly 10% of the market in 2017 and percentage wise is expected to grow further.

在中國龐大的醫藥市場中，腫瘤學是最大的技術援助之一，2017年佔市場份額近10%，預計佔比將進一步成長。

They had the highest growth rate among all other therapeutical areas.

在所有其他治療領域中，它們的成長率最高。

There are over 4 million new cancer patient in China each year.

中國每年新增癌症患者超過400萬人。

And the number is larger than the combined total cancer incidents of U.S., EU-5 countries and Japan.

這個數字比美國、歐盟五國和日本癌症發病總數還要多。

In addition, there are specific tumor types, like lung cancer, gastric, liver and esophageal cancer, which are more prevalent in China compared to other countries.

此外，還有一些特定的腫瘤類型，如肺癌、胃癌、肝癌和食道癌，這些腫瘤在中國比其他國家更常見。

We believe the medical unmet needs, the regulatory reform and the new reimbursement scale for innovative oncology drug means the oncology therapeutical market will grow strongly for some time going forward in China.

我們認為，醫療未滿足的需求、監管改革和創新腫瘤藥物的新報銷規模意味著中國腫瘤治療市場將在未來一段時間內強勁成長。

Next slide, 16.

下一張投影片，16。

Since the -- taking over the Celgene commercial operation in China, we have grown the team substantially from this size of originally 130 people.

自從接管 Celgene 在中國的商業營運以來，我們的團隊規模在最初 130 人的基礎上有了大幅成長。

And now in the last year, the team has reached 4x of the original size.

而現在在去年，團隊規模已經達到原來的4倍。

As of today, we have over 600 people in our commercial team.

截至今天，我們的商務團隊已有 600 多人。

We have hired into all functions, from sales to market access.

我們聘請了所有職能部門的員工，從銷售到市場進入。

The majority of all commercial talent comes from the best multinational operations in China.

大多數商業人才來自中國最好的跨國公司。

The ultimate goal for us is to cover hospitals where the majority of the patients get treated in China.

我們的最終目標是涵蓋中國大多數患者接受治療的醫院。

We are building a specialized oncology commercial team that will cover 800 to 1,000 hospitals.

我們正在建立一支專業的腫瘤商業團隊，將涵蓋800至1000家醫院。

And our commercial efforts go beyond sales and as we believe you must build a dedicated team with support in several functions such as government affairs, regulatory affairs, sales, marketing, medical affair, key account payers, payers management and market access because, in China market, this market is complex with multiple layers and many stakeholders that you need to address to deal with and to interact with them.

我們的商業努力不僅僅是銷售，我們相信您必須建立一支專業團隊，在政府事務、監管事務、銷售、行銷、醫療事務、大客戶付款人、付款人管理和市場准入等多個職能方面提供支持，因為在中國市場，這個市場很複雜，有多個層面和許多利益相關者，您需要解決這些問題才能與他們打交道並互動。

The next slide, Slide 17.

下一張投影片，投影片 17。

The investment in our commercial organization has generated excellent growth from our marketed inline product.

對我們商業組織的投資為我們銷售的內聯產品帶來了良好的成長。

The overall portfolio has grown to be well over doubled of its original revenue level.

整體投資組合已成長至原始收入水準的兩倍以上。

This was made up of substantial growth from all 3 products.

這是由所有 3 種產品的大幅成長組成的。

Our sales performance has proven that our commercial strategy is working.

我們的銷售業績證明我們的商業策略正在發揮作用。

And revenue has grown despite of the generic competition our market now facing in China.

儘管我們的市場目前在中國面臨普遍的競爭，但收入仍然成長。

Growth of the inline product demonstrated the capability of our successful "go to the market" model and our capabilities.

內嵌產品的成長證明了我們成功的「走向市場」模式的能力和我們的能力。

Those 3 products are integral parts of our business.

這三種產品是我們業務不可或缺的一部分。

And this enable us to gain real-world experience establishing market access [in action], interacting with key opinion leaders and the build out of our commercial network, laying the groundwork for our anticipated new launch of zanubrutinib and tislelizumab.

這使我們能夠獲得建立市場准入的實際經驗，與關鍵意見領袖互動以及建立我們的商業網絡，為我們預期的新推出的 zanubrutinib 和 tislelizumab 奠定基礎。

There are different level of interaction with external stakeholders in preparation of commercial launches of our internal-developed candidates, which I will show you in the next slide.

在準備我們內部開發的候選人的商業發佈時，與外部利益相關者進行了不同程度的互動，我將在下一張幻燈片中向您展示。

Slide 18.

幻燈片 18。

What differentiated us is that we can leverage our existing marketed products to pave the way for our commercial launch of new product.

我們的與眾不同之處在於，我們可以利用現有的已上市產品為新產品的商業發布鋪路。

As we -- as I previously mentioned, we have built our infrastructure and network because of the current inline product.

正如我之前提到的，由於目前的內聯產品，我們已經建立了我們的基礎設施和網路。

REVLIMID and VIDAZA overlap with hem doctors.

REVLIMID 和 VIDAZA 與下擺醫生重疊。

ABRAXANE allows us interaction with solid tumor, oncologists and hospitals, and we are building access experience with hospital listing and reimbursement.

ABRAXANE 使我們能夠與實體腫瘤、腫瘤科醫生和醫院進行互動，並且我們正在建立醫院清單和報銷方面的准入經驗。

Through those interactions with different stakeholders, we understand the market inside interaction with treating oncologists and key opinion leaders, which help us to build our brand name.

透過與不同利害關係人的互動，我們了解市場內部與治療腫瘤學家和關鍵意見領袖的互動，這有助於我們建立我們的品牌。

With those 3 products, inline product, we have been actively engaged with oncologists, oncology community and with like -- such like CSCO as well as BeiGene-sponsored events throughout the whole last year.

憑藉這 3 個產品（即內嵌產品），我們在去年全年一直積極與腫瘤學家、腫瘤學界以及 CSCO 和百濟神州贊助的活動等合作。

In addition, we held commercial launches of VIDAZA and the newly approved indication for REVLIMID, as well as our patient assistant program launch for newly diagnosed multiple myeloma patients.

此外，我們還舉行了 VIDAZA 和新批准的 REVLIMID 適應症的商業上市，以及針對新診斷的多發性骨髓瘤患者的患者助理計畫的啟動。

And the list goes on.

這樣的例子還在繼續。

We believe we are positioned to play an important role in shaping and building the ecosystem system in China for oncology treatment and become a significant player.

我們相信，我們有能力在塑造和建立中國腫瘤治療生態系統方面發揮重要作用，並成為重要參與者。

So next slide, Slide 19.

下一張投影片，投影片 19。

Our commercialization strategy for zanubrutinib and tislelizumab begin with our hypothesis that those products are differentiated assets and are generating -- and we are generating data that we believe is consistent with that differentiation.

我們對 zanubrutinib 和 tislelizumab 的商業化策略始於我們的假設，即這些產品是差異化資產並且正在產生 - 我們正在產生我們認為與這種差異化一致的數據。

In addition, we are pursuing a broad program of development so that we have extensive labels.

此外，我們正在追求廣泛的開發計劃，以便我們擁有廣泛的標籤。

This is particularly important in China, where reimbursement and even the utilization of patient assistance program are only allowed to occur when the product is used for labeled indication.

這在中國尤其重要，因為只有當產品用於標籤適應症時，才允許報銷甚至使用患者援助計劃。

Finally, we are putting a high, energetic commercial effort behind those assets that is already beginning to provide visibility and build our revenue upon the established infrastructure we have in both solid tumor and hematology area.

最後，我們正在為這些資產投入大量、充滿活力的商業努力，這些資產已經開始提供可見性，並在我們在實體瘤和血液學領域擁有的現有基礎設施上建立我們的收入。

Next slide.

下一張投影片。

So let's shift a little bit from China to the global, for our global commercial preparation.

所以讓我們把目光從中國轉向全球，為我們的全球商業準備。

As we strive to become a global player, we are preparing for the launch of zanubrutinib with potential filing in the United States this year or early next year.

在我們努力成為全球參與者的同時，我們正在準備推出 zanubrutinib，並可能在今年或明年初在美國提交申請。

We have also hired senior leadership for key commercial functions.

我們也聘請了高階領導來負責關鍵的商業職能。

Our plan in the U.S. is at a minimum to substantially participate in the commercialization of our new product.

我們在美國的計畫至少是大幅參與新產品的商業化。

As for Europe, we are evaluating our commercial strategy and we are open to partner, to potential partnership in certain regions with a local player maybe more efficient.

至於歐洲，我們正在評估我們的商業策略，我們對合作夥伴持開放態度，在某些地區與當地參與者建立潛在的合作關係可能會更有效。

And finally, our broad clinical program and also program in China are also potentially a leverage for our commercial strategy in emerging market.

最後，我們廣泛的臨床項目以及在中國的項目也可能成為我們在新興市場的商業策略的槓桿。

So with that, I will end my presentation.

我的演講到此結束。

I turn over to Dr. Hedrick, Eric Hedrick, to review our clinical program.

我請赫德里克醫生埃里克赫德里克審查我們的臨床計劃。

Eric?

艾瑞克？

Okay, thanks, Dr. Wu.

好的，謝謝吳醫師。

And good morning, everyone on the call.

大家早安。

On Slide 24 (sic) [22].

在投影片 24（原文如此）[22] 上。

This depicts our robust product portfolio and pipeline, which includes 3 marketed projects in China, 3 late-stage drug candidates and 6 early-stage programs, which are evenly split between internally developed and collaborative programs.

這描繪了我們強大的產品組合和管道，其中包括3個在中國上市的項目、3個後期候選藥物和6個早期項目，這些項目均勻分佈在內部開發和合作項目之間。

We currently have more than 50 ongoing or planned clinical trials.

目前我們有超過 50 項正在進行或計劃中的臨床試驗。

And with respect to our 2 lead programs, the BTK inhibitor zanubrutinib and the PD-1 inhabitor tislelizumab, both programs are broad in nature, addressing multiple indications contemporaneously, with the intent to support multiple labeled indications across the globe, including China, U.S. and Europe.

至於我們的兩個主導項目，BTK 抑制劑zanubrutinib 和PD-1 抑制劑tislelizumab，這兩個項目本質上都很廣泛，同時解決多種適應症，旨在支持全球範圍內的多種標記適應症，包括中國、美國和歐洲。

Turning specifically to zanubrutinib on Slide 25 (sic) [23].

特別轉向投影片 25（原文如此）上的 zanubrutinib（扎魯替尼）[23]。

We are running a broad registration-enabling program across various B cell malignancies.

我們正在針對各種 B 細胞惡性腫瘤進行廣泛的註冊支援計畫。

This includes chronic lymphocytic leukemia, mantle cell lymphoma, Waldenström macroglobulinemia, marginal zone lymphoma and follicular lymphoma, noting that follicular lymphoma indication would be unique amongst BTK inhibitors.

這包括慢性淋巴細胞白血病、套細胞淋巴瘤、瓦爾登斯特倫巨球蛋白血症、邊緣區淋巴瘤和濾泡性淋巴瘤，並指出濾泡性淋巴瘤的適應症在BTK 抑制劑中是獨一無二的。

We have filed an application in China based on pivotal data in CLL and MCL that have been granted priority review by the CDE.

我們已根據 CLL 和 MCL 的關鍵數據在中國提交了申請，並已獲得 CDE 的優先審查。

In the U.S., we've been granted Fast Track designation for Waldenström and breakthrough designation in mantle cell lymphoma.

在美國，我們獲得了瓦爾登斯特倫治療的快速通道資格和套細胞淋巴瘤的突破性資格認定。

In the next few slides, I will review in greater detail the ongoing trials which are intended to support global filings in multiple indications for zanubrutinib.

在接下來的幾張投影片中，我將更詳細地回顧正在進行的試驗，這些試驗旨在支持 zanubrutinib 多種適應症的全球申請。

Moving to Slide 26 (sic) [24].

前往投影片 26（原文如此）[24]。

Our lead indication globally is Waldenstrom's macroglobulinemia, where we are conducting a head-to-head Phase III trial of zanubrutinib versus ibrutinib, the currently approved BTK inhibitor in this indication.

我們在全球的主要適應症是華氏巨球蛋白血症，我們正在進行 zanubrutinib 與 ibrutinib（目前批准用於該適應症的 BTK 抑制劑）的頭對頭 III 期試驗。

This trial completed enrollment in July 2018, and we're anticipating a data readout in the second half of this year.

該試驗於 2018 年 7 月完成註冊，我們預計將在今年下半年公佈數據。

As shown here, the trial randomized patients with MYD88 mutation, which defines about 90% of Waldenström's patients, in the 1:1 ratio to treatment with either zanubrutinib or ibrutinib.

如圖所示，該試驗將具有 MYD88 突變的患者（約佔華登斯特倫氏症患者的 90%）以 1:1 的比例隨機分配至 zanubrutinib 或 ibrutinib 治療組。

The study is designed to detect superiority for zanubrutinib with respect to response quality, in this case defined as the proportion of patients achieving at least a 90% reduction in disease burden.

該研究旨在檢測 zanubrutinib 在反應品質方面的優越性，在本例中定義為疾病負擔減輕至少 90% 的患者比例。

Patients lacking the typical MYD88 mutation, who have traditionally not been responsive to ibrutinib, received zanubrutinib on a third nonrandomized arm.

缺乏典型 MYD88 突變的患者傳統上對依魯替尼沒有反應，但在第三個非隨機組中接受了 zanubrutinib。

It should be noted that the data from this nonrandomized arm has been submitted to a major conference this year for a presentation.

應該指出的是，這個非隨機組的數據已提交給今年的一次重要會議進行演示。

Moving to CLL on Slide 27 (sic) [25].

前往投影片 27（原文如此）[25] 上的 CLL。

2 Phase III trials intended to support approval globally are currently being conducted.

2 目前正在進行旨在支持全球核准的 III 期試驗。

The initial registration trial is the comparison to zanubrutinib to the BR regimen in patients with previously untreated disease.

最初的註冊試驗是在先前未經治療的疾病患者中將 zanubrutinib 與 BR 方案進行比較。

This is a PFS primary endpoint trial in which patients who do not harbor a 17p deletion, which is a marker of resistance to traditional chemoimmunotherapy, were randomized to receive either zanubrutinib or BR.

這是一項 PFS 主要終點試驗，其中不存在 17p 缺失（傳統化學免疫療法抗藥性標記）的患者被隨機分配接受 zanubrutinib 或 BR。

There was a separate nonrandomized arm looking at patients with the 17p deletion.

有一個單獨的非隨機組研究 17p 缺失的患者。

The trial as a whole should complete enrollment this year.

整個試驗應於今年完成註冊。

One other note about this design: A similar Phase III study comparing the first-generation BTK inhibitor ibrutinib to BR was presented at last year's ASH meeting, showing a highly significant PFS advantage for the BTK inhibitor-treated patients.

關於此設計的另一個注意事項：去年的ASH 會議上提出了一項類似的III 期研究，比較了第一代BTK 抑製劑依魯替尼與BR，結果顯示接受BTK 抑製劑治療的患者俱有非常顯著的PFS 優勢。

This certainly raises our confidence in the outcome of our Phase III trial.

這無疑增強了我們對 III 期試驗結果的信心。

On this slide you also see a second Phase III trial, this in patients with relapsed or refractory CLL.

在這張投影片上，您還可以看到第二個 III 期試驗，該試驗針對的是復發或難治性 CLL 患者。

This is an ongoing study, and we plan to enroll 400 patients.

這是一項正在進行的研究，我們計劃招募 400 名患者。

The primary endpoint of this trial is overall response rate defined as complete plus partial response.

本試驗的主要終點是整體緩解率，定義為完全緩解加部分緩解。

And the study is powered to detect superiority for zanubrutinib in a hierarchial analysis plan which will first test noninferiority.

該研究旨在透過分層分析計劃檢測 zanubrutinib 的優越性，該計劃將首先測試非劣效性。

On Slide 28 (sic) [26], we'd like to provide an update today that the nonrandomized deletion 17p arm in the first-line study has completed enrollment with 110 patients.

在投影片 28（原文如此）[26] 上，我們今天要提供更新，第一線研究中的非隨機刪除 17p 組已完成 110 名患者的入組。

Importantly, this is the largest cohort of treatment-naive 17p-deleted CLL patients who have been prospectively studied.

重要的是，這是前瞻性研究中最大的一次未接受治療的 17p 缺失 CLL 患者群組。

And we should be able to analyze the response data from the study arm this year.

我們應該能夠分析今年研究部門的反應數據。

On Slide 29 (sic) [27].

在投影片 29（原文如此）[27] 上。

We are also investigating zanubrutinib in combination with obinutuzumab in relapsed or refractory follicular lymphoma based on Phase Ib data that was presented in 2017 which showed high rates of overall and complete response with the combination.

我們也正在根據 2017 年提交的 Ib 期數據研究 zanubrutinib 與 obinutuzumab 聯合治療復發或難治性濾泡性淋巴瘤，該數據顯示聯合用藥的整體和完全緩解率很高。

As noted previously, no BTK inhibitor has been approved to date in this indication.

如前所述，迄今為止，尚未批准用於該適應症的 BTK 抑制劑。

Slide 30 (sic) [29], summarizes the effects of zanubrutinib that may ultimately be able to address specific limitations that presently exist with BTK inhibitor therapy.

投影片 30（原文如此）[29] 總結了 zanubrutinib 的作用，最終可能能夠解決 BTK 抑制劑治療目前存在的特定限制。

We believe that improvement and continuous target occupancy may ultimately translate to differences in response quality.

我們相信，改進和持續目標入住率可能最終轉化為回應品質的差異。

And this is being tested in the 2 head-to-head Phase III trials, as I mentioned earlier.

正如我之前提到的，這正在 2 個頭對頭的 III 期試驗中進行測試。

However, in practice, particularly in studying CLL, toxicity and tolerability issues are for more commonly treatment limiting, more so than limitations in efficacy.

然而，在實踐中，特別是在研究 CLL 時，毒性和耐受性問題更常見的是治療限制，而不是療效限制。

In this regard, we've been encouraged by the low rates of toxicity-related treatment discontinuation and cumulative off-target events such as myalgia, arthralgia, hypertension that have been observed to date in zanubrutinib clinical trials.

在這方面，迄今為止在 zanubrutinib 臨床試驗中觀察到的毒性相關治療中止率和累計脫靶事件（如肌痛、關節痛、高血壓）的發生率較低，這令我們感到鼓舞。

Additionally, we believe that a comparatively favorable drug-drug interaction profile for zanubrutinib, particularly in lack of a CYP3A liability, will translate well into practice studying such CLL, will come with the disease and requirement for concomitant medications can be challenging with ibrutinib.

此外，我們相信zanubrutinib 相對有利的藥物交互作用特徵，特別是在缺乏CYP3A 責任的情況下，將很好地轉化為研究此類CLL 的實踐，將伴隨疾病，並且對伴隨藥物的要求可能對ibrutinib 具有挑戰性。

On Slide 31 (sic) 29 , we move on to our next significant near-term development opportunity that is tislelizumab, our PD-1 antibody.

在投影片 31（原文如此）29 中，我們繼續討論下一個重要的近期開發機會，即我們的 PD-1 抗體替雷利珠單抗。

Tislelizumab is an Fc engineered antibody that does not bind Fc receptor on macrophages and thereby potentially avoids macrophage-driven TF factor self-suppression.

替雷利珠單抗是一種 Fc 工程抗體，不會結合巨噬細胞上的 Fc 受體，可能避免巨噬細胞驅動的 TF 因子自我抑制。

The broad registration trial's program for tislelizumab is summarized here.

替雷利珠單抗的廣泛註冊試驗計劃總結如下。

And as you can see it focuses largely on opportunities in the most prevalent cancers in Asian patients, including non-small cell lung cancer, hepatocellular cancer, esophageal cancer and gastric cancer.

正如您所看到的，它主要關注亞洲患者中最常見癌症的機會，包括非小細胞肺癌、肝細胞癌、食道癌和胃癌。

The global registration program is being conducted in collaboration with Celgene, though BeiGene is presently sponsoring and operating the vast majority of the global clinical trials and all of the China-focused registration trials.

全球註冊計畫正在與新基公司合作進行，儘管百濟神目前贊助並經營絕大多數的全球臨床試驗和所有針對中國的註冊試驗。

Tislelizumab is also a backbone as an expanding roster of combination development efforts.

替雷利珠單抗也是不斷擴大的共同開發工作的支柱。

Listed here are the combinations of internally developed agents.

這裡列出的是內部開發的代理的組合。

And I will mention shortly the evolving combination development program was partnered at, such as sitravatinib.

我很快就會提到合作的不斷發展的聯合開發項目，例如西特拉替尼。

Slide 32 (sic) [30], depicts the ongoing registrational trials for tislelizumab, including those in trials intended to support approval in multiple regions and those focused on enabling registration in China.

投影片 32（原文如此）[30]描述了替雷利珠單抗正在進行的註冊試驗，包括旨在支持多個地區批准的試驗以及專注於在中國註冊的試驗。

We're investigating tislelizumab in registrational trials in both solid tumor indications and hematologic malignancies.

我們正在實體腫瘤適應症和血液惡性腫瘤的註冊試驗中研究替雷利珠單抗。

Notably, the study is intended to support global approval or for a significant proportion of patients from China and representing BeiGene's focus on conducting single trials that are global in the truest sense of the word.

值得注意的是，該研究旨在支持全球批准或針對很大一部分來自中國的患者，並代表百濟神州專注於進行真正意義上的全球單一試驗。

Most of the trials in the program were initiated in late 2017 to 2018.

該計劃的大部分試驗於 2017 年底至 2018 年啟動。

And this includes programs in hepatocellular cancer both in the relapse and first-line setting, in gastric cancer in the first-line setting, in esophageal cancer of squamous cell [regime] in second- and first-line settings and in non-small cell lung cancer in the first- and second-line settings; and the Phase III program in patients with locally advanced disease in combination with radiation therapy.

這包括復發和一線環境中的肝細胞癌、一線環境中的胃癌、二線和一線環境中的鱗狀細胞癌[方案]以及非小細胞癌的項目一線和二線治療中的肺癌；以及局部晚期疾病患者合併放射治療的 III 期項目。

Listed at the bottom are the ongoing studies meant to support registration predominantly in China.

底部列出的是正在進行的研究，旨在支持主要在中國進行註冊。

One of these studies, a pivotal trial in patient for classical Hodgkin's disease, has been filed with the CDE and is currently under review.

其中一項研究是針對經典霍奇金氏病患者的關鍵試驗，已向 CDE 備案，目前正在接受審查。

A second pivotal trial in later-line bladder cancer has completed enrollment, with a plan to file with the CDE in 2019.

第二項針對晚期膀胱癌的關鍵試驗已完成入組，計劃於 2019 年向 CDE 提交申請。

2 Phase III non-small cell lung cancer trials are also actively enrolling.

2項III期非小細胞肺癌試驗也積極入組。

On Slide 33 (sic) [31].

在投影片 33（原文如此）[31] 上。

We are announcing here today that the Phase II study in second- or later-line HCC has completed enrollment of approximately 250 patients after being initiated in April of 2018.

我們今天在此宣布，二線或以後線 HCC 的 II 期研究自 2018 年 4 月啟動以來，已完成約 250 名患者的入組。

Moving to Slide 34 (sic) [32].

轉到投影片 34（原文如此）[32]。

Our late-development portfolio also includes the PARP inhibitor pamiparib.

我們的後期開發產品組合還包括 PARP 抑制劑 pamiparib。

It is currently being evaluated in 2 registrational trials in China, one in later-line BRCA mutated ovarian cancer.

目前正在中國進行兩項註冊試驗的評估，其中一項針對晚期 BRCA 突變卵巢癌。

And one is a maintenance agent for patients with second-line platinum-sensitive ovarian cancer.

其中一種是二線鉑敏感卵巢癌患者的維持劑。

The global program is focused on using the maintenance setting in gastric cancer that is responsive to platinum-based regimens; and exploratory trials in the setting of glioblastoma, where we believe the CNS quality of pamiparib could be important.

該全球計劃的重點是使用對鉑類治療方案有反應的胃癌維持環境；以及針對膠質母細胞瘤的探索性試驗，我們認為帕米帕尼的中樞神經系統品質可能很重要。

Lastly, Slide 35 (sic) [33] summarizes our expanding early-development pipeline.

最後，投影片 35（原文如此）[33] 總結了我們不斷擴大的早期開發流程。

Included is sitravatinib, a multi-kinase inhibitor which we inlicensed from Mirati for development and commercial rights in Asia, Australia and New Zealand last year.

其中包括sitravatinib，一種多激酶抑制劑，我們去年從 Mirati 獲得了在亞洲、澳洲和紐西蘭的開發和商業權利。

We're evaluating sitravatinib in combination with our PD-1 inhibitor tislelizumab in non-small cell lung cancer, renal cell carcinoma, ovarian cancer, hepatocellular cancer and gastric cancer in Phase Ib and Phase II studies.

我們正在 Ib 期和 II 期研究中評估 Sitravatinib 與 PD-1 抑制劑 tislelizumab 聯合治療非小細胞肺癌、腎細胞癌、卵巢癌、肝細胞癌和胃癌。

Combinational studies of lifirafenib, a RAF dimer inhibitor, with a MEK inhibitor from SpringWorks in solid tumors; and a zanubrutinib in combination with a PI3K delta inhibitor from MEI Pharma in B cell malignancies are also being initiated.

RAF 二聚體抑制劑 lifirafenib 與 SpringWorks 的 MEK 抑制劑在實體腫瘤的聯合研究； MEI Pharma 的 zanubrutinib 與 PI3K delta 抑制劑聯合治療 B 細胞惡性腫瘤也正在啟動。

We also have a PD-L1 antibody, BGB-A333; and a TIM-3 antibody, BGB-A425, in early clinical development as single agent and in combination with tislelizumab.

我們還有PD-L1抗體，BGB-A333；以及 TIM-3 抗體 BGB-A425，處於早期臨床開發階段，作為單藥或與替雷利珠單抗合併使用。

And with that, I will turn the call over to Howard, who'll review the financial results and the upcoming events.

接下來，我會將電話轉給霍華德，他將審查財務表現和即將舉行的活動。

Howard?

霍華德？

Thanks so much, Eric.

非常感謝，埃里克。

Now I'm on Slide 35.

現在我在投影片 35 上。

So I'd like to provide a financial summary for our 2018 results, starting with cash resources.

因此，我想提供 2018 年業績的財務摘要，從現金資源開始。

We closed the year with $1.8 billion in cash and short-term investments.

我們以 18 億美元的現金和短期投資結束了這一年。

In 4Q, the total cash decrease was $292 million.

第四季度，現金減少總額為 2.92 億美元。

And key components of this included operating cash burn of $194 million, licensing payment of $60 million to Zymeworks, capital expenditures of $54 million primarily for our Guangzhou manufacturing facility construction and Beijing research facility purchase.

其中的關鍵組成部分包括 1.94 億美元的營運現金消耗、向 Zymeworks 支付 6,000 萬美元的許可費用、主要用於廣州製造設施建設和北京研究設施購買的 5,400 萬美元資本支出。

Excluding proceeds from financing and equity issuances, outbound licensing and debt proceed, cash burn totaled $736 million in 2018.

不包括融資和股票發行、對外許可和債務收益的收益，2018 年現金消耗總額為 7.36 億美元。

And this included cash used in operations of $548 million, payments for inlicensing and business development of $70 million and capital expenditures of $109 million.

其中包括 5.48 億美元的營運現金、7,000 萬美元的許可和業務開發費用以及 1.09 億美元的資本支出。

Next slide and turning to a summary of income statement.

下一張投影片轉向損益表摘要。

Our total revenues for 2018 were $198 million, including $131 million in product sales.

我們 2018 年的總營收為 1.98 億美元，其中產品銷售額為 1.31 億美元。

And this is -- represents a [$106 million] year-over-year increase offset by a decrease in collaboration revenues, which included onetime upfront payment from the Celgene collaboration in 2017.

這是－[1.06 億美元]的年成長被合作收入的減少所抵消，其中包括 2017 年與 Celgene 合作的一次性預付款。

Our 4Q product revenue was relatively flat compared to the third quarter.

與第三季相比，我們第四季的產品收入相對持平。

In RMB currency -- in RMB we had increase of 1.5% quarter-over-quarter.

以人民幣計算——以人民幣計算，我們的季度環比增長了 1.5%。

In -- when translating to dollars, U.S. dollars, it's a 1.8% decrease.

如果換算成美元，則下降了 1.8%。

This is impacted by seasonal patterns in 4Q that I will explain in the next slide.

這受到第四季度季節性模式的影響，我將在下一張投影片中對此進行解釋。

Year-over-year 4Q product sales -- portfolio product revenues was 2.5-fold of the prior year, of 4Q in 2017.

第四季產品銷售額年增－組合產品收入是前一年（2017 年第四季）的 2.5 倍。

On the expense side, R&D expense was $679 million in 2018 and $257 million in the fourth quarter.

費用方面，2018年研發費用為6.79億美元，第四季研發費用為2.57億美元。

The sequential growth, relative to the third quarter of $110 million was contributed in large part by expenses related to business development activities, including for Zymeworks $60 million and $19 million for the transaction with Merck KGaA.

相對於第三季 1.1 億美元的環比成長，很大程度上是由與業務開發活動相關的支出貢獻的，其中包括 Zymeworks 的 6,000 萬美元以及與 Merck KGaA 交易的 1,900 萬美元。

SG&A expense was $195 million in 2018 and $72 million in the fourth quarter.

2018 年 SG&A 費用為 1.95 億美元，第四季為 7,200 萬美元。

Increases over 2017 and prior quarters primarily relate to the expansion of our commercial organization in China to support the growth and the current product portfolio and to prepare for our upcoming launches.

2017 年及前幾季的成長主要與我們在中國的商業組織的擴張有關，以支持成長和當前的產品組合，並為我們即將推出的產品做好準備。

The -- and as well as establishment of our commercial organization in the U.S. and expanded global operations.

我們在美國建立了商業組織並擴大了全球業務。

Expenses included $78 million (sic) [$87 million] of stock-based compensation expense compared to in 2018 compared to $43 million in 2017.

與 2018 年相比，費用包括 7,800 萬美元（原文如此）[8,700 萬美元]的股票薪酬費用，而 2017 年為 4,300 萬美元。

We had a net loss of $674 million for 2018.

2018 年，我們的淨虧損為 6.74 億美元。

Next slide.

下一張投影片。

Dr. Wu talked about our 3 inlicensed products previously.

吳博士之前談到了我們的3個授權產品。

I want to provide more color on our -- on their performance in 2018.

我想為他們 2018 年的表現提供更多的資訊。

The sales of ABRAXANE, REVLIMID and VIDAZA in China totaled about $38 million and $131 million respectively for the fourth quarter and 2018.

ABRAXANE、REVLIMID和VIDAZA第四季和2018年在中國的銷售額分別約為3,800萬美元和1.31億美元。

If we look at the year-over-year performance compared to our fourth quarter last year, as just mentioned, there's a growth of -- sequential growth of about 150% in revenues.

如果我們看一下與去年第四季相比的同比業績，正如剛才提到的，營收環比成長了約 150%。

Historically, fourth quarter sales for both ABRAXANE and REVLIMID tend to be slow.

從歷史上看，ABRAXANE 和 REVLIMID 的第四季度銷售往往都很緩慢。

There have been similar patterns of slower sales in the fourth quarter in China among other oncology brands.

其他腫瘤品牌第四季在中國也出現了類似的銷售放緩模式。

To give you a sense of the historical pattern: In the 3 years between 2015 and 2017, Q4 ABRAXANE sales on average were down by 25% versus Q3.

為了讓您了解歷史模式：在 2015 年至 2017 年間的 3 年中，第四季度 ABRAXANE 銷售額比第三季平均下降了 25%。

We had a 14% sequential decline in Q4 of 2018.

2018 年第四季度，我們的業績環比下降了 14%。

For REVLIMID, sales declined on average by 19% Q4 versus Q3 for 2015 through 2017.

對於 REVLIMID，2015 年至 2017 年第四季的銷售額與第三季相比平均下降了 19%。

We actually had a 15% sequential growth in the fourth quarter of 2018.

實際上，2018 年第四季我們的環比成長了 15%。

We continue to be excited about the growth product of our commercial portfolio.

我們繼續對我們商業產品組合的成長產品感到興奮。

On this slide we also provide more details about revenue makeup, the three - this was also presented during Dr. Wu's presentation.

在這張幻燈片上，我們還提供了有關收入構成的更多詳細信息，這三個部分在吳博士的演講中也有所介紹。

ABRAXANE continue to grow and is our largest product, contributing 50% of our product revenue among the REVLIMID has been the fastest-growing product, contributing over 40% by the end of the year.

ABRAXANE持續成長，是我們最大的產品，貢獻了我們產品收入的50%，而REVLIMID是成長最快的產品，到年底貢獻了40%以上。

And VIDAZA has shown a very strong growth since its first commercial availability in February of 2018.

自 2018 年 2 月首次商用以來，VIDAZA 表現出非常強勁的成長。

Next slide, Slide 38.

下一張投影片，投影片 38。

Let me close today's presentation by highlighting some of the key milestones and catalyst efforts for 2019.

在結束今天的演講時，我將重點介紹 2019 年的一些關鍵里程碑和催化劑工作。

This will be an important year for BeiGene, a year in which we expect approvals for our internally developed product candidates zanubrutinib and tislelizumab.

對於百濟神州來說，今年將是重要的一年，我們預計內部開發的候選產品 zanubrutinib 和 tislelizumab 將在這一年獲得批准。

In China, we expect to announce data from our first Phase III head-to-head study of zanubrutinib versus ibrutinib in Waldenström.

在中國，我們預計將公佈在 Waldenström 進行的第一個 zanubrutinib 與 ibrutinib 的 III 期頭對頭研究的數據。

We expect to submit our first NDA filing in the U.S. this year or early 2020.

我們預計今年或 2020 年初在美國提交第一份 NDA 申請。

For tislelizumab, we expect data from potentially registration-enabling trials and expect to complete enrollment of key Phase III trials for lung cancer and liver cancer.

對於替雷利珠單抗，我們預計來自潛在的註冊試驗的數據，並預計完成肺癌和肝癌關鍵 III 期試驗的入組。

In addition, we will seek to expand the label for our commercial products in China of REVLIMID and ABRAXANE.

此外，我們將尋求擴大REVLIMID和ABRAXANE在中國的商業產品標籤。

We expect to complete the construction of our biologic manufacturing facility in Guangzhou in preparation for the growth -- long-term further growth of tislelizumab in China.

我們預計將完成廣州生物製劑生產設施的建設，為替雷利珠單抗在中國的長期進一步成長做好準備。

We expect it will be a full year of execution across different themes at BeiGene, and we're excited about 2019.

我們預計這將是百濟神州執行不同主題的一整年，我們對 2019 年感到興奮。

So with that, I'll open the floor for questions from analysts.

接下來，我將邀請分析師提問。

Operator, can you please give instructions?

接線生，您能指點一下嗎？

(Operator Instructions) Our first question comes from Matthew Harrison with Morgan Stanley.

（操作員說明）我們的第一個問題來自摩根士丹利的馬修哈里森。

This is Vikram on for Matthew.

這是馬修的維克拉姆。

So we had a question about the commercial landscape for PD-1 antibodies in China.

因此我們有一個關於 PD-1 抗體在中國的商業前景的問題。

Could you provide us your updated view on what the current commercial dynamics are and how that might be impacting your strategy when it comes to a potential launch, especially with regards to pricing?

您能否向我們提供您對當前商業動態的最新看法，以及當涉及到潛在的發佈時，這可能會如何影響您的策略，特別是在定價方面？

Sure, sure.

當然，當然。

Thanks for the question.

謝謝你的提問。

This is John.

這是約翰。

I think that there's really little that's changed from our perspective.

我認為從我們的角度來看，幾乎沒有改變。

The PD-1 opportunity is really an opportunity that is going to require reimbursement in China.

PD-1機會確實是中國需要報銷的機會。

And I think, as we've stated consistently over time, our strategy has been to pursue a very broad label in the important indications.

我認為，正如我們長期以來一直指出的那樣，我們的策略是在重要適應症中追求非常廣泛的標籤。

Reimbursement in China is label based.

中國的報銷是基於標籤的。

And I think that, as we've experienced with our Celgene portfolio, being able to have a broad label dramatically helps you from a commercial perspective.

我認為，正如我們在 Celgene 產品組合中所經歷的那樣，擁有廣泛的標籤能夠從商業角度極大地幫助您。

It's really necessary.

確實很有必要。

So we continue to work aggressively clinically to reach labels in the important indications and the important lines of those indications and the important combinations as quickly as possible, believing that, that is one of the key elements to the commercial opportunity in China.

因此，我們繼續積極進行臨床工作，盡快獲得重要適應症、這些適應症的重要係列以及重要組合的標籤，並相信這是在中國獲得商業機會的關鍵要素之一。

I think the second opportunity associated with things is ensuring that you have robust commercial manufacturing and that it's reliable and issue free.

我認為與事物相關的第二個機會是確保您擁有強大的商業製造並且可靠且無問題。

And I think, from that perspective, BeiGene has chosen to work with BI since day 1, one of the most experienced and reputable companies in the world.

我認為，從這個角度來看，百濟神州從第一天起就選擇與 BI 合作，BI 是世界上最有經驗、最有信譽的公司之一。

And they have a facility in Shanghai that we're working with.

他們在上海設有我們正在合作的工廠。

And that -- as we have provided some update, we're building our own facility that's quite substantial in Guangzhou.

正如我們提供的一些最新消息，我們正在廣州建造自己的相當大的設施。

And I think, through those high-quality efforts and initiatives, we believe the second issue is making sure you have substantial capacity in couple years down the road when reimbursement kicks into place and that it's of the highest quality.

我認為，透過這些高品質的努力和舉措，我們相信第二個問題是確保您在未來幾年報銷到位時擁有強大的能力，並且是最高品質的。

And I think the last thing is we do believe that we're going to have to price in a way that we can be reimbursed.

我認為最後一件事是我們確實相信我們必須以可以報銷的方式定價。

And I think we have been sharing over time the historic reimbursement numbers and, I think I have slides that have been made available for us before related to that, that show a reimbursement range in China for oncology drugs.

我認為我們一直在分享歷史性的報銷數字，而且我想我之前已經向我們提供了與此相關的幻燈片，這些幻燈片顯示了中國腫瘤藥物的報銷範圍。

And I think we've always felt that's where the pricing will land.

我認為我們一直認為這就是定價的落腳點。

And I don't think that that's changed nor is out of our expectations.

我認為這沒有改變，也沒有超出我們的預期。

I think we do continue the comment which is all companies that are China domestic are capacity constrained in the short term versus the immense demand that exists.

我認為我們確實會繼續這樣的評論：與現有的巨大需求相比，所有中國本土公司的產能在短期內都受到限制。

So our expectation has been people are going to be able to commercialize substantially to their capacity but be capacity gated.

因此，我們的期望是人們將能夠充分發揮其能力進行商業化，但會受到能力限制。

From the other perspective, we do believe that it's very, very important, as I said, to work through the label.

從另一個角度來看，正如我所說，我們確實相信透過標籤進行工作非常非常重要。

And that's what we're doing.

這就是我們正在做的事情。

Our next question comes from Yaron Werber with Cowen.

我們的下一個問題來自 Yaron Werber 和 Cowen。

I had a question about the Waldenström's Phase III, the head-to-head study of zanu against ibrutinib.

我對 Waldenström 的 III 期研究有疑問，該研究是 zanu 與 ibrutinib 的頭對頭研究。

Maybe can you give us a little bit of a sense, how are you thinking about the powering, and response rates to primary here, in terms of what you might want to see and also whether the response rate endpoint is limited or it's capped by a certain duration?

也許您能給我們一點了解，您如何考慮這裡的供電和主要響應率，就您可能希望看到的內容以及響應率端點是否受到限製或受到限製而言一定的持續時間？

Or is it open ended to sort of best response?

或者它是開放式的，以求最佳回應？

Yes.

是的。

This is Eric.

這是埃里克。

Thanks for the question.

謝謝你的提問。

I think, in regard to the powering, the initial powering of the study was around very good partial response or complete response.

我認為，就動力而言，該研究的最初動力是圍繞著非常好的部分反應或完全響應。

And looking for professionally a doubling of that rate compared to the historical rate for ibrutinib, which is around 15%.

與依魯替尼的歷史發病率（約 15%）相比，專業地尋求該發病率翻倍。

Keep in mind that we overenrolled that trial a bit so there's a bit more power around that.

請記住，我們對該試驗的註冊人數有所增加，因此該試驗的威力更大。

In terms of the specific definition or response, the best overall response endpoint, so it's not particularly time gated.

就具體定義或響應而言，最好的整體響應端點，因此它沒有特別的時間限制。

In discussions with regulators, it's typical, we agreed to a certain minimum follow-up for all patients because the agencies will be looking for not only response rate but response durability.

在與監管機構的討論中，我們通常同意對所有患者進行一定程度的最低限度隨訪，因為各機構不僅要考慮緩解率，還要考慮緩解持久性。

But it's a "best overall response" trial.

但這是一次「最佳總體反應」試驗。

And Eric, like how long is the follow-up that you're going to be doing?

艾瑞克，你的後續行動要持續多久？

Yes, I don't know if we commented specifically on the follow-up, but we completed enrollments to the trial here, and we expect the readout to be sometime in the second half of this year.

是的，我不知道我們是否對後續行動進行了具體評論，但我們在這裡完成了試驗的註冊，我們預計讀數將在今年下半年的某個時候進行。

And our next question comes from Ziyi Chen with Goldman Sachs.

我們的下一個問題來自高盛的陳子儀。

All right.

好的。

This is Dave from Goldman.

我是高盛的戴夫。

I got a question regarding the liver cancer indication because per the presentation that we have already completed the patient enrollment for liver cancer HCC second-line, third line-setting.

我有一個關於肝癌適應症的問題，因為根據介紹，我們已經完成了肝癌 HCC 二線、三線設定的患者入組。

However, earlier this month, I think KEYTRUDA reported the KEYNOTE-240 results.

然而，本月早些時候，我認為 KEYTRUDA 報告了 KEYNOTE-240 結果。

And it felt to me that total primary endpoint is quite similar trial compared with our trial in that indication.

我覺得總的主要終點與我們在這個適應症上的試驗非常相似。

So what is our take of that result?

那我們對這個結果有何看法？

And how should we look at potential outcome of our trial on this?

我們應該如何看待我們的試驗的潛在結果？

It's Eric again.

又是埃里克。

Thanks for the question.

謝謝你的提問。

One thing I'll note is that the KEYNOTE-240 trial, which I think you have alluded to, was a randomized trial versus best supportive care in second-line patients and had had co-primary endpoints of overall survival and progression-free survival.

我要注意的一件事是，我想您已經提到了KEYNOTE-240 試驗，它是一項隨機試驗，與二線患者中的最佳支持治療進行比較，並且具有總生存期和無進展生存期的共同主要終點。

And I suspect that one of the reasons why it missed on those endpoints statistically was by virtue of having a co-primary endpoint rather than just a overall survival primary endpoint.

我懷疑它在統計上錯過這些終點的原因之一是擁有共同主要終點，而不僅僅是整體生存主要終點。

Our trial in the second- and third-line setting is a single-arm trial.

我們在二線和三線環境的試驗是單臂試驗。

So as is typical for single-arm pivotal trials, we're looking at response rate and response durability as the approval endpoints.

因此，正如單臂關鍵試驗的典型情況一樣，我們將反應率和反應持久性作為批准終點。

And so we don't expect there to be a significant impact of the KEYNOTE-240 trial on our study.

因此，我們預期 KEYNOTE-240 試驗不會對我們的研究產生重大影響。

It will all depend on what we see in terms of response rate activity and response durability.

這完全取決於我們在回應率活動和回應持久性方面所看到的情況。

I think we do acknowledge that it may raise some questions or some level of doubt amongst regulators, but in that regard it's also important to keep in mind that there's a second pembrolizumab Phase III trial in HCC that is in Asian patients.

我認為我們確實承認這可能會在監管機構中引起一些問題或某種程度的懷疑，但在這方面，同樣重要的是要記住，還有第二項針對亞洲患者的HCC 帕博利珠單抗III 期試驗。

And so we'll certainly be interested in the readout of that trial, and I suspect that regulators will be as well before really making any further determination or action on pembrolizumab indication.

因此，我們肯定會對該試驗的結果感興趣，而且我懷疑監管機構在真正對派姆單抗適應症做出任何進一步的決定或採取行動之前也會感興趣。

Great.

偉大的。

If I may, I've got a follow-up question on -- it's probably a little more bigger picture question on our overseas strategy for tislelizumab, the trials in the future.

如果可以的話，我有一個後續問題——這可能是一個關於我們替雷利珠單抗的海外戰略、未來試驗的更宏觀的問題。

Given that Celgene support -- we'll probably get Celgene's support on the funds, so is there any change that we should be aware of in the clinical development strategy in our overseas market?

鑑於Celgene的支持－我們很可能會得到Celgene的資金支持，那麼我們海外市場的臨床開發策略有什麼改變是我們應該注意的嗎？

Sure.

當然。

It's Eric again here, Dave.

戴夫，艾瑞克又來了。

I'll take the first shot at this and others can chime in late.

我將首先對此進行嘗試，其他人可以稍後加入。

One thing that's important to remember, and I mentioned it during the presentation, operationally, even though we're collaborating with Celgene, BeiGene is sponsoring and operationalizing the vast majority of the global trials as is.

需要記住的一件事很重要，我在演示中提到了這一點，在操作上，儘管我們正在與新基合作，但百濟神州仍按原樣贊助和實施絕大多數全球試驗。

And so in a scenario where the Celgene acquisition by BMS goes through, in that scenario, we would likely get back global rights to the program.

因此，在百時美施貴寶收購新基（Celgene）的情況下，在這種情況下，我們可能會收回該專案的全球權利。

And in terms of strictly the study program or operation from study program, we'd expect that to have just modest impact, not a significant impact, since we're operationalizing the vast majority of the trials at this point.

嚴格來說，就研究計劃或研究計劃的實施而言，我們預計這只會產生適度的影響，而不是重大影響，因為我們目前正在實施絕大多數試驗。

And maybe others can comment.

也許其他人可以發表評論。

Yes.

是的。

I mean, Eric, the only thing I'd throw in is the reason we structured the deal that way as we've talked about, we believe right now there's a new opportunity from a clinical trial perspective to really run these China-inclusive global registration trials.

我的意思是，埃里克，我唯一要說的是我們以我們所討論的方式構建交易的原因，我們相信，從臨床試驗的角度來看，現在有一個新的機會來真正運營這些包括中國在內的全球項目。

And that's what we're doing with PD-1.

這就是我們對 PD-1 所做的事情。

And that's how we've been able to become a leader, and it's helped us build and support this very large and capable clinical trial team.

這就是我們成為領導者的方式，它幫助我們建立和支持這個非常龐大且有能力的臨床試驗團隊。

So that's why we're operationalizing so much of that deal.

這就是我們實施如此多交易的原因。

It's just made sense for us.

這對我們來說很有意義。

And it's a capability that we like for the rest of our portfolio and we like for partnerships.

我們喜歡我們的其他產品組合以及合作夥伴關係都具有這種功能。

So as you said, that's the way the deal was structured.

正如你所說，這就是交易的結構方式。

And in either scenario that comes out whether that deal goes through or doesn't go through, I think we're very, very comfortable with our ability to bring this drug as effectively as possible to patients across the globe.

無論交易是否成功，我認為我們都對我們盡可能有效地將這種藥物帶給全球患者的能力感到非常非常滿意。

Our next question comes from Katherine Xu with William Blair.

我們的下一個問題來自凱瑟琳·徐和威廉·布萊爾。

Since IMBRUVICA, KEYTRUDA and OPDIVO have been approved and launched in China, and of course priced, can you just comment on how the pricing has been effecting the sales, commercial launches so far and how things are generally going for these sort of products; and how you are considering pricing strategy for zanubrutinib and tislelizumab.

自從 IMBRUVICA、KEYTRUDA 和 OPDIVO 在中國獲得批准和上市以來，當然還有定價，您能否簡單評論一下定價如何影響銷售、迄今為止的商業發布以及此類產品的整體進展？以及您如何考慮 zanubrutinib 和 tislelizumab 的定價策略。

And then for tislelizumab, if the BMS-Celgene deal goes through, are you going to look for another partner?

那麼對於替雷利珠單抗，如果 BMS-Celgene 交易成功，您會尋找另一個合作夥伴嗎？

And finally, there are some antagonistic reports on BTK inhibitor and PD-1.

最後，有一些關於 BTK 抑制劑和 PD-1 拮抗的報告。

I'm just curious about your views on that.

我只是好奇你對此的看法。

You have a study -- at least one study ongoing as well.

你有一項研究——至少還有一項正在進行中。

Okay, we got to parse those out.

好吧，我們得把它們解析出來。

So I think the first question was around just the pricing of both PD-1 and BTK in China and reimbursement.

所以我認為第一個問題是關於 PD-1 和 BTK 在中國的定價和報銷。

To that end...

為此...

Yes.

是的。

As you mentioned, yes, we've seen in the last year or plus the approval and launch of ibrutinib, OPDIVO and KEYTRUDA.

正如您所提到的，是的，我們在去年或去年就看到了 ibrutinib、OPDIVO 和 KEYTRUDA 的批准和上市。

And I think, from that perspective, some of the PD-1 numbers are out and shared, but I think that the growth has been well received, the numbers that are public.

我認為，從這個角度來看，一些 PD-1 數據已經公佈並共享，但我認為成長受到了好評，這些數據是公開的。

And from our perspective, there continues to be strong growth for those multinational launches.

從我們的角度來看，這些跨國公司的推出將繼續強勁成長。

And so I think that has been a success.

所以我認為這是成功的。

Clearly, they're not on national reimbursement at this point, nor are they priced in the ranges that we've shared and that are public for historic reimbursements.

顯然，它們目前不在國家報銷範圍內，它們的定價也不在我們共享的和公開的歷史報銷範圍內。

From the other perspective, ibrutinib has launched and is on national reimbursement.

從另一個角度來看，依魯替尼已經上市，並且正在國家報銷。

And it is priced at the very high end of that range.

而且它的價格處於該範圍的非常高端。

And so they have been able to achieve that, and that should be reflected in the future in their commercial numbers.

所以他們已經能夠實現這一目標，這應該反映在他們未來的商業數字中。

To us, in terms of -- and I think we've heard that the local companies are beginning to launch Junxure has that pricing.

對我們來說，我認為我們已經聽說當地公司開始推出 Junxure 的定價。

And in event has signaled that they'll price somewhere between Junxure and multinationals in public statements.

並且在公開聲明中已經表明，他們的定價將介於 Junxure 和跨國公司之間。

From our perspective, we're less worried about the competitors.

從我們的角度來看，我們不太擔心競爭對手。

We're more worried about -- not worried, but we understand where reimbursement needs to be, through the historic data.

我們更擔心——不是擔心，而是透過歷史數據了解需要報銷的地方。

And I think, from a BTK perspective there's a clear signal ibrutinib was able to get on national reimbursement at the high end of that range.

我認為，從 BTK 的角度來看，有一個明確的訊號，即依魯替尼能夠在該範圍的高端獲得國家報銷。

So I think that tells us something as we think about bringing our BTK to market there, which as we've always said we feel is a molecule that will be better for patients.

所以我認為，當我們考慮將 BTK 推向那裡的市場時，這告訴了我們一些事情，正如我們一直所說的，我們認為這是對患者更好的分子。

In terms of PD-1, I think we view ourselves as needing to price to be reimbursed.

就 PD-1 而言，我認為我們認為我們需要定價才能得到報銷。

And that's necessary.

這是必要的。

At the same point in time again, pricing when you're on reimbursement is only an issue when you have label.

再次在同一時間點，只有當您有標籤時，報銷時的定價才成為問題。

And a much more important issue is to work through to have the label and the appropriate settings for the big indications, and so that's the focus of our time and energy.

更重要的問題是為大適應症制定標籤和適當的設置，這就是我們時間和精力的重點。

I would also point out with our PD-1 we have reported our data and we're likely to have the most attractive initial label, which is nice from a commercial perspective.

我還想指出，我們已經透過 PD-1 報告了我們的數據，並且我們可能擁有最具吸引力的初始標籤，從商業角度來看，這很好。

In addition to that, we have manufactured with a partner that gives, I think, comfort around the quality of our product.

除此之外，我認為我們還與一個合作夥伴一起生產，該合作夥伴對我們的產品品質感到放心。

And in addition to that, we're running trials in over 20 countries and we have those regulatory bodies reviewing all of our data, our safety data, our protocol, everything we're doing.

除此之外，我們正在 20 多個國家進行試驗，我們讓這些監管機構審查我們所有的數據、我們的安全數據、我們的協議以及我們正在做的一切。

So we have a lot of eyes, including regulators across the globe, including Celgene and their reputation, including BI and their reputation, on everything we're doing with our product.

因此，我們有許多人的目光，包括全球監管機構、Celgene 及其聲譽、BI 及其聲譽，並關注我們對產品所做的一切。

And we do believe that, that will give comfort to a lot of people about the quality of our product.

我們確實相信，這會讓很多人對我們產品的品質感到放心。

And ultimately, we're running these global trials to get a global label, and I think that provides an additional amount of validation which helps us position our product.

最終，我們正在進行這些全球試驗以獲得全球標籤，我認為這提供了額外的驗證，有助於我們定位我們的產品。

I do think we're very different than the other alternatives, and the opportunity exists.

我確實認為我們與其他選擇有很大不同，而且機會是存在的。

And I think that will be relatively clear as the next couple years play out.

我認為隨著未來幾年的發展，這一點將會相對清晰。

But it's a great question.

但這是一個很好的問題。

So that was PD-1.

這就是 PD-1。

The second question was would we look for another partner.

第二個問題是我們是否會尋找另一個合作夥伴。

I think we always have discussions with everyone around everything we do because that's our -- we want to do what's best for patients, we want to do what's best for the assets, and we want to do what's best for our investors.

我認為我們總是圍繞著我們所做的一切與每個人進行討論，因為這就是我們的——我們希望為患者做最好的事情，我們希望為資產做最好的事情，我們希望為我們的投資者做最好的事。

So of course, we'll entertain and have those conversations with people.

當然，我們會與人們進行娛樂和對話。

Do we feel like that's necessary or the most desirable?

我們覺得這是必要的還是最可取的？

Not necessarily.

未必。

We're building global capabilities to launch our zanubrutinib, anyway.

無論如何，我們正在建立全球能力來推出我們的 zanubrutinib。

And I think that we'll listen, but we feel like we can certainly get this approved.

我認為我們會傾聽，但我們覺得我們絕對可以得到批准。

From the third perspective, you asked about the BTK and PD-1 combination work that we're doing and you referred to something I didn't quite hear, you clicked out, but maybe you could answer that, Eric.

從第三個角度來看，您詢問了我們正在做的 BTK 和 PD-1 組合工作，您提到了一些我沒聽清楚的內容，您點擊了出來，但也許您可以回答這個問題，Eric。

Yes.

是的。

I -- and Katherine, I'm sorry.

我──還有凱瑟琳，我很抱歉。

Maybe I'm not addressing the specific question you asked, but in regard to our combination program, we've really focused that now on a couple of indications, Richter's transformations, primary CNS lymphoma.

也許我沒有回答您提出的具體問題，但就我們的聯合計劃而言，我們現在確實專注於幾個適應症，即里氏轉化、原發性中樞神經系統淋巴瘤。

So we've sort of focused that on sort of more aggressive histology, really no longer exploring that combination in the more indolent histologies.

因此，我們將重點放在更具侵略性的組織學上，實際上不再在更惰性的組織學中探索這種組合。

Our next question comes from Michael Schmidt with Guggenheim Partners.

我們的下一個問題來自古根漢合夥人公司的麥可‧施密特。

This is Yige on for Michael.

這是邁克爾的易格。

We have a question on zanubrutinib.

我們有關於 zanubrutinib 的問題。

In the global Phase II front-line CLL study, control arm is BR, bendamustine plus rituximab.

在全球II期一線CLL研究中，對照組為BR、苯達莫司汀加利妥昔單抗。

However, chlorambucil plus obinutuzumab is used in a competitor trial.

然而，在一項競爭對手試驗中使用了苯丁酸氮芥加奧比妥珠單抗。

So since BR is a newer regimen and is more potent than chlorambucil plus obinutuzumab, does it raise the bar for the study to succeed?

那麼，既然 BR 是一種較新的治療方案，並且比苯丁酸氮芥加奧比妥珠單抗更有效，它是否會提高研究成功的門檻？

This is Eric.

這是埃里克。

Thanks for the question.

謝謝你的提問。

Yes, I will -- the reason we chose BR as comparing regimen was that we wanted to study our drug

是的，我會的——我們選擇 BR 作為比較方案的原因是我們想研究我們的藥物

(technical difficulty)

（技術難度）

instead of restrict it down to over in sicker patients.

而不是將其限制在病情較重的患者身上。

And so we really want our study to represent that population.

因此，我們確實希望我們的研究能夠代表該族群。

I will grant you that it's probably more effective than chlorambucil plus obinutuzumab, but I would also refer you to the results that compare ibrutinib to BR that was presented at ASH and showed through an overwhelmingly, statistically significant advantage in PFS.

我承認它可能比苯丁酸氮芥加奧比妥珠單抗更有效，但我還要向您推薦ASH 上發表的伊布替尼與BR 的比較結果，該結果顯示在PFS 方面具有壓倒性的、統計上顯著的優勢。

And so our assumption is that our BTK inhibitor performances have been in our earlier-phase -- we're sort of confident in that result.

因此，我們的假設是，我們的 BTK 抑制劑表現已處於早期階段——我們對此結果充滿信心。

Our next question comes from Tyler Van Buren with Piper Jaffray.

我們的下一個問題來自 Tyler Van Buren 和 Piper Jaffray。

Can you just speak a little bit more towards the launch preparations that still need to be done in terms of both the launches in China and the potential launches of zanu in the States eventually?

您能否多談談在中國的發射以及最終可能在美國發射 zanu 方面仍需要完成的發射準備工作？

On that one slide you have, I think, 600-plus folks of the commercial team and going up into the right.

我認為在那一張投影片上有 600 多名商業團隊成員，以及右邊的人員。

So just curious how many more people you need to add; and how that could affect operating expenses since year-over-year it was, I think, up 2.7x.

所以只是好奇你還需要增加多少人；以及這對營運支出有何影響，因為我認為營運支出比去年同期成長了 2.7 倍。

So just from a modeling perspective, it would be helpful.

因此，僅從建模角度來看，這會很有幫助。

Yes.

是的。

So for the -- it's Xiaobin Wu.

吳曉斌。

For the commercial launch preparation in China, we have -- as I said before, we have built all functions across the border, from sales rep, marketing.

為了準備在中國進行商業發布，正如我之前所說，我們已經跨國建立了所有職能，從銷售代表到行銷。

We have all marketing people in place.

我們所有的行銷人員都已就位。

And we have market access, government affair and payers management.

我們有市場准入、政務管理和納稅人管理。

All people are in place and -- including training.

所有人都就位－包括培訓。

We have marketing brand planning in place.

我們有適當的行銷品牌規劃。

And we will continue to expand our footprint into the provincial hospitals.

我們將繼續將業務拓展至省級醫院。

And currently, we have 600 people in the commercial.

目前，我們有 600 位廣告人員。

We'll continue to build up.

我們將繼續建設。

By end of this year, we will have other people -- and we will hire additional people to cover 800 to 1,000 hospital, where we have the -- cover the 80% of the oncology market.

到今年年底，我們將擁有其他人員，我們將僱用更多人員來涵蓋我們擁有的 800 至 1,000 家醫院，涵蓋 80% 的腫瘤市場。

So that is for China.

這就是中國的情況。

And for the U.S. we are talking near term.

對於美國，我們談論的是近期。

So zanubrutinib, we have hired senior leaderships for the commercial arm.

因此，zanubrutinib，我們已經為商業部門聘請了高階領導層。

So starting from the marketing, payers management, SFE training and all functions, market access.

所以從行銷、付款人管理、SFE 培訓和所有職能、市場准入開始。

And Tyler, this is Howard.

泰勒，這是霍華德。

Just on your expense questions, the -- we're -- obviously, the cost of sales reps in China is still a bit lower than in United States.

就你的費用問題而言，顯然，中國銷售代表的成本仍然比美國低一些。

So you can just simply do the math.

所以你可以簡單地做一下數學計算。

And we're talking about -- we're probably not talking about adding thousands of people, so we are talking about hundreds.

我們談論的是——我們可能不是在談論增加數千人，所以我們談論的是數百人。

So that should give you an idea, so it's not a dramatic increase.

所以這應該給你一個想法，所以它不是一個戲劇性的成長。

Okay, that's helpful.

好的，這很有幫助。

And just the follow-up was Eric earlier, in response to a question, spoke about kind of a modest impact on the global clinical trials strategy if you guys regain full rights to tisle.

艾瑞克早些時候在回答一個問題時表示，如果你們重新獲得 tile 的全部權利，將對全球臨床試驗策略產生一定的影響。

Is it possible to quantify what the increase in operating spend or in R&D might be if you guys do get rights back?

如果你們確實收回了權利，是否可以量化營運支出或研發支出的增加量？

Maybe I'll take that.

也許我會接受。

This is Howard.

這是霍華德。

So we are -- we've always spoken about this in the past, that, for example, in the -- we have 11 Phase III or potential registration-enabling studies ongoing.

因此，我們過去一直在談論這一點，例如，我們有 11 項 III 期或潛在的註冊支持研究正在進行中。

So for these studies, for operating 10 of them, Celgene is paying for some of these ongoing studies but in the form of reimbursement -- R&D reimbursement.

因此，對於這些研究，對於其中的 10 項研究，新基公司正在支付其中一些正在進行的研究的費用，但以報銷的形式——研發報銷。

So these are -- there are 3 studies that Celgene is reimbursing, and they are actually the ones that we have started earlier in the course of the program.

Celgene 正在償還 3 項研究，它們實際上是我們在該計劃過程中較早開始的研究。

And so they, by the time, assuming the close later this year, most of the study costs would have been paid for.

因此，假設今年稍後結束，到那時他們就已經支付了大部分研究費用。

And there is some residual amount.

並且還有一定的殘留量。

There are some left for these studies, but that we'll also get -- we expect to get a termination fee if that happens.

這些研究還剩下一些，但我們也會得到——如果發生這種情況，我們預計會得到終止費用。

So I think the cost impact -- there is the impact, but overall it's mostly picking up the additional costs of the additional study that Celgene is running.

所以我認為成本影響——確實有影響，但總體而言，它主要是新基公司正在進行的額外研究的額外成本。

Our next question comes from Wangzhi Li with Ladenburg.

我們的下一個問題來自拉登堡的李旺志。

I want to expand on the John's point that the broad label is a key for reimbursement in China.

我想進一步闡述約翰的觀點，即廣泛的標籤是中國報銷的關鍵。

I guess, 2 question on that is we see recently the domestic China companies to initially price their PD-1 at about $28,000 a year.

我想，第二個問題是我們最近看到中國國內公司將其 PD-1 的初始定價約為每年 28,000 美元。

And we know, if you get into the national reimbursement drug list, usually there is a significant discount 40% or more.

而且我們知道，如果進入國家報銷藥品目錄，通常會有40%以上的大幅折扣。

So do you think eventually we are talking about like the around $15,000-a-year enterprise?

那麼您認為最終我們談論的是年收入約 15,000 美元的企業嗎？

And that's before the kind of charity programs or what's your view on kind of price you can get in the reimbursement?

那是在什麼樣的慈善計劃之前，或者你對報銷中可以獲得的價格有什麼看法？

So that is the first question.

這是第一個問題。

The second question is just in terms of the process for getting reimbursement, getting into the national drug -- reimbursement drug list.

第二個問題就是報銷的流程，進入國家藥品報銷目錄。

It looks like it's going to become more dynamic, right?

看起來它會變得更有活力，對吧？

So how the broad label or the timing of approval to affect your position in terms of getting reimbursement.

那麼，廣泛的標籤或批准時間如何影響您在獲得報銷方面的地位。

And maybe to add one more is: Do you have any insight, so far, on the off-label use of KEYTRUDA and OPDIVO since their approval a few months ago?

也許還需要補充一個問題：自從幾個月前獲批以來，到目前為止，您對 KEYTRUDA 和 OPDIVO 的標籤外使用有何見解？

Sure.

當然。

Thanks.

謝謝。

Those are great questions.

這些都是很好的問題。

I'm not sure if I got the second one exactly right, but I think I would go back to there's very clear history and messaging.

我不確定我的第二個是否完全正確，但我想我會回到那裡，那裡有非常清晰的歷史和資訊。

And we've -- I think we've tabulated that data and shared it in a way that's nicely presented, but it's public, the past 3 years of oncology drug reimbursement and the range that's associated with that from a pricing perspective.

我認為我們已經將這些數據製成表格並以一種很好地呈現但公開的方式共享它，過去三年的腫瘤藥物報銷以及從定價角度來看與之相關的範圍。

And I think we clearly view that is where this market winds up in a couple years.

我認為我們清楚地看到這就是這個市場幾年後的結局。

We also view you cannot be reimbursed if you're off label because we have that experience with the Celgene products.

我們也認為，如果您超出標籤範圍，您將無法獲得報銷，因為我們在 Celgene 產品方面擁有相關經驗。

At this moment, the vast majority of use is off label.

目前，絕大多數的使用都是標籤外的。

We believe that there's a lot of use from that perspective in China, although it's not our product we don't know, but the labels are in small bench indications at this point in time and the sales are quite substantial.

我們相信，從這個角度來看，在中國有很多用途，雖然我們不知道這不是我們的產品，但目前標籤還處於小範圍的適應症中，而且銷量相當可觀。

So that is our belief, but I think, when you go back to that pricing range from looking at facts and real data, it's clear and it's compelling and it's understandable and markets -- products which are nicher products, like ibrutinib, like REVLIMID, can be at the high end of that range and products that are very big and very broadly used are probably not likely to be at the highest end of that range.

這就是我們的信念，但我認為，當你從事實和真實數據回到定價範圍時，它是清晰的、令人信服的、可以理解的和市場的——產品是小眾產品，如依魯替尼、瑞復美、可能處於該範圍的高端，而規模非常大且使用非常廣泛的產品可能不會處於該範圍的最高端。

They're probably more in the middle.

他們可能更多地處於中間。

So from that perspective, that's what we believe.

所以從這個角度來看，這就是我們所相信的。

I don't think that the Junxure pricing affects that at all.

我認為 Junxure 的定價根本不會影響這一點。

When you ask a drug to reduce its price in half -- these are drugs that have been historically coming in at very, very high levels.

當你要求一種藥物的價格降低一半時，這些藥物的價格在歷史上一直處於非常非常高的水平。

That may or may not be the case when you have a player like Junxure that comes in at a much lower level from day 1. I actually think that, when you look at the data, it's pretty clear.

當你有像 Junxure 這樣從第一天開始就處於較低水平的玩家時，情況可能會也可能不會。

What matters is your cost per month.

重要的是你每個月的費用。

And yes, they haven't left themself enough room negotiate if your paradigm is you must have a 50% decrease, but when you start at a very different point, it's hard to believe that -- Merck, if they reduce their price 50% and was nationally reimbursed, that the government would require a drug in the same class to be at 1/4 of that price to be reimbursed.

是的，如果你的範式是必須降價 50%，他們沒有給自己留下足夠的談判空間，但當你從一個非常不同的點開始時，很難相信——默克，如果他們降價 50%並且是全國報銷的，政府會要求同類藥品以該價格的1/4報銷。

So I don't really follow the logic of, when you have a broad sort of things in that class, that you're going to require a percentage.

所以我並不真正遵循這樣的邏輯：當你在該類別中擁有廣泛的內容時，你將需要一個百分比。

I'm not sure that's the right metric.

我不確定這是正確的衡量標準。

I think the right metric is looking at the actual data and how does that work.

我認為正確的衡量標準是查看實際數據及其運作方式。

And I think, from the second perspective, it's very clear that no company has the capacity to serve even a substantial portion of this market.

我認為，從第二個角度來看，很明顯沒有一家公司有能力服務這個市場的很大一部分。

So that is in a scenario where Chinese government nor the market dynamics would result in something that drives everybody to that price.

因此，在這種情況下，中國政府或市場動態都會導致每個人都達到這個價格。

So I think that's our view from that perspective.

所以我認為這就是我們從這個角度的觀點。

And again, in a world where you're reimbursed very substantially, which is the national reimbursement situation in China, when you're not on reimbursement, it's all out of pocket.

再說一次，在一個你報銷非常多的世界裡，這就是中國的國家報銷情況，當你沒有報銷時，一切都是自掏腰包。

So getting to the label is really, really what matters.

因此，獲得標籤確實非常重要。

And it is expensive to get to the label.

而且獲得該標籤的成本很高。

And it's hard.

這很難。

And when you look at the trials that we're running, it's for CHL and for melanoma.

當您查看我們正在進行的試驗時，您會發現這是針對 CHL 和黑色素瘤的試驗。

These were small single-arm trials which are pretty easy for biotech company to execute on.

這些都是小型單臂試驗，對於生技公司來說非常容易執行。

There's a long history of biotech companies that are small being able to do that, but when you look at the big indications, you're actually talking about comparator studies that are blinded; that are randomized; that have hundreds and hundreds of patients in many, many sites.

小型生物技術公司能夠做到這一點由來已久，但當你看到大的跡象時，你實際上是在談論盲目的比較研究；是隨機的；在很多很多地方都有成百上千的病人。

This is where it's very, very difficult to execute and to execute in a high-quality fashion.

這就是執行和以高品質方式執行非常非常困難的地方。

And what we're asking all of these companies to do, ourselves included, is execute in a very, very broad program in a high-quality fashion on multiple things at the same time.

我們要求所有這些公司（包括我們自己）要做的就是以高品質的方式同時在多個方面執行一個非常非常廣泛的計劃。

And it's hard.

這很難。

It's hard for us.

這對我們來說很難。

And you look at the size of our organization.

你看看我們組織的規模。

You look at the back half of our clinical teams in the United States with a lot of experience from companies like Genentech and the other half is here in China, on the ground and from the best sources.

你看看我們在美國的臨床團隊的後半部分，他們擁有來自基因泰克等公司的豐富經驗，而另一半則在中國，在當地，擁有最好的資源。

It's a very large, very highly capable team.

這是一個規模非常大、能力非常強的團隊。

But what we're talking about to work towards broad label is very, very hard and it is not inexpensive.

但我們正在談論的努力實現廣泛的標籤是非常非常困難的，而且並不便宜。

We have Celgene helping us fund that historically.

歷史上，新基（Celgene）曾幫助我們資助這個計畫。

And we're the beneficiary of that, but there's a lot to do from an execution perspective.

我們是其中的受益者，但從執行的角度來看，還有很多工作要做。

So I do think you should look at the historic data and where China is reimbursing drugs on a per monthly basis.

所以我確實認為你應該看看歷史數據以及中國每月在哪裡報銷藥品。

You should think about this as a big class, so it's probably not at the high end of that range.

您應該將其視為一個大類，因此它可能不在該範圍的高端。

And you should really spend time and energy trying to understand when people are going to get the labels that matter from that perspective.

你真的應該花時間和精力去理解人們何時會從這個角度獲得重要的標籤。

I didn't answer all of your questions...

我沒有回答你所有的問題...

I'll just add 2 sentence.

我就補充2句話吧。

So Chinese government will start to update the NRDL in the next few months.

因此，中國政府將在未來幾個月內開始更新國家健保目錄。

And after that, that will be dynamic adjustment, so ad hoc.

之後，這將是動態調整，所以是臨時的。

So that will be cycle plus dynamic adjustment.

所以這將是循環加動態調整。

I hope that answered most of your questions, but if it didn't...

我希望這能回答您的大部分問題，但如果沒有…

Yes, that's very helpful.

是的，這非常有幫助。

Maybe, if I can, just one follow-up is, so far it looks like the China government will choose one drug for one class in the list, but doing PD-1s application so broad, do you think it's possible to have more than one drug on the reimbursement list for different indication or...

也許，如果可以的話，只有一個後續行動是，到目前為止，中國政府似乎會為清單中的一類藥物選擇一種藥物，但 PD-1 的應用如此廣泛，您認為有可能有超過報銷目錄中的一種藥物針對不同適應症或...

Sorry.

對不起。

So if you look at currently, for example, EGFR inhibitors, there's 3 of them, yes, they are reimbursed, yes.

所以如果你看目前的情況，例如 EGFR 抑制劑，有 3 種，是的，它們是報銷的，是的。

So it's yes.

所以是的。

Our next question and our final question will come from James [Zhang] with Industrial Securities.

我們的下一個問題和最後一個問題將來自興業證券的 James [Zhang]。

This is James from Industrial Securities.

我是興業證券的詹姆斯。

I have 2 questions.

我有 2 個問題。

This is what are our strategies for commercial teams, especially-- for the PD-1 and for the PARP publishing for our solid tumor in the U.S. and worldwide.

這就是我們針對商業團隊的策略，特別是針對 PD-1 以及針對美國和全球實體瘤的 PARP 發布。

And the next question is can we expect the [critics] data readout for the solid tumor just like the CHL?

下一個問題是我們能否期待像 CHL 一樣實體瘤的[批評家]數據讀出？

(foreign language)

（外語）

Howard?

霍華德？

Thank you, James.

謝謝你，詹姆斯。

This is Howard.

這是霍華德。

So the first question, on the -- our commercial strategy for PD-1 in solid tumors.

第一個問題是關於我們在實體腫瘤中 PD-1 的商業策略。

We are -- so we -- obviously we need to wait until -- and see what happens if deal closes between BMS and Celgene, but assuming that we get the full worldwide rights back, I think we have full options of -- from -- going along in some countries to partner completely with others in certain territories; and then in between, some sort of a co-promotion in -- so it's all the options are -- that are open and it probably depends on different territories.

我們 - 所以我們 - 顯然我們需要等到 - 看看如果 BMS 和 Celgene 之間的交易完成會發生什麼，但假設我們收回全部全球權利，我認為我們有充分的選擇 - 來自 - - 在某些國家與某些地區的其他國家完全合作；然後在這之間，某種聯合促銷——所以所有的選擇都是——開放的，這可能取決於不同的地區。

We'll have -- likely have different strategies, depending on the local target.

根據當地目標，我們可能會採取不同的策略。

We have -- as Dr. Wu has mentioned in open remarks, we have been building in the U.S. We're obviously very quite -- it's early days, but we have actually a very good, high-caliber focus on board, so we're confident that we can build a commercial team successfully in the U.S. And so that's certainly is a consideration that -- or certainly is an option that we have.

正如吳博士在公開演講中提到的那樣，我們一直在美國進行建設。成功建立一支商業團隊，因此這肯定是一個考慮因素，或者肯定是我們的一個選擇。

And so we're -- I think we do have, I think, a lot of options.

所以我們——我認為我們確實有很多選擇。

And we'll make decision specific for different countries.

我們將針對不同國家做出具體決定。

Regarding the solid tumor data that we're expecting, obviously as you mentioned, we'll -- we expect to have some readouts this year.

關於我們預期的實體瘤數據，顯然正如您所提到的，我們預計今年會得到一些數據。

We are -- so we're -- we have previously presented some of the data, Phase II data, in the -- in some indications in the past.

我們——所以我們——我們之前已經在過去的一些跡像中提供了一些數據，第二階段的數據。

So I think that should give you -- that will provide early data point in this indication.

所以我認為這應該給你——這將提供這個跡象的早期數據點。

So I think that, hopefully, that answers your questions.

所以我認為，希望這能回答你的問題。

And we'd like to thank everyone for joining us.

我們要感謝大家加入我們。

Ladies and gentlemen, thank you for participating in today's conference.

女士們、先生們，感謝你們參加今天的會議。

This does conclude the program.

這確實結束了該程式。

You may all disconnect, and have a wonderful day.

你們可以斷開連接，度過美好的一天。