HUTCHMED (China) Ltd (HCM) 2024 Q2 法說會逐字稿

Hello, everyone. Welcome to HUTCHMED 2014 (sic - 2024) interim results presentation. My name is David Ng, Head of HUTCHMED IR. Our results announcement as well as our presentation slides have already been uploaded to our company homepage as well as the Hong Kong Stock Exchange website.

大家好。歡迎參加 HUTCMED 2014（原文如此 - 2024）中期績效示範。我叫 David Ng，HUTCMED IR 負責人。我們的業績公告及簡報幻燈片已上載至本公司首頁及香港聯交所網站。

Before we star, just a few quick reminders. (Event Instructions) And finally, please read on page 2 of our presentation slides for the Safe Harbor statement and disclaimer. The performance and results of operation of the HUTCHMED contained within this presentation are historical in nature and past performance is no guarantee of future results.

在我們開始之前，請先簡單提醒一下。（活動說明）最後，請閱讀我們簡報投影片第 2 頁的安全港聲明和免責聲明。本簡報所包含的 HUTCMED 績效和營運結果本質上是歷史性的，過去的表現並不能保證未來的成果。

So with no further delay, let me introduce our Chief Executive Officer and Chief Scientific Officer, Dr. Su, to begin our presentation for day. Dr. Su?

因此，事不宜遲，請允許我介紹我們的執行長兼首席科學官蘇博士，開始我們今天的演講。蘇醫生？

Thanks, David. Good evening. Good morning, everyone. Welcome to HUTCHMED first-half 2024 results conference call. With me today are Johnny Chen, CFO; George Yuan, Head of Commercial. George joined us a month ago. George is a highly experienced veteran in oncology product sales and marketing. He joined us from Merck where he headed its China commercial operations for the last seven years with great success. And George will be followed by Mike, who will give a brief update on the pipeline.

謝謝，大衛。晚安.大家早安。歡迎參加 HUTCHMED 2024 年上半年業績電話會議。今天和我在一起的有財務長 Johnny Chen；喬治‧袁，商務主管。喬治一個月前加入我們。喬治是腫瘤產品銷售和行銷方面經驗豐富的資深人士。在加入我們之前，他曾在默克公司 (Merck) 任職，在過去的七年裡領導其中國商業業務並取得了巨大成功。喬治之後是麥克，他將簡要介紹管道的最新情況。

Next slide, please. Slide number 4 just to give you a quick summary, first half 2024. We continue to execute on our strategy towards self-sustaining. A big part of this strategy is globalization. We are launching fruquintinib worldwide with our partner Takeda, and we look forward to filing for approval for our second product, savolitinib, in the US later this year with our partner, AstraZeneca.

請下一張投影片。第 4 號投影片只是為了給您一個快速總結，2024 年上半年。我們繼續執行自我維持的策略。該戰略的一個重要組成部分是全球化。我們正在與我們的合作夥伴武田（Takeda）在全球範圍內推出呋喹替尼（fruquintinib），我們期待今年晚些時候與我們的合作夥伴阿斯利康（AstraZeneca）在美國申請批准我們的第二種產品沃利替尼（savolitinib）。

On the pipeline, we continue to file for life-cycle indications for the first wave of products. At the same time, the second-life products, savolitinib, tazemetostat NDAs are under review in China, and we expect to launch them in the next 6 to 12 months.

在管道中，我們繼續為第一批產品申請生命週期指示。同時，第二生命產品沃利替尼、他澤美司他新藥申請正在中國接受審查，我們預計在未來6至12個月內上市。

Our best-in-class IDH1/2 inhibitor, HMPL-306 entered into Phase 3 in recurrent and refractory AML.

我們一流的 IDH1/2 抑制劑 HMPL-306 已進入復發性難治性 AML 的 3 期臨床研究。

On commercialization, first, an update on FRUZAQLA US performance. First half in-market sales reached just over USD130 million, suggesting strong early uptake. We expect EU and Japan launches later this year. In China, all products experienced the double-digit growth while fighting through the fierce competition. Taken together, the combined market -- the combined in-market sales grew 145%, primarily driven by FRUZAQLA US sales.

關於商業化，首先介紹一下 FRUZAQLA 美國業績的最新情況。上半年市場銷售額略高於 1.3 億美元，顯示早期市佔率強勁。我們預計歐盟和日本將在今年稍後推出。在中國，各產品在激烈的競爭中均實現了兩位數的成長。總而言之，合併後的市場——合併後的市場內銷售額增長了 145%，這主要是由 FRUZAQLA 美國銷售推動的。

So with that, I'll turn it to Johnny Cheng, CFO, to give you more details on the financials. Johnny?

因此，我會將其轉給財務長 Johnny Cheng，為您提供有關財務狀況的更多詳細資訊。強尼？

Okay. Thank you, Dr. Su.

好的。謝謝你，蘇博士。

So on page 6, as you all can see, we have made profit of $26 million in the first half with revenue of our marketed products up 64% at constant exchange rates to $128 million. So oncology consolidated revenue achieved $168 million on track to meet our full-year revenue guidance of $300 million to $400 million. Our R&D expenditures have reduced to $95 million, mainly due to a strategic reorganization of the ex-China team and prioritization of projects.

因此，在第 6 頁上，正如大家所看到的，我們上半年的利潤為 2,600 萬美元，以固定匯率計算，我們銷售的產品收入成長了 64%，達到 1.28 億美元。因此，腫瘤學綜合收入達到 1.68 億美元，預計將達到我們 3 億至 4 億美元的全年收入指引。我們的研發支出減少至 9,500 萬美元，主要是因為對中國以外的團隊進行了策略重組以及專案的優先排序。

Turning to the next page, page 7. On the guidance, as highlighted just now, we are on track to meet our full-year oncology and immunology revenue guidance of $300 million to $400 million. So we are likely to achieve the high end of the guidance due to the potential additional commercial milestones from Takeda. In addition, we're also likely to receive EU- and Japan-related milestone in the second half.

翻到下一頁，第 7 頁。正如剛才所強調的，根據該指引，我們預計將實現 3 億至 4 億美元的全年腫瘤學和免疫學收入指引。因此，由於武田潛在的額外商業里程碑，我們很可能會實現指導的高端。此外，我們也可能在下半年收到與歐盟和日本相關的里程碑。

Moving on to the next page, page 8. On the balance sheet, as you can see, we continue to maintain a strong cash position of over $800 million. So on the bank borrowings, we're drawn from our low interest bearing facility for the construction of our new Shanghai factory. We are getting that positive income as our actual borrowing rate is lower than our interest rate earned on our short-term deposit.

轉到下一頁，第 8 頁。正如您所看到的，在資產負債表上，我們繼續保持超過 8 億美元的強勁現金狀況。因此，在銀行借款方面，我們從低利率貸款中提取資金用於建造上海新工廠。由於我們的實際借款利率低於我們的短期存款利率，我們獲得了正收入。

Now I will pass to our Head of Commercial, George Yuan. George?

現在我請我們的商務主管 George Yuan 發言。喬治？

Thanks, Johnny.

謝謝，強尼。

First, let's -- Dr. Su mentioned, we have a very strong start of fruquintinib in US. This shows you the -- slide 10 show you the US results. We'll see a very strong Q1 and an even stronger Q2. If you look at the future, we are expecting Japan approval in a very quick fashion and also, we are waiting for EU reimbursement decision.

首先，蘇博士提到，呋喹替尼在美國的起步非常強勁。這向您展示了——幻燈片 10 顯示了美國的結果。我們將看到非常強勁的第一季和甚至更強勁的第二季。如果你展望未來，我們預計日本很快就會批准，並且我們正在等待歐盟的報銷決定。

Next slide. And look at the China market, for fruquintinib a very competitive market. We still deliver a double-digit growth and we are still the market leader in the [cell line] mCRC and we believe the mCRC still has a room to grow in China. Additionally, we received on Hong Kong approval for mCRC cell line.

下一張投影片。再看看中國市場，對呋喹替尼來說是一個競爭非常激烈的市場。我們仍然實現兩位數的成長，我們仍然是[細胞系] mCRC 的市場領導者，我們相信 mCRC 在中國仍有成長空間。此外，我們的 mCRC 細胞係也獲得香港批准。

Next move to the next slides was SULANDA. This is -- we have delivered -- in the first half of this year, we deliver a very good growth. And we are the number two brand in the NEN treatment market. And also, we are gaining market share. If you look at the guideline, we get multiple endorsement for the treatment in CSCO, in CACA guideline. And also, we believe there's a lot of room to grow because this area is still underdiagnosed and some of the treatments do need to be more rational and afford to form the guideline.

下一張幻燈片是 SULANDA。這是——我們已經實現的——今年上半年，我們實現了非常好的成長。我們是 NEN 治療市場的第二大品牌。而且，我們正在獲得市場份額。如果你看一下指南，我們會在 CSCO 和 CACA 指南中獲得對治療的多重認可。而且，我們相信還有很大的成長空間，因為這個領域仍然診斷不足，一些治療方法確實需要更加合理並且能夠形成指南。

If you look at the next slides, the ORPATHYS, our first-in-class MET inhibit. We see the market become more cloud. The growth of the first half of this year is still strong. And the MET14 testing become a standard of care in the market. We still believe with AstraZeneca's strong platform in lung cancer, we can deliver a much stronger book growth in China.

如果您看下一張幻燈片，您會看到 ORPATHYS，我們一流的 MET 抑制劑。我們看到市場變得更加雲端化。今年上半年的成長依然強勁。MET14 測驗成為市場上的照護標準。我們仍然相信，憑藉阿斯特捷利康在肺癌領域的強大平台，我們能夠在中國實現更強勁的圖書成長。

Look forward, we are preparing our ITP market growth. If you look at this market, this is our first-in-class launch in China, and we are -- these products paving way for us to move into the knowledge field. And we will sequence our business priority to address the low-hanging fruits first, then go into a major market after [larger] application. Then if you look at our company, we are preparing the market, we are preparing the products, and we are preparing the organization to prepare the launch.

展望未來，我們正在為 ITP 市場的成長做好準備。如果你看看這個市場，這是我們在中國首次推出的產品，這些產品為我們進入知識領域鋪平了道路。我們將安排我們的業務優先順序，首先解決容易實現的目標，然後在[更大的]應用之後進入主要市場。然後，如果你看看我們公司，我們正在準備市場，我們正在準備產品，我們正在準備組織來準備發布。

And if you look at the overall China commercial environment, we believe with current encouragement of China innovation, the market situation become more favorable for the innovative medicine.

如果你看一下中國整體的商業環境，我們相信在當前中國鼓勵創新的情況下，市場情勢將變得更有利於創新藥物。

Now let's introduce Mike, our CMO.

現在讓我們介紹一下我們的首席行銷長麥克。

Thank you, George.

謝謝你，喬治。

Next slide. Yeah, our product pipeline continues to grow and mature. As you can see, we're actually making a lot of progress. We have six NDA or supplementary NDA under review globally, not only for fruquintinib. We have international approval based on the FRESCO-2 results. We also have the FRUTIGA and also the FRUSICA-1 for additional indication in gastric cancer in endometrial cancer.

下一張投影片。是的，我們的產品線不斷成長和成熟。正如您所看到的，我們實際上取得了很大進展。我們在全球範圍內有六項 NDA 或補充 NDA 正在接受審查，而不僅僅是呋喹替尼。基於 FRESCO-2 結果，我們獲得了國際認可。我們還有 FRUTIGA 和 FRUSICA-1，用於胃癌和子宮內膜癌的額外適應症。

More importantly, we also have a new product as under review. We have the sovleplenib for the second-line ITP and also a new product, tazemetostat, we licensed from Ipsen also under priority review in China. And additionally, we have the savolitinib also for the confirmatory trial for MET Exon14 under review for first-line non-small cell lung cancer.

更重要的是，我們還有一個新產品正在審核中。我們有用於二線ITP的sovleplenib，還有一個新產品tazemetostat，我們從Ipsen獲得許可，也在中國處於優先審查階段。此外，我們也正在審查用於一線非小細胞肺癌的 MET Exon14 驗證性試驗的沃利替尼。

So additional pipeline continues to grow. We are very excited later this year, our partner, AstraZeneca, based on the SAVANNAH trial, will have the potential to bring the savolitinib into the US NDA submission. And also in the next few years, we continue to advance our pipeline in the registration study. And Dr. Su mentioned about the RAPHAEL study, our new class compound IDH1 and 2 inhibitor, HMPL-306 also initiate the Phase 3 trial.

因此，額外的管道繼續增長。我們非常興奮，今年晚些時候，我們的合作夥伴阿斯利康基於 SAVANNAH 試驗，將有可能將沃利替尼納入美國 NDA 提交。在接下來的幾年裡，我們將繼續推進我們的註冊研究。蘇博士提到了RAPHAEL研究，我們的新一類化合物IDH1和2抑制劑HMPL-306也啟動了3期試驗。

Next slide, slide 18. We have presented our second-line gastric cancer for fruquintinib, in combination with paclitaxel at the ASCO Plenary early in February and also had the updated results at the ASCO Plenary session. We are really pleased that the robust clinical data showing double objective response rate and also the progression-free survival. And also, we look at the longest overall survival in the second-line setting has been reported and this NDA is currently under the CDE review.

下一張投影片，投影片 18。我們已於 2 月初在 ASCO 全體會議上展示了呋喹替尼聯合紫杉醇治療胃癌的二線藥物，並在 ASCO 全體會議上公佈了最新結果。我們非常高興的是，強有力的臨床數據顯示了雙重客觀緩解率和無惡化存活期。此外，我們還研究了已報告的二線治療中最長的總存活期，該 NDA 目前正在接受 CDE 審查。

Slide 19, please. And also, we update our FRUSICA trial. And fruquintinib with PD-1 sintilimab in the endometrial cancer reported the results at ASCO and we have seen very robust overall response rate, 35.6% overall response rate and a median PFS of 9.5 months. So this NDA has been accepted under priority review at the CDE.

請投影片 19。此外，我們也更新了 FRUSICA 試驗。呋喹替尼合併 PD-1 信迪利單抗治療子宮內膜癌在 ASCO 上報告了結果，我們看到了非常強勁的整體緩解率，整體緩解率為 35.6%，中位 PFS 為 9.5 個月。因此，該 NDA 已被 CDE 優先審查。

Next slide. Also our fruquintinib plus sintilimab in the RCC also fully recruited. We are waiting for the events for later this year. If positive, we're going to file additional NDA for fruquintinib in the RCC.

下一張投影片。我們的呋喹替尼加信迪利單抗在 RCC 中也已全面招募。我們正在等待今年晚些時候的活動。如果呈陽性，我們將在 RCC 中提交額外的呋喹替尼新藥申請 (NDA)。

Slide 21. And also, we are very excited about our next new product, our first innovative molecule, the Syk inhibitor. We reported with ESLIM-1 trial in the Phase 3 at the EHA and also with a simultaneous publication and [Lonza hematology]. It really shows this compound has a very robust, best-in-class molecule.

幻燈片 21。而且，我們對我們的下一個新產品、我們的第一個創新分子 Syk 抑制劑感到非常興奮。我們在 EHA 報告了 ESLIM-1 的第 3 階段試驗，並同時發表了[龍沙血液學]。它確實表明該化合物具有非常強大、一流的分子。

In heavily pretreated patients, over 75% of the patients pretreated with TPO/TPO-RA also show a very robust durable response rate, 48%, an overall response rate of 71%. This platelet increases very rapid within -- after week and also the side-effect profile is very favorable compared with the low off-target effect and has no thrombolytic event like TPO-RA has.

在經過大量預處理的患者中，超過 75% 的接受 TPO/TPO-RA 預處理的患者也表現出非常穩健的持久緩解率（48%），整體緩解率為 71%。這種血小板在一週後增加非常迅速，與低脫靶效應相比，副作用特徵非常有利，並且沒有像 TPO-RA 那樣的溶栓事件。

And also internationally, we started the Phase 1 trial in ITP in US, EU, and Australia. And also at the EHA, we presented our clinical proof-of-concept trial for warm autoimmune hemolytic anemia and also selected plenary presentation also show very robust 48% durable response rate and overall response rate of 67%. So the Phase 3 trial has already started in enrolling patients.

在國際上，我們在美國、歐盟和澳洲啟動了 ITP 的第一階段試驗。同樣在 EHA 上，我們展示了針對溫性自體免疫溶血性貧血的臨床概念驗證試驗，並且選定的全體會議演示也顯示出非常穩健的 48% 持久緩解率和 67% 的總體緩解率。因此，3期試驗已經開始招募病患。

And that for international development, we really think this is a great molecule, has best-in-class potential, and multiple development opportunity. For example, in second-line TPO and TPO-RA pretreated patients, and also, you know, there are other opportunities in combination with standard of care and also potentially secondary ITP or other autoimmune disease.

對於國際發展，我們確實認為這是一個偉大的分子，具有一流的潛力和多種發展機會。例如，在二線 TPO 和 TPO-RA 預處理的患者中，而且您知道，還有其他機會與標準護理相結合，也有可能繼發 ITP 或其他自體免疫疾病。

Slide 22, we're also excited to see that advancement for savolitinib. Our MET inhibitor, we have approval in China and also our global partner, AstraZeneca, is completing the -- has completed the re-enrollment and with the readout in the second/third-line TAGRISSO combination trial in MET aberrated patients. So the results were waiting eagerly with the potential for our second international NDA later this year.

在幻燈片 22 中，我們也很高興看到沃利替尼的進步。我們的 MET 抑制劑已在中國獲得批准，我們的全球合作夥伴阿斯特捷利康正在完成針對 MET 異常患者的二線/三線 TAGRISSO 聯合試驗的重新入組和讀數。因此，我們正在熱切地等待結果，並有可能在今年稍後進行第二次國際 NDA。

And also in China, we already submitted the MET Exon14 in the first line and also as a confirmatory trial for approval in Met Exon14 skipping mutated patients. And also the -- our second-line EGFR refractory patients with MET amplification, the SACHI study, we're aiming to complete the enrollment later this year. And in addition, our partner and continue to enroll in the other four Phase 3 trials ongoing, two led by AstraZeneca and two in China.

同樣在中國，我們已經提交了一線的 MET Exon14，並作為 Met Exon14 跳躍突變患者的驗證性試驗獲得批准。還有我們的二線 EGFR 難治性 MET 擴增病患 SACHI 研究，我們的目標是在今年稍後完成入組。此外，我們的合作夥伴繼續參與正在進行的其他四項三期試驗，其中兩項由阿斯特捷利康領導，兩項在中國。

Next slide. And also at the R&D day, we update the outside world about we are launching this Phase 2/3 trial for surufatinib there in combination with chemo in first-line pancreatic cancer. This is really based on the high unmet need and also the robust clinical data we have seen from IIT trial in surufatinib plus camrelizumab, the PD-1 inhibitor, plus S1 and Abraxane versus the standard of care AG. We can see the overall response rate of reaching 50% versus 27% median PFS 9 months versus 5.8 months and also the lung overall survival of 13 months. So this is really exciting data. We really continue to enroll in this Phase 2/3 trial and further advancing our pipeline in this first-line PDAC.

下一張投影片。同樣在研發日，我們向外界通報了我們正在啟動索凡替尼聯合一線胰臟癌化療的 2/3 期試驗。這實際上是基於高度未滿足的需求，以及我們從IIT 試驗中看到的可靠的臨床數據，即索凡替尼加卡瑞利珠單抗、PD-1 抑製劑、加上S1 和Abraxane 與標準護理AG 的比較。我們可以看到，9 個月和 5.8 個月的中位無惡化存活期 (PFS) 分別達到 50% 和 27%，肺部總存活期為 13 個月。所以這確實是令人興奮的數據。我們確實繼續參加這項 2/3 期試驗，並進一步推進我們在一線 PDAC 中的研發管線。

Slide 24. And also, I mentioned that RAPHAEL trial has started enrolling patients. This is our first dual inhibitore IDH1 and 2 mutated double mutant inhibitor and this stressing a high proportion of AML patients. And with high unmet need, we have reported our data, both the China AML trial and also the international trial, we have seen very robust dual CR response.

幻燈片 24。另外，我提到 RAPHAEL 試驗已經開始招募病人。這是我們的第一個雙重抑制劑 IDH1 和 2 突變雙突變抑制劑，這對高比例的 AML 患者產生了壓力。由於未滿足的需求很高，我們報告了我們的數據，無論是中國 AML 試驗還是國際試驗，我們都看到了非常強烈的雙重 CR 反應。

Next slide, as you can see, we reported at RP2D dose, which is the 250 milligram loading dose followed by 100 milligram dose. We have observed very robust CR and CRh rate in the IDH1 mutated patient. You can see, we reached 50%. And in the IDH2 mutated patients, see 62.5%, which is really robust result, if you excluding the co-driver mutation FLT3 or KRAS. And also very importantly, we observed very long overall survival, and we have seen the 13 months overall survival in this IDH1 or IDH2 mutated patients. So really showing this compound has a best-in-class potential in inhibiting both IDH1 and IDH2. So the Phase 3 RAPHAEL trial is currently ongoing and enrolling patients. We are very, very excited about this compound.

下一張投影片，如您所見，我們報告了 RP2D 劑量，即 250 毫克負荷劑量，然後是 100 毫克劑量。我們在 IDH1 突變患者中觀察到非常強烈的 CR 和 CRh 率。你可以看到，我們達到了50%。在 IDH2 突變患者中，如果排除共同驅動突變 FLT3 或 KRAS，則為 62.5%，這確實是一個穩健的結果。而且非常重要的是，我們觀察到了非常長的總存活期，我們在這個 IDH1 或 IDH2 突變患者中看到了 13 個月的總存活期。因此，真正表明該化合物在抑制 IDH1 和 IDH2 方面具有同類最佳的潛力。因此，3 期 RAPHAEL 試驗目前正在進行中並正在招募患者。我們對這個化合物感到非常非常興奮。

Next, I'll turn back Dr. Su.

接下來我就回蘇博士了。

Okay. Thanks, Mike. To sum it up, we had a strong first half and we are optimistic about the second half. Our previous target was to achieve profitability by end of 2025. We believe we are well on our way and potentially ahead of the curve.

好的。謝謝，麥克。總而言之，我們上半場表現強勁，對下半場持樂觀態度。我們先前的目標是到 2025 年底實現獲利。我們相信我們已經走在了正軌上，並且有可能處於領先地位。

Looking ahead, there are a lot of events on this map, all the lineup for 2025, 2026, and beyond. These events, if achieved, will help fuel the growth for years to come.

展望未來，這張地圖上有許多事件，2025 年、2026 年以及以後的所有陣容。這些活動如果實現，將有助於推動未來幾年的成長。

This concludes the presentation and thank you again for attending the call. The next is going to be Q&A.

演示到此結束，再次感謝您參加電話會議。接下來是問答環節。

(Event Instructions) Alec Stranahan, Bank of America.

（活動說明）Alec Stranahan，美國銀行。

Thanks, guys, for the questions and congrats on the progress in the first half. Great to see the FRUZAQLA launch hitting on all cylinders in the US. Two questions on SAVANNAH.

謝謝大家提出的問題，並祝賀上半場的進展。很高興看到 FRUZAQLA 在美國的推出如火如荼。關於薩凡納的兩個問題。

First, how do you see the data earlier this year at ACR for savo? It's potentially reading into what we could see in the full-data readout from SAVANNAH later this year. And then, who would be leading the US submission for savo? And is the year end timing sort of, from you guys or from AstraZeneca or both?

首先，您如何看待今年早些時候 ACR for savo 的數據？它可能會解讀我們在今年稍後從薩凡納讀出的完整數據中看到的內容。那麼，誰將領導美國提交薩沃案呢？年底的時間是你們的還是阿斯特捷利康的，還是兩者都有？

Thank you.

謝謝。

Okay. Thanks, Alex, for the question on. So briefly, obviously, AstraZeneca is leading the trial but for NDA submission, it will be a complete package including preclinical early development. So we will be contributing to the package. But operationally, AstraZeneca is leading the whole thing.

好的。謝謝亞歷克斯提出的問題。簡而言之，顯然阿斯特捷利康正在主導這項試驗，但對於新藥申請的提交，這將是一個完整的方案，包括臨床前早期開發。因此，我們將為該計劃做出貢獻。但在營運方面，阿斯特捷利康處於領先地位。

In terms of data, I'll ask Mike to comments.

在數據方面，我會請麥克發表評論。

Yeah, so we have reported our data previously, right, that WCLC and particularly in MET driven population. We do see good MET amplified patients, you know, with 50% of our overall response rate and over seven month PFS. So certainly, we are quite excited about this molecule and the clinical data. And so we'll expect the readout, of course, from AstraZeneca, right? Once the data mature later this year, if this is positive or repeat for previous study, previous result is certainly per the agreement with FDA. This will be the NDA some submission package AstraZeneca is going to submit.

是的，我們之前已經報告過 WCLC 的數據，尤其是 MET 驅動族群的數據。您知道，我們確實看到了良好的 MET 擴增患者，其整體緩解率為 50%，PFS 超過 7 個月。當然，我們對這種分子和臨床數據感到非常興奮。所以我們當然會期待來自阿斯特捷利康的讀數，對嗎？一旦今年稍後數據成熟，如果這是積極的或重複先前的研究，先前的結果肯定是根據與 FDA 的協議。這將是阿斯特捷利康將提交的 NDA 提交包。

Great. Thanks.

偉大的。謝謝。

And maybe one quick one, if I can, just on FRUZAQLA. Given you guys are manufacturing for Takeda, what kind of inventory stocking dynamics do you expect is going on? And what kind of inventory levels are you guys shooting for? Thank you.

如果可以的話，也許可以在 FRUZAQLA 上快速介紹一下。鑑於你們正在為武田製造，你們預計會出現什麼樣的庫存動態？你們的庫存水準是多少？謝謝。

And so we are obviously helping Takeda on the manufacturing. I think they are catching up on the inventory. In the early going, it was a pretty thing. I think now pretty much caught up. Kind of the same time, now we are preparing for the European launch and also the Japan launch as well. So we're basically full-time manufacturing for Takeda to support the preparation for launches.

因此，我們顯然正在幫助武田進行製造。我認為他們正在追趕庫存。在早期，這是一件很漂亮的事。我想現在已經差不多了。同時，我們現在正在準備在歐洲和日本的發布。因此，我們基本上是武田的全職製造人員，以支持上市準備工作。

Chen Chen, UBS.

陳晨，瑞銀。

Thank you, management, for taking my questions.

謝謝管理層回答我的問題。

So my first question is on fruquintinib. Well, it has very strong sales momentum in the US. So any chance for us to raise the sales guidance? And also, can management please elaborate a bit more on its EU sales strategy? And can you please also update on the regulatory approval status in China in second-line gastric cancer? That's my first question.

我的第一個問題是關於呋喹替尼。嗯，它在美國的銷售勢頭非常強勁。那我們有機會提高銷售指導嗎？另外，管理階層能否詳細說明一下其歐盟銷售策略？能否介紹一下中國二線胃癌的監管審核情況？這是我的第一個問題。

And my second question is on sovleplenib. I want to know like is China commercial strategy and what is our sales guidance for the first year of commercialization and also any PD progress. And it would be good if we could also elaborate a bit more is US and EU clinical trial plan. Thank you very much.

我的第二個問題是關於 sovleplenib 的。我想知道中國的商業策略是什麼，我們商業化第一年的銷售指導是什麼，以及任何PD進展。如果我們還可以詳細說明美國和歐盟的臨床試驗計劃，那就太好了。非常感謝。

Okay, Thank you very much for the question. While we are happy with the early performance of fruquintinib in the US, Takeda doesn't have any at the moment -- doesn't have any update on the forecast or guidance. So we'll let you know, as soon as we hear from Takeda on that.

好的，非常感謝你的提問。雖然我們對呋喹替尼在美國的早期表現感到滿意，但武田目前沒有任何預測或指導的更新。因此，一旦我們收到武田的相關訊息，我們就會立即通知您。

Regarding Europe, obviously it was approved in late June and we've been supporting Takeda in preparation for launch there. And this going to be country by country. Obviously, pricing negotiation, reimbursement, payer, obviously, it's very complicated. But we do expect a potential launch before end of this year in Europe. And I think Japan will -- at the moment, the NDA review is on track as well.

至於歐洲，顯然它已於 6 月下旬獲得批准，我們一直支持武田準備在歐洲推出。這將是逐個國家的。顯然，定價談判、報銷、付款人，顯然，這是非常複雜的。但我們確實預計今年底前可能會在歐洲推出。我認為日本會—目前，NDA 審查也已步入正軌。

Sovleplenib, obviously, PD discussions are ongoing. We continue to engage with potential partners. And at the same time, we are just focused on clinical development globally or outside China. As Mike mentioned, our dose optimization study kicked off earlier this year and we have multiple centers in US and in Europe now and we are just screening patients and enrolling patients at the moment.

顯然，Sovleplenib 的 PD 討論正在進行中。我們將繼續與潛在的合作夥伴接觸。同時，我們只專注於全球或中國以外的臨床開發。正如麥克所提到的，我們的劑量優化研究於今年稍早啟動，我們現在在美國和歐洲設有多個中心，目前我們只是篩選患者並招募患者。

And I would expect that the business development discussions will continue along with clinical development as we progress through the dose optimization and towards potential registration or kickoff of the registration study. I think that's about clinical development. In terms of China commercialization or China -- preparation for China launch, a lot of work is going on at the moment.

我預計，隨著我們在劑量優化和潛在註冊或註冊研究啟動方面取得進展，業務開發討論將與臨床開發一起繼續進行。我認為這與臨床開發有關。就中國商業化或中國推出的準備而言，目前正在進行大量工作。

As George already pointed out, we are still working on the marketing strategy and also preparing the organization as well. So work is ongoing. At the moment, we don't have any forecast for next year. I think we'll have to walk through the models. And I think a major piece of it will be pricing. At the moment, we are not ready to make any decisions on that yet.

正如喬治已經指出的那樣，我們仍在製定行銷策略並準備組織。所以工作正在進行中。目前，我們對明年沒有任何預測。我認為我們必須遍歷這些模型。我認為其中一個主要部分是定價。目前，我們還沒有準備好就此做出任何決定。

So when we are ready to share, we'll share with everybody via our forecast going forward. So really nothing to share at the moment other than to say, we are working very hard to prepare for the launch.

因此，當我們準備好分享時，我們將透過未來的預測與大家分享。因此，目前確實沒有什麼可分享的，除了說，我們正在非常努力地準備發布。

Yeah, thanks for the information provided and can you also please let us know the regulatory approval status of fruquintinib in second-line gastric cancer? Can we expect anything in August or September?

是的，感謝您提供的信息，您能否讓我們了解一下呋喹替尼用於二線胃癌的監管批准情況？我們能在八月或九月期待什麼嗎？

So all we can say is the NDA review is still ongoing and we don't comment -- we actually can comment on regulatory processes. But maybe, Mike, if you have anything to add, please jump in.

因此，我們只能說 NDA 審查仍在進行中，我們不發表評論——我們實際上可以對監管流程發表評論。但也許，麥克，如果您有什麼要補充的，請加入。

Yeah, I think like Dr. Su said, right, the regulatory is ongoing. We cannot come around. And although we have prepared, I mean, the updates right for additional analysis to CDE, but we anticipate a decision will be Q3 this year.

是的，我想就像蘇博士說的，對，監管正在進行中。我們不能回頭。我的意思是，儘管我們已經準備好對 CDE 進行額外分析的更新，但我們預計將在今年第三季做出決定。

(Event Instructions) Clara Dong, Jefferies.

（活動說明）Clara Dong，Jefferies。

Good morning. This is Clara on for Kelly. Thanks for taking our question and congratulations on all the progress.

早安.這是克拉拉為凱利代言的。感謝您提出我們的問題並祝賀所有的進展。

So just one quick question on fruquintinib. After around 10 months of launch in the US, so obviously, we're seeing really good launch momentum. Wondering have you seen any dynamic of fruquintinib being used in earlier lines in colorectal cancer. And wondering have you and your partner, Takeda, discussed any opportunity for fruquintinib beyond geographic expansion. Like what's the appetite like for potential further development? Thank you.

關於呋喹替尼的一個簡單問題。在美國推出大約 10 個月後，很明顯，我們看到了非常好的推出動能。想知道您是否看到呋喹替尼在結直腸癌早期治療中使用的任何動態。想知道您和您的伴侶武田（Takeda）是否討論過呋喹替尼在地域擴張之外的任何機會。例如對潛在進一步發展的興趣如何？謝謝。

Okay. Yeah, thanks, Clara, for the question. Obviously, you know, US launch is still young and very early into the launch. We don't have any information. Actually Takeda has not shared with us any information regarding usage in earlier lines.

好的。是的，謝謝克拉拉的提問。顯然，你知道，美國的發布還很年輕，而且還處於發布的早期階段。我們沒有任何資訊。實際上，武田尚未與我們分享任何有關早期產品線使用情況的資訊。

With regard to clinical development, maybe Mike, can share more about data generated in China in earlier lines, second line, first line as well as maintenance setting. And these are very -- I think there are a lot of strong data there and we continue to discuss with Takeda how we position in this particular disease segment. Mike?

關於臨床開發，也許Mike可以分享更多關於中國在早期、二線、第一線以及維持環境中產生的數據。我認為這些數據非常有力，我們將繼續與武田討論我們在這一特定疾病領域的定位。麥克風？

Yes. So we have done quite some IIT study in earlier-line setting. First, I think, reported both at ESMO last year and also ASCO-GI and ASCO this year, right? There are first-line maintenance setting combined with capecitabine. We actually see very good tolerability and the long PFS1 to PFS2 that was reported and also in the second-line setting. There are also multiple IITs really working on that combination with standard of care, including for [Ferrari]. And also that was reported -- have a pretty good day overall response rate and the PFS.

是的。所以我們在前期已經做了相當多的IIT研究。首先，我認為去年在 ESMO 以及今年的 ASCO-GI 和 ASCO 上都有報導，對吧？有一線維持設置聯合卡培他濱。實際上，我們在二線治療中看到了非常好的耐受性和較長的 PFS1 至 PFS2。還有多個 IIT 真正致力於將這種方法與標準護理相結合，包括[法拉利]。據報道，這一天的總體回應率和 PFS 都非常好。

So it's certainly the safety for combo is really well. That's really reflect fruquintinib's highly specific by JAK inhibitor and combined with a lot of other therapies, right, PD-1, chemo, or so. And also, we see the combination with PD-1 also see quite good survival data. So we are providing all these information to Takeda and certainly the Takeda team was well (inaudible) and positioning their development down the road.

因此，組合的安全性確實非常好。這確實反映了呋喹替尼透過 JAK 抑制劑的高度特異性，並與許多其他療法結合，對吧，PD-1，化療等等。而且，我們看到與 PD-1 的組合也看到了相當好的生存數據。因此，我們向武田提供所有這些信息，當然，武田團隊做得很好（聽不清楚），並為他們的發展奠定了基礎。

Adam McCarter, Cavendish.

亞當麥卡特，卡文迪許。

Thanks, David. Thanks, everyone. Great representation and obviously, congratulations on the result. Great to see the news on FRUZAQLA and the momentum it's getting in the US.

謝謝，大衛。謝謝大家。很好的代表性，顯然，祝賀結果。很高興看到 FRUZAQLA 的新聞及其在美國的發展勢頭。

I guess, just my first question, really as again just on fruquintinib and the story that's evolving there in gastric cancer. So obviously, not asking the management team to predict the outcome. But I don't know if you could give us an indication of how confident you are in the strength of the data package that has been submitted to the Chinese regulators.

我想，這只是我的第一個問題，同樣是關於呋喹替尼以及胃癌中正在發展的故事。顯然，不要求管理團隊預測結果。但我不知道您是否可以向我們表明您對已提交給中國監管機構的資料包的強度有多大信心。

And then just second question, just on looking at costs going forward to the second half of the year. Obviously, we saw the first period, so quite a reduction in the R&D expenses, but just wanted to see -- understand so how to think about that going forward, obviously, with the initiation of ESLIM-02 and the RAPHAEL Phase 3 studies in the second half of the year? Thank you very much.

然後是第二個問題，就是關於今年下半年的成本。顯然，我們看到了第一階段，因此研發費用大幅減少，但只是想了解如何思考未來，顯然，隨著 ESLIM-02 和 RAPHAEL 第 3 階段研究的啟動，下半年？非常感謝。

Okay. Thanks, Evan, for the questions. Maybe I'll ask Mike to comment on fruquintinib GC and also the RAPHAEL study, and Johnny can comment on cost in -- expected costs in second half. Mike, go first.

好的。謝謝埃文提出的問題。也許我會請 Mike 對 fruquintinib GC 以及 RAPHAEL 研究發表評論，Johnny 可以對下半年的預期成本發表評論。麥克，你先走。

I think we did mention earlier, right, this -- the clinical data was presented at ASCO Plenary and ASCO, right, the data was quite strong. If you can see the response rate, the PFS really doubled and this study was -- it was the design that with PFS and OS -- dual primary endpoint. I just want to emphasize, right, if one of the endpoints is positive, it is considered a [positive] trial.

我想我們之前確實提到過，對吧，這個——臨床數據是在ASCO全會和ASCO上公佈的，對吧，數據是相當強大的。如果你能看到回應率，PFS 確實翻了一番，而且這項研究的設計是 PFS 和 OS 雙重主要終點。我只是想強調，對吧，如果其中一個終點是積極的，那麼它就被認為是一項[積極]試驗。

And the OS in particular, it does not reach the statistical influence significance, but we did observe this as that. The reported OS is actually quite long compared with the -- in the second-line setting. One of the reasons it did not reach statistical significance is really we have reported during the ASCO Plenary and also the publication published in the Nature Medicine.

特別是作業系統，它沒有達到統計影響顯著性，但我們確實觀察到了這一點。與二線設定中的相比，報告的作業系統實際上相當長。它沒有達到統計顯著性的原因之一是我們在 ASCO 全體會議上以及《自然醫學》上發表的出版物中確實進行了報告。

There is the imbalance of the post treatment, right, and there's a significant higher percentage of patients in the placebo arm. Almost 20% higher received the post-treatment therapy. And so this is one region it did not reach statistical significance, because highly, we believe this is clinically relevant numerical increase of OS and there's some fun confounded by the post-trial post-therapy treatment.

治療後存在不平衡，對吧，安慰劑組的患者比例明顯較高。接受治療後治療的人數增加了近 20%。因此，這是一個沒有達到統計顯著性的區域，因為我們高度相信這是 OS 的臨床相關數字增加，而試驗後的治療後治療混淆了一些樂趣。

Okay. So again, the data was submitted and I had also mentioned additional analysis, whatever we reported this CDE, but I cannot comment right about the approval. So I think the decision will come most likely by Q3, yeah.

好的。因此，數據已提交，我還提到了額外的分析，無論我們報告了此 CDE，但我無法對批准發表正確評論。所以我認為這個決定最有可能在第三季做出，是的。

Okay. So on the R&D expenditure, first half, as you can see, we spend about $95 million. Certainly, I think we haven't given any guidance to the market in terms of the total full-year R&D expenditure. But you can expect -- because of the phasing, one should expect that we will continue to invest in our R&D program. So second half, you can expect, we will ramp up more R&D investment, certainly will be more than our first half. So full year, I think, is still within the range that we have basically given some indication earlier that we will continue to invest in a similar level of last year. But certainly, this year although, I think, will be less than last year, slightly. Yeah.

好的。所以在研發支出方面，正如你所看到的，上半年我們花了大約 9500 萬美元。當然，我認為我們在全年研發支出總額方面還沒有給市場任何指引。但你可以預期——由於分階段的緣故，人們應該預期我們將繼續投資於我們的研發計畫。所以下半年，你可以預期，我們將加大研發投入，一定會比上半年更多。我認為，全年仍處於我們之前基本上給出的一些跡象表明我們將繼續以與去年類似水平進行投資的範圍內。但當然，我認為今年會比去年略有減少。是的。

Paul Choi, Goldman Sachs.

保羅‧崔，高盛。

Thank you for taking the questions. Good evening. My first question is just with regard to tazemetostat in China. Can you comment first on your appetite to explore in additional indications beyond follicular lymphoma, particularly either post BTK or post post-BCL? It seems like there's logic to target opportunities like double-hit lymphoma and others other lymphomas.

感謝您提出問題。晚安.我的第一個問題是關於他澤美司他在中國的問題。您能否先評論一下您對探索濾泡性淋巴瘤以外的其他適應症的興趣，特別是 BTK 後或 BCL 後？似乎有邏輯可以針對雙重打擊淋巴瘤和其他淋巴瘤等機會。

And then second, in terms of the cadence of development for savolitinib, I know you obviously targeted ITP first here and just on the cadence, but if you maybe also comment on what the cadence of what we should expect next in terms of development might be? Thank you.

其次，就沃利替尼的開發節奏而言，我知道您顯然首先針對的是 ITP，而且只是節奏，但如果您也評論一下我們接下來在開發方面應該期望的節奏可能是什麼？謝謝。

Okay, Mike, why don't you take first comment on this?

好吧，麥克，你為什麼不先對此發表評論呢？

Yeah. Thank you, Paul. I think tazemetostat is certainly first-in-class EZH2 inhibitor. And to follow your question, not only in that, our of filing is the third-line follicular lymphoma. It was based on the bridging study or the global study. And we are also currently doing a second-line volatility format, along with our partner, Ipsen. This is a global Phase 3 trial. In the second-line FL, we are we are working together with Ipsen on enrolling a Phase 3 trial is tazemetostat, combined with R square versus R square. So this is certainly a big indication to expand the indication.

是的。謝謝你，保羅。我認為他澤美司他無疑是一流的 EZH2 抑制劑。依照你的問題，不只如此，我們的申請是第三線濾泡性淋巴瘤。它是基於橋接研究或全球研究。我們目前也與我們的合作夥伴 Ipsen 一起開發二線波動率格式。這是一項全球 3 期試驗。在二線 FL 中，我們正在與 Ipsen 合作進行 tazemetostat 的 3 期試驗，並結合 R square 與 R square 進行比較。所以這無疑是擴大適應症的一大跡象。

And also, currently, we, are at least or mechanistically, we're evaluating other opportunity for this indication. We have some combination study exploring the PI3K. combination with tazemetostat. And certainly, Ipsen has done quite some exploratory study before. So we are working with Ipsen to address any of the new indication development.

而且，目前，我們至少或機械地正在評估該適應症的其他機會。我們進行了一些探索 PI3K 的組合研究。與他澤美司他聯用。當然，伊普森之前已經做過相當多的探索性研究。因此，我們正在與 Ipsen 合作解決任何新適應症的開發問題。

And sovleplenib internationally, right, because certainly, we see the ITP durable response rate, 48% is really robust comparable with any of these ITP treatment because this agonism, we believe it is actually quite unique, blocking the phagocytosis, through the Syk inhibition, and also working on the B-cell to reduce the autoantibody production. So certainly, this is a dual mechanism. Really explain this superiority compared with other molecule. And also, particularly, we are excited about -- these patients are -- over 75% actually treated with the TPO/TPO-RA. Average prior line of therapy is four line.

Sovleplenib 在國際上是對的，因為當然，我們看到ITP 持久反應率，48％，與任何這些ITP 治療相比，確實很穩健，因為這種激動作用，我們相信它實際上是相當獨特的，透過Syk 抑制阻斷吞噬作用，也致力於 B 細胞以減少自體抗體的產生。當然，這是一個雙重機制。真實地解釋了與其他分子相比的這種優越性。而且，我們特別感到興奮的是，這些患者中超過 75% 的患者實際上接受了 TPO/TPO-RA 治療。平均先前的治療線為四條線。

So certainly, ITP is a first indication, but we believe this go far beyond that. And (inaudible) also currently we're doing this trial in China, and this is certainly a high unmet need because there just no standard therapy second-line therapy globally, nothing, yeah. And so this is certainly a great indication to continue to develop it for the registration path. And also, we are working.

當然，ITP 是第一個跡象，但我們相信這遠遠不止於此。（聽不清楚）目前我們也在中國進行這項試驗，這肯定是一個未滿足的需求，因為全球範圍內沒有標準的二線治療，沒有，是的。因此，這無疑是繼續開發註冊路徑的一個很好的跡象。而且，我們正在工作。

We think the Syk pathway is a -- has a lot of opportunity, autoimmune disease, rheumatoid arthritis, whereas all the other indication. So we think, certainly, we are working additional possible Park trial to further explore the opportunity for sovleplenib.

我們認為 Syk 途徑有很多機會，如自體免疫疾病、類風濕性關節炎，而所有其他適應症。因此，我們認為，當然，我們正在進行更多可能的 Park 試驗，以進一步探索 sovleplenib 的機會。

Thanks, Mike. I just want to add, though, Paul, regarding tazemetostat, yes, we have, at the moment, follicular and epithelioid sarcoma but there has been quite some progress in clinics in solid tumors, including Pfizer's recent report on CRPC. So internally, we are looking at these various potential solid tumors, obviously, biomarker-driven both in addition to CRPC, potentially ovarian, small cell lung cancer, and so forth. So for this, I think, it would be even more exciting than the third-line follicular where it's been -- obviously, it's getting quite crowded there.

謝謝，麥克。Paul，我只想補充一點，關於他澤美司他，是的，目前我們有濾泡性和上皮樣肉瘤，但實體腫瘤臨床已經取得了相當大的進展，包括輝瑞最近關於 CRPC 的報告。因此，在內部，我們正在研究這些各種潛在的實體腫瘤，顯然，除了 CRPC、潛在的卵巢癌、小細胞肺癌等之外，生物標記驅動的實體瘤。因此，我認為，這將比三線卵泡更令人興奮——顯然，那裡變得非常擁擠。

But still, tazemetostat has a great safety profile, can be combined with many other therapies in the second-line setting in combination with R square, for instance, well-tolerated and in the dose optimization study and also early proof of concept, great data there as well. So we think it's got great potential.

但是，他澤美司他仍然具有很好的安全性，可以與二線治療中的許多其他療法與R 方結合使用，例如，耐受性良好，並且在劑量優化研究中以及早期概念驗證和大量數據中那裡也有。所以我們認為它具有巨大的潛力。

(Event Instructions) [Yang Jing], Shanghai Pudong Development Bank.

（活動說明）【楊靜】，上海浦東發展銀行。

Thanks management for taking my questions. Congratulations on the strong results. I've got two quick questions.

感謝管理層回答我的問題。祝賀取得了優異的成績。我有兩個簡單的問題。

The first one was on fruquintinib. We have seen strong US sales. I'm wondering you tend to have shared with us the doctors' feedback on fruquintinib. So in terms of the patient's constitutions, have we seen more patients which -- who are relapsed from the long serve or the new third-line CRC patients, who never used long serve before?

第一個是呋喹替尼。我們看到美國的銷售強勁。我想知道您是否願意與我們分享醫生對呋喹替尼的回饋。那麼從患者的體質來看，我們是否看到更多的長期服藥後復發的患者，或者以前從未使用過長期服藥的新三線CRC患者？

And regarding for the quarterly sales trajectory of fruquintinib, considering we have our Europe approval already and also Japan imminent approval, how do we think about the quarterly sales trajectory for the oversea sales of fruquintinib? What are our current sales guidance for the overseas fruquintinib?

至於呋喹替尼的季度銷售軌跡，考慮到我們已經在歐洲獲得批准，並且日本即將獲得批准，我們如何看待呋喹替尼海外銷售的季度銷售軌跡？目前我們對海外呋喹替尼的銷售指導是怎麼樣的？

And the second question is about our bottom line because we are surprised to see that company has achieved that net income in the first half. And in the opening remark, I believe we mentioned that HUTCHMED achieved breakeven ahead of our guidance year 2025. So does that mean we will achieve breakeven 2024 and turn profitable in afterwards?

第二個問題是關於我們的利潤，因為我們很驚訝地看到該公司在上半年實現了淨利潤。在開場白中，我相信我們提到 HUTCMED 在我們的指導年 2025 年之前實現了盈虧平衡。那麼這是否意味著我們將在 2024 年達到收支平衡並隨後轉虧為盈？

These are my two questions. Thanks, management.

這是我的兩個問題。謝謝，管理層。

Okay. Thanks for your question. So with regard to patient mix in the US, we have no clarity at the moment as Takeda hasn't shared with us. But in the FRESCO-2 study, obviously the study population was patients who already failed long serve or STIVARGA. So I mean, still clearly demonstrated clinical benefit for those patients. So obviously, in the US, we worked with the US FDA to use -- the China study, FRESCO, and also the global study, FRESCO-2, to support third-line approval.

好的。謝謝你的提問。因此，關於美國的患者組合，我們目前還不清楚，因為武田沒有與我們分享。但在FRESCO-2研究中，顯然研究族群是長期服藥或STIVARGA已經失敗的患者。所以我的意思是，仍然清楚地證明了對這些患者的臨床益處。顯然，在美國，我們與美國 FDA 合作，利用中國研究 FRESCO 以及全球研究 FRESCO-2 來支持三線審批。

Clearly, fruquintinib has a very unique pharmacological profile. Even patients failed on STIVARGA can still benefit from the fruquintinib treatment. So although we don't have any clarity as to how many patients treated so far in the US are fourth line and how many are third line, so at the moment, we don't have the information.

顯然，呋喹替尼具有非常獨特的藥理學特徵。即使 STIVARGA 治療失敗的患者仍可從呋喹替尼治療中受益。因此，儘管我們不清楚迄今為止在美國接受治療的患者中有多少是四線患者，有多少是第三線患者，所以目前我們沒有資訊。

With regard to full-year guidance, as I mentioned -- alluded to earlier, Takeda

關於全年指導，正如我之前提到的，武田

has not shared with us any updated version of the guidance. So we don't have anything to share. I think if you looked at Takeda's report -- their quarterly report just came out today. They say they expect their oncology sales as a whole, I guess majority would be -- the vast majority would be fruquintinib. They expect more than 100% growth this year. So we don't have any more specific guidance to share at the moment.

尚未與我們分享該指南的任何更新版本。所以我們沒有什麼可以分享的。我想如果你看過武田的報告——他們的季度報告今天剛發布。他們說他們預計他們的腫瘤學銷售作為一個整體，我想大多數是——絕大多數是呋喹替尼。他們預計今年的成長將超過 100%。因此，我們目前沒有任何更具體的指導可以分享。

The bottom line $20 million, $25 million profit. It was a lot of effort internally from cost savings to maximizing the commercial values for all compounds. Again, as I pointed out early on that our previous target was end of 2025 to a breakeven or to reach profitability. I think we are well on our way. I think we probably will achieve that ahead of '25, super sure.

底線 2000 萬美元，利潤 2500 萬美元。從節省成本到最大化所有化合物的商業價值，內部付出了巨大的努力。正如我早些時候指出的，我們先前的目標是在 2025 年底實現收支平衡或實現盈利。我認為我們進展順利。我認為我們可能會在 25 年前實現這一目標，非常確定。

Julie Simmonds, Panmure Liberum.

朱莉‧西蒙茲，《潘穆爾‧自由》。

Thank you very much. I was just wondering with the reduction in R&D expenditure in the first half of the year and sort of maybe a slight reorganization of the focus away from ex-China trials, does that affect any of your earlier stage programs? Because clearly, we got quite good visibility into the later stage ones, but does it change the balance of web spending as going?

非常感謝。我只是想知道，上半年研發支出的減少，以及可能將重點從中國以外的試驗上稍微調整一下，這是否會影響你們的早期項目？因為顯然，我們對後期階段有了很好的了解，但這是否會改變網路支出的平衡？

Okay. Thanks, Julie, for the question. I think, obviously, we do routine portfolio prioritization, but any program was investing, we fully support. I don't think we are terminating all the early programs. So if anything, the portfolio prioritization is a largely driven by data and by prospects. So really not so much about purely cost savings at all. If anything, we just initiated the Phase 1 study on our menin inhibitor, which we think is a great compound, has best-in-class potential in the class. And we are building actually an AML strategy.

好的。謝謝朱莉的提問。我認為，顯然，我們會進行常規投資組合優先排序，但任何項目都是投資，我們完全支持。我不認為我們會終止所有早期計劃。因此，如果有的話，投資組合的優先順序很大程度上是由數據和前景驅動的。所以其實根本不是純粹的節省成本。如果有什麼不同的話，那就是我們剛剛啟動了 Menin 抑制劑的一期研究，我們認為這是一種很棒的化合物，在同類藥物中具有最佳的潛力。我們實際上正在製定反洗錢策略。

So our precision on the portfolio prioritization is largely data driven and also driven by our portfolio. As we always communicated, we are more like a pipeline company instead of just targets. We don't necessarily chase the hot targets. Instead we look at our pipeline, look at what we have, what additional targets or compound that we need to better cover the tumor types and address clinical needs.

因此，我們對投資組合優先順序的精確度很大程度上是由數據驅動的，也是由我們的投資組合所驅動的。正如我們一直以來所傳達的那樣，我們更像是一家管道公司，而不僅僅是目標公司。我們不一定要追逐熱門目標。相反，我們會審視我們的產品線，看看我們擁有什麼，我們需要哪些額外的標靶或化合物來更好地涵蓋腫瘤類型並滿足臨床需求。

So that said, basically, the answer -- the short answer is that we may delay a few specific programs that we think the data will support or the data is not clear. But by and large, we continue to invest in China.

也就是說，基本上，答案是——簡短的答案是，我們可能會推遲一些我們認為數據會支持或數據不清楚的特定計劃。但總的來說，我們繼續在中國投資。

(Event Instruction) And so Dr. Su, I have one quick question on the Q&A box. Maybe I'll just read it out. So the question is regarding our cash balance that, you know, we have been quite well positioned and going to be profitable. Has the Board considered how to use this surplus capital? Would it be -- how will we deploy to further business development or will be returned to shareholders? Dr. Su?

（活動說明）蘇博士，我有一個關於問答框的簡單問題。也許我會把它讀出來。所以問題是關於我們的現金餘額，你知道，我們已經處於有利地位並且將實現盈利。董事會有沒有考慮如何使用這筆盈餘資本？我們將如何部署以進一步發展業務，或將如何回報股東？蘇醫生？

I mean, we do have a very strong cash position with over $800 million in cash at the moment. However, we anticipate it gradually increase our investments in programs in R&D and also in our commercialization as well to better cover immunology section, for instance.

我的意思是，我們目前的現金狀況確實非常強勁，超過 8 億美元。然而，我們預計它將逐漸增加對研發項目和商業化的投資，以便更好地涵蓋免疫學等領域。

I think it's just some more of capital management, if you will. So we clearly will continue to invest heavily in R&D, preparing for the future. I talked about the path to profitability and beyond and all the way beyond 2027, '28. But we have a lot coming, very exciting programs from our discovery. I anticipate, certainly, the investment in R&D will gradually increase over the next few years. We do have a lot coming very exciting stuff in discovery.

如果你願意的話，我認為這只是更多的資本管理。因此，我們顯然將繼續大力投資研發，為未來做好準備。我談到了盈利之路以及更遠的未來，一直到 2027 年，'28。但我們的發現有很多即將到來的、非常令人興奮的項目。當然，我預計未來幾年研發投資將逐漸增加。我們確實有很多令人興奮的發現。

Thank you, Dr. Su. And then another question on the line is regarding our European launch. Of course, this will be depending on our partner. So the question is while we await the outcome individual country reimbursement decision, will there be any possible sales happening before the reimbursement decision has been made? Does it mean that we have to wait till much later this year or maybe next year before the sales can happens from Europe?

謝謝你，蘇博士。另一個問題是關於我們在歐洲的推出。當然，這取決於我們的合作夥伴。因此，問題是，當我們等待各國報銷決定的結果時，在報銷決定做出之前是否會發生任何可能的銷售？這是否意味著我們必須等到今年稍後或明年才能從歐洲進行銷售？

I mean, it goes country by country, I guess. I think Takeda is working simultaneously with all these EU countries. In some countries, the process is shorter. In other countries, it can take longer, but you need to gain country level approval before you can launch in these countries. At the moment, EU recommended, but still approved -- but still need to work at a country level. They are working very hard and this launch as well, we'll come and we'll start later this year.

我的意思是，我猜它會逐個國家進行。我認為武田正在與所有這些歐盟國家同時合作。在一些國家，這個過程更短。在其他國家/地區，可能需要更長的時間，但您需要獲得國家/地區級別的批准才能在這些國家/地區推出。目前，歐盟建議，但仍獲得批准——但仍需要在國家層級開展工作。他們工作非常努力，這次發布也是如此，我們會來，我們將在今年晚些時候開始。

Thank you, Dr. Su. We don't have any more questions on the line. Dr. Su, would you like to make some concluding remarks?

謝謝你，蘇博士。我們沒有其他問題了。蘇博士，您能做一下總結嗎？

Sure. I just want to thank everyone again for attending the call. Clearly, as you can see, we are executing well on our strategy towards profitability. We made huge progress and we had a very strong first half of this year, and we expect the momentum to continue. And again, thank you very much for attending the call.

當然。我想再次感謝大家參加這次電話會議。顯然，正如您所看到的，我們在盈利策略方面執行得很好。我們取得了巨大進步，今年上半年表現非常強勁，我們預計這一勢頭將繼續下去。再次非常感謝您參加這次電話會議。

With that, it concludes our '24 interim result presentation. And if you have any further questions, please feel free to e-mail us and talk to our IR team. Thank you very much, everyone.

我們的 24 年中期業績介紹到此結束。如果您還有任何其他問題，請隨時給我們發送電子郵件並與我們的 IR 團隊聯繫。非常感謝大家。