HUTCHMED (China) Ltd (HCM) 2023 Q4 法說會逐字稿

Good day and thank you for standing by. Welcome to HUTCHMED 2023 full year financial results conference call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. (Operator Instructions) Please be advised that today's conference is being recorded.

美好的一天，感謝您的支持。歡迎參加 HUTCMED 2023 全年財務績效電話會議。此時，所有參與者都處於只聽模式。演講者演講結束後，將進行問答環節。（操作員指示）請注意，今天的會議正在錄製中。

I'd now like to pass the call over to your first speaker today, Mr. Mark Lee, Senior Vice President, Corporate Managements and Communications of HUTCHMED. Thank you. Please go ahead.

現在我想將電話轉給今天第一位發言者，HTCHMED 企業管理和傳播部高級副總裁 Mark Lee 先生。謝謝。請繼續。

Thank you, Devon. Welcome, everybody. Good morning, good afternoon, and good evening. Just a brief message as usual, the performance results and operations of HUTCHMED are historic in nature and past performance is no guarantee of the future.

謝謝你，德文郡。歡迎大家。早安，下午好，晚上好。像往常一樣，只是簡短的訊息，HTCHMED 的業績結果和營運本質上是歷史性的，過去的業績並不能保證未來。

We've got forward-looking statements, which mean within the meaning of the Safe Harbor provisions of the US SEC, it's -- this presentation is for investors only and information on pharmaceuticals are not intended as advertising or medical advice.

我們有前瞻性聲明，這意味著在美國證券交易委員會安全港條款的含義內，本簡報僅供投資者使用，有關藥品的資訊無意作為廣告或醫療建議。

The presentation contains statistical and other third-party data which we have not independently verified, so we can't guarantee on their accuracy. Nothing in this presentation constitutes an offer to -- for sale of shares. No representation warranty is implied on this information. And anything in this presentation should be read in conjunction with HUTCHMED's results for the year ended December 31, 2023.

該簡報包含我們尚未獨立驗證的統計數據和其他第三方數據，因此我們無法保證其準確性。本簡報中的任何內容均不構成出售股份的要約。此資訊不暗示任何陳述保證。本簡報中的所有內容應與 HUTCMED 截至 2023 年 12 月 31 日的年度表現結合閱讀。

So with that, I'd like to hand over to Dr. Weiguo Su, our CEO and Chief Scientific Officer. Weiguo?

接下來，我想將工作交給我們的執行長兼首席科學官蘇衛國博士。衛國？

Thank you very much, Mark. Good evening, good morning, and welcome again to HUTCHMED 2023 annual results presentation. 2023 was an exceptional year for HUTCHMED. We focused on fruquintinib global registration and launch with our partner, Takeda, while continuing to execute on our strategy towards profitability.

非常感謝你，馬克。晚上好，早安，歡迎再次來到 HTCHMED 2023 年度業績發表會。 2023 年對 HTCHMED 來說是不平凡的一年。我們與合作夥伴武田一起專注於呋喹替尼的全球註冊和上市，同時繼續執行我們的獲利策略。

This is a year where we made significant progress. The pipeline progresses significantly now more significant than the US approval of fruquintinib for advanced CRC, a historic milestone for HUTCHMED. Financially, we ended 2023 with a very strong cash position, thanks to the Takeda partnership and also strong growth from our China commercial operations.

今年是我們取得重大進展的一年。該管道目前的進展比美國批准呋喹替尼用於晚期結直腸癌更重要，這是 HUTCMED 的歷史性里程碑。在財務方面，由於武田的合作夥伴關係以及我們中國商業業務的強勁增長，我們在 2023 年結束時擁有非常強勁的現金狀況。

Next slide is slide number four. Let me quickly introduce the agenda today. So Johnny Cheng, our CFO, will go through the financial results for the full year 2023, followed by commercial update. Mr. Chen Hong is not available today and Johnny will cover for him.

下一張投影片是第四張投影片。我先簡單介紹一下今天的議程。因此，我們的財務長 Johnny Cheng 將審查 2023 年全年的財務業績，然後進行商業更新。陳宏先生今天沒空，強尼將代替他。

And next will be Dr. Wu, who will be giving a manufacturing update, particularly on our new facility and also our global supply strategy, followed by Michael Shi, who will be giving an update on our late-stage pipeline and a wrap up -- I'll wrap it up -- followed by Q&A. And for the Q&A, the full team will be available.

接下來是吳博士，他將介紹製造方面的最新情況，特別是我們的新工廠以及我們的全球供應策略，隨後是 Michael Shi，他將介紹我們後期管道的最新情況並進行總結 - - 我將結束它- 接下來是問答。對於問答環節，整個團隊都將出席。

So now, for details of all the updates, let me invite our CFO, Johnny, for financial results. Johnny?

現在，為了了解所有更新的詳細信息，讓我邀請我們的財務長約翰尼來了解財務業績。強尼？

Thank you, Dr. Su. And can we turn to page 6? So yeah, Page 6, please. I think the screen is not moving. Yeah. Next page.

謝謝你，蘇博士。我們可以翻到第 6 頁嗎？是的，請看第 6 頁。我認為螢幕沒有動。是的。下一頁。

Okay. So we have a strong cash position at end of last year with over $880 million cash contributed by $400 million of upfront payment from Takeda. So for which we have recognized $280 million with the remaining $120 million to be recognized over the course of the next three years. Can we move to the next page, please?

好的。因此，截至去年年底，我們擁有強勁的現金狀況，武田公司預付款 4 億美元，提供了超過 8.8 億美元的現金。因此，我們已確認 2.8 億美元，其餘 1.2 億美元將在未來三年內確認。我們可以轉到下一頁嗎？

Page 7. The screen is not moving so. Okay. So our operating performance -- yeah, our operating performance, we have -- regarding the top line, we have doubled the total revenue from last year to over $830 million. So oncology consolidated revenue was around $530 million, which met the high end of our guidance.

第 7 頁。螢幕就這樣不動了。好的。因此，我們的經營業績——是的，我們的經營業績——就營收而言，我們的總收入比去年翻了一番，達到超過 8.3 億美元。因此，腫瘤學綜合收入約為 5.3 億美元，達到了我們指導的上限。

As to the bottom line, we made a sizable profit of over $100 million contributed by restructuring of our US commercial operation, prioritizing R&D investments and tightly controlling operating expenses.

就利潤而言，我們透過美國商業營運重組、優先研發投資和嚴格控制營運費用貢獻了超過 1 億美元的可觀利潤。

Moving on to the next page. Our 2024 oncology guidance, page 8. So our 2024 oncology guidance is $300 million to $400 million driven by 30% to 50% growth targets for market and product revenue. This guidance is in line with our 2023 product revenue growth of 39%.

轉到下一頁。我們的 2024 年腫瘤學指南，第 8 頁。因此，我們的 2024 年腫瘤學指引為 3 億至 4 億美元，由市場和產品收入成長 30% 至 50% 的目標推動。該指引與我們 2023 年 39% 的產品收入成長相符。

Move on to the next page, page 9. A quick update on the sales of our FRUZAQLA in US. Takeda achieved $15 million in market sales in the last seven weeks of '23 after FDA approval. So we are now waiting for approval from EU and Japan targeted sometime later this year.

轉到下一頁，第 9 頁。FRUZAQLA 在美國的銷售情況快速更新。FDA 批准後，武田在 23 年最後七週內實現了 1500 萬美元的市場銷售額。因此，我們現在正在等待歐盟和日本的批准，目標是在今年稍後。

As shown in the bar chart below (multiple speakers) Yeah. We are on page 9. Correct. So as shown in the bar chart below, besides the US, there is a significant unmet medical need in EU and Japan for CRC patients.

如下長條圖所示（多個發言者） 是啊。我們在第 9 頁。正確的。因此，如下條形圖所示，除了美國之外，歐盟和日本的結直腸癌患者的醫療需求也存在顯著的未滿足的需求。

Okay. So we move onto the commercial on page -- the next page, page 11. So China commercial environment, just to give you all a quick update, a number of new policies have been issued recently to support quicker access to innovative medicines. So for example, accelerating the review process for breakthrough designated drugs and simplifying the NRDL renewal process.

好的。因此，我們轉到第 11 頁的廣告。那麼中國的商業環境，給大家快速通報一下，最近發布了一些新的政策來支持更快地獲得創新藥物。例如，加快突破性指定藥物的審查流程，簡化國家醫保目錄更新流程。

On the right-hand side of the chart, you can see we have scaled up our commercial presence, deepening hospital penetration, also expanding pharmacy coverage.

在圖表的右側，您可以看到我們擴大了商業影響力，加深了醫院滲透率，同時擴大了藥房覆蓋範圍。

Turn to the next page, page 12. For ELUNATE performance, we have continued to grow our business and achieved over $100 million in market sales in 2023.

翻到下一頁，第 12 頁。對於 ELUNATE 的業績，我們不斷發展業務，並在 2023 年實現了超過 1 億美元的市場銷售額。

On the right-hand side, as you can see, we have further expanded our market share over STIVARGA.

在右側，如您所見，我們進一步擴大了 STIVARGA 的市場份額。

Moving on to SULANDA, next page, page 13. We were able to maintain strong growth for this product, achieving 43% growth versus last year. On the right hand side of the chart -- actually, we should be on page 13. On the right hand side of page 13, as you can see, we are widening our lead over Sutent and Afinitor in terms of market share.

轉到 SULANDA，下一頁，第 13 頁。我們能夠維持該產品的強勁成長，與去年相比實現了 43% 的成長。在圖表的右側—實際上，我們應該在第 13 頁。在第 13 頁的右側，如您所見，我們正在擴大我們在市場份額方面對索坦和飛尼妥的領先優勢。

Moving on to ORPATHYS. Page 14. This is a product commercialized by AstraZeneca and was admitted to NRDL in March '23. They have overall achieved a 19% growth despite a 38% price reduction after NRDL inclusion. So looking forward, based on strong clinical results from the confirmatory study, we may have a potential label expansion to first-line later this year, which could drive stronger sales growth.

繼續討論 ORPATHYS。第 14 頁。這是阿斯特捷利康商業化的產品，並於2023年3月進入國家健保目錄。儘管納入國家醫保目錄後價格下降了 38%，但它們總體實現了 19% 的增長。因此，展望未來，基於驗證性研究的強有力的臨床結果，我們可能會在今年稍後將標籤擴展到一線，這可能會推動更強勁的銷售成長。

I will now pass on to Dr. Wu to give you an update on our manufacturing operation. Dr. Wu?

現在我將請吳博士向您介紹我們製造業務的最新情況。吳醫生？

Thank you, Johnny. Let's go to slide number 16. As you will hear throughout today's presentation, what we are typically trying to do is to; one, increase number of products in the market in different indications; and two, try to expand into other markets. So our manufacturing strategy is try to support this goal for the company. So in the last year 2023, we've been focusing on expanding our capacity for both China and the global market.

謝謝你，強尼。讓我們來看第 16 張投影片。正如您將在今天的演示中聽到的那樣，我們通常想做的是：一、增加市面上不同適應症的產品數量；第二，嘗試擴展到其他市場。所以我們的製造策略就是努力支持公司的這個目標。所以在2023年的最後一年，我們一直專注於擴大在中國和全球市場的產能。

The first thing we would like to update you is our Shanghai facility, and we have completed the facility construction and qualification. So now we're in a very good position to leverage this brand new facility, which will give us five times more capacity. And we intend to have clinical supply made here this year. And also, we're doing work to enable us to commercial supplies from this facility to be ready in 2025.

我們首先要向您介紹的是我們的上海工廠，我們已經完成了工廠建設和資格認證。因此，現在我們處於非常有利的位置，可以利用這個全新的設施，這將使我們的產能增加五倍。我們打算今年在這裡進行臨床供應。此外，我們正在努力使該設施的商業供應能夠在 2025 年準備就緒。

Another area we've been focusing on is to establish a global supply chain. As you know, we have our fourth product launched in the US. And so we have done well in this regard with our API CMO in China qualified for the US. market. For the drug product, we actually have two sites qualified. Our Suzhou site, it's our own facility, which we passed pre-approval and inspection by the FDA that was qualified.

我們一直關注的另一個領域是建立全球供應鏈。如您所知，我們在美國推出了第四種產品。所以我們在這方面做得很好，我們在中國的 API CMO 獲得了美國的資格。市場。對於藥品，我們實際上有兩個合格的地點。我們蘇州工廠，是我們自己的工廠，我們通過了FDA的預審和檢查，是合格的。

We also qualified a site in Switzerland as CMO that will supply a drug to the US market. As we gain approval for the EU and Japan, this supply chain will also be ready for making supplies for those markets. And last, I want to mention that in this new Shanghai facility, we have installed a solar panel so we could reduce our electricity usage and also reduce the emission, and that's always a part of our ongoing efforts. Thank you.

我們還在瑞士的一個工廠獲得了 CMO 資格，該工廠將向美國市場供應藥物。隨著我們獲得歐盟和日本的批准，該供應鏈也將準備好為這些市場提供供應。最後，我想提一下，在上海的這個新工廠中，我們安裝了太陽能板，這樣我們就可以減少用電量並減少排放，這始終是我們持續努力的一部分。謝謝。

And now I would like to introduce Dr. Shi, who is going to teach you -- tell you about our pipeline. Mike?

現在我想介紹一下石博士，他將教你——告訴你我們的管道。麥克風？

Thank you, Dr. Wu. And slide 18, please. Our clinical program continues to grow and mature and cover a broad spectrum of hematology and oncology product. And here, the slides on showing the 15-plus ongoing registration for the 7 leading product globally.

謝謝吳醫生。請幻燈片 18。我們的臨床計畫不斷發展和成熟，涵蓋廣泛的血液學和腫瘤學產品。這裡的幻燈片顯示了全球 7 個領先產品的 15 多個正在進行的註冊。

And just to highlight a few key milestone. And in addition, fruquintinib approval in the US last year and the EU filing and the Japan NDA submission, we also make a tremendous advancement in the life cycle indication, fruquintinib NDA for second-line gastric cancer accepted for review in China and also the pivotal Phase II for our second-line endometrial cancer and a Phase III renal cancer in combination with sintilimab also completed recruitment. And we expect an NDA filing early for 2024 for EMC and top-line results for the RCC in the end of 2024.

只是為了強調幾個關鍵的里程碑。另外，呋喹替尼去年在美國獲批以及歐盟備案和日本新藥申請，我們在生命週期適應症上也取得了巨大進展，呋喹替尼二線胃癌新藥在中國接受審評，也是關鍵的藥物。我們的二線子宮內膜癌的II 期試驗和與信迪利單抗聯合治療的III 期腎癌試驗也完成了招募。我們預計 EMC 將於 2024 年初提交新藥申請 (NDA)，RCC 將於 2024 年底獲得頂線結果。

And also for savolitinib, an exon 14 non-small cell lung cancer confirmatory trial Phase III already achieved a positive result and we expect the NDA filing early '24 and including the new label expansion in the first-line setting. And also -- our partner, AstraZeneca, also had a pivotal global Phase II trial, SAVANNAH, completed recruitment and also the potential US filing around the end of 2024.

對於沃利替尼來說，外顯子 14 非小細胞肺癌驗證性試驗 III 期已經取得了積極的結果，我們預計 NDA 將於 24 年初提交，並包括在一線環境中擴展新標籤。此外，我們的合作夥伴阿斯特捷利康 (AstraZeneca) 也進行了一項關鍵的全球 II 期試驗 SAVANNAH，已完成招募，並可能於 2024 年底左右在美國提交申請。

And also, we are very pleased that sovleplenib, our novel Syk inhibitor and for the primary immune thrombocytopenia, the ESLIM-01 trial also achieved positive Phase III and the NDA acceptance and granted a priority review in China.

此外，我們非常高興的是，我們的新型Syk 抑制劑sovleplenib 和針對原發性免疫性血小板減少症的ESLIM-01 試驗也取得了積極的III 期臨床試驗和NDA 受理，並在中國獲得優先審查。

So it will be also achieved a positive Phase II readout for sovleplenib in another autoimmune indication, warm autoimmune hemolytic anemia and the Phase III will start in quarter one this year. And the other product, the bridging study for tazemetostat, our in-licensed product from Ipsen, will have the readout and potential filing later this year.

因此，sovleplenib 在另一種自體免疫適應症（溫熱自體免疫溶血性貧血）的 II 期試驗中也將取得積極成果，而 III 期試驗將於今年第一季開始。另一種產品，即 tazemetostat 的橋接研究，我們從 Ipsen 獲得許可的產品，將於今年稍後公佈結果並可能提交申請。

And also, multiple life cycle indications launched product and the late-stage asset in registration trial expected to readout and file NDAs for 2025 and '26 in the timeframe, so paving the way for accelerated growth in the 2025 and beyond. And I also want to provide an update for another hematology product, amdizalisib, our PI3K inhibitor. And in view of the changing regulatory environment, we are currently evaluating the clinical development plan and the regulatory path before designing regulatory strategy for indication.

此外，多個生命週期適應症推出的產品和註冊試驗中的後期資產預計將在 2025 年和 26 年的時間內讀出並提交 NDA，從而為 2025 年及以後的加速增長鋪平道路。我還想提供另一种血液學產品 amdizalisib（我們的 PI3K 抑制劑）的更新。並且鑑於不斷變化的監管環境，我們目前正在評估臨床開發計劃和監管路徑，然後設計適應症的監管策略。

Let's move to Slide 19. And also, I want to highlight the fruquintinib China second-line gastric cancer trial. And this has been -- let's go to Slide 19, please. I don't see the advancement.

讓我們轉到投影片 19。另外，我想重點介紹一下呋喹替尼中國二線胃癌試驗。現在，請讓我們轉到投影片 19。我沒有看到進步。

So gastric cancer is expanding globally and newly diagnosis case over 1 million and China is really accounting for 44% of global new cases. And treatment option is very limited in the second-line gastric setting, representing an urgent unmet medical need. So the FRUTIGA trial is designed to treat the fruquintinib in combination with paclitaxel in this second-line gastric cancer. So we could have passed 700 patients, and this, we're hoping to expand the new indication.

因此，胃癌在全球範圍內不斷擴大，新增確診病例超過100萬，而中國確實佔全球新增病例的44%。二線胃病的治療選擇非常有限，代表著迫切的未滿足的醫療需求。因此，FRUTIGA 試驗旨在將呋喹替尼與紫杉醇合併治療這種二線胃癌。所以我們可能已經超過了 700 名患者，我們希望擴大新的適應症。

So slide 20 highlights some of the top-line results for FRUTIGA. And trial results was selected for ASCO Plenary presentation. Slide 20, please. Fruquintinib plus paclitaxel almost doubled the progression-free survival and -- from 2.7 months to 5.6 months, hazard ratio of [0.56] with a p-value less than 0.0001. And the Kaplan-Meier curve show an early separation in favor of fruquintinib plus paclitaxel group and also maintain over the duration of the study. And this improvement of PFS is not only statistically significant, but also clinically better meaningful.

因此，幻燈片 20 重點介紹了 FRUTIGA 的一些主要業績。試驗結果被選為 ASCO 全體會議報告。請投影片 20。呋喹替尼合併紫杉醇使無惡化存活期幾乎翻倍，從 2.7 個月延長至 5.6 個月，風險比為 [0.56]，p 值小於 0.0001。 Kaplan-Meier 曲線顯示早期分離有利於呋喹替尼加紫杉醇組，在研究期間也保持不變。而PFS的這種改善不僅具有統計意義，在臨床上也更有意義。

And next slide, slide 21. And for overall survival, the other dual-primary endpoint, we see fruquintinib plus paclitaxel prolong OS from 8.4 to 9.6 months, absolutely improvement of 1.2 months. However, the OS did not reach a statistical significance. And so we observed there is an imbalance between the 2 treatment group with 20% more patients in the placebo group receiving subsequent therapy compared to fruquintinib group. So the OS result could be confounded by these subsequent therapies.

下一張投影片，投影片 21。對於總存活期（另一個雙重主要終點），我們看到呋喹替尼加紫杉醇將 OS 從 8.4 個月延長至 9.6 個月，絕對改善了 1.2 個月。然而，OS 並未達統計顯著性。因此我們觀察到兩個治療組之間存在不平衡，與呋喹替尼組相比，接受後續治療的安慰劑組患者多了 20%。因此，這些後續療法可能會混淆 OS 結果。

Next slide, slide 22. Further analysis were conducted to examine the OS in patient received and did not receive subsequent anti-tumor therapy. And the results here support the OS benefit in addition fruquintinib to paclitaxel. The OS was improved regardless of whether the patient received subsequent anti-tumor therapy or not. Although the patient without the subsequent therapy, we do see a statistically improvement of OS. This is a pre-planned analysis.

下一張投影片，投影片 22。我們進行了進一步的分析，以檢查接受和未接受後續抗腫瘤治療的患者的 OS。這裡的結果支持除紫杉醇之外呋喹替尼還具有 OS 益處。無論患者是否接受後續抗腫瘤治療，OS 均得到改善。儘管患者沒有接受後續治療，但我們確實看到 OS 有統計學上的改善。這是預先計劃好的分析。

Moving on to the next slide, slide 23. So the 23 present a promising second-line treatment offer in gastric cancer. So the slide 23 show to -- put the FRUTIGA data into perspective with another approved therapy in second-line treatment option in China with ramucirumab plus paclitaxel. This is a cross-draw comparison showing the RAINBOW-Asia study, which is a large study of over 400 patients. So you can see the fruquintinib clearly show a more robust improvement of overall response rate and the PFS and also numerically better OS improvement.

轉到下一張投影片，即投影片 23。因此，這 23 種藥物為胃癌提供了一個有前景的二線治療方案。因此，幻燈片 23 展示了——將 FRUTIGA 數據與中國二線治療方案中另一種已批准的療法（雷莫蘆單抗加紫杉醇）結合起來。這是 RAINBOW-Asia 研究的交叉比較，該研究是一項涉及 400 多名患者的大型研究。因此，您可以看到呋喹替尼清楚地顯示出整體緩解率和 PFS 的更強勁改善，並且在數值上也顯示出更好的 OS 改善。

Slide 24. Okay. So I also mentioned about the other fruquintinib life cycle indication development. We received the breakthrough designation in China for a combination with sintilimab, slide 24.

幻燈片 24。好的。所以我還提到了其他呋喹替尼生命週期適應症的發展。我們與信迪利單抗的組合在中國獲得了突破性認定，幻燈片 24。

Yeah, so in the endometrial cancer. The EMC indices on mortality are really projected to grow in China and the patients who are progressed on first-line therapy remains very high unmet medical need. So we have completed the single-arm FRUSICA registration Phase II trial study and the regulatory filing expected early 2024.

是的，子宮內膜癌也是。中國的 EMC 死亡率指數預計將會成長，且第一線治療取得進展的患者仍未滿足的醫療需求仍然很高。因此，我們已經完成了單臂 FRUSICA 註冊 II 期試驗研究，並預計在 2024 年初完成監管備案。

Slide 25, please. Increased mortality rate in RCC in China also outpaced the other developed nation and the second-line treatment options remain very limited. So we have completed second-line RCC FRUSICA registration trial. And this is a Phase III trial versus axitinib or everolimus in second-line setting. So we completed enrollment last year. And hopefully, the favorable results from this trial could potentially lead to regulatory filing late 2024.

請投影片 25。中國腎細胞癌死亡率的上升也超過了其他已開發國家，且二線治療選擇仍然非常有限。至此我們已經完成二線RCC FRUSICA註冊試驗。這是一項與阿西替尼或依維莫司在二線環境中進行對比的 III 期試驗。所以我們去年就完成了招生。希望這項試驗的有利結果可能會在 2024 年底向監管機構提交申請。

Next slide, slide 26. The Phase II trial, fruquintinib plus sintilimab, a POC study in RCC was published in the ASCO 2023. The results are highly encouraging with ORR about 60% and the medium PFS almost 16 months. So the POC result is highly favorable compared with other IL plus VEGF therapy in RCC and we anticipate the top-line results later this year for FRUSICA-2 Phase III trial and the subsequent NDA filing in 2025.

下一張投影片，投影片 26。呋喹替尼加信迪利單抗治療 RCC 的 POC 研究 II 期試驗發表在 ASCO 2023 上。結果非常令人鼓舞，ORR 約為 60%，中等 PFS 接近 16 個月。因此，與 RCC 中的其他 IL 加 VEGF 療法相比，POC 結果非常有利，我們預計今年稍後 FRUSICA-2 III 期試驗的頂線結果以及隨後在 2025 年提交的新藥申請 (NDA)。

Next slide, slide 27. And our second wave molecule are advancing rapidly in the late-stage development and sovleplenib, which is a highly differentiated oral Syk inhibitor with a breakthrough designation in the immune thrombocytopenia in China.

下一張投影片，投影片 27。我們的第二波分子在後期開發中進展迅速，sovleplenib是一種高度差異化的口服Syk抑制劑，在中國免疫性血小板減少症方面具有突破性的認定。

And the current treatment target either TREG or B-cell pathway for producing autoantibody or stimulate the megakaryocyte to produce more platelets. Syk offers a dual mechanism by targeting both B-cells to inhibit autoantibody production and also prevent the macrophage to destroy the platelet.

目前的治療目標是TREG或B細胞途徑產生自體抗體或刺激巨核細胞產生更多血小板。Syk 提供了一種雙重機制，透過靶向 B 細胞來抑制自身抗體的產生，並防止巨噬細胞破壞血小板。

So we have completed the China Phase III ESLIM-01 in the second-line plus ITP patients. It met the primary and secondary endpoint. NDA is accepted by NMPA this last month and the priority review for breakthrough destination. So we are very, -- also cleared the US IND for our Phase Ib/II trial and in the start-up stage for global development.

所以我們已經在二線+ITP患者中完成了中國III期ESLIM-01。它達到了主要和次要終點。NDA於上個月獲得NMPA受理，並成為突破性目的地的優先審查。因此，我們也為我們的 Ib/II 期試驗以及全球開發的啟動階段批准了美國 IND。

Next slide, slide 28. So 28 is IQVIA report on the China ITP treatment landscape. We believe sovleplenib not only can compete in the currently treated ITP patients, about 250,000 patients, and also, they can potentially help the patients who lost follow-up primarily due to no other effective treatment.

下一張投影片，投影片 28。28 號是 IQVIA 關於中國 ITP 治療情況的報告。我們相信 sovleplenib 不僅可以在目前接受治療的 ITP 患者（約 250,000 名患者）中競爭，而且還可以潛在地幫助主要由於沒有其他有效治療而失去隨訪的患者。

Slide 29, please. We are particularly encouraged by our Phase I/II trial, demonstrated a robust overall response rate of 80% overall response and the durable response rate of 40% in relapsed/refractory ITP patients. The high response rate are on par with the current widely used second-line treatment option, which is TPO-RA.

請投影片 29。我們的 I/II 期試驗尤其令我們感到鼓舞，該試驗證明了復發/難治性 ITP 患者的整體緩解率為 80%，持久緩解率為 40%。高緩解率與目前廣泛使用的二線治療方案 TPO-RA 相當。

Despite in our trial, the sovleplenib trials had even more heavily pre-treated patients and with 75% of patients who also failed the prior TPO-RA treatment. And compared with the other approved product, Tavalisse, which is a Syk inhibitor, you can see only the 18% durable response and 40% overall sponsor. So clearly, sovleplenib has the best-in-class potential in the ITP indication.

儘管在我們的試驗中，sovleplenib 試驗中有更多接受嚴格治療的患者，且 75% 的患者先前的 TPO-RA 治療也失敗了。與另一種核准產品 Tavalisse（Syk 抑制劑）相比，您只能看到 18% 的持久反應和 40% 的整體贊助商。顯然，sovleplenib 在 ITP 適應症中具有同類最佳的潛力。

Next slide, slide 30. And we also achieved a positive Phase II. Next slide. Yeah, the ITP Phase III ESLIM already completed and we submitted NDA, it's under priority review. Hopefully, we can see the approval later this year.

下一張投影片，投影片 30。我們也取得了正面的第二階段成果。下一張投影片。是的，ITP III期ESLIM已經完成，我們提交了NDA，正在優先審查中。希望我們能在今年稍後看到批准。

Okay. Next slide, slide 31. And similarly, like the ITP and sovleplenib also currently in development in another autoimmune indication, warm autoimmune hemolytic anemia, it serve the same mechanism by preventing the red blood cell engulfed by the macrophages and also prevent the autoantibody production from B-cells. So this unique dual mechanism can also be a potential treatment option for the ITP patients, for the AIHA patients. And so the targets already got achieved and we are starting the Phase III shortly.

好的。下一張投影片，投影片 31。同樣，與目前也在另一種自體免疫適應症（溫性自體免疫溶血性貧血）中開發的ITP 和sovleplenib 一樣，它透過防止紅血球被巨噬細胞吞噬並防止B 細胞產生自身抗體來發揮相同的機制。因此，這種獨特的雙重機制也可以成為 ITP 患者、AIHA 患者的潛在治療選擇。所以目標已經實現，我們很快就會開始第三階段。

Okay. Slide 32. And also, I want to mention the other product. There are 7 registration trials for the MET inhibitors, savolitinib and currently enrolling, they are led by our partner AstraZeneca globally for 3 trial and HUTCHMED leading the other 4 indications, including newly initiated Phase III gastric cancer in the second-line setting.

好的。幻燈片 32。另外，我想提一下另一個產品。MET抑制劑沃利替尼有7個註冊試驗，目前正在入組，其中3個試驗由我們的合作夥伴阿斯特捷利康在全球領導，HUTCHMED領導另外4個適應症，包括新啟動的二線胃癌III期試驗。

Next slide, slide 33. And we have presented our first-line MET Exon 14 data in non-small cell lung cancer with MET Exon 14 skipping mutation. It showed a deep and durable response for 60% overall response rate and the updated data will be presented at an oral presentation next month at the ELCC in Prague.

下一張投影片，投影片 33。我們也展示了具有 MET 外顯子 14 跳躍突變的非小細胞肺癌的一線 MET 外顯子 14 數據。它顯示出深入而持久的反應，總體反應率為 60%，更新的數據將於下個月在布拉格 ELCC 舉行的口頭報告中公佈。

Next slide, slide 34, please. And also updating you about the progress of savolitinib global development and global pivotal SAVANNAH trial has completed the enrollment. And despite some of the new data readout like [MARIPOSA], TL05 and ORIENT-31, we believe savolitinib plus TAGRISSO represented oral-only chemo-free option for biomarkers like the MET-positive patients in the EGFR mutation who progressed on TAGRISSO.

請下一張投影片，投影片 34。同時向您通報沃利替尼全球開發進度，全球關鍵 SAVANNAH 試驗已完成入組。儘管出現了一些新的數據，如[MARIPOSA]、TL05 和ORIENT-31，但我們相信沃利替尼加TAGRISSO 代表了生物標誌物（如EGFR 突變的MET 陽性患者在接受TAGRISSO 治療後病情進展）的純口服無化療選擇。

And the anticipated US NDA filing around late this year by our partner AstraZeneca. And it will be a huge catalyst for HUTCHMED after fruquintinib US approval in the RCC. So we are bringing our second in-house developed novel medicine closer to global approval.

我們的合作夥伴阿斯特捷利康預計將於今年底在美國提交 NDA 申請。呋喹替尼在美國獲得 RCC 批准後，這將成為 HUTCMED 的巨大催化劑。因此，我們正在使我們的第二種內部開發的新藥更接近全球批准。

Okay. So just to recap our R&D progress, and we have a deep and broad portfolio in oncology, hematology, and also recent advancement in autoimmune disease. So I'm very proud of our R&D team and the global partners remain focused and executed very well for the past year and a multiple near-term global development catalysts for 2024 and 2025.

好的。回顧我們的研發進展，我們在腫瘤學、血液學以及自體免疫疾病方面的最新進展方面擁有深入而廣泛的產品組合。因此，我為我們的研發團隊和全球合作夥伴感到非常自豪，他們在過去的一年中保持專注並執行得很好，並為 2024 年和 2025 年提供了多個近期全球發展催化劑。

So I will turn the stage to Dr. Weiguo Su, our CEO and CSO. Weiguo?

現在我將把舞台轉向我們的執行長兼首席策略長蘇衛國博士。衛國？

Okay. Thank you very much, Mike. Let's go to slide number 36. So 2023 was an extraordinary year. We made a lot of progress in 2023, both in R&D, the progress in the pipeline, as well as commercialization in China. We managed a great robust growth in China commercial. But obviously, we are most proud of fruquintinib approval in the US, our first approval outside China, a big step towards our vision of bringing our innovative medicines to global patients.

好的。非常感謝你，麥克。讓我們來看第 36 號投影片。所以2023年是不平凡的一年。2023年我們取得了許多進展，無論是在研發、在研產品的進展，或是在中國的商業化。我們在中國商業領域實現了強勁的成長。但顯然，我們最自豪的是呋喹替尼在美國獲得批准，這是我們在中國境外的首次批准，朝著我們將創新藥物帶給全球患者的願景邁出了一大步。

2024 and beyond, obviously, we have a lot to look forward to on our way to profitability hopefully by 2025. We will focus on near-term and mid-term launches of new products and new indications in China. We are obviously very excited about sovleplenib for ITP.

顯然，2024 年及以後，我們對 2025 年實現盈利的道路有很多期待。我們將重點放在近期和中期新產品和新適應症在中國的推出。顯然，我們對用於 ITP 的 sovleplenib 感到非常興奮。

ITP represents a major unmet medical need in China, as Mike pointed out. Almost half of the patients after they try everything, they remain -- their medical need remain unmet. And obviously, the second indication, wAIHA, now in registration trial for sovleplenib as well.

正如 Mike 指出的那樣，ITP 是中國未滿足的一個主要醫療需求。幾乎一半的患者在嘗試了所有方法後，他們的醫療需求仍未被滿足。顯然，第二個適應症 wAIHA 目前也正在進行 sovleplenib 的註冊試驗。

At the same time, we expect the approval of fruquintinib in Europe and Japan as well as the NDA submission potentially in the US for our second drug savolitinib with our partner, AstraZeneca. So this is again, a major progress for savolitinib. And these regulatory activities will ensure a steady flow of new approvals and accelerate our revenue and profit growth in years to come. We are confident about our goal of becoming self-sustaining by 2025 and well positioned for accelerated growth beyond 2025.

同時，我們預計呋喹替尼將在歐洲和日本獲得批准，並可能與我們的合作夥伴阿斯特捷利康在美國提交第二種藥物沃利替尼的 NDA 申請。所以這又是沃利替尼的重大進展。這些監管活動將確保新批准的穩定流動，並在未來幾年加速我們的收入和利潤成長。我們對 2025 年實現自我維持的目標充滿信心，並為 2025 年後的加速成長做好了準備。

So next slide, just to wrap up, slide number 37. Again, we are really focused on execution of our strategy towards self-sustaining 2025 and look at our product portfolio and new product approvals outside China, for instance, savolitinib for lung cancer and also sovleplenib moving outside China for clinical development as well. So we are extremely excited about the near term and longer term for that matter, future for HUTCHMED.

下一張投影片是 37 號投影片的總結。再說一遍，我們真正專注於執行我們的2025年自我維持策略，並關注我們的產品組合和中國境外的新產品批准，例如用於肺癌的沃利替尼（savolitinib）以及也在中國境外進行臨床開發的索普尼布（sovleplenib）。因此，我們對 HUTCMED 的近期和長期未來感到非常興奮。

And with that, I would like to thank you for your attention and close the presentation and we'll be open for Q&A. Thank you.

在此，我要感謝您的關注，並結束演示，我們將開始問答。謝謝。

(Operator Instructions) Louise Chen, Cantor.

（操作員說明）Louise Chen，Cantor。

Congratulations on all the progress. So first question I wanted to ask you is what you've learned from the US launch of FRUZAQLA? And how can you apply that to the rest of your global expansion initiatives? Second question I wanted to ask, I know you went over a lot of this in the presentation, but just to distill it down for investors. You do have a very large and productive pipeline, so what are the key readouts and events that you think we should really focus on? Maybe if you could pick two or three.

祝賀所有的進展。所以我想問您的第一個問題是您從 FRUZAQLA 在美國上市中學到了什麼？您如何將其應用到您的其他全球擴張計劃中？我想問的第二個問題，我知道您在演示中討論了很多這個問題，但只是為了向投資者提煉出來。你們確實擁有非常龐大且富有成效的管道，那麼你們認為我們應該真正關注的關鍵讀數和事件是什麼？也許你可以選擇兩個或三個。

Okay. Louise, maybe I'll do a quick response and I can ask Mike to chime in. So FRUZAQLA launch, I think Takeda is a great partner and they prepared well. And we work together very well through NDA submission, both NDA submission in the US and MAA in Europe as well as Japan submission. So we work together extremely well and we also prepared the launch extremely well as well.

好的。路易絲，也許我會快速回复，然後我可以請麥克插話。所以 FRUZAQLA 的推出，我認為武田是一個很好的合作夥伴，他們準備得很好。我們透過 NDA 提交進行了很好的合作，包括美國的 NDA 提交、歐洲的 MAA 以及日本的提交。所以我們合作得非常好，我們也為發布做了非常充分的準備。

Given in the US the approval came ahead of our original expectation because it was granted priority review and approved only -- less than 6 months, but Takeda really prepared well and we work together very well as well. So for instance, we had drug product all mapped out and we were ready to go as soon as we received the approval. The first prescription was written within a couple of days basically and NCCN guideline inclusion within 1 week. So clearly, Takeda was ready to go, the launch team, and we were waiting for the approval.

鑑於美國的批准提前了我們最初的預期，因為它獲得了優先審查，並且僅在不到 6 個月的時間內獲得批准，但武田確實準備充分，我們也合作得很好。舉例來說，我們已經制定了所有藥品的計劃，一旦獲得批准，我們就準備好了。第一個處方基本上在幾天內就寫好了，一週內就納入了 NCCN 指南。很明顯，武田的發射團隊已經準備好出發，而我們正在等待批准。

So I think it kind of demonstrates the power of partnership, if you will. And going forward, in EU and Japan, we'll be doing the same. And for our second product, savolitinib, obviously, our focus now is on NDA submission behind SAVANNAH. Obviously, we have so much data to support and submit. So we'll be working very closely with AstraZeneca on savolitinib. We believe it's a great drug.

所以我認為這在某種程度上展示了夥伴關係的力量，如果你願意的話。展望未來，在歐盟和日本，我們也將這樣做。對於我們的第二個產品 savolitinib，顯然我們現在的重點是 SAVANNAH 背後的 NDA 提交。顯然，我們有很多數據需要支持和提交。因此，我們將與阿斯特捷利康就沃利替尼進行密切合作。我們相信這是一種很好的藥物。

With regard to pipeline, we continue to actually prioritize our portfolio and make sure that we invest on the highest value projects. So behind the 3 approved products, we believe sovleplenib can be a very important product. Not only it's going to be the first immunology product, but it represents a very different, entirely different indication, talking about chronic disease and a major unmet medical need. Almost half of the patients, they stop trying because nothing works for them.

在管道方面，我們繼續實際優先考慮我們的投資組合，並確保我們投資於最高價值的項目。所以在這3個核准產品背後，我們相信sovleplenib可以是個非常重要的產品。它不僅將成為第一個免疫學產品，而且代表了一種非常不同、完全不同的適應症，談論慢性疾病和未滿足的主要醫療需求。幾乎一半的患者會停止嘗試，因為沒有什麼對他們有效。

Behind sovleplenib, we have additional compound, we moved into several compounds. We actually moved into registration studies, including our IDH1/2 inhibitor for AML and also potentially solid tumors as well and more targeted therapies in the pipeline as well. But these are really for future registration and launches. So we'll be actually really focused on sovleplenib in China this year and also global development. We have a meeting scheduled with FDA to discuss the registration path and the plan. So really important for sovleplenib. So I think we believe it is going to be a major product for us.

在 sovleplenib 之後，我們有其他化合物，我們進入了幾個化合物。我們實際上已進入註冊研究，包括針對 AML 和潛在實體瘤的 IDH1/2 抑制劑，以及正在研發中的更多標靶療法。但這些實際上是為了將來的註冊和發布。因此，今年我們實際上將重點放在 sovleplenib 在中國的發展以及全球的發展。我們計劃與 FDA 舉行會議，討論註冊路徑和計劃。對於 sovleplenib 來說非常重要。所以我認為我們相信它將成為我們的主要產品。

Mike, do you have anything else to add on?

麥克，你還有什麼要補充的嗎？

Yeah. I think just add on to Dr. Su mentioned, right, sovleplenib clearly represented a major novel mechanism for the ITP and other autoimmune disease. So it's just we're going to present our Phase III data in upcoming conference and publications. So hopefully, that will put a very strong path forward for the development plan.

是的。我想補充一下蘇博士提到的，對吧，sovleplenib 清楚地代表了 ITP 和其他自體免疫疾病的一種主要新機制。因此，我們將在即將舉行的會議和出版物中展示我們的第三階段數據。因此，希望這將為發展計劃提供一條非常強大的道路。

And then also to add on the FRUZAQLA product launch, I think the HUTCHMED team and Takeda team actually worked very well together. We actually planned the drug supply ahead of the time. We are really hoping we can really launch in October timeframe, just to get that to the patients, right, to prescription. So the product launch preparation went very well. The add on to the NCCN guideline in a week time.

然後還要補充 FRUZAQLA 產品的發布，我認為 HUTCMED 團隊和武田團隊實際上合作得很好。我們實際上提前規劃了藥品供應。我們真的希望我們能夠在 10 月的時間範圍內真正推出，只是為了讓患者能夠獲得處方。所以產品發布的準備工作進行得很順利。一週內即可新增至 NCCN 指南。

And also, I think Takeda is really having a strong Japan presence. So if we are doing alone, I don't think that we can actually submit Japan that soon. So I think that's really a good collaboration with our global partner. And we hope that savolitinib going to repeat for our next molecule to reach the global patients.

而且，我認為武田在日本確實擁有強大的影響力。因此，如果我們單獨行動，我認為我們不可能很快就屈服於日本。所以我認為這確實是我們與全球合作夥伴的良好合作。我們希望我們的下一個分子能夠重複使用沃利替尼，以惠及全球患者。

Alec Stranahan, Bank of America.

亞歷克·斯特拉納漢，美國銀行。

Congrats on the progress in '23. Three quick ones from me on sovleplenib. I guess, first, what is your go-to-market strategy for sovleplenib if it's approved? Would you be able to handle the launch leveraging your current sales force in China or would you need maybe a separate commercial arm given it's a new indication for you?

祝賀'23取得的進展。我在 sovleplenib 上快速提供了三個。我想，首先，如果 sovleplenib 獲得批准，你們的上市策略是什麼？您是否能夠利用您目前在中國的銷售人員來處理此次發布，或者考慮到這對您來說是一個新的適應症，您是否需要一個單獨的商業部門？

Second question. How big of a contributor do you see this in your current 2024 oncology revenue guidance or could this be maybe additional to that? And then just lastly, I know you said in your press release that you plan to initiate clinical development outside of China for sovleplenib in 2024, would the plan be to partner for these studies and I guess, ultimate commercialization ex-China?

第二個問題。您在目前的 2024 年腫瘤學收入指南中認為這項貢獻有多大，或者這可能是額外的貢獻？最後，我知道您在新聞稿中說過，您計劃於 2024 年在中國境外啟動 sovleplenib 的臨床開發，該計劃是否會與這些研究合作，我想最終會在中國以外的地區進行商業化？

Okay. Thanks, Alec, for the question. Sovleplenib commercial launch, obviously, we already started to prepare. We have the infrastructure in place. We obviously need to build a specialty team to support it. So that's the current plan in China. Obviously, we can leverage the -- our commercial infrastructure in China. We do need a special team to support marketing and also sales as well. So that's the plan. And we are -- we obviously have time to prepare.

好的。謝謝亞歷克的提問。Sovleplenib 商業推出，顯然我們已經開始準備了。我們擁有適當的基礎設施。我們顯然需要建立一個專業團隊來支持它。這就是中國目前的計畫。顯然，我們可以利用我們在中國的商業基礎設施。我們確實需要一個特殊的團隊來支持行銷和銷售。這就是計劃。我們顯然有時間做好準備。

With regard to revenue contribution to 2024 in our forecast, it's almost -- it's nothing basically. We expect it to be approved towards the end of the year. So contribution should come actually in 2025. '24, we'll probably just get going as soon as it's approved, but that will be towards -- really towards the end of the year.

至於我們預測的 2024 年收入貢獻，幾乎——基本上沒什麼。我們預計它將在今年年底獲得批准。因此，捐款應該在 2025 年實際到位。 '24，一旦獲得批准，我們可能會立即開始行動，但這將是在接近年底的時候。

Your last question about US development or ex-China development and partnerships. So as I mentioned, we have a meeting scheduled with the FDA shortly and we'll discuss the development -- our development plan and seek endorsement from FDA. Once that's clarified and we'll get going very quickly.

你的最後一個問題是關於美國的發展或中國以外的發展和夥伴關係。正如我所提到的，我們很快就會與 FDA 舉行會議，我們將討論我們的開發計劃並尋求 FDA 的認可。一旦明確了這一點，我們很快就會開始工作。

Partnership discussion, these discussions are ongoing as always. And I think once we publish the data -- very soon actually, it could be some time mid-year this year at a major conference. Also, at the same time, we'll publish the proof-of-concept data for the second indication, the wAIHA, all very strong data.

夥伴關係討論，這些討論一如既往地持續進行。我認為，一旦我們發布數據——實際上很快，可能會在今年年中的某個時候舉行大型會議。此外，同時，我們將發布第二個適應症 wAIHA 的概念驗證數據，所有這些數據都非常強大。

So I think it will attract more potential partners. So the plan is to just kind of -- we're already engaged, but we will continue to engage with potential partners. And I expect once we have clarified the development pathway outside China and also the data is published, we'll probably intensify the discussion.

所以我認為這會吸引更多潛在的合作夥伴。因此，我們的計劃是——我們已經參與其中，但我們將繼續與潛在合作夥伴接觸。我預計，一旦我們明確了中國以外的發展路徑並且公佈了數據，我們可能會加強討論。

Paul Choi, Goldman Sachs.

保羅‧崔，高盛。

Congratulations on all the progress. My first question is on savolitinib and with regard to the SANOVO study, which you expect to, I believe, complete later this year. Just in terms of the incremental opportunity in terms of the frontline population, can you maybe just expand on how many patients are currently actively treated in China with available MET inhibitors? And just kind of how you think about the commercial opportunity there for the first-line opportunity? And then I have a follow-up question.

祝賀所有的進展。我的第一個問題是關於沃利替尼和 SANOVO 研究，我相信您預計該研究將於今年稍後完成。就一線人群的增量機會而言，您能否詳細說明目前中國有多少患者正在接受可用 MET 抑制劑的積極治療？您如何看待一線機會的商業機會？然後我有一個後續問題。

Yes. So Paul, at the moment, savolitinib is approved for second-line and above non-small cell lung cancer with Exon 14 mutation or skipping mutations. So that's the label. Obviously, given the extent of its efficacy comparing to chemo or I/O as well as now we already published the first-line data, I would not be surprised there could be some usage into the first-line.

是的。所以Paul，目前沃利替尼被批准用於二線及以上外顯子14突變或跳躍突變的非小細胞肺癌。這就是標籤。顯然，考慮到其與化療或 I/O 相比的功效程度以及現在我們已經發布了一線數據，我不會感到驚訝一線可能會有一些使用。

But all in all, I think it's been at the moment mostly second-line patients. The population in first-line, we think, we believe it should be much bigger. And that you have combined to better clinical, even better clinical benefit for these patients. So we believe it will translate into a significant opportunity.

但總而言之，我認為目前主要是二線患者。我們認為，一線的人口應該更多。你們的結合為這些患者帶來了更好的臨床效果，甚至是更好的臨床效益。因此，我們相信這將轉化為一個重大機會。

Okay. Great. And then as a follow-up question, maybe turning to -- back to sovleplenib for a minute and ITP. As you think about sort of different standards of care in markets and regions outside of China, how are you thinking about potentially coordination on a placebo arm or whether the studies will require a active comparator arm just to harmonize requirements, let's say, between the US, Europe and other geographies? Just maybe some high level thoughts on whether an active comparator would be required versus placebo-controlled trial would be great? Thank you.

好的。偉大的。然後作為後續問題，也許會回到 sovleplenib 一會兒和 ITP。當您考慮中國以外的市場和地區的不同護理標準時，您如何考慮安慰劑組的潛在協調，或者研究是否需要主動比較組來協調要求，比方說，美國之間、歐洲和其他地區？也許只是對是否需要主動比較劑與安慰劑對照試驗進行一些高層次的思考會很棒嗎？謝謝。

Yes. Again, for this specific question, we don't have a lot to offer at the moment, Paul. We'll be in discussion with the FDA very shortly. And once we have it clarified, we'll let you know. Actually we'll announce once we are into clinical development in the US.

是的。再說一次，對於這個具體問題，我們目前沒有太多可以提供的，保羅。我們很快就會與 FDA 進行討論。一旦我們澄清了這一點，我們就會通知您。實際上，一旦我們在美國進入臨床開發階段，我們就會宣布。

Kelly Shi, Jefferies.

施凱莉，傑弗里斯。

This is Clara on for Kelly. Congrats on the progress. So maybe just a quick question on ITP. So once the global study will be initiated, how should we think about the cost change on R&D in general? And also, for warm autoimmune hemolytic anemia, how large is the market in China? And like what do you need to see for this indication to initiate maybe future global development?

這是克拉拉為凱利代言的。祝賀取得的進展。所以也許只是一個關於 ITP 的簡單問題。那麼，一旦全球研究啟動，我們該如何看待研發成本的整體變化？還有，溫熱性自體免疫溶血性貧血在中國的市場有多大？您需要看到什麼才能使這一跡象啟動未來的全​​球發展？

Okay. Thank you for your question. Well, ITP, it's -- at the moment, anyways, you can see the market or the treatment has been dominated by TPO or TPO-RA, and -- but a lot of patients, there are a lot of other treatment options, but not necessarily approved. Some of those are just off-label usages.

好的。謝謝你的問題。嗯，ITP，無論如何，目前，你可以看到市場或治療方法已經以 TPO 或 TPO-RA 為主，而且，對於許多患者來說，還有很多其他治療選擇，但不一定被批准。其中一些只是標籤外用途。

So we believe sovleplenib represents a novel mechanism of action. Patients -- there are a lot of patients that they don't -- they probably already tried everything. And typically, somewhere between 8 to 10 years of various treatments and then they gave -- nothing works for them, they just gave up or they just lost to follow-up. So it represents a big unmet medical need.

因此，我們相信 sovleplenib 代表了一種新穎的作用機制。病人——有很多病人沒有——他們可能已經嘗試了一切。通常情況下，經過 8 到 10 年的各種治療，然後他們給予了——沒有任何效果，他們只是放棄，或者只是失去了後續治療。因此，它代表了一個巨大的未滿足的醫療需求。

So I think ITP is a very specific disease. So how we're going to deal with -- target the patients globally outside China, how big is the study -- so we like to understand the same, particularly as you say, the impact on our R&D spending. So until we have clarity, until we align on the development plan with FDA, it's hard to estimate. And obviously, a lot to do with the study design, the line of prior therapies, for instance, the sample size and so forth.

所以我認為 ITP 是一種非常特殊的疾病。那麼我們將如何處理——針對中國以外的全球患者，研究的規模有多大——所以我們想了解同樣的問題，特別是正如你所說的，對我們研發支出的影響。因此，在我們弄清楚之前，在我們與 FDA 協調開發計劃之前，很難估計。顯然，這與研究設計、先前的療法系列（例如樣本量等）有很大關係。

We also, behind the FRESCO and FRESCO-2, we would at least share the data with the US FDA on FRESCO-2 -- sorry, on ESLIM-01 study in China, hope that can serve as part of core registration studies. So whether this can reduce the sample size for this upcoming study outside China or how we think about this, so it all depends on discussion with FDA and alignment with the FDA. Until then, we think it would be manageable in terms of the cost. Certainly, if we line-up a partner, then it should be less of -- it will be much less material on the cost.

我們也，在FRESCO和FRESCO-2的背後，我們至少會與美國FDA分享FRESCO-2的數據——抱歉，關於中國的ESLIM-01研究，希望可以作為核心註冊研究的一部分。因此，這是否可以減少這項即將在中國境外進行的研究的樣本量，或者我們如何看待這個問題，所以這一切都取決於與 FDA 的討論以及與 FDA 的一致。在那之前，我們認為成本是可控的。當然，如果我們安排一個合作夥伴，那麼成本應該會少很多。

The warm autoimmune hemolytic anemia, which is actually a very rare disease, it's even more rare than ITP. However, it has almost no treatment today. So it represents a very rare disease with a even stronger unmet medical need. So we believe this mechanism should target this disease very well and sovleplenib has generated very strong proof-of-concept data. We're already into the Phase III in China. And likely, we could do the same outside China once we align with the US FDA on ITP when a dose optimization completes, yeah, it could be an option.

溫熱性自體免疫溶血性貧血，其實是一種非常罕見的疾病，甚至比ITP還要罕見。然而，今天它幾乎沒有治療方法。因此，它代表了一種非常罕見的疾病，具有更強烈的未滿足的醫療需求。因此，我們相信這種機制應該能夠很好地針對這種​​疾病，而 sovleplenib 已經產生了非常強大的概念驗證數據。我們在中國已經進入第三階段。一旦劑量優化完成，我們就 ITP 與美國 FDA 保持一致，我們就可以在中國境外做同樣的事情，是的，這可能是一種選擇。

(Operator Instructions) Mike Mitchell, Panmure Gordon.

（操作員說明）Mike Mitchell、Panmure Gordon。

Great performance for the period. Just one focused question and one broader question, if that's okay. And the focused question on fruquintinib. I'm just thinking, of course, we have the submission in with the China regulator for gastric cancer. But in terms of ex-China development on gastric, what should we anticipate in terms of the appetite for potential further development? I'm just thinking about the overall survival endpoint and the standard of care reference used in the FRUTIGA study. So just thinking what else you might need to do to orate the product for other markets or is that just not on the agenda at present?

期間表現出色。如果可以的話，只有一個重點問題和一個更廣泛的問題。以及關於呋喹替尼的焦點問題。我只是在想，當然，我們已經向中國胃癌監管機構提交了申請。但就胃病在中國以外的發展而言，我們應該對潛在進一步發展的需求有何預期？我只是在考慮 FRUTIGA 研究中使用的整體存活終點和護理參考標準。那麼，想想您可能還需要做什麼來向其他市場宣傳該產品，或者目前這還沒有列入議程？

The short answer is not relevant for outside China in the second-line setting. You just mentioned the standard of care difference for instance, as a matter of fact, at the ASCO Plenary, there was a panel of experts on the call and kind of concluded great data, could be a treatment option for patients in need. However, the data will not support outside China registration. Separate study needs to be done because of the standard of care difference and patient difference as well.

簡短的回答與中國以外的二線環境無關。你剛才提到了護理標準的差異，事實上，在 ASCO 全體會議上，有一個專家小組參加了電話會議，得出了很好的數據，可能是有需要的患者的一種治療選擇。但該數據不支援中國境外註冊。由於護理標準和患者的差異，需要進行單獨的研究。

So yeah, the same study will not support global registration. However, we continue to believe fruquintinib has a role in gastric cancer, whether in combination with chemo, such as paclitaxel or in combination with I/O. PD-1, for instance, we actually published a very strong data in combination with PD-1 as well. So in gastric cancer outside China, we think there is a role for fruquintinib, how we design the study, which line to target, we are still assessing this opportunity.

所以是的，同一項研究將不支持全球註冊。然而，我們仍然相信呋喹替尼在胃癌中具有作用，無論是與化療（如紫杉醇）聯合使用還是與 I/O 聯合使用。以PD-1為例，我們實際上也發布了與PD-1結合的非常強大的數據。因此，在中國以外的胃癌中，我們認為呋喹替尼有一定的作用，我們如何設計研究，針對哪個線，我們仍在評估這個機會。

Okay. Got it. No, that's really helpful. And then just on a more broad question. I know there will be a little bit of give and take with the recognition of Takeda payments in the P&L, but I'm just thinking about the balance sheet strength and how R&D tracks from here in light of the lower R&D spend versus last year? There was obviously a shift pre and post the new strategy in terms of how hard you wanted to push on R&D investments. But is this still going to be a story of managing it within a range or is there an opportunity to fine-tune, perhaps accelerate internal investment from this point onwards?

好的。知道了。不，這真的很有幫助。然後是一個更廣泛的問題。我知道，在損益表中承認武田付款後，會有一些讓步，但我只是在考慮資產負債表的實力，以及鑑於研發支出較去年有所下降，研發如何從這裡進行跟踪？在新策略實施前後，在推動研發投資的力道方面顯然發生了變化。但這仍然是一個在一定範圍內進行管理的故事，還是有機會進行微調，也許從現在開始加速內部投資？

Yeah, good question. So as I mentioned earlier, we will be very careful on spending, very prudent on spending, and we actually routinely now do portfolio prioritization, looking at every compound, every indication very carefully to make sure -- just to make sure that we invest the highest value project possible. So we don't see any expansion or any increase of R&D costs this year.

是的，好問題。因此，正如我之前提到的，我們將非常謹慎地支出，非常謹慎地支出，我們實際上現在通常會進行投資組合優先級排序，非常仔細地研究每種化合物、每種跡象，以確保——只是為了確保我們投資可能的最高價值項目。因此，我們今年不會看到任何擴張或研發成本的增加。

We have no questions at this time. Allow me to hand the call back to management for closing remarks.

目前我們沒有問題。請容許我將電話轉交給管理階層以供結束語。

Okay. Yeah, thank you all very much for attending the call. And we'll be happy to be further engaged through email or any other communication channels or if you have any questions, let us know. Thank you.

好的。是的，非常感謝大家參加電話會議。我們很樂意透過電子郵件或任何其他溝通管道進一步參與，或者如果您有任何疑問，請告訴我們。謝謝。

That concludes today's conference call. Thank you for your participation. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。