使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主
David Ng - Head of Investor Relations and Capital Strategies
David Ng - Head of Investor Relations and Capital Strategies
Hello, everyone. Welcome to HUTCHMED 2025 full year results and business update. Today, we're going to go through our results in a formal presentation by our senior management, and then it will be followed by Q&A. Before I start, let's turn to page 2 with our usual safe harbor statement. Basically, the performance and results of our operation contained within this presentation are historical in nature, and the past performance is no guarantee of future results.
各位好。歡迎參加和黃醫藥(HUTCHMED)2025全年業績及業務更新。今天我們將由高級管理層以正式簡報形式帶大家回顧業績,隨後進入問答環節。在開始之前,請先翻到第2頁,查看我們一貫的「安全港」聲明。基本上,本簡報所載的經營表現與業績屬於歷史性資料,過往表現不保證未來結果。
The information in this presentation is subject to changes and HUTCHMED has no liability for any loss arising from the use of this content. My name is David. I'm the Head of IR of HUTCHMED. We are very happy that we're going to have our senior management to present the results. Let me hand off the time to our acting Chief Executive Officer and Chief Financial Officer, Johnny Cheng.
本簡報中的資訊可能會變更,和黃醫藥對因使用本內容而產生的任何損失不承擔責任。我叫David。我是和黃醫藥的投資者關係主管。我們非常高興由高級管理層為大家介紹業績。接下來把時間交給我們的代理行政總裁兼財務總監鄭澤宇(Johnny Cheng)。
Johnny?
Johnny?
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Thank you, David, and thank you, everyone, for attending HUTCHMED's 2025 results webcast. Joining me today is our Deputy CFO, Lorenso Chiu, who will give us an overview of our financial performance. Our Head of Commercial, George Yuan, who will share with you our commercial performance; and our Head of Discovery, Dr. Guangxiu Dai, who will provide an update on our R&D pipeline progress. Next slide, please.
謝謝你,David,也謝謝各位出席和黃醫藥2025業績網路直播。今天與我一同出席的有副財務總監Lorenso Chiu,他將為我們概述財務表現。商業化負責人George Yuan,將與各位分享商業表現;以及研發發現部門負責人戴廣秀博士(Dr. Guangxiu Dai),將就研發管線進展作出更新。請看下一頁。
A quick highlight of our 2025 achievements. We are pleased with our ex-China FRUZAQLA sales, which had 26% growth versus last year, resulting in $366 million in in-market sales. More importantly, FRUZAQLA has rolled out to over 38 countries already. As for our China sales, it has rebounded in the second half of the year, achieving 21% in-market sales growth versus our first half interim results.
先快速回顧我們在2025年的重點成果。我們對FRUZAQLA在中國以外的銷售表現感到滿意,較去年增長26%,實現市場端銷售額3.66億美元。更重要的是,FRUZAQLA已在超過38個國家完成上市推廣。至於中國銷售方面,下半年已出現反彈,較上半年中期業績所對應的市場端銷售增長21%。
In terms of our cash position, we have about $1.4 billion, which allows us to accelerate our global ATTC development and provide resources to explore potential in-licensing and M&A opportunities. On the right-hand side, we have now advanced two of our ATTC programs into the clinic, which we believe will have huge market potential. In addition, we are pursuing potential business development opportunities with multinational companies. In terms of the progress of our pipeline, I will leave it to Dr. Dai to share with you later on.
在現金狀況方面,我們約有14億美元,這使我們能加速全球ATTC的開發,並提供資源以探索潛在的引進授權(in-licensing)及併購(M&A)機會。右側顯示,我們目前已將兩個ATTC項目推進至臨床階段,我們相信其具備巨大的市場潛力。此外,我們也正與跨國公司推進潛在的業務發展機會。至於管線進展,我稍後交由戴博士與各位分享。
I will now turn it over to Lorenso for the financial review and outlook. Lorenso?
現在我把時間交給Lorenso,進行財務回顧與展望。Lorenso?
Lorenso Chiu - Deputy Chief Financial Officer
Lorenso Chiu - Deputy Chief Financial Officer
Yes. Thanks, Johnny. And let me give an overview of our key financial highlights for 2025. Total oncology revenue was $286 million. This includes $71 million R&D-related upfront and milestone revenues.
好的。謝謝你,Johnny。我先概述我們2025年的主要財務亮點。腫瘤業務總收入為2.86億美元。其中包括7,100萬美元與研發相關的首付款及里程碑收入。
For oncology products revenue, as Johnny already mentioned, there was a rebound from our China oncology products, which recorded 21% growth in in-market sales in the second half, while FRUZAQLA continues its global expansion. On net income, we recorded a profit of $457 million for 2025, mainly due to the SHPL divestment gain of $416 million. Excluding this onetime gain, our core operations remain profitable.
在腫瘤產品收入方面,如Johnny剛才提到,中國腫瘤產品出現反彈,下半年市場端銷售增長21%,同時FRUZAQLA持續推進全球擴張。在淨利方面,我們2025年錄得4.57億美元利潤,主要來自SHPL剝離交易帶來的4.16億美元處置收益。剔除這項一次性收益後,我們的核心營運仍保持盈利。
Next, please. Our R&D expenses for 2025 was 148 million. Expenses were lower versus 2024 as many of our late-stage trials are in the completion stage with multiple NDAs now awaiting approvals. In addition, we began shifting our investments into our early-stage ATTC assets with two candidates already in the clinic. Our cash position has been further strengthened to about $1.4 billion.
請看下一頁。我們2025年的研發開支為1.48億美元。相較2024年有所下降,原因是多項後期試驗已進入收尾階段,且目前有多個NDA正等待審批。此外,我們開始把投資重心轉向早期ATTC資產,已有兩個候選項目進入臨床。我們的現金狀況進一步增強至約14億美元。
That positions us well to accelerate both investments and developments of our ATTC programs. Next, looking forward to 2026, our oncology revenue guidance is in the range of $330 million to $450 million. This reflects a solid growth from 2025, driven by strong growth in our China commercial products with contributions from new indications as well as FRUZAQLA continued scope expansions. In addition, let's consider the potential partnership opportunities for our new drug candidates, including ATTC. Now I'd like to hand over to George to give an overview of the China commercial.
這使我們具備良好條件,加速ATTC項目的投資與開發。展望2026年,我們的腫瘤收入指引區間為3.30億至4.50億美元。這反映相較2025年的穩健增長,主要由中國商業化產品的強勁增長所帶動,新適應症的貢獻以及FRUZAQLA持續擴大覆蓋範圍亦提供支持。此外,我們也將考慮新藥候選項目(包括ATTC)的潛在合作夥伴機會。現在我把時間交給George,概述中國商業化情況。
George Yuan - Executive Vice President, Head of Commercial
George Yuan - Executive Vice President, Head of Commercial
Thanks, Lorenso. First, let's look at the FRUZAQLA, our business partner, Takeda's performance. They delivered a very strong 2025 with 26% growth, and if you look at the Q2 -- the second half, the second half, the growth actually is accelerated mainly due to the market expansion we launched some of the new markets like Portugal, Belgium and South Korea. Also, the strong Japanese performance and some of the Europe performance uptake also contribute a second half strong growth. This reflects a market needs for safe and effective medicine in the later-line mCRC treatment.
謝謝你,Lorenso。首先看看FRUZAQLA,我們的合作夥伴武田(Takeda)的表現。他們在2025年交出非常強勁的成績,增長26%;如果看Q2——也就是下半年——增長其實有所加速,主要因為我們拓展了市場,新增了一些市場,例如葡萄牙、比利時及韓國。此外,日本市場的強勁表現以及部分歐洲市場的放量,也共同推動下半年強勁增長。這反映在後線mCRC治療中,市場對安全且有效藥物的需求。
Also the physicians experience enhancement and also the reimbursement progress contributed to those growth. If you look at the U.S., we do see some of the headwind, mainly due to the medical Part D redesign.
同時,醫師使用經驗的提升以及報銷進展也促成了這些增長。若看美國市場,我們確實看到一些逆風,主要源於醫療保險Part D的重新設計。
Next slide. For China performance under the brand name ELUNATE -- in China, we posted a minus 13% growth, mainly due to a soft performance in the first half as we scale back some of the sales force after our GC second line setback and also some of the productivity improvement programs. But we successfully turned around the business with more efficient approach to focus on the top-tier cities and hospitals. In second half, we delivered 33% growth and successfully renewed our online deal with no price cut and include our EMC second line. Also, we submit NDA for RCC, those are all contribute to our future growth.
下一頁。在中國,以ELUNATE品牌銷售的產品——在中國我們錄得負13%的增長,主要由於上半年表現偏弱;原因是我們在GC二線受挫後縮減部分銷售團隊規模,同時推行一些生產力提升計劃。但我們以更高效率的方式成功扭轉業務,聚焦一線城市與重點醫院。下半年我們實現33%的增長,並成功續簽線上協議,未有降價,且納入我們的EMC二線。此外,我們亦已就RCC提交NDA,這些都將推動未來增長。
Next slide. If you look at the ORPATHYS and SULANDA, which is 11% of our total 2025 in-market sales, they are relatively soft due to the fierce competition. For SULANDA, we also face multiple PRRT those nuclear medicine moving to the clinical stage and fighting with us with limited patient pool. Although we have some kind of headwinds, we do see some progress. First is for ORPATHYS, we have a first-line METex skipping, adding to the NRDL.
下一頁。如果看ORPATHYS與SULANDA,兩者合計佔我們2025年市場端銷售的11%,由於競爭激烈,表現相對偏弱。就SULANDA而言,我們也面臨多個PRRT核醫藥物推進至臨床階段的競爭,在有限的患者池中與我們競爭。儘管存在一些逆風,我們仍看到一些進展。首先是ORPATHYS,我們有一線METex跳讀(skipping)納入NRDL。
Also, we have SACHI approval to drive future growth. Our SAFFRON/SANOVO readout what we are expecting in this year. For SULANDA, we maintain our market leader position in NET performance in the TKI markets. Also, we have renewed our NRDL with no price cut. Our Phase III PDAC study is on track.
此外,我們獲得SACHI批准,將推動未來增長。我們預期今年將讀出SAFFRON/SANOVO的結果。就SULANDA而言,我們在TKI市場的NET領域仍維持市場領先地位。同時,我們已在未降價的情況下完成NRDL續約。我們的III期PDAC研究進展如期。
Next slide. We are building on behalf -- in addition to our solid tumor, we are building our hematology portfolio. We get our first medicine, first-in-class treatment for EZH2 mutation and follicular lymphoma approved. This is our first hematology products launched in China. This also gives us a beachhead in the hematology, and also the TAZVERIK include our China's first commercial insurance drug list.
下一張投影片。我們正在打造——除了我們的實體腫瘤之外,我們也在建立血液腫瘤產品組合。我們的第一款藥物、針對 EZH2 突變與濾泡性淋巴瘤的同類首創(first-in-class)治療已獲核准。這是我們在中國上市的第一個血液腫瘤產品。這也讓我們在血液腫瘤領域取得立足點,同時 TAZVERIK 也納入了中國首份商業保險用藥清單。
We are one of the 19th medicine including drug list. This gives us a kind of future growth opportunity to explore the commercial insurance.
我們是該用藥清單中的第 19 個藥品之一。這為我們帶來一種未來成長機會,可進一步開拓商業保險。
On the other side, those TAZVERIK provide us a beachhead in the hematology to leverage these products, we can engage our hematology opinion leaders, establish our core team with expertise in the hematology to prepare the future hematology launch. [Sovleplenib] prepared to launch early 2027, and our ITP is already resubmit and wAIHA indicating will potentially submit in the first half of 2026. Also, we have additional pipeline in the hematology, the IDH1 and two inhibitor for AML and also the BTK in the DLBCL also start our Phase III study. So in long run, we were aiming to build our very strong hematology portfolio. Now let's turn over to our Dr. Dai.
另一方面,TAZVERIK 為我們在血液腫瘤領域提供了立足點;藉由這些產品,我們可以與血液腫瘤領域的意見領袖互動,建立具備血液腫瘤專業的核心團隊,為未來的血液腫瘤產品上市做準備。[Sovleplenib] 預計於 2027 年初準備上市,而我們的 ITP 已重新遞交申請,wAIHA 適應症則可能在 2026 年上半年遞交。此外,我們在血液腫瘤領域還有更多研發管線,包括用於 AML 的 IDH1 與第二個抑制劑,以及用於 DLBCL 的 BTK,也已啟動第三期研究。因此,從長期來看,我們的目標是建立非常強大的血液腫瘤產品組合。現在交給戴博士。
Guangxiu Dai - Executive Vice President, Head of Discovery & Global Portfolio Management
Guangxiu Dai - Executive Vice President, Head of Discovery & Global Portfolio Management
Thank you, George. I'll provide an update on our R&D pipeline progress. The 2025 proved to be a great year for our pipeline, featured by fast regulatory movement and high-impact clinical data. We have achieved major progresses across our core areas, oncology, hematology and our next-generation technology platforms. In oncology, savolitinib has reached critical regulatory and clinical milestones in both China and global markets.
謝謝你,George。我將更新我們研發(R&D)管線的進展。2025 年被證明是我們管線表現非常出色的一年,其特點是法規推進迅速以及高影響力的臨床數據。我們在核心領域——腫瘤、血液腫瘤以及下一代技術平台——都取得了重大進展。在腫瘤領域,savolitinib 在中國與全球市場均達成關鍵的法規與臨床里程碑。
SACHI was approved in China in a speed record for second-line EGFR mutant, MET-amplified non-small cell lung cancer. SANOVO and SAFFRON completed Phase III enrollment and third-line gastric cancer filed NDA in China in late December 2025.
SACHI 在中國以創紀錄的速度獲批,用於二線 EGFR 突變、MET 擴增的非小細胞肺癌。SANOVO 與 SAFFRON 已完成第三期入組,並於 2025 年 12 月下旬在中國就三線胃癌遞交 NDA。
In hematology, savolitinib, our Syk inhibitor has solidified its position with ITP NDA resubmission and robust positive Phase III data readout in wAIHA. Perhaps most excitingly, our antibody target therapy conjugate ATTC platform is now a clinical reality with our lead assets, A251 and 580 moving into global clinical development. A251 has started patient enrollment in China and in the US, closely followed by our second ATTC drug candidate, 580, which was first dosed in patients just yesterday. Beyond this, we are seeing broad success with Fruquintinib EMC included in NRDL, Fruquintinib RCC and Fanregratinib, IHCC gaining NDA acceptance and Surufatinib moving into Phase III for first-line PDAC.
在血液腫瘤方面,savolitinib(我們的 Syk 抑制劑)透過 ITP NDA 重新遞交以及 wAIHA 第三期強勁的正向數據讀出,鞏固了其地位。最令人振奮的是,我們的抗體靶向治療偶聯(ATTC)平台如今已在臨床上成為現實,領先資產 A251 與 580 正進入全球臨床開發。A251 已在中國與美國開始病人入組,緊接著我們第二個 ATTC 候選藥物 580,也就在昨天首次對病人給藥。除此之外,我們也看到多項廣泛進展:Fruquintinib EMC 納入 NRDL、Fruquintinib RCC 與 Fanregratinib、IHCC 的 NDA 獲受理,以及 Surufatinib 推進至一線 PDAC 的第三期。
Next, I'll dive deep into how this progress is define our growth trajectory. Next slide, please. With savolitinib, we have dual focuses here, maintaining leadership in China and expanding the global footprint. In non-small cell lung cancer savolitinib has been approved in China for first- and second-line METex14 alteration as a single agent. For second line, the combination of savolitinib and osimertinib represents a promising chemo-free oral treatment strategy to address mechanisms of resistance due to MET alteration following EGFR TKI treatment in this advancing setting.
接下來,我將深入說明這些進展如何界定我們的成長軌跡。請看下一張投影片。針對 savolitinib,我們有兩個重點:維持在中國的領導地位,以及擴大全球版圖。在非小細胞肺癌方面,savolitinib 已在中國獲批,作為單藥用於一線與二線 METex14 變異。在二線治療中,savolitinib 與 osimertinib 的聯合方案代表一種具前景、無化療的口服治療策略,用以因應在 EGFR TKI 治療後、由 MET 變化所導致的抗藥機制,適用於此進展期情境。
In this setting, SACHI has been approved in China and SAFFRON is expected to have a readout in mid-2026. For first-line SANOVO Phase III study of savolitinib and osimertinib will read out in the first half -- in the second half of 2026 or early 2027. Savolitinib is more than just a lung cancer drug. We also reached an important milestone in gastric cancer with China NDA for third-line MET-amplified gastric cancer being accepted and priority review granted.
在此情境下,SACHI 已在中國獲批,而 SAFFRON 預計於 2026 年年中讀出結果。在一線方面,savolitinib 與 osimertinib 的 SANOVO 第三期研究將於 2026 年下半年或 2027 年初讀出。Savolitinib 不僅僅是一款肺癌藥物。我們在胃癌方面也達成重要里程碑:用於三線 MET 擴增胃癌的中國 NDA 已獲受理並被授予優先審評。
Next, please. The data from SACHI is compelling. In 2026 Lancet publication, SACHI study demonstrated a clinically meaningful OS benefit, 22.9 months versus 7.9 months in ITT patients who didn't receive subsequent MET inhibitor treatment. The hazard ratio of 0.32 is a clear indicator of OS benefit. Earlier, we have presented at ASCO that combination of savolitinib and osimertinib shows a clinically meaningful improvement in overall response rate and duration of response versus chemotherapy as second-line treatment.
下一張,請。SACHI 的數據相當有說服力。在 2026 年《Lancet》發表中,SACHI 研究顯示具有臨床意義的 OS 獲益:在未接受後續 MET 抑制劑治療的 ITT 病人中,OS 為 22.9 個月對比 7.9 個月。風險比 0.32 清楚顯示 OS 獲益。更早之前,我們在 ASCO 發表過:savolitinib 與 osimertinib 的聯合方案作為二線治療,相較化療在總反應率與反應持續時間方面呈現具臨床意義的改善。
In particular, SACHI demonstrated clinically and statistically meaningful PFS improvement in ITT patients as well as in patients who failed third-generation EGFR TKI treatment.
特別是,SACHI 在 ITT 病人以及第三代 EGFR TKI 治療失敗的病人中,均顯示具臨床與統計學意義的 PFS 改善。
Next slide, please. Turning to Sovleplenib, a Syk inhibitor. Our focus is on addressing the large unmet medical needs in immune-mediated hematological disorders. In ITP, we have resubmitted our NDA in China. NDA has been accepted and granted with the breakthrough therapy designation and priority review.
請看下一張投影片。接著談 Sovleplenib,一款 Syk 抑制劑。我們的重點是解決免疫介導的血液疾病中龐大的未被滿足醫療需求。在 ITP 方面,我們已在中國重新遞交 NDA。NDA 已獲受理,並被授予突破性療法認定與優先審評。
The clinical profile of Sovleplenib is highly competitive in the three year follow-up study, the median duration of exposure is over 86 weeks. The cumulative durable response reaches over 66 weeks. Over 51% of patients achieved durable response. This is highly consistent with 48.4% durable response rate in the double-blind phase of ESLIM-01 study. Sovleplenib shows a superior durable response rate compared to many existing ITP therapies, including Syk inhibitor fostamatinib and BTK inhibitor, Rilzabrutinib as well as Efgartigimod and FcRn drug approved for ITP in Japan.
Sovleplenib 的臨床特徵極具競爭力:在三年追蹤研究中,中位暴露時間超過 86 週。累積的持久反應超過 66 週。超過 51% 的病人達到持久反應。這與 ESLIM-01 研究雙盲期的 48.4% 持久反應率高度一致。相較多種現有 ITP 治療(包括 Syk 抑制劑 fostamatinib、BTK 抑制劑 Rilzabrutinib,以及在日本獲批用於 ITP 的 Efgartigimod 與 FcRn 藥物),Sovleplenib 顯示更優異的持久反應率。
Sovleplenib's durable response rate is comparable to or better than TPO/TPO -RA drugs. A key differentiation for sovleplenib is its safety, particularly regarding vascular risks. It's well known that TPO/TPO -RA drugs have been associated with thromboembolic and thrombolic complications in ITP patients. Sovleplenib clearly demonstrates a highly competitive clinical profile in the safety and efficacy. Next slide, please.
Sovleplenib 的持久反應率可與 TPO/TPO-RA 藥物相當或更佳。Sovleplenib 的一項關鍵差異化在於其安全性,特別是血管風險方面。眾所周知,TPO/TPO-RA 藥物與 ITP 病人的血栓栓塞與血栓性併發症相關。Sovleplenib 在安全性與有效性方面清楚展現高度具競爭力的臨床特徵。請看下一張投影片。
The ITP market potential is significant and growing. In China alone, there are over 250,000 actively treated ITP patients, representing an addressable market of USD500 million to USD700 million. Next, please. Next is our innovation engine, the ATTC platform. This platform is designed to combine the precise delivery of antibodies with the potency of target inhibitors.
ITP 市場潛力可觀且持續成長。僅在中國,就有超過 250,000 名正在接受治療的 ITP 病人,對應可觸及市場規模約 5 億至 7 億美元。下一張,請。接下來是我們的創新引擎——ATTC 平台。此平台旨在結合抗體的精準遞送與靶向抑制劑的強效作用。
A251 is a first-in-class ATTC consisting of a potent PI3K/PIKK inhibitor conjugated to an HER2 antibody with a DAR four through a cleavable linker. Next slide. A251 targets a massive global market across several HER2-expressing solid tumors, including breast cancer, gastric, gynecologic cancer and many other HER2-expressing cancer types. Next, please. The scientific and strategic importance of this platform targeting the PAM pathway cannot be overstated.
A251 是同類首創(first-in-class)的 ATTC,由具強效的 PI3K/PIKK 抑制劑作為載荷,透過可切割連接子以 DAR 4 偶聯至 HER2 抗體。下一張投影片。A251 鎖定多個 HER2 表達的實體腫瘤所構成的龐大全球市場,包括乳癌、胃癌、婦科癌症以及許多其他 HER2 表達的癌種。下一張,謝謝。此平台鎖定 PAM 路徑在科學與策略上的重要性再怎麼強調都不為過。
The PAM pathway is the most frequently altered pathway in solid tumors appearing in 38% to 50% of all tumor cases, much higher than the other major drivers like RAS, HER2, EGFR and ALK.
PAM 路徑是實體腫瘤中最常發生改變的路徑,出現在 38% 到 50% 的所有腫瘤病例中,遠高於其他主要驅動因子如 RAS、HER2、EGFR 與 ALK。
For instance, PAM alterations are often seen in breast cancer, gastric, ovarian and cancers, prostate cancers. This gives A251 and other assets from this platform a massive total addressable market. Next slide. While small molecule inhibitors targeting PAM pathway and PIKK pathway have historically faced issues with high toxicities and poor -- PK properties, it is always challenging to balance clinical efficacy and safety. The ATTC platform is designed to reduce these on-target off-tumor toxicities by delivering the payload directly to the tumors.
例如,PAM 的改變常見於乳癌、胃癌、卵巢癌與其他癌症、前列腺癌。這使得 A251 以及此平台的其他資產擁有龐大的總可服務市場(TAM)。下一張投影片。過去,針對 PAM 路徑與 PIKK 路徑的小分子抑制劑一直面臨高毒性與不佳的藥物動力學(PK)特性等問題,因此在臨床療效與安全性之間取得平衡始終具有挑戰。ATTC 平台的設計目的,是透過將載荷直接遞送至腫瘤,以降低這些「靶向但非腫瘤」(on-target off-tumor)毒性。
The A251 payload is a potent inhibitor targeting multiple nodes in PAM pathway and PI3K pathway with high affinities in PI3K alpha, other PI3K isoforms and mTOR, ATR and ATM.
A251 的載荷是一種強效抑制劑,可高親和力地抑制 PAM 路徑與 PI3K 路徑中的多個節點,包括 PI3K alpha、其他 PI3K 同功型,以及 mTOR、ATR 與 ATM。
Its biochemical profile significantly differentiates from the profiles of the others targeting PAM and PIKK. We believe this is an advantage of the ATTC approach. The payload demonstrates high kinase specificity in a broad kinase panel hitting targets in the two families only. Next slide, A251 demonstrates strong HER2-dependent inhibitory activities, meaning IC50 is in the range of 0.2 nanomolar in HER2-positive cells regardless of PAM status in a single-digit nanomolar in HER2 low compared to 36 nanomolar in HER2 non cells. The HER2 expression level really determines how much of the payload is delivered to the tumor cells and how potent A251 can be.
其生化特徵與其他針對 PAM 與 PIKK 的藥物特徵有顯著差異。我們相信這是 ATTC 方法的優勢之一。在廣泛的激酶面板中,該載荷展現出高度激酶專一性,僅命中這兩個家族的標的。下一張投影片,A251 顯示出強烈的 HER2 依賴性抑制活性,亦即在 HER2 陽性細胞中,不論 PAM 狀態如何,IC50 約為 0.2 奈莫耳;在 HER2 低表達細胞中為個位數奈莫耳;相較之下,在 HER2 不表達(HER2 non)細胞中為 36 奈莫耳。HER2 的表達量確實決定了有多少載荷能被遞送至腫瘤細胞,以及 A251 能有多強的效力。
And crucially, A251 exhibits a bystander effect that allows it to overcome HER2 heterogeneity by killing neighboring HER2 non cells.
而且至關重要的是,A251 具有旁觀者效應(bystander effect),使其能透過殺死鄰近的 HER2 non 細胞來克服 HER2 的異質性。
The preclinical data has been published at 2025 EORTC conference. Next slide, please. A251 has started a global Phase I study in the U.S. and in China. The dose escalation and building dose expansion and optimization is essentially one study in China and U.S.
臨床前數據已於 2025 年 EORTC 會議發表。下一張投影片,謝謝。A251 已在美國與中國啟動全球第一期(Phase I)研究。劑量遞增、以及後續的劑量擴展與最佳化,基本上是在中國與美國以同一項研究進行。
following the same protocol. We believe this is the fastest way to define a global dose. The trial targets HER2-expressing solid tumors with PAM status being tested retro respectively. This will inform the biomarker strategy for future development. The strategy includes utilizing A251 as a monotherapy for late-line treatment and exploring combination therapies in frontline setting.
遵循相同的試驗方案。我們相信這是界定全球劑量最快的方式。該試驗鎖定 HER2 表達的實體腫瘤,並將回溯性(retro respectively)檢測 PAM 狀態。這將為未來開發提供生物標記策略的資訊。策略包括將 A251 作為單藥用於後線治療,並在一線治療情境中探索合併療法。
Next slide. We are accelerating discovery and development of ATTC and ADCs and this is the next-generation innovation time line. Our second ATTC asset 580 has started the Phase I opening sites and recruiting patients in China and in the U.S.
下一張投影片。我們正在加速 ATTC 與 ADC 的發現與開發,這是下一代創新時間線。我們的第二個 ATTC 資產 580 已在中國與美國啟動第一期(Phase I)開站並開始招募病人。
The third ATTC asset 830 is anticipated to enter global Phase I this year. We are committed to maintain the momentum from the innovative platform in the coming years. Next slide. Looking ahead next 15 months, the upcoming milestones include for savolitinib, we expect readouts for both SAFFRON and SANOVO. We anticipate the label expansion with China NDA approval for the third-line gastric cancer indication.
第三個 ATTC 資產 830 預計將於今年進入全球第一期(Phase I)。我們承諾在未來幾年持續維持此創新平台的動能。下一張投影片。展望未來 15 個月,即將到來的里程碑包括:對於 savolitinib,我們預期 SAFFRON 與 SANOVO 兩項試驗都將有讀出結果。我們預期在中國第三線胃癌適應症的 NDA 核准後,將進一步擴大標籤適應症。
For Sovleplenib, our Phase III trial in wAIHA successfully met its primary endpoint, clearing the path for the next regulatory filing, which will happen in the coming months. Our next major milestone will be the China NDA approval for ITP. For the innovation platform, three ATTCs will all be in the clinical development in 2026. Beyond these highlights today, we expect China NDA approvals for Fruquintinib, RCC and Fanregratinib in IHCC as well as Surufatinib PDAC enrollment completion within the next 15 months. We look forward to another great year.
對於 Sovleplenib,我們在 wAIHA 的第三期試驗成功達成主要終點,為下一步的法規申報鋪平道路,該申報將在未來數月內進行。我們下一個重大里程碑將是 ITP 的中國 NDA 核准。就創新平台而言,三個 ATTC 都將在 2026 年進入臨床開發。除今天的重點之外,我們也預期在未來 15 個月內取得 Fruquintinib(RCC)與 Fanregratinib(IHCC)的中國 NDA 核准,並完成 Surufatinib(PDAC)的入組。我們期待再迎來精彩的一年。
And with that, I'll turn back to our acting CEO, Johnny.
接下來,我把時間交回給我們的代理執行長 Johnny。
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Thank you, Dr. Dai. So in summary, we are very excited about our outlook for 2026 and beyond. We have multiple potential NDA filings upcoming, so including from SAFFRON and SANOVO readouts later this year. In addition, our new hematology products are expected to drive future sales growth in China.
謝謝你,Dai 博士。總結來說,我們對 2026 年及之後的展望感到非常振奮。我們有多項潛在的 NDA 申報即將到來,包括今年稍晚 SAFFRON 與 SANOVO 的讀出結果所帶來的申報。此外,我們新的血液學產品預期將推動中國未來的銷售成長。
On the innovation side, our strategic efforts will be focused on accelerating global development of our ATTC programs and at the same time, exploring business development opportunities to further validate and add value to this platform. Finally, our oncology revenue guidance of $330 million to $450 million factors in our FRUZAQLA ex-China commercial growth and the positive impact of adding new indications for Elunate.
在創新方面,我們的策略重點將放在加速 ATTC 計畫的全球開發,同時探索商務拓展(business development)機會,以進一步驗證並提升此平台的價值。最後,我們腫瘤業務營收指引為 3.30 億至 4.50 億美元,已納入 FRUZAQLA 在中國以外的商業成長,以及 Elunate 新增適應症所帶來的正面影響。
With that, I will turn it over to David to start our Q&A session.
接下來,我把時間交給 David,開始我們的問答環節。
David Ng - Head of Investor Relations and Capital Strategies
David Ng - Head of Investor Relations and Capital Strategies
Thank you, Johnny. Thank you, everyone, for the presentation. We will now do the Q&A session. (Event Instructions) The first question comes from CLSA, Matthew.
謝謝你,Johnny。謝謝各位的簡報。我們現在開始問答環節。(活動說明)第一個問題來自 CLSA 的 Matthew。
Unidentified Participant
Unidentified Participant
Hello. Thanks for taking my questions and the very comprehensive elaboration of the results and congrats on the results. I've got a few questions. First is regarding the oncology guidance in '26. In '25, you received multiple, for example, sales team restructuring kind of stuff, the growth is actually a decrease. So the '26 guidance seems to imply something 15% to 16% year over year oncology growth.
你好。謝謝讓我提問,也謝謝對業績結果非常全面的說明,並恭喜這次的成果。我有幾個問題。第一個是關於 2026 年的腫瘤業務指引。在 2025 年,你們有多項因素,例如銷售團隊重整之類的事情,成長其實是下滑的。因此,2026 年的指引看起來意味著腫瘤業務年增約 15% 到 16%。
So can you elaborate a little bit more about how I should be modeling the key drug sales for this, yes. This is my first question.
所以你能否再多說明一下,我應該如何在模型中推估各個關鍵藥品的銷售,是的。這是我的第一個問題。
Asking my question in one batch. And second thing is about the kind SAFFRON readout. Do you have any color why the top line readout has been delayed from first half to second half? And third question is -- the last question is about -- can you elaborate more on the indication of the ATTC platform the first two candidates into the clinic, for example, the A251 -- And my understanding right that is more like on the post HER2 refractory breast cancer setting what kind of setting we are looking at in the future?
我把問題一次問完。第二個問題是關於 SAFFRON 的讀出。你們能否提供一些背景,為什麼頂線(top line)讀出從上半年延後到下半年?第三個問題——也是最後一個問題——是關於 ATTC 平台的適應症:能否更詳細說明前兩個進入臨床的候選藥物,例如 A251——依我理解,它比較像是在 HER2 難治(refractory)乳癌的後線治療情境,那未來我們會看到的是什麼樣的治療情境?
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Thank you, Matthew. So for the first question, I will defer to Lorenso and the second and third question is to Dr. Dai. Lorenso?
謝謝你,Matthew。第一個問題我會請 Lorenso 回答,第二和第三個問題請戴博士回答。Lorenso?
Lorenso Chiu - Deputy Chief Financial Officer
Lorenso Chiu - Deputy Chief Financial Officer
Yes. About the guidance -- Matthew, thanks for the questions. About the guidance, as you pointed out, for 2025, there was a decline in the product sales. But as you can see, in the second half, we saw a strong momentum of recovery. And we expect that this will continue in the 2026.
是的。關於指引——Matthew,謝謝你的提問。關於指引,如你所指出,2025 年產品銷售有所下滑。但如你所見,在下半年我們看到強勁的復甦動能。我們預期這將延續到 2026 年。
And together, we'd like to highlight, that we're expecting more growth coming from the new indications. As you can see, we have the -- RCC, which is currently under review. And we believe that with that approval, that will bring in more revenue and the growth. And also about the FRUZAQLA, there's a strong growth in '26 expected due to the continued expansions of Takeda. And also, we can see that there are more and more countries are now in the market.
同時我們也想強調,我們預期更多成長將來自新的適應症。如你所見,我們有——RCC,目前正在審評中。我們相信一旦獲批,將帶來更多營收與成長。另外關於 FRUZAQLA,由於武田持續擴張,預期 2026 年將有強勁成長。同時我們也看到,越來越多國家正在進入市場。
And then with that full year penetration in 2026, that will continue the growth. Johnny, do you anything you want to add?
而在 2026 年實現全年滲透後,將持續推動成長。Johnny,你有什麼想補充的嗎?
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Okay. So second and third question, Guangxiu -- Dr. Dai.
好的。那第二和第三個問題,Guangxiu——戴博士。
Guangxiu Dai - Executive Vice President, Head of Discovery & Global Portfolio Management
Guangxiu Dai - Executive Vice President, Head of Discovery & Global Portfolio Management
Yes. So the SAFFRON readout is expected to happen in mid-2026. And the third question, A251 now is enrolling HER2 expressing solid tumor patients not restricted to post HER2 patients.
是的。SAFFRON 的讀出預計在 2026 年年中發生。第三個問題,A251 目前正在招募 HER2 表達的實體腫瘤患者,不限於 HER2 後線患者。
Unidentified Participant
Unidentified Participant
Okay, thank you.
好的,謝謝。
David Ng - Head of Investor Relations and Capital Strategies
David Ng - Head of Investor Relations and Capital Strategies
All right, David. Okay, thank you, Matthew. The next question comes from Matthew Guggenbiller. Go ahead, Matthew.
好的,David。好的,謝謝你,Matthew。下一個問題來自 Matthew Guggenbiller。請說,Matthew。
Matthew Guggenbiller - Analyst
Matthew Guggenbiller - Analyst
Hey, can you hear me okay?
嗨,你們聽得到我嗎?
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Yes.
聽得到。
Matthew Guggenbiller - Analyst
Matthew Guggenbiller - Analyst
Great. This is Matthew, on for Alec Stranahan from Bank of America. I guess two questions from us. On the SAFFRON readout, you said expected May 2026. Can you maybe clarify expected location of that medical meeting versus company event?
太好了。我是 Matthew,代表美國銀行的 Alec Stranahan 提問。我們這邊有兩個問題。關於 SAFFRON 的讀出,你們說預計是 2026 年 5 月。能否澄清一下,預計會在醫學會議上公布,還是公司活動上公布?
And then for ATTC readouts, can you just maybe clarify expected patient number sort of follow-up we can expect from those? Thanks.
另外關於 ATTC 的讀出,你能否澄清一下,我們可以期待的患者數量以及隨訪情況大概是什麼?謝謝。
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Dr. Dai?
戴博士?
Guangxiu Dai - Executive Vice President, Head of Discovery & Global Portfolio Management
Guangxiu Dai - Executive Vice President, Head of Discovery & Global Portfolio Management
Okay. So the SAFFRON readout will be in, like I said, in the mid-2026. We'll share the data as soon as -- informs us of the results. What's your second question? Can you repeat your question?
好的。SAFFRON 的讀出會在——如我所說——2026 年年中。一旦——我們收到結果通知——我們會盡快分享數據。你的第二個問題是什麼?你可以重複一下你的問題嗎?
Matthew Guggenbiller - Analyst
Matthew Guggenbiller - Analyst
Yes. In terms of initial clinical data for the ATTC assets, sort of size and scope of those in terms of patient number follow-up?
可以。就 ATTC 資產的初步臨床數據而言,在患者數量與隨訪方面,規模與範圍大概會是怎樣?
Guangxiu Dai - Executive Vice President, Head of Discovery & Global Portfolio Management
Guangxiu Dai - Executive Vice President, Head of Discovery & Global Portfolio Management
The trial is still at early stage. We don't have a definitive time line for the data readout.
試驗仍處於早期階段。我們目前沒有明確的數據讀出時間表。
Matthew Guggenbiller - Analyst
Matthew Guggenbiller - Analyst
Got you. And then maybe one on commercial dynamics as well. I think first half had some headwinds from off-label sales, increased generic competition and sort of sales force turnover. I guess, can you speak to how those trends are looking in the second half and whether you expect those to stabilize throughout '26? Thanks.
了解。另外也想問一個商業動態方面的問題。我認為上半年受到一些逆風影響,包括超適應症用藥銷售、學名藥競爭加劇,以及銷售團隊人員流動。能否談談這些趨勢在下半年看起來如何,以及你們是否預期這些情況在 2026 年會趨於穩定?謝謝。
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Okay. Matthew, we invite our Head of Commercial, George, to answer this question.
好的。Matthew,我們請商業負責人 George 來回答這個問題。
George Yuan - Executive Vice President, Head of Commercial
George Yuan - Executive Vice President, Head of Commercial
We -- because we cannot -- for the GC last year, we faced some GC setback. The indication is not yet approved. That's why if you look at the sales force, the original setting is we prepare for the GC. So the field force is a little bit overcapacity when we lost the GC indication. That's why we rationalized the team and also we try to focus more on the top hospitals.
我們——因為我們無法——去年在 GC 方面遇到一些挫折。該適應症尚未獲批。因此如果你看銷售團隊,原本的配置是為 GC 做準備。所以在失去 GC 適應症後,一線團隊出現些許人力過剩。因此我們精簡了團隊,同時也嘗試更聚焦於頂尖醫院。
And that's why we have some kind of -- the team, which lead to some kind of performance issue in the Q1 and the first half -- but everything is moving into the right direction. The turnover is significantly reduced. Also the vacancy is already filled. That's why we have a very strong team now, and those kind of momentum will carry over to the 2026.
也因此我們的團隊出現了一些——導致第一季以及上半年出現一些績效問題——但一切都在往正確方向發展。人員流動率已顯著降低。空缺也已補齊。因此我們現在有一支非常強的團隊,這樣的動能也會延續到 2026 年。
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Thank you, no follow-up question, then David.
謝謝,如果沒有追問的話,David。
David Ng - Head of Investor Relations and Capital Strategies
David Ng - Head of Investor Relations and Capital Strategies
Thank you. Next question is from Cavendish, Adam.
謝謝。下一個問題來自 Cavendish 的 Adam。
Adam McCarter - Analyst
Adam McCarter - Analyst
Thanks very much, thanks for the presentation. So a couple of questions. So yes, just in today's announcement, I noticed that you mentioned that AstraZeneca continues its efforts to increase MET testing as a standard of care in late-stage non-small cell lung cancer. And could you comment on how the pace of MET testing adoption might influence the potential uptake of savolitinib in the -- setting in China and then globally, if SAFFRON is successful?
非常感謝,也謝謝你們的簡報。我有幾個問題。在今天的公告中,我注意到你們提到阿斯特捷利康持續努力,將 MET 檢測提升為晚期非小細胞肺癌的標準照護。你們能否評論一下,MET 檢測採用速度可能如何影響 savolitinib 在中國該——治療情境中的潛在採用,以及若 SAFFRON 成功,在全球的影響?
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Yes. So Dr. Dai, yes.
是的。那戴博士,請。
Guangxiu Dai - Executive Vice President, Head of Discovery & Global Portfolio Management
Guangxiu Dai - Executive Vice President, Head of Discovery & Global Portfolio Management
We do not have additional information on this question.
關於這個問題,我們沒有額外資訊可以補充。
Adam McCarter - Analyst
Adam McCarter - Analyst
Okay, no problem, thank, thanks very much. Just on the second question then. So on the ATTC platform, could you elaborate on your partnering strategy, you are pursuing with the multinational pharmaceutical companies? And more specifically, are you considering out-licensing certain assets earlier in development to accelerate validation of the platform while potentially regaining greater control over other assets to maximize longer-term value?
好的,沒問題,非常感謝。那第二個問題。關於 ATTC 平台,你們能否更詳細說明與跨國藥廠合作的策略?更具體地說,你們是否考慮在開發較早期就對部分資產進行對外授權,以加速平台驗證,同時可能重新取得對其他資產更大的控制權,以最大化長期價值?
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Well, I think I will answer these question. In terms of our strategy for the partnering with the ATTC program, first of all, I think as you can see, we have a strong pipeline already building up for this ATTC platform. So we now have positive responses from potential partners, and many of which are multinational companies. We have ongoing discussion with all those potential partners.
我想我來回答這個問題。就 ATTC 計畫的合作策略而言,首先,如你所見,我們已在這個 ATTC 平台上建立起強勁的產品管線。因此我們目前已收到潛在合作夥伴的正面回應,其中許多是跨國公司。我們正與所有這些潛在合作夥伴進行持續討論。
So with our large portfolio that we anticipate that we will build on, I think we want to advance and accelerate this development. So hence, we have considered to potentially license out some of these programs. So also, in addition, I think we also have this AI capability, which we can further develop some more candidates into our platform. As a result, I think this is why we also consider potential partnering opportunities. Furthermore, I think as this platform is really one of our next wave, we would also like to validate this through this partnering strategy.
基於我們預期將建立的龐大組合,我們希望推進並加速開發。因此,我們也考慮可能將其中一些計畫對外授權。此外,我們也具備 AI 能力,可進一步開發更多候選項目納入平台。因此,我們也在考慮潛在的合作機會。再者,鑑於這個平台確實是我們下一波的重要方向,我們也希望透過這樣的合作策略來驗證它。
Adam McCarter - Analyst
Adam McCarter - Analyst
That's great. And I guess just if I could try my hand on final question is just sort of maybe a broader one. As we think about the HUTCHMED story going forward, how should investors balance the contribution of the existing commercial portfolio against the emerging opportunity from the ATTC platform? And in particular, do you see the next phase of value creation increasingly driven by the pipeline and the platform assets rather than the marketed product?
很好。如果我可以再嘗試問最後一個、比較宏觀的問題。展望 HUTCHMED 未來的發展,投資人應如何在既有商業化產品組合的貢獻,與 ATTC 平台所帶來的新興機會之間取得平衡?特別是,你們是否認為下一階段的價值創造將越來越由研發管線與平台資產驅動,而不是已上市產品?
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Well, we see, as we have our second wave of, as we mentioned, hematology asset that will be going into the commercial side that would add into our existing commercial -- already commercialized portfolio. So that would be increasing our balance of our investment in R&D. So we will continue to ramp up our R&D expenditure. Last year, in 2025, in terms of our investment in R&D was probably the lowest in recent years, mainly due to a lot of programs we're waiting for approval -- pending for approval, and we are also at the early stage of development of this ATTC program. But going forward, we do take this accelerate our global development strategy for ATTC.
嗯,我們看到,正如我們提到的,我們的第二波血液學資產將進入商業化端,並將納入我們現有的商業——已經商業化的產品組合。因此,這將提高我們在研發方面的投資比重。所以我們將持續加大研發支出。去年,也就是2025年,就研發投資而言,可能是近年來最低的一年,主要是因為有許多專案在等待核准——仍在審批中,同時我們的 ATTC 計畫也仍處於開發早期階段。但展望未來,我們確實會藉此加速 ATTC 的全球開發策略。
And at the same time, with the expanded commercial assets, we will be able to generate more income, so we can balance out our ATC investment.
同時,隨著商業化資產的擴充,我們將能夠創造更多收入,因此可以平衡我們在 ATC 上的投資。
Adam McCarter - Analyst
Adam McCarter - Analyst
That's excellent, thank you very much, and thanks for taking my questions.
非常好,十分感謝,也謝謝你回答我的問題。
David Ng - Head of Investor Relations and Capital Strategies
David Ng - Head of Investor Relations and Capital Strategies
Thank you, The next question is coming from UBS, Chen Chen.
謝謝。下一個問題來自瑞銀(UBS)的 Chen Chen。
Chen Chen - Analyst
Chen Chen - Analyst
Thank you for taking my question. Well, my first question is on surufatinib. We see that it has started Phase III patient enrollment. So I'm interested in like partner strategy. So are you considering like BD like after data readout? Or you are now in talks with any potential partners right now because the Phase III will enroll like a few hundred people, so it would be very expensive. Thank you.
謝謝讓我提問。我的第一個問題是關於 surufatinib。我們看到它已開始第三期臨床的病人入組。所以我想了解你們的合作夥伴策略。你們是否考慮在數據讀出後再進行商務開發(BD)?或者你們現在就正在與任何潛在合作夥伴洽談?因為第三期將入組數百人,成本會非常高。謝謝。
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Okay. I will answer from a strategic side, and then I will invite Dr. Dai to comment further. We have no -- at the moment, no intention to partner this program out. But Dr.
好的。我會先從策略層面回答,然後我會請戴博士再補充評論。目前我們沒有——目前沒有打算把這個專案對外授權合作。不過戴博士。
Dai in terms of the status of our development, you can -- perhaps you can comment a little bit.
戴博士,就我們開發進度的狀態而言,你可以——或許你可以稍微評論一下。
Guangxiu Dai - Executive Vice President, Head of Discovery & Global Portfolio Management
Guangxiu Dai - Executive Vice President, Head of Discovery & Global Portfolio Management
Sure, Johnny. So the Phase III first patient in has -- was achieved in December 2025, and we hope to finish the Phase III enrollment in the next 15 months. And we hope that surufatinib can provide another therapeutic option for the first-line PDAC patients and agree with Johnny that currently, we don't have our licensing.
好的,Johnny。第三期的首位受試者入組已——已於2025年12月達成,我們希望在接下來15個月內完成第三期入組。我們希望 surufatinib 能為一線 PDAC 病患提供另一個治療選擇,也同意 Johnny 的看法,目前我們沒有進行授權合作。
Chen Chen - Analyst
Chen Chen - Analyst
I see. That's very clear. Well, so my second question is on your like R&D guidance in this year. So we noticed that you have started like a few Phase III trials such as like surufatinib as we discussed just now and also like BTK, DLBCL and also a few like early-stage trials such as ATTC candidates. So I'm just wondering like what's your guidance for your R&D expense this year?
了解。非常清楚。那我的第二個問題是關於你們今年的研發指引。我們注意到你們已啟動了幾項第三期試驗,例如我們剛討論的 surufatinib,還有 BTK、DLBCL,以及一些早期試驗,例如 ATTC 候選項目。所以我想請問你們今年研發費用的指引是什麼?
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Okay. Just to clarify, we do not give out any public guidance on R&D expenditure. But as we mentioned that 2025 was the lowest level. We do intend to ramp up, as you also mentioned, a number of programs that we are actually advancing as well as our strategy on accelerating our ATTC program. So going forward in the next few years, we do want to ramp up to a very reasonable kind of higher level of investment on R&D in the range of $250 million to $300 million, I think that would be the ideal level of R&D investment.
好的。先澄清一下,我們不會對外提供任何公開的研發支出指引。但如我們所提到,2025年是最低水準。我們確實打算提高投入,正如你提到的,我們正在推進多個專案,同時也在加速 ATTC 計畫的策略。因此,未來幾年我們希望把研發投資提高到一個相當合理、較高的水準,大約在2.5億到3億美元的區間,我認為那會是理想的研發投資水準。
Of course, we will be -- stick to our commitment to the investors that we will be profitable in a sustainable situation. So therefore, we will be investing as we will be able to generate sufficient commercial income to cover our R&D investment.
當然,我們也會——遵守對投資人的承諾,在可持續的情況下保持獲利。因此,我們會在能夠產生足夠商業收入以覆蓋研發投資的前提下進行投入。
Chen Chen - Analyst
Chen Chen - Analyst
Okay. Great. Maybe the last question for me. So I saw that you have a very strong cash position by the end of 2025. And you also mentioned that you are planning to do some like in-license and also some M&A.
好的。很好。我最後一個問題。我看到你們在2025年底的現金部位非常強。你們也提到計畫做一些引進授權(in-license)以及一些併購(M&A)。
So can you please elaborate a bit more on that side? Thank you.
能否請你們在這方面再多說明一些?謝謝。
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Yes. So yes, $1.4 billion of cash on hand. So our priority is, of course, as we mentioned, accelerating our global development for ATTC program. We are open because with these cash resources, we are open if the opportunity arise for in-licensing late-stage commercial assets or potentially some assets that is complementary to our portfolio. But I think M&A and this in-licensing opportunity, we are open-minded because we are in a good financial position, but we have no fixed target at this stage.
是的。所以,是的,手上有14億美元現金。我們的優先事項當然是,如我們所提到的,加速 ATTC 計畫的全球開發。同時,憑藉這些現金資源,如果出現機會,我們也願意引進授權後期、具商業化潛力的資產,或是一些能與我們產品組合互補的資產。但我認為,對於併購以及這些引進授權的機會,我們會保持開放態度,因為我們財務狀況良好,但目前階段沒有固定的目標。
Chen Chen - Analyst
Chen Chen - Analyst
Okay, that's very clear. Thank you so much.
好的,非常清楚。非常感謝。
David Ng - Head of Investor Relations and Capital Strategies
David Ng - Head of Investor Relations and Capital Strategies
Thank you, Chen Chen. The next question comes from Panmure, Julie Simmonds.
謝謝你,Chen Chen。下一個問題來自 Panmure 的 Julie Simmonds。
Julie Simmonds - Analyst
Julie Simmonds - Analyst
Thank you very much. I was just wondering on the move into hematology products, whether this changes what you're investing in sales and marketing and what changes to the sales infrastructure it requires. Thank you.
非常感謝。我想請問,轉向血液學產品是否會改變你們在銷售與行銷上的投資,以及對銷售基礎設施需要做哪些調整?謝謝。
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Thank you, Julie. So George, would you like to comment on this?
謝謝你,Julie。George,你願意就此評論一下嗎?
George Yuan - Executive Vice President, Head of Commercial
George Yuan - Executive Vice President, Head of Commercial
Thank you. Because hematology is a very specialized team, that's why we already start up a new business unit with dedicated sales, marketing and medical capability to address this kind of market opportunity. And with the future pipeline adding to the business, we will expand the team.
謝謝。因為血液學是一個非常專業的團隊,所以我們已經成立了一個新的事業部,配置專屬的銷售、行銷以及醫學能力,以因應這類市場機會。隨著未來管線資產加入業務,我們將擴充團隊。
Julie Simmonds - Analyst
Julie Simmonds - Analyst
Lovely. And then secondly, just on the impact in the U.S. of the Medicare Part D changes. Just wondering how much impact you expect that to have on sales in 2026, whether you can make any comment?
很好。第二個問題是關於美國 Medicare Part D 變更的影響。想請問你們預期這對2026年的銷售會有多大影響,是否可以評論一下?
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Sorry, I didn't hear your question. Could you repeat again?
抱歉,我沒有聽清楚你的問題。你可以再重複一次嗎?
Julie Simmonds - Analyst
Julie Simmonds - Analyst
Yes. Just questioning about the changes to Medicare Part D that went on in the states that are obviously impacting your sales there. And if you've got any thoughts on what impact that might have into 2026?
好的。我想問的是,美國那邊 Medicare Part D 的變更,顯然正在影響你們在當地的銷售。你們是否對這可能延伸到2026年的影響有任何看法?
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
We have received no new changes so far. The impact factors into 2025 has been reflected. Despite that impact for U.S., I mean, we still achieved a 26% growth for our food sector through our partners. So we do anticipate that in -- sorry, 2026, we will be expanding rolling out of all the ex U.S. countries.
到目前為止,我們沒有收到任何新的變更。影響在2025年已經反映出來。儘管美國市場受到影響,我是說,我們仍透過合作夥伴在我們的 food sector 實現了26%的成長。因此我們預期在——抱歉,2026年,我們將擴大在所有美國以外國家的推廣與上市。
So far, already 38 countries have been commercialized in terms of this food sector. And we continue to see that the NRDL in those countries will be expanded. So the total impact for ex-China sales, we see that U.S. will continue to grow, but also outside of U.S., that is the key driver also. Thank you.
截至目前,就這個 food sector 而言,已經在38個國家實現商業化。我們也持續看到這些國家的 NRDL 將會擴大。因此,對於中國以外的銷售總體影響,我們認為美國將持續成長,但美國以外市場同樣也是關鍵驅動力。謝謝。
David Ng - Head of Investor Relations and Capital Strategies
David Ng - Head of Investor Relations and Capital Strategies
Thank you, Julie. Next question coming from Daiwa, Wilfred Yuen.
謝謝你,Julie。下一題來自大和證券(Daiwa)的 Wilfred Yuen。
Wilfred Yuen - Analyst
Wilfred Yuen - Analyst
Thanks. Thanks for taking my question.
謝謝。謝謝讓我提問。
I want to follow up on the revenue guidance that range from $330 million to $450 million, which is a wide range versus last year anyway. Maybe can you give us more color as to the breakdown between the oncology product sales and the R&D milestones payment? Are you expecting some additional milestone maybe to hit the high end of the guidance $450 million?
我想追問一下營收指引區間為 3.30 億美元到 4.50 億美元,這個區間相較去年而言仍然很寬。能否請你們提供更多細節,說明腫瘤產品銷售與研發里程碑付款之間的拆分?你們是否預期會有額外的里程碑入帳,以支撐指引高端 4.50 億美元?
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Lorenso, would you like to tackle this question? I will add to it.
Lorenso,你想先回答這個問題嗎?我也會補充。
Lorenso Chiu - Deputy Chief Financial Officer
Lorenso Chiu - Deputy Chief Financial Officer
Yes. Further to what I explained earlier, I think you can look in this way because we do not give any guidance of particular items within this revenue guidance. But for your information, I think it will be worth to note that in 2025, our revenue has included some of the upfront and milestones, which if you exclude those, the base would be lower. And then for the 2026, the guidance reflect a kind of a solid growth from 2025. In addition, I think some of the factors that I mentioned, the growth from our China -- China products with the new label expansions and also the new indications would drive further growth.
是的。延續我先前的說明,我認為你可以這樣看,因為我們不會在這個營收指引中,針對特定項目提供任何指引。但供你參考,我認為值得注意的是,在 2025 年,我們的營收包含了一些預付款與里程碑款;若將這些排除,基礎營收會較低。而對於 2026 年,該指引反映了相較 2025 年的穩健成長。此外,我提到的一些因素,例如我們中國——中國產品在新標籤擴展以及新增適應症的帶動下,也將推動進一步成長。
So I hope that could address the questions. Johnny, do you want to add some more comments on this?
所以我希望這能回答你的問題。Johnny,你要再補充一些評論嗎?
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
So Wilfred, I think basically, you should take the guidance as the middle of this range, right? So the lower end potentially, if some of the -- at this, I think the low end of the guidance is where we are very confident, and we are also very confident that to achieve high of this guidance. So $330 million has factored in, as Lorenso said, many of the organic growth.
Wilfred,我認為基本上你應該把指引視為這個區間的中位數,對吧?所以低端的情況,可能是如果某些——在這裡,我認為指引低端是我們非常有把握的,我們也非常有把握能達到這個指引的高端。所以 3.30 億美元已經納入了如 Lorenso 所說的許多內生成長。
In addition, we also factor in for a base kind of baseline growth for our ex-China sales, which, of course, is run by our partner. So conservatively speaking, we are very conservative to give this low-end guidance, but you can expect the midrange of that is almost like a 36% growth. between $330 million to $450 million is about -- that is more like 36% growth versus this year's 2025 performance. So I think this is a guidance that basically can reflect the business growth as well as the potential if we have licensing, of course, we won't take all the upfront income. We will potentially apportion part of the upfront income and factoring into the upside.
此外,我們也把中國以外銷售的基礎性成長納入考量,當然這部分是由我們的合作夥伴推動。保守地說,我們在給出這個低端指引時非常保守,但你可以預期其中位數幾乎相當於 36% 的成長。3.30 億美元到 4.50 億美元之間大約——相較今年 2025 年的表現,約為 36% 的成長。所以我認為這個指引基本上反映了業務成長,以及若我們有授權交易的潛在上行;當然,我們不會把所有預付款收入一次性全數計入。我們可能會把部分預付款收入分攤,並將其納入上行空間的考量。
Wilfred Yuen - Analyst
Wilfred Yuen - Analyst
Got it. Thanks for the color. Thanks. Thank.
了解。謝謝補充說明。謝謝。謝謝。
David Ng - Head of Investor Relations and Capital Strategies
David Ng - Head of Investor Relations and Capital Strategies
Next question coming from Goldman Sachs, Paul Choi.
下一題來自高盛(Goldman Sachs)的 Paul Choi。
Paul Choi - Analyst
Paul Choi - Analyst
Hello, and thank you for taking our question. My question is on savolitinib and assuming clinical success coming up here with SAFFRON, can you maybe comment on how you think Tagrisso, savolitinib combination would be sequenced in the treatment paradigm given the recent launch of J&J's RYBREVANT bispecific? And just how you think about guidelines evolving directing oral options versus bispecific options? Thank you very much for taking our question.
你好,謝謝讓我們提問。我的問題是關於 savolitinib,並假設 SAFFRON 即將取得臨床成功,你們能否評論一下,在近期 J&J 的 RYBREVANT 雙特異性抗體上市後,你們認為 Tagrisso 與 savolitinib 的聯合療法在治療流程(treatment paradigm)中會如何排序使用?以及你們如何看待指引(guidelines)演進,會更偏向口服選項還是雙特異性選項?非常感謝讓我們提問。
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Yes. Thank you. So George, do you have any color to share on this?
是的。謝謝。George,你對此有什麼補充可以分享嗎?
George Yuan - Executive Vice President, Head of Commercial
George Yuan - Executive Vice President, Head of Commercial
Yes. This is -- I think this first thing is this provides an oral -- two oral products for those EGFR-resistant MET amplification patients. So this is -- we provide very efficacy and as well as convenience. But we do know the J&J bispecific antibody do provide another option, but all depends on doctors' perception regarding how the treatment paradigm shift is still precision medicine win the game or not. The testing, the secondary testing win the game or not.
是的。我想——我認為第一點是,這為那些 EGFR 抗藥且 MET 擴增的患者提供了口服——兩個口服產品。因此我們提供了很好的療效以及便利性。但我們也知道 J&J 的雙特異性抗體提供了另一個選項,不過一切取決於醫師的看法:治療流程的轉變是否仍是精準醫療勝出。檢測、二次檢測是否能勝出。
So it depends on how AstraZeneca is shaping the --
所以這取決於阿斯特捷利康(AstraZeneca)如何塑造--
Paul Choi - Analyst
Paul Choi - Analyst
Okay, thank you.
好的,謝謝。
David Ng - Head of Investor Relations and Capital Strategies
David Ng - Head of Investor Relations and Capital Strategies
Thank you, Paul. I see a couple of questions in the chat box. Some of that actually has been kind of answered already. There's a question -- Johnny, the question is what is the thought about the need to decide appointment of a permanent CEO? Or are we happy with the current situation?
謝謝你,Paul。我在聊天室看到幾個問題。其中一些其實已經算是回答過了。有一個問題——Johnny,問題是對於是否需要決定任命一位正式 CEO 的想法是什麼?或者我們對目前的狀況是否滿意?
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Okay. I think we have -- the company has made an announcement in August. I think no status change as yet regarding the announcement. So Dr. SU is focusing on his health right now.
好的。我想我們——公司已在 8 月發布公告。就該公告而言,目前尚無狀態變更。所以蘇博士目前正專注於他的健康。
And yes, so we have this interim arrangement. And as you can see, we have a lot of talents within our management team. Today, we have Dr. Dai and also we have Lorenso Chiu joining this webcast. So the company has been running for 20-odd years, and we have a very loyal and also capable talents within our talent pool.
是的,所以我們目前採取臨時安排。如你所見,我們管理團隊內有很多人才。今天有戴博士,也有 Lorenso Chiu 參與本次網路直播。公司已營運 20 多年,我們的人才庫中有非常忠誠且能力出眾的人才。
So -- and everything has been running very, very smoothly and also progressing in terms of our pipeline as well as our commercial strategy, everything it is now working as per plan.
所以——一切運作都非常、非常順暢;而且無論是我們的研發管線或商業策略,都在持續推進,目前一切都按計畫進行。
David Ng - Head of Investor Relations and Capital Strategies
David Ng - Head of Investor Relations and Capital Strategies
Thank you, Johnny. I don't see any outstanding questions right now (Event Instructions) There's another question talking about SAFFRON readout delay from first half to second half. But as Dr. Dai has mentioned, the most likely scenario will be around mid-'26. If no further questions, Johnny, would you like to do a concluding remark?
謝謝你,Johnny。我目前沒有看到任何尚未回答的問題(活動指示)。另外還有一個問題談到 SAFFRON 的讀出時間從上半年延後到下半年。但如戴博士所提到,最可能的情境會是在 26 年年中左右。如果沒有其他問題,Johnny,你要做個結語嗎?
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Johnny Cheng - Executive Director, Acting Chief Executive Officer and Chief Financial Officer
Thank you again, everyone, for spending the time to attend this webcast. And if you have further questions, please by all means to feed through our IR colleagues. Thank you.
再次感謝各位撥冗參加本次網路直播。如果你們還有進一步問題,請務必透過我們的投資人關係(IR)同事提出。謝謝。
David Ng - Head of Investor Relations and Capital Strategies
David Ng - Head of Investor Relations and Capital Strategies
Thank you, everyone. And this concludes our results presentation. Thank you very much. Thank you very much.
謝謝各位。本次業績簡報到此結束。非常感謝。非常感謝。