Zai Lab Ltd (ZLAB) 2026 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to Zai Lab's third quarter 2026 financial results conference call. (Operator Instructions) As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to Christine Chiou, Senior Vice President of Investor Relations. Please go ahead.

各位女士、先生，感謝您稍候，歡迎參加再鼎醫藥（Zai Lab）2026年第三季財務業績電話會議。（接線員指示）提醒各位，今天的電話會議將被錄音。現在我很榮幸將會議交給投資人關係資深副總裁Christine Chiou。請開始。

Thank you, operator. Hello and welcome, everyone. Today's earnings call will be led by Dr. Samantha Du, Zai Lab's founder, CEO, and chairperson. She will be joined by Dr. Rafael Amado, President and Head of Global Research and Development, and Dr. Yajing Chen, Chief Financial Officer. Dr. Shan He, our Chief Business Officer, and Dr. Yizhe Wang, our operating partner, will also be available to answer questions during the Q&A portion of the call.

謝謝，接線員。各位好，歡迎大家。今天的財報電話會議將由再鼎醫藥創辦人、執行長兼董事長杜瑩博士（Dr. Samantha Du）主持。與會者還包括全球研發總裁兼負責人Rafael Amado博士，以及財務長陳雅靜博士（Dr. Yajing Chen）。我們的首席商務官何珊博士（Dr. Shan He）與營運合夥人王一哲博士（Dr. Yizhe Wang）也將在問答環節回答問題。

As a reminder, during today's call, we will be making certain forward-looking statements based on our current expectations. These statements are subject to numerous risks and uncertainties that may cause actual results to differ materially from what we expect due to a variety of factors, including those discussed in our SEC filings. We will also refer to adjusted loss from operations, which is a non-GAAP financial measure. Please refer to our earnings release furnished with the SEC on November 5, 2026 for additional information on this non-GAAP financial measure.

提醒各位，在今天的電話會議中，我們將基於目前的預期作出若干前瞻性陳述。這些陳述受到多項風險與不確定性影響，可能因各種因素（包括我們向美國證券交易委員會（SEC）提交文件中所討論者）而導致實際結果與我們的預期存在重大差異。我們也將提及經調整營運虧損（adjusted loss from operations），這是一項非GAAP財務衡量指標。有關此非GAAP財務衡量指標的更多資訊，請參閱我們於2026年11月5日向SEC提交的財報新聞稿。

At this time, it is my pleasure to turn the call over to Dr. Samantha Du.

現在我很榮幸將電話會議交給杜瑩博士。

Thanks, Christine. Good morning and good evening, everyone. We're entering one of the most important periods in Zai Lab's history. I founded Zai Lab to discover and develop innovative medicines for patients around the world. We have spent years building the talent, scientific capabilities, and infrastructure to make that possible.

謝謝，Christine。各位早安、晚安。我們正進入再鼎醫藥歷史上最重要的時期之一。我創立再鼎醫藥，是為了為全球患者發現並開發創新藥物。多年來，我們投入建置人才、科學能力與基礎設施，以實現這一目標。

With Zoci advancing toward a potential US BLA submission next year, that vision is within our reach. Our first-line ESMO data strengthened our confidence that Zoci can become the ADC backbone in small cell lung cancer. We are advancing the Zoci doublet into a global Phase 3 study and building on it through our T-cell engager collaborations with Amgen and BI. The next two years are pivotal.

隨著Zoci朝著明年可能提交美國BLA申請邁進，這一願景已近在咫尺。我們的一線治療ESMO數據進一步增強了我們的信心：Zoci有望成為小細胞肺癌的ADC基石療法。我們正推進Zoci雙藥方案進入全球第3期研究，並透過與安進（Amgen）及BI的T細胞接合器合作在此基礎上持續拓展。未來兩年至關重要。

By year-end, we expect three registrational studies underway across small cell lung cancer and neuroendocrine carcinomas. In 2027, we anticipate two registrational readouts and our first potential US BLA submission, positioning us for a US launch as early as 2028. This would be a defining achievement for our company.

預計到年底，我們將在小細胞肺癌與神經內分泌癌領域啟動三項註冊性研究。在2027年，我們預期將有兩項註冊性研究讀出結果，以及首次可能提交美國BLA申請，最早可望於2028年在美國上市。這將是公司具有里程碑意義的成就。

Our recent $250 million financing further strengthened our ability to deliver on the plan. Our ambition extends well beyond zoci. Next week, we'll present the first clinical data for ZL-1503, our internally developed bispecific for atopic dermatitis. We also expect three additional oncology and immunology assets in clinical development next year. Meanwhile, we continued to strengthen our China commercial business.

我們近期完成的2.5億美元融資，進一步強化了我們落實計畫的能力。我們的抱負遠不止於Zoci。下週，我們將公布ZL-1503（我們內部研發、用於異位性皮膚炎的雙特異性抗體）的首批臨床數據。我們也預期明年將有另外三項腫瘤與免疫領域資產進入臨床開發。同時，我們持續強化中國商業化業務。

Net product revenue grew 2% sequentially. Our China business remained profitable. This performance is consistent with the stabilization we outlined on our second quarter call. We remain on track with that trajectory and continue to expect a return to year-over-year product revenue growth in 2027. I'm very proud of what our team has accomplished, but our most important achievements are still ahead of us, and I look forward to updating you over the next year.

產品淨收入較上一季成長2%。我們的中國業務仍維持獲利。這一表現與我們在第二季電話會議中所提到的穩定化趨勢一致。我們仍按此軌跡推進，並持續預期在2027年恢復產品收入的年增長。我為團隊所取得的成果感到非常自豪，但我們最重要的成就仍在前方，我期待在未來一年持續向各位更新進展。

With that, I'll turn the call over to Rafael. Thank you.

接下來我把電話會議交給Rafael。謝謝。

Thank you, Samantha. I'll focus on our two lead programs, Zoci and ZL-1503. Let me start with zoci, our potential first-in-class DLL3-targeting ADC. At ESMO, we presented first-line small cell lung cancer data from our global Phase 1 study of Zoci plus atezolizumab. Across 33 efficacy-evaluable previously untreated patients at the selected 1.6 mg/kg dose, the doublet achieved a confirmed objective response rate of 81.8%.

謝謝你，Samantha。我將聚焦於我們兩個領先項目：Zoci與ZL-1503。先從Zoci開始，這是一款可能成為同類首創（first-in-class）的DLL3靶向ADC。在ESMO上，我們公布了全球第1期研究中Zoci聯合atezolizumab用於一線小細胞肺癌的數據。在選定的1.6 mg/kg劑量下，33名可評估療效且先前未接受治療的患者中，該雙藥方案達到經確認的客觀緩解率（ORR）81.8%。

Responses were rapid, with nearly all observed in the first tumor assessment. We're also seeing encouraging signs of durability. In all 33 patients, the estimated six-month progression-free survival was 81.9%. Among the first 15 patients who had a median follow-up of 10 months, median progression-free survival and median duration of response had not been reached. At the data cutoff, 10 of these 15 patients have not progressed.

反應出現迅速，幾乎都在首次腫瘤評估時觀察到。我們也看到令人鼓舞的持久性跡象。在全部33名患者中，估計的6個月無進展存活期（PFS）為81.9%。在最早入組且中位隨訪10個月的15名患者中，中位PFS與中位緩解持續時間（DOR）均尚未達到。截至數據截止日，這15名患者中有10名尚未出現疾病進展。

For context, chemo-IO has historically delivered a median PFS of roughly five months. What further differentiates Zoci is its potential to deliver this level of efficacy with substantially improved tolerability. With the 1.6 mg/kg doublet, Grade 3 or higher zoci-related adverse events occurred in 9.1% of patients. There was a single case of Grade 1 interstitial lung disease, which is consistent with our monotherapy experience. By comparison, Grade 3 or higher treatment-related adverse events occur in roughly 60% or more of patients with chemo-IO.

作為背景，化療合併免疫治療（chemo-IO）在歷史上提供的中位PFS約為5個月。Zoci的另一個關鍵差異在於：它有望在顯著改善耐受性的同時，提供這一水準的療效。在1.6 mg/kg雙藥方案中，3級或以上與Zoci相關的不良事件發生於9.1%的患者。僅出現1例1級間質性肺病，與我們的單藥治療經驗一致。相比之下，使用chemo-IO時，約60%或以上患者會出現3級或以上的治療相關不良事件。

We believe these results are unprecedented in first-line small cell lung cancer in an unselected patient population for platinum responsiveness. Together, these data challenge the conventional view of what an ADC-based regimen could achieve in first-line small cell lung cancer, both in terms of efficacy, durability, and tolerability. On the strength of these data, we're advancing Zoci 1.6 mg/kg plus immunotherapy doublet into a global randomized Phase 3 study. We're also building on this backbone with T-cell engagers. The scientific rationale is complementary: Zoci rapidly reduces tumor burden, while the T-cell engager provides durable immune-mediated responses.

我們認為，這些結果在一線小細胞肺癌中、於未針對鉑類敏感性進行篩選的患者族群裡，是前所未見的。綜合而言，這些數據挑戰了傳統對於以ADC為基礎的一線小細胞肺癌治療方案所能達成效果的看法，無論是在療效、持久性或耐受性方面。基於這些強勁數據，我們正推進Zoci 1.6 mg/kg聯合免疫治療的雙藥方案進入全球隨機第3期研究。我們也正以T細胞接合器在此基礎上持續拓展。其科學理據具互補性：Zoci可快速降低腫瘤負荷，而T細胞接合器可提供持久的免疫介導反應。

Importantly, zoci's favorable tolerability profile may be particularly advantageous in these combinations, as T-cell engagers carry their own toxicity risk. Our global Phase 1b study in small cell lung cancer with Amgen is moving rapidly, and our collaboration with BI is also advancing. Beyond first-line disease, our registrational Phase 3 DLLEVATE study is evaluating Zoci in second-line and later disease, including patients previously treated with tarlatamab. Contingent on enrollment sufficient post-tarlatamab, in addition to second-line patients, an interim analysis in 2027 could support a US BLA submission for accelerated approval.

重要的是，Zoci良好的耐受性特徵在這些聯合方案中可能特別有利，因為T細胞接合器本身帶有其毒性風險。我們與安進（Amgen）在小細胞肺癌領域進行的全球第1b期研究進展迅速，與BI的合作也在推進中。除了一線疾病之外，我們的註冊性第3期DLLEVATE研究正在評估Zoci用於二線及後線治療，包括既往接受過tarlatamab治療的患者。若在tarlatamab治療後的入組人數充足，並加上二線患者，則2027年的期中分析可能支持提交美國BLA申請以尋求加速核准。

Turning to extrapulmonary neuroendocrine carcinomas, or epNECs. This is an aggressive disease where there is no established standard of care beyond first-line chemotherapy. Historical response rates are between 10% to 20%, and median overall survival is about six months. We have completed enrollment in our Phase 1b/2 second-line epNEC study. Tomorrow, at the North American Neuroendocrine Tumor Society Conference, we will present preliminary results showing activity observed across a diversity of epNEC subtypes.

接著談到肺外神經內分泌癌（extrapulmonary neuroendocrine carcinomas），或稱 epNECs。這是一種侵襲性疾病，除了一線化療之外，尚無既定的標準治療。歷史反應率約為 10% 至 20%，整體存活期中位數約六個月。我們已完成第 1b/2 期二線 epNEC 研究的受試者招募。明天在北美神經內分泌腫瘤學會年會上，我們將發表初步結果，顯示在多種 epNEC 亞型中均觀察到活性。

Based on the totality of the clinical data thus far and feedback from the FDA, we plan to pursue a potential accelerated approval supported by this single-arm study. We expect final results in 2027 and a potential submission that same year. Now turning to immunology and ZL-1503, our internally discovered long-acting IL-13/IL-31 receptor alpha bispecific antibody for atopic dermatitis. ZL-1503 is designed to address two major drivers of disease: IL-13-driven inflammation and IL-31-mediated itch. Simultaneously blocking both pathways, ZL-1503 has the potential to break the itch-scratch-inflammation cycle, providing more comprehensive disease control with a single biologic.

基於迄今為止全部臨床數據以及 FDA 的回饋，我們計畫推進由此單臂研究支持的潛在加速核准。我們預期於 2027 年取得最終結果，並可能在同一年提交申請。接著談到免疫學與 ZL-1503，這是我們內部發現、用於異位性皮膚炎的長效型 IL-13/IL-31 受體 α 雙特異性抗體。ZL-1503 的設計旨在解決兩個主要致病驅動因素：由 IL-13 驅動的發炎，以及由 IL-31 介導的搔癢。透過同時阻斷兩條路徑，ZL-1503 有潛力打破「搔癢—抓癢—發炎」循環，以單一生物製劑提供更全面的疾病控制。

ZL-1503 also incorporates YTE modifications that extend its half-life with the goal of enabling substantially less frequent dosing than currently available biologics. Next week at the American College of Allergy, Asthma & Immunology meeting in Phoenix, we will present first-in-human data from the single ascending dose portion of our global Phase 1 study in healthy volunteers.

ZL-1503 亦納入 YTE 修飾以延長其半衰期，目標是使給藥頻率顯著低於目前可用的生物製劑。下週在鳳凰城舉行的美國過敏、氣喘與免疫學學會（ACAAI）年會上，我們將發表全球第 1 期研究中、健康受試者單次遞增劑量（SAD）部分的首次人體數據。

The SAD study has met its prespecified endpoints, and we will share results demonstrating its safety profile, pharmacokinetics, immunogenicity, and sustained inhibition of the IL-13 inflammatory pathway. Two more datasets follow next year: 1st, clinical efficacy, including itch control in patients with moderate-to-severe atopic dermatitis; and 2nd, initial data from our fully enrolled IV to subcutaneous bridging study. We are planning Phase 2b development in atopic dermatitis, while also evaluating the potential for ZL-1503 across additional IL-13- and IL-31-mediated diseases.

SAD 研究已達成其預先設定的終點，我們將分享結果，展示其安全性概況、藥物動力學、免疫原性，以及對 IL-13 發炎路徑的持續抑制。明年還將有兩組數據：第一，臨床療效，包括中重度異位性皮膚炎患者的止癢控制；第二，我們已完成收案的靜脈注射（IV）至皮下注射（SC）橋接研究的初步數據。我們正規劃在異位性皮膚炎推進第 2b 期開發，同時也評估 ZL-1503 在其他由 IL-13 與 IL-31 介導疾病中的潛力。

Our next wave of global assets continues to advance. This includes ZL-6201, our LRRC15-targeted ADC; ZL-1311, our MUC17 targeting T-cell engager; and ZL-1222, our PD-1/IL-12 immunocytokine. Lastly, with our China regional pipeline, we continue to progress multiple regulatory and development opportunities, including potential additional filings for efgartigimod and the ongoing registrational development of efgartigimod in thyroid eye disease.

我們下一波全球資產持續推進。其中包括 ZL-6201（靶向 LRRC15 的 ADC）、ZL-1311（靶向 MUC17 的 T 細胞接合器），以及 ZL-1222（PD-1/IL-12 免疫細胞激素）。最後，在我們中國區域產品線方面，我們持續推進多項法規與開發機會，包括 efgartigimod 可能的額外申報，以及 efgartigimod 在甲狀腺眼病的持續註冊性開發。

And with that, I'll hand it over to Yajing.

接下來，我把時間交給雅靜。

Thank you, Rafael. Our financial priorities are clear: return our China commercial business to growth, maintain a disciplined cost structure, and fund our highest-value global programs. Our third quarter results showed progress on all three. Total revenue was $108.2 million. Net product revenue increased 2% sequentially, reflecting continued stabilization of our China commercial business.

謝謝你，Rafael。我們的財務優先事項很明確：讓中國商業業務重回成長、維持嚴謹的成本結構，並為我們最高價值的全球專案提供資金。第三季業績顯示這三方面皆有進展。總營收為 1.082 億美元。產品淨營收較前一季成長 2%，反映我們中國商業業務持續趨於穩定。

Across our priority brands, Zejula held its competitive position despite ongoing volume-based pricing-related dynamics and a competitive PARP inhibitor landscape. Vyvgart volumes continue to grow sequentially on new patient starts. KarXT continued to gain traction ahead of potential NRDL inclusion next year. We expect a return to year-over-year product revenue growth in 2027, driven by continued demand across our priority brands and a new NRDL listing. At the same time, we have maintained strong discipline in managing our operating expenses.

在我們的重點品牌中，Zejula 儘管面臨持續的以量計價相關動態以及競爭激烈的 PARP 抑制劑市場，仍維持其競爭地位。Vyvgart 的用量在新病人開始治療的帶動下，持續逐季成長。KarXT 在明年可能納入 NRDL 之前持續獲得更多動能。我們預期 2027 年產品營收將恢復年對年成長，動能來自重點品牌需求持續，以及新的 NRDL 掛網。同時，我們在營運費用管理上維持高度紀律。

Both R&D and SG&A expenses remained relatively stable compared with the prior-year period, reflecting the operational efficiencies and resource optimization initiatives we have implemented across the organization. Our China commercial business remained profitable, providing a strong operating foundation as we continue investing in our global development program. We ended the quarter with a cash position of $659.7 million as of September 30, 2026. And in October, we raised approximately $250 million in equity at no discount to market, which further provides the financial flexibility to continue investing in the highest-value opportunities. In summary, we have a profitable commercial business, a disciplined cost structure, and a balance sheet that supports our global innovative pipeline through its most important milestones.

研發（R&D）與銷售、一般及行政（SG&A）費用相較去年同期維持相對穩定，反映我們在全組織推行的營運效率與資源最佳化措施。我們的中國商業業務仍維持獲利，為我們持續投資全球開發計畫提供穩健的營運基礎。截至 2026 年 9 月 30 日，本季末現金部位為 6.597 億美元。此外，我們於 10 月以不折價於市價的條件進行股權募資，募集約 2.5 億美元，進一步提升我們持續投資最高價值機會的財務彈性。總結而言，我們擁有獲利的商業業務、嚴謹的成本結構，以及可支持全球創新產品線達成最重要里程碑的資產負債表。

With that, I will open it up for questions.

接下來，我們開放提問。

(Operator Instructions)

（接線員指示）

Anupam Rama, J.P. Morgan.

Anupam Rama，摩根大通（J.P. Morgan）。

With the pivotal DLLEVATE study enrollment ongoing here, based on your discussions with regulators, can you give us a sense of how many patients, the amount of follow-up, and if there's an ORR threshold that you need to meet for accelerated approval?

目前關鍵性 DLLEVATE 研究仍在收案中；根據你們與監管機關的討論，能否讓我們了解加速核准所需的受試者人數、追蹤時間，以及是否有需要達到的 ORR 門檻？

Sure. Hi, this is Rafael. Let me take that question, and thanks for it. We did have discussions with the agency. The study is a randomized trial with overall survival as primary endpoint, but there's a possibility that there's accelerated approval based on response rate.

好的。大家好，我是 Rafael。我來回答這個問題，也謝謝你的提問。我們確實與主管機關進行過討論。這是一項隨機試驗，以整體存活期為主要終點，但也存在基於反應率取得加速核准的可能性。

So to answer your question, the number of patients in the response rate accelerated approval analysis, which is a formal interim analysis, includes 200 patients, and this will be a mixture of patients that are after platinum progression or after platinum plus atezolizumab. In terms of the length of follow-up, it would be six months after the first scan assessment so that we can assess durability of response. The other criterion is all patients must be accrued by the time this analysis is done.

回答你的問題：在反應率加速核准分析中的受試者人數（這是一項正式的期中分析）為 200 名，將包含鉑類治療後疾病進展的患者，以及鉑類合併 atezolizumab 後進展的患者。至於追蹤時間，將在第一次影像掃描評估後再追蹤六個月，以便評估反應的持久性。另一項條件是，在進行此分析時必須完成所有患者的入組。

And in terms of assumptions, we don't disclose assumptions, but with 200 patients, the study is overpowered really for efficacy, given that the historical rates are in the 20% range or so, and we've disclosed data in the 60% overall response rate in the second line plus. So the reason for the 200 is so that we have a good safety database in addition to efficacy. So hopefully those details help you understand interim analysis and the possibility of accelerated approval and deciding to announce it.

至於假設條件，我們不對外揭露；但以 200 名受試者而言，考量歷史反應率約在 20% 左右，該研究在療效上其實是超額設計（overpowered）的，而我們也已揭露二線及以上治療的整體反應率（ORR）達 60% 的數據。因此設定 200 名的原因，是除了療效之外，也能建立良好的安全性資料庫。希望這些細節能幫助你理解期中分析、加速核准的可能性，以及我們決定是否對外宣布的考量。

Michael Yee, UBS.

Michael Yee，瑞銀（UBS）。

Yes, so maybe two questions. On the DLL3 opportunity, clearly there is a multi-billion dollar horizon given what Amgen's tarlatamab is showing this week, and yet they're also partnering or collaborating, I should say, with your ADC. Can you talk a little bit about how that collaboration is going and what studies have started or how you envision the two mechanisms perhaps working together such that you could maximize that multi-billion dollar opportunity? So that's question one.

是的，我有兩個問題。關於 DLL3 的機會，鑑於本週安進（Amgen）的 tarlatamab 所展現的結果，顯然有數十億美元的前景；但他們同時也在與你們的 ADC 進行合作或協作。你能否談談這項合作目前進展如何、已啟動哪些研究，或你如何看待兩種機制可能如何協同運作，以便最大化這個數十億美元的機會？這是第一個問題。

And then maybe the second question is, presuming that we do have great data next year and we're going to file to the FDA, do you have any view on whether you would partner or launch yourself? How are you thinking about the different scenarios for your product?

然後也許第二個問題是，假設我們明年確實會有很好的數據並且將向 FDA 申報，你對於你們會選擇合作夥伴還是自行上市有什麼看法嗎？你們如何思考產品在不同情境下的策略？

Thanks, Michael. I think Rafael will answer the first question, and this is Samantha, I'll address your second one.

謝謝你，Michael。我想 Rafael 會回答第一個問題；我是 Samantha，我來回應你的第二個問題。

Thanks, Mike. With regards to the collaboration with Amgen, obviously, the results of DeLLphi-305 are, I think, practice-changing, and we're pretty excited to see those results. At the same time, we presented data ourselves with the combination with IO where the PFS hadn't been reached after 10 months. I think their PFS was in the order of about 7.4 months. So, yes, there's a possibility of using Zoci with IO, but the big promise, I think, is the combination because, as you know, in the 305, there were a number of patients, a percentage of patients that couldn't really get maintenance because they progressed.

謝謝，Mike。關於與安進（Amgen）的合作，顯然 DeLLphi-305 的結果我認為會改變臨床實務，我們也很興奮看到這些結果。同時，我們也自行發表了與 IO 聯合治療的數據，其中 PFS 在 10 個月後仍未達到。我想他們的 PFS 大約是 7.4 個月左右。所以，是的，Zoci 與 IO 聯用是有可能的，但我認為更大的前景在於聯合方案，因為如你所知，在 305 試驗中，有一些病人（一定比例）其實無法真正進入維持治療，因為他們出現了疾病進展。

They had less unstable disease on platinum etoposide and IO. So being able to get everybody on maintenance should be superior to that study because the disease control rate using Zoci is pretty high, approaching 100%. So with regards to how things are going, that is progressing well. We started with tarlatamab progressors to make sure there was combinability. We started with two different doses.

他們在鉑類＋依托泊苷（etoposide）加 IO 的治療下，疾病較不穩定。因此，若能讓所有人都進入維持治療，理論上會優於該研究，因為使用 Zoci 的疾病控制率相當高，接近 100%。至於目前進展，合作推進得很順利。我們先從 tarlatamab 進展後的病人開始，以確認可合併用藥。我們也從兩個不同劑量開始。

We're pretty confident we can get to the standard dose of 1.6 mg/kg for combinability. And, you know, we look forward to the results of treating patients that are treatment-naive with the triplet, and then continue to discuss with Amgen options going forward. But we believe that both Zoci plus IO and Zoci plus TCE plus IO would be for patients that would move the field beyond even what 305 has done.

我們相當有信心，在合併用藥方面可以達到 1.6 mg/kg 的標準劑量。而且你知道，我們很期待以三聯療法治療未接受過治療（treatment-naive）的病人之結果，並持續與安進討論後續選項。但我們相信，無論是 Zoci＋IO，或是 Zoci＋TCE＋IO，都將使治療領域超越甚至 DeLLphi-305 所達成的成果。

Yes, Michael, in terms of your second question about whether partnering or not, I think our current plan is to take Zoci forward ourselves, and that planning is already underway. Our priority today is execution. We're advancing our global program of dosing aggressively and remain fully committed to deliver the key clinical milestones we outlined.

是的，Michael，關於你第二個問題—是否合作—我想我們目前的計畫是自行推進 Zoci，而相關規劃也已在進行中。我們今天的優先事項是執行。我們正積極推進全球給藥計畫，並完全致力於達成我們所概述的關鍵臨床里程碑。

That said, we're also disciplined, as you mentioned. Global partners are interested in this asset, and we'll evaluate any option that could accelerate patient access or increase shareholder value. Those evaluations are independent of our development plans, and I don't think they will change the pace or urgency with which we are advancing the program. Thank you, Michael.

話雖如此，我們也如你所提到的，會保持紀律。全球合作夥伴對這項資產有興趣，我們會評估任何能加速病患取得治療或提升股東價值的選項。這些評估與我們的開發計畫是獨立的，我不認為它們會改變我們推進該計畫的速度或急迫性。謝謝你，Michael。

Li Watsek, Cantor Fitzgerald.

Li Watsek，Cantor Fitzgerald。

Congrats on the progress. Two questions from me. So in terms of dosing second-line epNECs, can you talk a little bit about your alignment with the FDA on the AA submission and what the bar is, and then in terms of the confirmatory study, what would be the design timing of that? For example, do you need to enroll a certain number of patients before you file for AA? And then second, in terms of the TCE combinations, you have two partners here. When will you be in a position to select a go-forward regimen, and what goes into that decision? Thanks.

恭喜進展。我有兩個問題。首先，關於二線 epNECs 的給藥，你能否談談你們與 FDA 在 AA（加速核准）申請上的一致性，以及門檻是什麼？另外，就確認性試驗而言，其設計與時程會是如何？例如，在你們申請 AA 之前，是否需要先入組一定數量的病人？第二，關於 TCE 的聯合治療，你們這裡有兩個合作夥伴。你們何時會有條件選定後續要推進的治療方案（go-forward regimen），以及做出該決策會考量哪些因素？謝謝。

This is Rafael. I'll take both questions. With regards to epNEC or epNEC, we will present tomorrow at the NET conference in Las Vegas the latest dataset of about 60 patients. It's an update from what we presented at AACR. Just to give you a sense, there's really no standard second-line for extrapulmonary neuroendocrine carcinoma, and people treat with a variety of regimens.

我是 Rafael。我來回答兩個問題。關於 epNEC（或 epNEC），我們明天會在拉斯維加斯的 NET 會議上發表最新資料集，約 60 位病人。這是我們在 AACR 發表內容的更新。先讓你了解一下，肺外神經內分泌癌在二線治療上其實沒有真正的標準方案，臨床上會使用各式各樣的療程。

Generally, the response rate is between 10% to 20%, the progression-free survival in the order of two months. So essentially the next time that patients are scanned, they -- most of them have progressed. So the bar is really low, with recent response rate approaching 40% and durability between five and six months. This is really being perceived as an advance in the field, particularly given that the tolerability is quite good. And, you know, in second-line plus small cell lung cancer, the treatment-related adverse events have been in the mid-teens.

一般而言，反應率約在 10% 到 20% 之間，無惡化存活期（PFS）大約是兩個月。所以基本上，病人下一次影像掃描時——大多數人都已經進展。因此門檻其實很低；而我們近期的反應率接近 40%，持續性約在五到六個月之間。這被視為該領域的一項進展，特別是考量到耐受性相當不錯。而且你知道，在二線加上小細胞肺癌中，治療相關不良事件大約在十幾%的中段水準。

So those are the discussions we've had with the agency. We have two sets of single-arm data that amount to about 100 patients, and depending on how the results read out after waiting for six months after the first scan, then that will determine whether or not we'll be able to file for accelerated approval based on those single-arm studies. As you said, there will need to be a confirmatory study. We have discussed a design with the agency that was accepted. The design will be in frontline.

以上就是我們與主管機關討論的內容。我們有兩組單臂數據，合計約 100 位病人；而在第一次掃描後再等待六個月、看結果如何讀出之後，將決定我們是否能基於這些單臂研究申請加速核准。如你所說，將需要一項確認性試驗。我們已與主管機關討論並獲接受一個設計。該設計將在一線治療（frontline）中進行。

We will get into more detail as we get that study going. But we need to get it well underway before the action date. So, the study will start early next year so that there's no delay to the potential accelerated approval filing that we expect to follow next year. With regard to TCE, well, we're working with both companies IMDELLTRA and obrixtamig, Amgen and BI, respectively. Obviously, Amgen has got a very dominant position in this space.

待研究啟動後，我們會提供更多細節。但我們需要在行動日期（action date）之前，讓該研究有相當進展。因此，研究將在明年初開始，以確保不會延誤我們預期明年隨後提出的潛在加速核准申請。至於 TCE，我們分別與兩家公司合作：IMDELLTRA 與 obrixtamig，合作方分別是安進（Amgen）與勃林格殷格翰（BI）。顯然，安進在這個領域具有非常主導的地位。

We will obviously follow the development path of both compounds. You know, my sense is that the combination with IMDELLTRA may move faster, but we will just have to see. All I can say is that it's a very fruitful collaboration, and I described before what the makeup of the Phase 2 study is, and we will take the data from there and if it is positive, discuss with our partners how to advance the field with that combination. So that's sort of where we are at the moment. But our desire is to move to the most active combination with the best benefit-risk as soon as possible.

我們當然會追蹤兩個化合物的開發路徑。你知道，我的感覺是與 IMDELLTRA 的聯合可能會推進得更快，但我們還得再觀察。我能說的是，這是一個非常富有成果的合作；我之前也描述過第二期研究的組成，我們會以該研究的數據為基礎，若結果正面，將與合作夥伴討論如何透過該聯合方案推動領域進一步發展。所以目前大致就是這樣。但我們的目標是盡快推進到活性最強、且效益風險最佳的聯合方案。

Yigal Nochomovitz, Citigroup.

Yigal Nochomovitz，花旗集團（Citigroup）。

Hi, this is Caroline on for Yigal. We noticed NUZYRA came in stronger than expected this quarter. Can you help us understand what drove this upside, and has anything changed in your view of the product's longer-term growth outlook?

嗨，我是代替 Yigal 的 Caroline。我們注意到 NUZYRA 本季表現優於預期。你能否協助我們了解是什麼因素帶動了這個超預期表現？以及你們對該產品長期成長前景的看法是否有任何改變？

Yajing, can you take that question?

雅靜，你可以回答這個問題嗎？

Can you repeat the first part? My audio's a little bit choppy here --

你可以重複一下第一部分嗎？我這邊音訊有點斷斷續續——

I was saying NUZYRA came in stronger than expected this quarter. Could you help us understand what drove this upside and whether your long-term view has changed?

我剛才是說，NUZYRA 本季表現比預期更強。你能否幫我們理解是什麼因素推動了這個超預期表現，以及你們的長期看法是否有所改變？

You mean -- which brand? You mean the revenue -- total revenue?

你的意思是——哪個品牌？你是指營收——總營收嗎？

Sales, yes.

銷售額，是的。

Yajing, she's asking about NUZYRA sales.

雅靜，她在問 NUZYRA 的銷售額。

Oh, NUZYRA sales. Sorry, really choppy audio, I really apologize. Yes, I think it's really about -- this is our strong partnership with our partners. The NUZYRA sales coming in is a little bit stronger. But again, as I said, I think we should be looking at our business in its totality. We do believe that NUZYRA could be one of the drivers for our total business going forward. Yes, so we believe this trend will continue.

喔，NUZYRA 的銷售額。抱歉，音訊真的很斷，我非常抱歉。是的，我認為這主要是——我們與合作夥伴之間強而有力的合作關係。NUZYRA 的銷售表現確實稍微強一些。但再次如我所說，我認為我們應該從整體來看我們的業務。我們確實相信，NUZYRA 未來可能會成為推動我們整體業務的動力之一。是的，所以我們相信這個趨勢會持續。

Daina Graybosch, Leerink Partners. Please go ahead.

Daina Graybosch，Leerink Partners。請開始。

Hi, thanks for the question. I wonder if you could talk about a frontline strategy should Amgen's DeLLphi-312, where they're giving tarlatamab with an induction of traditional chemo, be successful. If that's great and you have a traditional chemo option in frontline, how do you envision moving forward in frontline with Zoci and tarlatamab?

嗨，謝謝讓我提問。我想請你談談，如果安進（Amgen）的 DeLLphi-312 成功——他們在誘導期用傳統化療搭配 tarlatamab——那麼在一線治療策略上你們會如何應對。如果那個結果很好，而且一線有傳統化療的選項，你們如何看待未來在一線使用 Zoci 與 tarlatamab 的推進方式？

Yes, great question. And I think this is really what happens when a drug is being developed in the midst of a field that's evolving. So IMDELLTRA, for some patients will become a frontline drug, either in the maintenance setting or if that study is positive in the induction setting. I think the question will be how positive that study is, what the tolerability is of a full-dose chemotherapy plus IO on these four cycles plus tarlatamab, and again, how that compares to the maintenance data and the data with the ADCs.

是的，這是個很好的問題。我認為這正是當一款藥物在一個持續演進的領域中開發時會發生的情況。因此，對某些患者而言，IMDELLTRA 會成為一線用藥，可能是在維持治療情境，或如果那項研究在誘導期情境呈陽性。我認為問題在於那項研究的陽性程度、在四個療程中使用足量化療加 IO 再加 tarlatamab 的耐受性如何，以及同樣地，這與維持治療數據以及與 ADC 的數據相比如何。

We still see -- we're pretty confident that the efficacy that we've seen with IO is pretty strong. The response rates are incredibly high in the 80% range and long PFS. So I think -- and then we'll have to see what the overall survival is eventually. We're launching that study this year, the frontline doublet study against standard of care. So I think the data will really dictate what physicians and patients will choose.

我們仍然認為——我們相當有信心，我們在 IO 上看到的療效相當強。反應率高得驚人，約在 80% 的區間，且 PFS 很長。所以我認為——然後我們最終還需要看到總生存期（OS）的結果。我們今年會啟動那項一線雙藥研究，與標準治療進行對照。因此，我認為數據將真正決定醫師與患者會選擇什麼。

Yes, my sense is that we will have to evaluate what the safety of that induction combination is. And the tolerability of Zoci is superior to carbo-etoposide IO by 40%, a really big margin. So is that triplet with standard chemotherapy-sparing type of approach at least equal or superior to chemotherapy plus tarlatamab IO? And I think it would be a preferred regimen to use Zoci than to use carbo-etoposide. Carbo-etoposide is a very old regimen, over 40 years old, and I think the field -- my sense and the sense of many of the experts that I talked to in this space is that the field will move away from chemotherapy if we can demonstrate that an ADC, either with IO or in combination with tarlatamab plus IO -- by IO I mean checkpoint inhibitor -- is superior and is safer. So it's a great question, but the data are not yet there. But the hope is that we can simplify the regimen, make it safer and more effective.

是的，我的感覺是，我們必須評估那個誘導期組合的安全性如何。而且 Zoci 的耐受性比 carbo-etoposide IO 好 40%，差距非常大。所以，這個三聯方案、以避免標準化療為導向的做法，是否至少不劣於或優於「化療加 tarlatamab IO」？我認為使用 Zoci 會是比使用 carbo-etoposide 更偏好的方案。Carbo-etoposide 是非常老的療法，已有 40 多年歷史；而我認為這個領域——我的感覺以及我在這個領域與許多專家交流後的共識是：如果我們能證明 ADC（無論是與 IO 併用，或與 tarlatamab 加 IO 的組合——這裡的 IO 指的是檢查點抑制劑）更優且更安全，這個領域將會逐步遠離化療。所以這是個很好的問題，但目前數據尚未到位。但我們的希望是能簡化治療方案，使其更安全且更有效。

(Operator Instructions)

（接線員指示）

Linhai Zhao, Goldman Sachs. Please go ahead.

趙林海，高盛。請開始。

So regarding our sales growth outlook in 2027, can you bridge the key drivers required to deliver the anticipated resumed growth in 2027, including the access expansion like NRDL coverage, the new launches, and the stabilization of the mature portfolio? Thanks.

關於我們 2027 年的銷售成長展望，你能否串聯說明要實現 2027 年預期恢復成長所需的關鍵驅動因素，包括准入擴張（例如 NRDL 覆蓋）、新品上市，以及成熟產品組合的穩定？謝謝。

Thank you for the question. I'll take this. Yes, we remain confident in our 2027 guidance on meaningful growth. The key drivers are really a couple of fronts. The first one, in anticipation of NRDL, there will be volume expansion coming from key brands like Vyvgart Subcu, as well as KarXT, and also our main core brand Zejula has regained its important patient share.

謝謝你的提問。我來回答這個問題。是的，我們仍然對 2027 年指引中所提到的顯著成長充滿信心。關鍵驅動因素主要來自幾個面向。第一，隨著 NRDL 的預期推進，像 Vyvgart Subcu、以及 KarXT 等關鍵品牌將帶來量的擴張；同時，我們的核心主力品牌 Zejula 也已重新取得重要的患者份額。

We believe that business will return to growth next year. And also NUZYRA, as our supply constraint is relieved, we will see meaningful growth as well. So all in all, we are quite confident that we will be able to drive in 2027 meaningful revenue growth. In addition, we believe the positive environment overall in China now favors an innovation portfolio, which Zai has. And we believe that in combination with our discipline and focused execution will allow us to really provide predictable and consistent growth in 2027.

我們相信明年業務將恢復成長。此外，隨著 NUZYRA 的供應限制解除，我們也將看到顯著成長。總體而言，我們相當有信心能在 2027 年推動顯著的營收成長。另外，我們認為目前中國整體的正向環境有利於創新產品組合，而這正是再鼎所具備的。我們相信，結合我們的紀律性與聚焦執行，將使我們能在 2027 年提供可預期且一致的成長。

Thank you. I am showing no further questions. I will now turn the conference back to Dr. Samantha Du for her closing comments.

謝謝。我這邊顯示沒有其他問題。現在我把電話會議交回給 Samantha Du 醫師作結語。

Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support and look forward to updating you again after the fourth quarter of 2026. Operator, you may now disconnect the call. Thank you.

謝謝你，接線員。我要感謝各位今天撥冗參加我們的電話會議。我們感謝各位的支持，並期待在 2026 年第四季之後再次向各位更新。接線員，現在可以中斷通話。謝謝。

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect your lines.

感謝各位參與今天的會議。本次活動到此結束。你們現在可以掛斷電話線。