Zai Lab Ltd (ZLAB) 2025 Q4 法說會逐字稿

Hello, ladies and gentlemen. Thank you for standing by. Welcome to Zai Lab's fourth-quarter and full-year 2025 financial results conference call. (Operator Instructions) As a reminder to this call, it's being recorded.

各位女士、先生，大家好。感謝各位耐心等候。歡迎參加再鼎醫藥 2025 年第四季及全年財務業績電話會議。(接線員指示) 提醒各位，本次電話會議將被錄音。

It's now my pleasure to turn the floor over to Christine Chiou, Senior Vice President of Investor Relations. Thank you. Please go ahead.

現在我很榮幸將會議交給投資者關係資深副總裁 Christine Chiou。謝謝。請開始。

hank 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 Josh Smiley, President and Chief Operating Officer; 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, 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主持。與會者還包括總裁兼營運長 Josh Smiley；全球研發總裁兼負責人 Rafael Amado 博士；財務長陳雅靜博士；此外，我們的首席商務官何珊博士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.

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。這些陳述存在眾多風險與不確定性，可能因多種因素（包括我們向美國證券交易委員會提交的文件中所討論者）而導致實際結果與預期存在重大差異。我們也將提及經調整的營運虧損，這是一項非 GAAP 財務衡量指標。

Please refer to our earnings release furnished with the SEC on February 26, 2026, for additional information on this non-GAAP financial measure. At this time, it is my pleasure to turn the call over to Dr. Samantha Du.

有關此非 GAAP 財務衡量指標的更多資訊，請參閱我們於 2026 年 2 月 26 日向 SEC 提交的財報新聞稿。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. Thank you for joining us today. Zai Lab is at an important point in our evolution. We are building a company increasingly defined by global innovation, resting on a foundation, supported by a commercially profitable China business and R&D infrastructure. Today, our global oncology immunology pipeline is reaching a scale and maturity that fundamentally changes the profile of this company.

謝謝 Christine。各位早安、晚安。感謝各位今天加入我們。再鼎醫藥正處於公司演進的重要節點。我們正在打造一家日益以全球創新為核心特徵的公司，其基礎由在中國具備商業獲利能力的業務與研發基礎設施所支撐。目前，我們的全球腫瘤與免疫管線正達到一個規模與成熟度，從根本上改變了公司的輪廓。

We have multiple global programs advancing rapidly through the clinics, with zoci in pivotal stage. We see a clear path toward our first potential US approval by 2028. Importantly, we advanced zoci from IND to global Phase 3 in less than two years, the industry-leading pace that reflects the strength of our integrated US and China development model. This capability enables faster, more capital-efficient execution, is now being applied across our broader pipeline.

我們有多個全球項目在臨床階段快速推進，其中 zoci 已進入關鍵性階段。我們看到一條清晰路徑，有望在 2028 年前取得我們在美國的首個潛在核准。重要的是，我們在不到兩年的時間內將 zoci 從 IND 推進至全球第三期，這一領先業界的速度反映了我們整合美國與中國的開發模式之優勢。這項能力使我們能更快、以更高資本效率執行，並已開始應用於更廣泛的產品管線。

Our China business continues to provide stability and leverage for our global R&D efforts. Despite a challenging macro and operating environment, full-year revenue grew 15% year over year, and our commercial profitability continues to improve

我們在中國的業務持續為全球研發工作提供穩定性與槓桿。儘管宏觀與營運環境充滿挑戰，全年營收仍年增 15%，且我們的商業獲利能力持續改善

Looking ahead to 2026, our priorities are very clear. This is a year focused on execution and preparation. We expect several meaningful pipeline catalysts, including clinical data for zoci in breast cancers, neuroendocrine carcinoma, and first-line small cell lung cancer, as well as first in human data from our IL-13/IL-31R bispecific program in atopic dermatitis. On the regional side, we have important pivotal data results for large opportunities, such as Povetacicept in IgAN and aliglubad in Thyroid Eye Disease, both of which enhance the durability of our China growth engine. Business development remains an important lever for us.

展望 2026 年，我們的優先事項非常明確。這將是聚焦執行與準備的一年。我們預期將迎來多項重要的管線催化劑，包括 zoci 在乳癌、神經內分泌癌，以及一線小細胞肺癌的臨床數據；同時也包括我們 IL-13/IL-31R 雙特異性項目在異位性皮膚炎的首次人體數據。在區域層面，我們也將獲得多個重大機會的關鍵性數據結果，例如 Povetacicept 用於 IgAN，以及 aliglubad 用於甲狀腺眼病，兩者都將提升我們中國成長引擎的持久性。商務拓展仍是我們的重要槓桿。

Our presence and capabilities in China provides access to one of the world's most important, fast-evolving innovation ecosystems, creating opportunities that can meaningfully strengthen and prioritize both our global and regional pipeline. Ultimately, our objective is to build a company that can make a lasting difference for patients while creating substantial value for shareholders. With that, I'll now hand the call over to Rafael, who will walk you through the progress of our R&D pipeline. Rafael?

我們在中國的佈局與能力，使我們得以進入全球最重要且快速演進的創新生態系之一，從而創造機會，實質強化並優先排序我們的全球與區域管線。最終，我們的目標是打造一家能為患者帶來長期改變、同時為股東創造可觀價值的公司。接下來我將把電話會議交給 Rafael，由他帶大家了解我們研發管線的進展。Rafael？

Thank you, Samantha. 2025 was a year of significant progress for our R&D organization as we continue to build globally competitive pipeline. Over the course of the year, we initiated a pivotal trial in oncology, advanced one additional oncology program into the clinic, and moved our lead immunology asset into clinical development. With that, I'd like to walk you through our progress, starting with zoci, our potential first and best-in-class DLL3 targeting ADC and a cornerstone of Zai Lab's global oncology portfolio.

謝謝你，Samantha。2025 年對我們研發組織而言是進展顯著的一年，我們持續打造具全球競爭力的產品管線。在這一年中，我們啟動了一項腫瘤領域的關鍵性試驗，將另一個腫瘤項目推進至臨床，並將我們領先的免疫資產推進至臨床開發。接下來我將帶大家回顧進展，先從 zoci 開始；zoci 是我們潛在的首創且同類最佳（first- and best-in-class）DLL3 靶向 ADC，也是再鼎醫藥全球腫瘤產品組合的基石。

In second line and third line small cell lung cancer, we have initiated a global registrational Phase 3 study, which will enroll approximately 480 patients across second line post platinum and third line post Atezolizumab settings, with a control arm reflecting real-world global practice, including topotecan, larotrectinib, or amrubicin --

在二線與三線小細胞肺癌方面，我們已啟動一項全球註冊性第三期研究，計畫在鉑類治療後的二線，以及 Atezolizumab 治療後的三線情境中，納入約 480 名患者；對照組將反映全球真實世界臨床實務，包括 topotecan、larotrectinib 或 amrubicin--

Importantly, zoci has advanced at a rapid pace, significantly faster than is typically observed for programs in this space. Based on current timelines, we anticipate a potential accelerated approval submission in 2027, and a first global approval in 2028. Clinically, zoci has demonstrated encouraging efficacy in heavily pretreated, extensive-stage small cell lung cancer, including an 80% objective response rate in 10 patients with untreated brain metastases.

重要的是，zoci 的推進速度非常快，顯著快於此領域項目通常所見的進度。基於目前時程，我們預期可於 2027 年提交潛在的加速核准申請，並於 2028 年取得首個全球核准。在臨床上，zoci 在經多線治療的廣泛期小細胞肺癌中展現令人鼓舞的療效，包括在 10 名未治療腦轉移患者中達到 80% 的客觀緩解率。

The ability to treat both intracranial and extracranial disease without treatment interruptions represent a meaningful potential advantage for patients, and we look forward to presenting this data in the coming months. Equally important, zoci continues to stand out for its favorable safety profile, with low rates of severe treatment-related adverse events. We believe this profile supports zoci's potential role as a backbone ADC in first-line combination regimens, including those that reduce chemotherapy burden.

能夠在不中斷治療的情況下同時治療顱內與顱外病灶，對患者而言代表一項具意義的潛在優勢；我們期待在未來幾個月公布這些數據。同樣重要的是，zoci 以其良好的安全性特徵持續脫穎而出，嚴重治療相關不良事件的發生率較低。我們相信，這一特徵支持 zoci 在一線聯合治療方案中作為骨幹 ADC 的潛在角色，包括可降低化療負擔的方案。

We plan to initiate a first-line pivotal trial in small cell lung cancer and to advance zoci into additional novel combination regimens before year-end. Beyond small cell lung cancer, we see a compelling opportunity for zoci in neuroendocrine carcinomas, or NECs, a large, underserved population with no approved DLL3-targeted therapies. Enrollment in our global phase 1b/2 is progressing very well, and we plan to present initial data this year with the goal of initiating a registrationally enabling study by the year-end.

我們計畫在年底前啟動一線小細胞肺癌的關鍵性試驗，並推進 zoci 進入更多新型聯合治療方案。除小細胞肺癌外，我們也看到 zoci 在神經內分泌癌（NEC）中的重大機會；這是一個龐大且未被充分滿足的族群，目前尚無已核准的 DLL3 靶向療法。我們的全球 1b/2 期研究入組進展非常順利，並計畫於今年公布初步數據，目標是在年底前啟動一項具註冊支持性的研究。

Taken together, we believe zoci's differentiated efficacy and safety profiles, including activity in brain metastases, positions it to address a significant unmet need across small cell lung cancer and neuroendocrine carcinomas, where the total addressable global market is estimated to exceed $9 billion. Beyond zoci, our next wave of innovative global assets continues to advance rapidly.

綜合而言，我們認為 zoci 具差異化的療效與安全性特徵（包括對腦轉移的活性），使其有望滿足小細胞肺癌與神經內分泌癌領域的重大未滿足醫療需求；這兩個領域的全球可服務市場總規模估計超過 90 億美元。除 zoci 之外，我們下一波創新型全球資產也持續快速推進。

ZL-6201, our internally discovered LRRC15-targeting ADC, received US IND clearance. The global Phase 1 study was quickly initiated thereafter. ZL-1222, our PD-1/IL-12 immunocytokine, is progressing through IND-enabling studies. ZL-1311, a next-generation T-cell engager or TCE targeting MUC17, represents our first globally owned TCE with an IND plan by year-end.

ZL-6201（我們內部發現、以 LRRC15 為靶點的 ADC）已獲美國 IND 核准。隨後迅速啟動全球第 1 期研究。ZL-1222（我們的 PD-1/IL-12 免疫細胞激素融合蛋白）正推進 IND 申報支援性研究。ZL-1311（以 MUC17 為靶點的次世代 T 細胞接合器／TCE）是我們首個全球自有的 TCE，並計畫於年底前提交 IND。

In immunology, ZL-1503 is our internally discovered IL-13/IL-31R bispecific antibody for atopic dermatitis, and is designed to address both itch and inflammation, with the potential for enhanced and faster onset of efficacy associated with less frequent dosing than current biologics. The global Phase 1/1B study is enrolling well. We expect first-in-human data later this year.

在免疫學領域，ZL-1503 是我們內部發現的 IL-13/IL-31R 雙特異性抗體，用於異位性皮膚炎，旨在同時改善搔癢與發炎；相較於現有生物製劑，具備以較低給藥頻率帶來更強且更快速起效的潛力。全球第 1/1B 期研究招募進展良好。我們預期將於今年稍晚取得首次人體（FIH）數據。

Turning briefly to our key late-stage regional programs, starting with our immunology portfolio, sulcardigimab continues to expand across multiple autoimmune indications, with ongoing development across a broad clinical program. Recent late-stage results support further label expansion and additional Phase 3 readouts are expected this year and next, with China being a valuable contributor to global enrollment. Povetacicept remains on track with an interim analysis for the global RAINIER Phase 3 study for IgAN, planned for the first half of 2026, and enrollment is ongoing in the global pivotal OLYMPUS Phase 2/3 study for primary membranous nephropathy.

簡要談及我們關鍵的區域性後期項目，先從免疫學產品組合開始：sulcardigimab 持續擴展至多項自體免疫適應症，並在廣泛的臨床計畫中持續開發。近期後期結果支持進一步擴大適應症標籤，且預期今年與明年將有更多第 3 期讀出；中國將成為全球招募的重要貢獻者。Povetacicept 仍按計畫推進：針對 IgAN 的全球 RAINIER 第 3 期研究預計於 2026 年上半年進行期中分析；同時，針對原發性膜性腎病的全球關鍵性 OLYMPUS 第 2/3 期研究亦持續招募中。

Lastly, for Elegrobart, our partner, Viridian, expects to report top-line data for the global registrational REVEAL one study in active TED. This will be in the first quarter of 2026, followed by top-line results from the global registrational REVEAL two study in chronic TED in the second quarter of 2026. Elegrobart has the potential to become the first subcutaneous IGF-1R therapy approved for TED in China.

最後，關於 Elegrobart，我們的合作夥伴 Viridian 預期將公布全球註冊性 REVEAL one 研究（活動期 TED）的主要結果。時間點為 2026 年第一季，隨後於 2026 年第二季公布全球註冊性 REVEAL two 研究（慢性 TED）的主要結果。Elegrobart 有潛力成為中國首個獲批用於 TED 的皮下注射 IGF-1R 治療。

Turning to our local oncology portfolio, for TIVDAK, we expect approval in China in the first half of 2026, which will build naturally on our established ZEJULA commercial platform, further deepening our leadership in women's cancers. Finally, for Tumor Treating Fields, the FDA approval for Optune Pax in locally advanced pancreatic cancer earlier this month represents an important milestone in this disease, and we will work closely with China's NMPA under the Innovative Medical Device Pathway to support an expedited review. Together, these achievements reflect the depth and quality of our pipeline, one that is advancing with speed and efficiency.

轉向我們本地腫瘤產品組合：就 TIVDAK 而言，我們預期將於 2026 年上半年在中國獲批，並可自然延伸我們既有的 ZEJULA 商業平台，進一步鞏固我們在女性癌症領域的領導地位。最後，關於腫瘤電場治療（Tumor Treating Fields），FDA 本月稍早核准 Optune Pax 用於局部晚期胰臟癌，代表此疾病領域的重要里程碑；我們將在創新醫療器械通道下與中國 NMPA 緊密合作，以支持加速審評。綜合而言，這些成果反映了我們研發管線的深度與品質，並正以速度與效率持續推進。

With that, I'll hand it over to Josh.

接下來，我把時間交給 Josh。

Thank you, Rafael. Hello, everyone. Before getting into quarterly performance by product, I want to briefly frame how the business progressed more broadly in 2025. During the year, we made important progress across market access, portfolio optimization, and business development. We successfully completed NRDL renewals for key products and achieved guideline updates supporting VYVGART in generalized myasthenia gravis and KarXT in schizophrenia, both of which strengthen the durability of our commercial portfolio over the long term.

謝謝你，Rafael。各位好。在按產品說明季度表現之前，我想先簡要說明 2025 年整體業務的更廣泛進展。在這一年中，我們在市場准入、產品組合優化與業務發展方面取得重要進展。我們順利完成關鍵產品的 NRDL 續約，並推動臨床指引更新以支持 VYVGART 用於全身型重症肌無力，以及 KarXT 用於思覺失調症；這些都強化了我們商業產品組合的長期韌性。

At the same time, we sharpened our focus by divesting non-core assets and regions, allowing us to reallocate resources toward higher priority growth opportunities and to improve operational efficiency. From a business development perspective, we maintained a highly selective and strategic approach.

同時，我們透過剝離非核心資產與區域來聚焦資源，使我們得以將資源重新配置至更高優先級的成長機會，並提升營運效率。在業務發展方面，我們維持高度審慎且具策略性的選擇性做法。

During the year, we entered targeted collaborations to explore novel combination strategies in first-line small cell lung cancer and strengthen our oncology platform with the addition of a MUC17/CD3 T-cell engager. Together, these actions reflect our disciplined approach to external innovation, complementing our internal pipeline while preserving financial flexibility.

在這一年中，我們達成具針對性的合作，以探索一線小細胞肺癌的新型聯合治療策略，並透過新增一項 MUC17/CD3 T 細胞接合器來強化我們的腫瘤平台。整體而言，這些行動體現了我們對外部創新的紀律性做法：在補強內部研發管線的同時，亦保留財務彈性。

With that broader context, I'll now turn to our quarterly commercial performance. Fourth-quarter revenues increased 17% year-over-year to $127 million, and full year revenues grew 15% to $460 million, reflecting steady progress across our commercial portfolio. Starting with VYVGART, physician confidence remains strong and patient demand has been stable. Fourth-quarter revenues, however, reflected channel dynamics related to NRDL renewal and hospital purchasing patterns.

在上述更宏觀的背景下，接著我將說明我們的季度商業表現。第四季營收年增 17% 至 1.27 億美元，全年營收年增 15% 至 4.60 億美元，反映我們商業產品組合的穩健進展。先從 VYVGART 開始，醫師信心依然強勁，病患需求維持穩定。然而，第四季營收反映了與 NRDL 續約及醫院採購模式相關的通路動態影響。

In 2026, we expect a more measured near-term growth profile influenced by pricing dynamics and evolving competition. The long-term trajectory of the franchise remains intact, supported by clinical guideline expansion, affordability initiatives, and additional indications and formulations.

展望 2026 年，我們預期短期成長曲線將較為溫和，主要受定價動態與競爭格局演變影響。該產品線的長期發展軌跡仍然穩固，並將受惠於臨床指引擴展、可負擔性措施，以及更多適應症與劑型。

Turning briefly to ZEJULA, we delivered a strong fourth quarter, driven by first-line BRCA positive new patient starts. While some variability is expected early in the year due to volume-based procurement dynamics for olaparib and seasonality, ZEJULA remains well positioned in the first-line setting.

簡要談到 ZEJULA，我們第四季表現強勁，主要由一線 BRCA 陽性新病患啟用所帶動。雖然年初可能因 olaparib 的以量換價採購動態及季節性因素而出現一定波動，但 ZEJULA 在一線治療情境中仍具良好定位。

Looking ahead, KarXT represents a significant near-term growth opportunity. We expect to initiate the commercial launch in the second quarter of 2026, with a clear focus on disciplined execution, building disease awareness, establishing clinical confidence, and laying the groundwork for broader adoption. Recent inclusion in a national expert consensus on negative symptom management builds on last year's inclusion in national treatment guidelines and reinforces growing recognition of KarXT's profile.

展望未來，KarXT 代表一項重要的短期成長機會。我們預期將於 2026 年第二季啟動商業上市，並明確聚焦於有紀律的執行：提升疾病認知、建立臨床信心，並為更廣泛採用奠定基礎。近期納入全國專家共識（針對陰性症狀管理）是在去年納入國家治療指引的基礎上更進一步，也強化了市場對 KarXT 特性的日益認可。

In summary, 2026 is a year focused on maintaining the strength and stability of our existing business while preparing for multiple growth opportunities ahead. That includes continuing to build the VYVGART franchise, executing a high-quality launch for KarXT in schizophrenia, and advancing key late-stage assets such as Povetacicept in IgAN, Elegrobart in TED, and TT Fields in pancreatic cancer. The investments we are making across commercial and R&D today are designed to support a multi-year growth trajectory extending well beyond 2026.

總結而言，2026 年的重點是在維持既有業務的強度與穩定性的同時，為多項未來成長機會做好準備。這包括持續打造 VYVGART 產品線、在思覺失調症領域高品質地推進 KarXT 上市，以及推動關鍵後期資產，例如 IgAN 的 Povetacicept、TED 的 Elegrobart，以及胰臟癌的 TT Fields。我們目前在商業與研發上的投資，旨在支持一條延伸至 2026 年之後、為期多年的成長軌跡。

With that, I will now pass the call over to Yujing to take us through our financial results. Yujing.

接下來，我把電話會議交給 Yujing，請她帶我們回顧財務結果。Yujing。

Thank you, Josh. Now, I will discuss highlights from our fourth-quarter and full-year 2025 financial results compared to the prior year-over-year period. Fourth quarter, total revenue grew 17% year over year to $127.6 million, driven by strong contributions from XACDURO and NUZYRA. XACDURO performance reflected strong patient demand and expanding hospital adoption, though supply constraints during the year limited the full realization of underlying demand. NUZYRA continued to benefit from broader market coverage and increased penetration. Total revenues for the full year were $460.2 million, representing 15% year-over-year growth.

謝謝你，Josh。接下來我將說明 2025 年第四季與全年財務結果的重點，並與前一年同期比較。第四季總營收年增 17% 至 1.276 億美元，主要由 XACDURO 與 NUZYRA 的強勁貢獻所帶動。XACDURO 的表現反映病患需求強勁且醫院採用擴大，但年度期間的供應限制使潛在需求未能完全轉化。NUZYRA 持續受惠於更廣泛的市場覆蓋與滲透率提升。全年總營收為 4.602 億美元，年增 15%。

Turning now to our expenses, our commitment to financial discipline is reflected in improved operating leverage, with both R&D and SG&A declining as a percentage of revenue year over year. R&D expenses for the full year declined 6%, driven by lower personnel compensation costs and an increase in the fourth quarter due to fast progression of global clinical trials. SG&A expenses decreased 12% and 7% year over year for the fourth quarter and full year, mainly due to the reduction in general and administrative expenses because of strategic resource optimization.

接著談到我們的費用，我們對財務紀律的承諾反映在營運槓桿的改善上，研發（R&D）與銷售、一般及行政（SG&A）費用占營收比重皆較去年同期下降。全年研發費用下降6%，主要受人員薪酬成本降低所帶動，但第四季因全球臨床試驗快速推進而有所增加。SG&A費用在第四季與全年分別年減12%與7%，主要因策略性資源優化使一般及行政費用降低。

Loss from operations improved 19% for the full year to $229.4 million and improved 25% when adjusted to exclude non-cash expenses, including depreciation, amortization, and share-based compensation. We maintain a strong cash position, ending the quarter with $790 million. Looking to 2026, our focus remains on strengthening the foundation of our regional business, executing across our global pipeline, and thoughtful capital deployment to support both near-term launches and long-term growth drivers.

全年營運虧損改善19%至2.294億美元；若調整排除折舊、攤銷及股份基礎給付等非現金費用，則改善25%。我們維持強勁的現金部位，季末現金達7.90億美元。展望2026年，我們仍將聚焦於強化區域業務基礎、推進全球產品線的執行，以及審慎的資本配置，以同時支持短期上市與長期成長動能。

With a strong balance sheet, we are well positioned to execute against these priorities. With that, I would now like to turn the call back over to the operator to open up lines for questions. Operator.

憑藉強健的資產負債表，我們已具備良好條件來落實這些優先事項。接下來，我想把電話交回給接線員，開放提問。接線員。

(Operator Instructions) Jonathan Chang, Leerink Partners.

（接線員指示）Leerink Partners 的 Jonathan Chang。

Hi, guys. Thanks for taking my questions. First question, can you provide any color on how we should be thinking about revenues and expenses for 2026? Second question on the global pipeline for zoci, can you remind us of the implications of the intracranial activity in patients with brain mets, and how does this impact the opportunity and positioning of the drug? Thank you.

嗨，各位。謝謝讓我提問。第一個問題，能否提供一些看法，讓我們了解應如何思考2026年的營收與費用？第二個問題關於 zoci 的全球產品線，能否提醒我們其在腦轉移（brain mets）患者中的顱內活性所代表的意涵，以及這如何影響該藥物的機會與定位？謝謝。

Thanks, Jonathan. It's Josh. I'll start with 2026, ask Yajing to make a comment, and then we'll hand it over to Rafael to talk about zoci. I think as we think about 2026, as we mentioned on the upfront comments we see good growth opportunities for VYVGART. We're seeing good volume gains throughout the second half of the year. We expect that to continue in 2026. We're pleased with how we ended the year with ZEJULA, and while we're facing a generic market now for Lynparza, we expect to continue to hold our position and in some cases, hopefully grow. XACDURO should be a good driver for us this year.

謝謝你，Jonathan。我是 Josh。我先談2026年，請 Yajing 補充評論，接著再交給 Rafael 談 zoci。談到2026年，如同我們在開場提到的，我們看到 VYVGART 有不錯的成長機會。我們在下半年整體看到良好的量能成長。我們預期這樣的趨勢將延續到2026年。我們對 ZEJULA 的年末表現感到滿意；雖然目前 Lynparza 面臨學名藥市場競爭，我們預期仍能維持既有地位，並在某些情況下希望能成長。XACDURO 今年應會成為我們的重要驅動力。

Of course, then we've got a couple important launches or coming. COBENFY in the second quarter will begin our commercial launch and then TIVDAK later this year. I think when you think about those things together, certainly. we're looking for good commercial performance and good growth on the top line for the year. For expenses, I think we're in good shape on SG&A, very modest investments required to support launches. Obviously, we're gonna put the field sales force in place to launch COBENFY, and that'll drive some incremental costs. I think otherwise, we're in good shape as it relates to synergies and efficiencies across our SG&A. R&D should be relatively in line with what we've seen the last few years.

當然，接下來我們也有幾項重要的上市計畫或即將到來。COBENFY 將於第二季啟動商業化上市，之後今年稍晚還有 TIVDAK。把這些因素合併來看，我們確實期待今年營收端有良好的商業表現與成長。在費用方面，我認為我們的 SG&A 狀況良好，為支持上市所需的投資相當有限。顯然，我們會建立前線銷售團隊以推動 COBENFY 上市，這將帶來一些增量成本。除此之外，就 SG&A 的綜效與效率而言，我們的狀況良好。研發費用應大致與過去幾年所見水準相當。

Obviously, big focus and resource allocation to our global portfolio. As some of our late phase opportunities start to in China, start to come offline, we've got capacity there. I think sort of flat to very modest growth in R&D. This year, pretty straightforward thinking. Obviously, we've got some pushes and pulls as it relates to when things are approved and when we get them into the market and otherwise. I think as we think about 2027 and on, we'll start to get the benefits of these launches, like COBENFY and TIVDAK and some of the assets that Rafael talked about in his in his upfront comments.

當然，我們將把重點與資源配置放在全球產品組合上。隨著部分後期階段機會在中國開始、開始逐步結束，我們在那裡會釋出一些產能。我認為研發費用大致持平到非常溫和的成長。今年的思路相當直接。當然，仍會因核准時點、以及我們將產品導入市場的時間等因素而出現一些拉動與抵銷。我想，當我們展望2027年及之後，將開始享受到這些上市帶來的效益，例如 COBENFY、TIVDAK，以及 Rafael 在開場評論中提到的一些資產。

Yajing, I don't know if you wanna add anything to that?

Yajing，你還想補充什麼嗎？

Maybe just to add a little bit more dynamics in 2026, and 2026 is a transition year. I think, underlying demand growth, as Josh talked about, is very true. Also, we want to be mindful of other dynamics moving pieces, including the IV, the VYVGART IV price adjustment, and maybe later on, the deal rebate dynamics in the fourth quarter for VYVGART, the ZEJULA. Then we are sort of, like, looking at the hospital budgeting purchasing behavior as well. This is part of the reason that we probably not going to provide the full year guidance at this time, but those are the moving pieces. When we get more clarity, we can share more specifics later in the year.

也許補充一些2026年的動態；2026年是一個過渡年。我認為如 Josh 所說，底層需求成長確實存在。同時，我們也希望留意其他動態變數，包括 VYVGART 靜脈注射（IV）劑型的價格調整，以及可能在第四季出現的 VYVGART、ZEJULA 的協議折讓（rebate）動態。此外，我們也在觀察醫院預算編列與採購行為。這也是我們目前可能不會提供全年指引的部分原因，但以上就是主要變動因素。待我們取得更清晰的資訊後，會在今年稍晚分享更具體的細節。

Thanks, Yajing. Rafael, do you wanna talk about zoci, please?

謝謝你，Yajing。Rafael，你可以談談 zoci 嗎？

Yeah, absolutely. Brain metastasis, obviously, in this disease is a big problem. About 70% of patients develop brain metastases, and I think the speed with which patients experience responses with zoci is well appreciated among investigators, and it's actually one of the key properties of the molecule. We've reported up to 80% response rates in patients with untreated metastases. There are two situations. If a patient comes in with brain metastases, oftentimes they have to have brachytherapy or some regional therapy, which delays systemic therapy. Whereas, if it's an uncomplicated untreated met, patients can go into zoci directly, and we see again pretty high activity in the brain.

好的，當然。腦轉移在這個疾病中顯然是一個重大問題。約有70%的患者會出現腦轉移；研究者也很清楚 zoci 讓患者快速產生反應的速度，而這其實是該分子的一項關鍵特性。我們曾報告在未治療轉移的患者中，反應率最高可達80%。這裡有兩種情境。若患者就診時已有腦轉移，往往需要接受近接放射治療（brachytherapy）或某些局部治療，這會延後全身性治療。相較之下，若是單純且未治療的轉移，患者可直接使用 zoci，我們也再次看到在腦部具有相當高的活性。

The other is there are some drugs that may have activity, but then there is a high rate of relapse in the brain, where the brain is a sanctuary site. Using zoci prevents recurrences in the brain, which is really important. We've reported in RECIST criteria before, and we're planning to report now in the first half of the year, using RANO criteria, which is a response assessment that is used in neuro-oncology. It's a much more stringent one, where it's a bidimensional and uses 50% instead of 30%. It really characterizes the response in the brain, and we look forward to presenting that in the first half of this year.

另一種情況是，有些藥物可能有活性，但腦部復發率很高，因為腦部是所謂的「庇護部位」（sanctuary site）。使用 zoci 可預防腦部復發，這非常重要。我們先前是依 RECIST 標準報告，而我們計畫在今年上半年改用 RANO 標準進行報告；RANO 是神經腫瘤學中使用的反應評估標準。這是一個更嚴格的標準，採用雙向量測，且門檻使用50%而非30%。它能更充分刻畫腦部反應，我們也期待在今年上半年對外發表。

Got it. Thanks for taking the questions.

了解。謝謝讓我們提問。

Li Watsek, Cantor.

Li Watsek，Cantor。

Hey, good morning. Thanks for taking my questions. I guess my first question is more about sort of the US, China development model that you alluded to in the opening. I just wonder, can you elaborate a little bit more, other than maybe sourcing assets from the region? I guess how much clinical de-risking or timeline acceleration can you achieve by leveraging some of the resources in the region?

嗨，早安。謝謝讓我提問。我想我的第一個問題比較是關於你們在開場時提到的美國、中國的開發模式。我想請問，除了可能從該地區取得資產之外，你們能否再多闡述一點？我想知道，透過運用該地區的一些資源，你們在臨床去風險或時程加速方面，究竟能達到多大程度？

Thanks, Li. It's Josh. Rafael, why don't you talk a little bit about this point to Li's question?

謝謝你，Li。我是Josh。Rafael，你要不要針對Li的問題談一下這點？

Sure. Our model obviously has been speedy development in China based on pretty efficient development structure, as well as regulatory and other functions in China, and that's led to the success of registrations local regionally. Now, we're applying that speed relationship with investigators and sites to add China to global trials, or to be the sole site when we want go, no-go decisions with products. We now have all our global trials really including China participation, and that really has allowed us to move with speed and quality. That will be also the case for Phase 3 studies. We expect that China will participate and enroll about a third of the patients.

當然。我們的模式顯然是在中國以相當高效率的開發架構，以及中國的法規與其他職能為基礎，進行快速開發，這也帶來了在當地/區域註冊上的成功。現在，我們正把這種速度，以及與研究者和試驗中心的合作關係，用於將中國納入全球試驗，或在我們需要對產品做出「繼續/停止（go/no-go）」決策時，讓中國成為唯一的試驗地點。目前我們所有的全球試驗基本上都包含中國的參與，這確實讓我們能以速度與品質並進。第三期研究也會是如此。我們預期中國將參與並收案約三分之一的病人。

At least that's our expectation, for instance, on our current pivotal trial and second line with zoci. I think all in all this efficiency that we have built over the course of the past 10 years in China is serving us well as we are now expanding our pipeline towards global assets. We are seeing the fruits of that by, for instance, zoci moving within two years to Phase 3 from IND, as an example.

至少這是我們的預期，例如在我們目前以zoci進行的二線關鍵性試驗。整體而言，我們在過去10年於中國建立的這套效率，正隨著我們把產品線擴展到全球資產而持續發揮效益。我們也看到了成果，例如以zoci為例，從IND到進入第三期僅用兩年。

My second question is on zoci, and obviously you guys are gonna present data in neuroendocrine. Just wanted to get a little color in terms of expectations, what sort of data you guys are gonna present, what's good data? In terms of regulatory pathway, can you maybe just conduct a single arm study to get approval? Maybe expand a little on that as well.

我的第二個問題是關於zoci，顯然你們將在神經內分泌領域發表數據。我想多了解一些你們的預期：你們會呈現什麼樣的數據？什麼樣的數據算是好的？就法規路徑而言，你們是否可能只做單臂試驗就取得核准？也請就此再多談一些。

Yeah. NEC is a complex group of diseases, and in first line, it's treated with chemotherapy. There is the gastroenteropancreatic subgroup, and then other neuroendocrine carcinomas that exclude lung, because lung tends to have a different prognosis. When you look across the board in second line, chemotherapy really has a dismal activity in terms of response rate and PFS. Our study has started in second line and is looking at GEP neuroendocrine carcinomas, non-GEP neuroendocrine carcinomas or extra pulmonary. There's a group that is looking at neuroendocrine tumors, which are less aggressive. An initial data set will be presented in second line. We are pleased with what we're seeing thus far.

好的。NEC是一組複雜的疾病，而在一線治療上通常使用化療。其中有胃腸胰（gastroenteropancreatic, GEP）亞群，另外還有其他神經內分泌癌，但會排除肺部，因為肺部通常有不同的預後。整體來看，在二線治療中，化療在反應率與PFS方面的療效確實相當不理想。我們的研究從二線開始，觀察GEP神經內分泌癌、非GEP神經內分泌癌或肺外（extra pulmonary）。另有一組在看神經內分泌腫瘤（neuroendocrine tumors），其侵襲性較低。初步數據將在二線治療中呈現。我們對目前看到的結果感到滿意。

We will have, I think, sufficient patients to make an assessment in terms of the response. The durability may be limited, but we think that there's enough information there to present in the first half of this year. There may be about 60-plus patients that will be included in this analysis.

我想我們會有足夠的病人數來評估反應。反應的持久性可能有限，但我們認為資訊量足以在今年上半年對外發表。這次分析可能會納入約60多位病人。

Like you said, we are sort of ourselves seeking a regulatory path for NEC in second line, and this is actually the subject of our regulatory discussions that we're initiating now in terms of whether a single arm would be sufficient or whether a randomized trial would be required. It's unclear what the control arm would be in the second option, but it's still a possibility.

如你所說，我們也正在為NEC二線治療尋求一條法規核准路徑，而這正是我們目前開始啟動的法規討論主題：單臂試驗是否足夠，或是否需要隨機對照試驗。若採第二種方案，對照組該用什麼目前並不清楚，但仍是一種可能性。

Those discussions are beginning now as we uncover the data. We're also thinking about what to do in frontline as well. As you know, some T-cell engagers are getting into this space, and we would probably consider something in first line in combination, but that is standalone in the future. We want to sort of see what we can do to help patients in second line, where options are just so scarce.

隨著我們揭露數據，這些討論現在正開始進行。我們也在思考一線治療該怎麼做。如你所知，一些T細胞接合器（T-cell engagers）正在進入這個領域，我們未來可能會考慮在一線以合併治療的方式切入，但也可能在未來作為單藥。我們希望看看能做些什麼來幫助二線病人，因為那裡的選擇實在非常有限。

Thank you.

謝謝。

Michael Yee, UBS.

Michael Yee，UBS。

Thank you. Good morning. We have two questions. First, just wanted to understand, given all the thoughts and comments you have talked about regarding steady revenue growth and pushes and pulls as it relates to financials this year, does the company believe that they could achieve breakeven or profitability by the end of the year? Do you think that's something that is achievable given what we had expectations for last year? The second question is, obviously, zoci and DLL3 are critically important. What is the expectation for completion of enrollment and the timing of reading out the primary endpoint on response rate in order to file? Thank you.

謝謝。早安。我們有兩個問題。第一個問題是，考量你們對今年財務面穩健營收成長以及各種推拉因素的想法與評論，公司是否認為在今年年底前能達到損益兩平或獲利？以我們對去年的預期來看，你覺得這是可達成的嗎？第二個問題，顯然zoci和DLL3至關重要。關於完成收案的預期，以及為了申報而讀出以反應率為主要終點的時間點，預期如何？謝謝。

Great. Thanks, Mike. How about Yajing Chen, you talk about the cash flow, and then we'll hand it over to Rafael.

很好。謝謝你，Mike。要不請Yajing Chen談一下現金流，然後我們再交給Rafael。

Our corporate profitability, I mean, the cash flow breakeven, it definitely continue to be a very clear objective for Zai Lab. We will manage the business accordingly. Our business right now is commercially profitable today, that provides a stable foundation for the company. At a corporate level, I think the timing of the profitability is really driven by the two primary factors. One is the top-line growth, the rate of the growth, the other one is the level of investment that we choose to make in the high-value global programs. I think at this time, we remain efficient, disciplining our spending. We do expect the corporate profitability to emerge.

就公司整體獲利而言，我是說現金流損益兩平，這確實仍然是再鼎醫藥非常明確的目標。我們會據此來管理業務。我們目前的商業化業務今天就已經是獲利的，這為公司提供了穩定的基礎。在公司層面，我認為獲利的時間點主要由兩個因素驅動。一是營收成長（top-line growth）及其成長速度，二是我們選擇在高價值全球項目上投入的投資水準。目前我們仍維持效率並嚴守支出紀律。我們確實預期公司層面的獲利將會出現。

I won't be able to share the guidance for 2026, where we're gonna be. That's definitely the goal for us to continue to drive.

我無法分享2026年的指引，也就是我們會到什麼位置。但這絕對是我們持續推進的目標。

Also I want to mention that we are focused on the progressing towards the goal, but also focused on the continue to expand our global pipeline. We do want to preserve the flexibility, to invest when we see the strong value.

另外我也想提到，我們一方面專注於朝目標推進，同時也專注於持續擴展我們的全球產品線。我們確實希望保留彈性，在看到強勁價值時能夠投入投資。

Thanks, Xiaji. Go ahead, Rafael.

謝謝，Xiaji。Rafael，請。

Thanks, Josh, and thanks, Michael, for the question. The study started in December. It's a global trial. It started in the US first, and China is coming online imminently as Europe will and North America and other countries in Asia as well, Asia Pacific. Our plan is to have about 75% of the patients enrolled by the end of the year. We have to have everybody enrolled before we do the interim analysis for response. We think that we will finish enrollment at the end of the first quarter of next year and do the analysis and subsequently file. We're hoping for an approval in 2028.

謝謝你，Josh，也謝謝你，Michael，提問。這項研究在12月啟動。這是一項全球試驗。先在美國啟動，中國也將很快上線；歐洲、北美以及亞洲其他國家（亞太地區）也會陸續啟動。我們的計畫是在年底前完成約75%的收案。在我們進行反應的期中分析之前，必須先完成所有病人的收案。我們認為將在明年第一季末完成收案，接著進行分析並隨後提交申報。我們希望在2028年獲得核准。

The study, as you know, is a combination of second-line as well as post-thalidomide patients, and we're balancing the accrual of each one of those subgroups in the study. 2027, end of accrual and filing, and 2028, hopefully, accelerated approval.

如你所知，這項研究結合了二線以及沙利度胺後（post-thalidomide）患者，我們正在研究中平衡各子群的入組。2027 年完成入組並提交申請，並希望於 2028 年取得加速核准。

Perfect. Thank you very much.

完美。非常感謝。

Yigal Nochomovitz, Citigroup.

Yigal Nochomovitz，花旗集團。

Hi, this is Caroline on for Yigal. Thanks for taking our question. Could you talk about your strategy to grow VYVGART, specifically how to increase cycles per patient? Thanks.

嗨，我是代替 Yigal 的 Caroline。感謝讓我們提問。能否談談你們擴大 VYVGART 的策略，特別是如何提高每位患者的治療週期數？謝謝。

Thanks, Caroline. Vyvgart, we are focused on moving the cycles per patient to the minimum of 3, which is what's embedded in the national myasthenia gravis guidelines in China that were updated in July of last year. Of course, in the clinical data, getting out to 5 or more over a 12-month period demonstrates really significant benefits.

謝謝你，Caroline。關於 Vyvgart，我們目前聚焦於將每位患者的治療週期數提升到至少 3 個週期，這也是中國重症肌無力國家指南（去年 7 月更新）所納入的最低標準。當然，從臨床數據來看，在 12 個月期間達到 5 個或以上週期，能展現非常顯著的效益。

Our focus right now is on 3. We're making reasonable progress, and we made reasonable progress in 2025. If you just look at average cycles, closing out the year in 2025, we improved versus 2024 by more than 50%. We're on the way, but we're not yet on average at 3.

我們目前的重點是 3 個週期。我們正在取得合理進展，且在 2025 年也取得了合理進展。若只看平均週期數，2025 年年底相較 2024 年提升超過 50%。我們正在朝目標前進，但平均值尚未達到 3。

I think we've got a couple key initiatives to help drive that focus. I mean, the first is to leverage the guidelines, and that's through our medical professionals and our sales professionals, and I think that's really important, and we're seeing the benefit of that. We know guidelines make a big difference in China. They make a big difference in most markets. This has been just. It's been a build the market approach with VYVGART. I think we're making good progress there and certainly have the clinical data and now the national guidelines to support that. We are also working on affordability initiatives while NRDL listing is clear for VYVGART.

我認為我們有幾項關鍵舉措可推動這個重點。第一是善用指南，透過我們的醫學專業人員與銷售團隊來推動；我認為這非常重要，而且我們已看到其效益。我們知道指南在中國影響很大。在多數市場也同樣影響很大。這一直是——對 VYVGART 而言，這是一種「建立市場」的做法。我認為我們在這方面進展良好，並且有臨床數據以及現在的國家指南作為支持。在 VYVGART 納入 NRDL（國家醫保藥品目錄）已明確的情況下，我們也在推動可負擔性相關措施。

Patients do pay, a co-pay and pay out-of-pocket. We've got in place an online support program that helps patients navigate things like appointments and resources and otherwise to help on the logistics and the co-pay. We have a targeted co-pay assistance program that helps. It really is focused on the national guidelines and focused on ensuring we can get patients out to three cycles without -- with as minimum economic burden as possible.

患者仍需支付自付額（co-pay）以及自費支出。我們已建立線上支援計畫，協助患者處理如掛號、資源等事項，並在流程與自付額方面提供協助。我們也有針對性的自付額補助計畫提供幫助。整體而言，重點在於依循國家指南，並確保患者能完成三個週期，同時將經濟負擔降到最低。

We are seeing the benefits of those focus points. I do expect during the year that we'll continue to see good expansion and duration of therapy and get the majority of our, certainly patients who are in the acute phase of the disease, that the majority of those patients, I think, this year are gonna get to three and more cycles. We also, this year, though, are expanding, really focusing on patients who are in the non-acute phase. They, of course, also benefit from long-term therapy and getting three or more cycles, but that's probably gonna be a little bit, a little bit longer climb to get there.

我們正看到這些重點措施帶來的效益。我確實預期今年我們將持續看到治療擴張與療程持續時間的良好提升；對於處於疾病急性期的患者，我認為今年多數患者將能達到三個或更多週期。不過今年我們也在擴大，並更聚焦於非急性期患者。他們當然也能從長期治療與三個或更多週期中受益，但要達到那個水準可能需要更長時間、爬坡會更久一些。

I think as we look at the data throughout the year, we've got great patient expansion opportunities by leveraging our strength in acute patients, moving to non-acute. Those acute patients, I think the initiatives are underway and having results that'll get us out to those on average, three or more cycles, and then the non-acute patients will start to pick up and add certainly good volume growth throughout the year. I think that's --we're quite excited about the opportunities with VYVGART this year, the opportunities to get to many more patients and for them to get the full benefits of the drug through persistence and duration. Thank you.

我認為，隨著我們全年持續觀察數據，我們可藉由在急性期患者上的優勢，進一步延伸到非急性期，從而帶來很好的患者擴張機會。對於急性期患者，我認為相關舉措已在推進並產生效果，將使我們的平均週期數達到三個或以上；而非急性期患者也會開始加速，並在全年帶來可觀的量能成長。我認為這——我們對今年 VYVGART 的機會感到非常興奮：能觸及更多患者，並透過更好的治療持續性與療程長度，讓他們獲得藥物的完整效益。謝謝。

Thank you.

謝謝。

Anupam Rama, JPMorgan.

Anupam Rama，摩根大通。

Hey, guys. Thanks so much for taking the question. On the global second, third line DLL3 study, which is enrolling patients, you kind of talked about this, but can you remind us what the ultimate regional breakdown of sites is going to be, given this is a global effort? Is there a breakdown of patients that need to be ex China for US and more global approvals? Thanks so much.

各位好。非常感謝讓我提問。關於正在入組的全球二線、三線 DLL3 研究，你們剛才有稍微提到，但能否提醒我們，作為一項全球性研究，最終各地區研究中心的分布會是如何？為了在美國及更廣泛的全球核准，是否需要一定比例的患者來自中國以外（ex China）？非常感謝。

Thanks, Anupam. I'll start, but Rafael can talk about the enrollment and how we're thinking about that. I think first, if we look at small cell lung cancer and focus first on the US, I think in the second line and later settings, we see about 15,000 patients available. First line's probably 25,000. If we sort of look at that on a major market, Western market, that's probably 100,000 patients total in small cell lung cancer that are eligible for treatment in first or later line settings.

謝謝你，Anupam。我先回答，Rafael 也可以談談入組以及我們的思考方式。我想首先，如果我們看小細胞肺癌，先聚焦美國市場，在二線及後線治療情境下，我們看到大約有 15,000 名可治療患者。一線大概是 25,000 名。如果把主要市場、西方市場加總來看，小細胞肺癌在一線或後線治療情境下，符合治療資格的患者總數大概是 100,000 名。

It's a big opportunity and of course when we sort of size that, and you guys have done this as well, it's approaching $10 billion probably in terms of total opportunity, and we think zoci can fit really well in that space. I think when we look at neuroendocrine, we're probably in the US, it's somewhere in that 5,000-10,000, sort of range, maybe similarly in other markets. We have more to learn here, I think, as we continue to work through the trial. It's not insignificant, I guess, is what I would say. Rafael, maybe you can talk about enrollment.

這是一個很大的機會；當然，當我們估算其規模——你們也做過類似估算——總體機會可能接近 100 億美元，我們認為 zoci 很適合切入這個領域。至於神經內分泌腫瘤，在美國可能大約在 5,000 到 10,000 的區間，其他市場可能也差不多。我認為隨著試驗推進，我們還需要進一步了解。但我想說的是，這個機會並非微不足道。Rafael，也許你可以談談入組。

Sure. The distribution, I think, of the countries and patients coming from China and other regions is, it's really designed to make sure that we have enough patients, post talatinib, that reflect real-world usage in the United States. That may be up to 30% of patients or so coming from the United States. About 30% of patients will come from China. This is a reasonable number. I don't think it's ever been questioned that a percent of patients of that magnitude can jeopardize approval in a positive study. The rest of the patients will come from Europe.

當然。我認為各國分布，以及來自中國與其他地區的患者比例，其設計目的在於確保我們有足夠的 talatinib 後（post talatinib）患者，並能反映美國真實世界的使用情況。來自美國的患者比例可能高達約 30%。約 30% 的患者將來自中國。這是合理的比例。我不認為曾有人質疑，在一項結果正向的研究中，如此比例的患者會危及核准。其餘患者將來自歐洲。

In terms of post talatinib patients, obviously, we count on Japan as well. We count on the UK, some countries where a lot of studies have been done with talatinib, and obviously, the United States, where talatinib is gaining market share. I think that's probably the distribution that you should expect on the study.

就 talatinib 後患者而言，顯然我們也會依賴日本。我們也會依賴英國，以及一些已進行許多 talatinib 研究的國家；當然也包括美國，因為 talatinib 在美國的市佔率正在提升。我認為這大概就是你應該預期的研究分布。

Thanks so much for taking our question.

非常感謝讓我們提問。

Cui Cui, Jefferies.

崔崔，Jefferies。

Thank you very much. Thank you, Samantha, Josh, Rafael, Yating, and Shen. I have three questions for the management team. The first one is as a follow-up to the JP Morgan question. Could you please share some more details on those? Because for this time, we are also very excited to see the clinical trial design for the first-line small cell lung cancer, including the combo Remagen, and also for the strategy of NEC, where it also be advanced to the first-line treatment in the future.

非常感謝。謝謝你，Samantha、Josh、Rafael、Yating 和 Shen。我有三個問題想請教管理團隊。第一個問題是延續 JP Morgan 的提問。能否請您分享更多細節？因為這次我們也非常期待看到一線小細胞肺癌的臨床試驗設計，包括與 Remagen 的聯合用藥；以及 NEC 的策略，未來是否也會推進到一線治療。

My second question is regarding the KarXT. What should we expect from KarXT in 2026 and 2027, and how will you build your commercialization team going onward?

第二個問題是關於 KarXT。我們在 2026 年與 2027 年可以期待 KarXT 帶來什麼？以及接下來你們將如何建立商業化團隊？

My last question is also, because for the past one year, we also saw some deals regarding the autoimmune bispecific. Can we talk about some big? Thank you so much.

最後一個問題是，因為過去一年我們也看到一些關於自體免疫雙特異性抗體的交易。我們能否談談一些更大型的（交易）？非常感謝。

Thanks, Cui Cui. Rafael, why don't you start, and then I'll come back in with the next two.

謝謝你，崔崔。Rafael，你先開始回答，然後我再回來補充後面兩個問題。

Yeah, maybe I'll focus on the first-line opportunity. I mean, just the overarching sort of desire for Zoci is to be the centerpiece ADC for different lines of therapies and combinations. That is because of its low incidence of grade 2 toxicity, activity in the brain and high response rate, really, and durability. On first line, we've seen in the first study, the Phase 1, 2, Study 001, we've been enrolling patients in first line for some time. We started with a doublet, with atezolizumab, and then a triplet, adding carboplatin. We hope to present mature data towards the second half of this year.

好的，我先聚焦在一線機會。我們對 Zoci 的整體願景，是讓它成為不同治療線別與各種聯合方案中的核心 ADC。原因在於它二級（grade 2）毒性發生率低、對腦部病灶有活性、反應率高，而且反應持久。在一線方面，我們在第一個研究（一期/二期的 001 研究）中，已經有一段時間在招募一線患者。我們先從雙藥組合開始，與 atezolizumab 聯用，之後再做三藥組合，加入 carboplatin。我們希望在今年下半年展示更成熟的數據。

We have just to give you a sense, we've treated about 60 patients or so, and we continue to follow these patients. I think once we have an idea of the activity, we will then make a decision of what the design of the frontline study should be. Our desire is for it to be one that spares chemotherapy, but also we have our eyes on how the frontline sort of landscape is going to change with the entrance of IMDELLTRA, potentially in frontline and other TCEs in frontline. If we continue to see this high level of activity, we will be testing with other agents as well to see whether this combination offers even more activity for patients in first line.

讓你有個概念，我們大約已治療了 60 位左右的患者，並持續追蹤。我認為一旦我們對療效有了更清楚的判斷，就會決定一線研究應採用什麼設計。我們希望能採用一種能減少化療使用的設計；但同時我們也在關注一線治療格局可能因 IMDELLTRA 的進入（可能進入一線）以及其他一線 TCE 的出現而改變。如果我們持續看到如此高水準的活性，我們也會與其他藥物一起測試，看看這種聯合是否能為一線患者帶來更高的療效。

I think it's stay tuned to the data, but our final design will be when we actually see the entire durability and activity in first line with the data that we've been able to elicit from the phase one, two study.

我想請大家持續關注數據；但我們最終的設計，會在我們真正看到一期/二期研究所獲得的一線完整持久性與活性數據後再做決定。

Thanks, Rafael. I'll talk about KarXT for a minute. Cui Cui, we're really excited about this opportunity, was approved without only product approved without a black box in this setting, first new mechanism in more than 70 years. There's a really exciting introduction here. We'll launch the product commercially in the second quarter, we're going through all the process now of getting product in, and labeled, and inspected and otherwise. Second quarter, we'll be out with the product in the market. Of course, we don't have NRDL listing this year, just given the timing, but we do expect that in 2027. This year's focus will be on getting physicians experienced using the drug.

謝謝你，Rafael。我來簡單談一下 KarXT。崔崔，我們對這個機會非常興奮；它在此適應症中獲批，且是唯一一個在此情境下獲批且沒有黑框警語的產品，也是 70 多年來第一個全新作用機制。這是一個非常令人振奮的引入。我們將在第二季進行商業上市，目前正在完成產品到貨、貼標、檢驗等所有流程。第二季產品就會在市場上推出。當然，基於時程因素，今年我們不會有 NRDL 納入；但我們預期在 2027 年會納入。今年的重點會放在讓醫師累積使用該藥的經驗。

Getting a commercial team up and running. I think prescribing here is really concentrated in China. While there were, I think, in 2024, over 2 billion days of atypical antipsychotic prescription use, when we look at how that's prescribed and how it's managed, it's probably 800 institutions, give or take, that make up a vast majority of that volume, at least from a sort of initial prescribing and monitoring perspective. We'll focus on those institutions at launch. That generates something in the range of 100 plus or minus sort of commercial team. very focused this year, and we'll expand as necessary, but we do see this as a relatively efficient, big opportunity.

並把商業團隊建立並運作起來。我認為在中國，處方其實非常集中。雖然我記得 2024 年非典型抗精神病藥的處方使用天數超過 20 億天，但當我們看其處方與管理方式時，從初始處方與監測的角度來看，可能大約是 800 家機構（上下浮動）貢獻了絕大多數的量。上市時我們會聚焦這些機構。這大致對應到約 100 人左右（上下浮動）的商業團隊；今年會非常聚焦，並視需要擴張，但我們確實認為這是一個相對高效率、且規模很大的機會。

Again, for this year, I think in terms of financials, I wouldn't expect significant sales. Again, this is gonna be a non-NRDL product for patients who otherwise aren't gonna have things like commercial insurance or other access to payment mechanisms. For 2027, I think if you look at NRDL and how to think about this, if you look at the brand, the brand of olanzapine, for example, it's in the range, I think, of about $5 a day on NRDL, paliperidone and similar. There's I think a pretty straightforward reference here. Final comment I'll make on KarXT is, I do think this is a relatively straightforward opportunity.

同樣地，就今年而言，從財務表現來看，我不預期會有顯著銷售。畢竟這將是一個未納入 NRDL 的產品，患者若沒有商業保險或其他支付機制，取得藥物會比較受限。至於 2027 年，如果看 NRDL 以及如何思考定價參考，例如 olanzapine 的品牌藥在 NRDL 上大約是每天 5 美元左右，paliperidone 及類似藥物也是如此。我認為這裡有一個相當直接的參考。我對 KarXT 的最後一點評論是：我確實認為這是一個相對直接明確的機會。

Atypical antipsychotics are monotherapy is, like, 90% plus of the standard of care today. This is a drug that brings great additional benefits in terms of safety and negative symptoms. We'll be educating physicians on that, on those points this year in preparation for what I think will be a exciting unlock in terms of financial value beginning in 2027.

目前非典型抗精神病藥以單藥治療為主，約占現行標準治療的 90% 以上。這款藥在安全性與陰性症狀改善方面能帶來很大的額外效益。今年我們會就這些重點對醫師進行教育，為我認為自 2027 年起在財務價值上的令人振奮的釋放做好準備。

On business development, we've got Shan on the phone and Rafael. We're spending a lot of time around the world looking at opportunities, certainly, as you mentioned, I think if you look at the innovation happening in China, particularly in areas that we're interested in, oncology and immunology, modalities like ADCs and T-cell engagers, there's a lot of good opportunities to pick from. You should expect us to continue to do that.

在商務拓展方面，Shan 和 Rafael 也在線上。我們花了很多時間在全球範圍內尋找機會；正如你提到的，如果看中國正在發生的創新，特別是在我們感興趣的領域——腫瘤與免疫——像 ADC 與 T 細胞銜接器（T-cell engagers）等技術路線，有很多不錯的機會可供選擇。你可以期待我們會持續這麼做。

We announced recently a deal on the MUC17, which I mentioned earlier. I think that's kind of our typical kind of deals you should think about from us, would be late preclinical targets that are -- have some biological precedence and where we can move fast, leverage the clinical development expertise that Rafael talked about earlier and have a chance to introduce first, invest in class, products in oncology and immunology, to the world. We're really excited about that. Thanks.

我們最近宣布了一項關於 MUC17 的交易，我之前也提到過。我認為那就是你可以期待我們典型會做的交易類型：偏後期的臨床前標的——具有一定的生物學先例——而且我們能快速推進，運用 Rafael 先前提到的臨床開發專長，並有機會向全球推出腫瘤與免疫領域的同類首創（first-in-class）產品。我們對此非常興奮。謝謝。

Thank you. Thank you so much, Josh.

謝謝。非常感謝你，Josh。

Thank you for the question.

謝謝你的提問。

Linhai Zhao, Goldman Sachs.

趙臨海，高盛。

Thanks for taking my question. My question is around zoci. The first one is regarding the Phase 3 trial for the second line small cell lung cancer. Understood that the current clinical protocol does not take talimogene as a control arm, but it was allowed to be available both as a prior treatment option and a post-progression treatment options.

感謝讓我提問。我的問題是關於 zoci。第一個問題是關於第二線小細胞肺癌的第 3 期試驗。我理解目前的臨床試驗方案並未將 talimogene 作為對照組，但允許其同時作為既往治療選項以及疾病進展後的治療選項。

On that end, I want to collect your thoughts on the potential risk of having a elongated OS for the control arm, given that you're allowing talimogene both before and after the second line treatment. That's the first question.

在這方面，我想請教你們對於對照組 OS（總生存期）可能被拉長的潛在風險有何看法，因為你們允許在第二線治療前後都使用 talimogene。這是第一個問題。

The second question is about the first line. Understood that you're going to share the Phase 1 trial data for both doublet and triplet in the second half. Just want to collect your detailed plans about when do you want to make a decision on what to choose from doublet versus triplet in first line? Thank you.

第二個問題是關於第一線。我理解你們將在下半年分享第 1 期試驗中 doublet 與 triplet 的數據。我想更詳細了解你們的規劃：你們打算在什麼時間點決定第一線要在 doublet 與 triplet 之間做出選擇？謝謝。

Go ahead, Rafael.

Rafael，請繼續。

Thanks for the question. Maybe let's start from the second one. In terms of first line, we would like to start the first line study, phase two study this year. In spite of the fact that it may take some time for us to see durability, we may just use a landmark in terms of patients without progression at a given number of months and then make a decision. Again, our strong desire is to spare chemotherapy, because that's really what leads to most of the morbidity and most patients can only get about four cycles of carboplatin and a checkpoint inhibitor because they progress. Actually, the majority of them, some of them are intolerant.

謝謝你的提問。也許我們先從第二個問題開始。就第一線而言，我們希望今年啟動第一線研究，也就是第 2 期研究。儘管要看到持久性可能需要一些時間，我們可能會採用一個里程碑指標，例如在特定月數時仍未進展的患者比例，然後據此做出決策。再次強調，我們強烈希望能避免化療，因為化療才是造成大多數發病率的主要原因，而且多數患者因為疾病進展，通常只能接受大約四個療程的卡鉑加上免疫檢查點抑制劑。事實上，大多數患者中也有一些是無法耐受的。

give more therapy with ZL-1310 plus a checkpoint inhibitor, with the kinds of responses that we see in second line, which should be better than first line, we think we stand a good chance of actually having a positive trial. That's for first line, expect that we will launch a study by the end of the year.

如果能以 ZL-1310 加上免疫檢查點抑制劑提供更多治療，並且呈現出我們在第二線所看到的那種反應（我們認為在第一線應該會更好），我們認為實際上有很大機會得到一個正向的試驗結果。這就是第一線的部分；預期我們會在今年年底前啟動一項研究。

With regards to your question about tarlatamab, I mean, the patients will be post tarlatamab in both arms, but they can only come in if they have progressed on tarlatamab. Some may have responded and progressed, some may have been the novel resistant patients, but they will be equally in each arm and the study is stratified for post tarlatamab versus no tarlatamab.

關於你對 tarlatamab 的問題，我的意思是，兩個組別的患者都會是 tarlatamab 治療後（post tarlatamab），但他們只有在 tarlatamab 治療後出現疾病進展時才能入組。有些人可能曾經有反應後又進展，有些人可能是新發耐藥的患者，但在每個組別中都會同樣分布，而且研究會按「tarlatamab 治療後」與「未使用 tarlatamab」進行分層。

In that regard, I think each arm will perform equally. With regards to post-progression therapies, the same things apply. We obviously cannot control post-progression therapy. Some patients may get tarlatamab, some may get lerwi, some may get something else. But they should, because it's a sufficiently large study, get those therapies equally in each arm. Whatever advantage tarlatamab may afford, in terms of survival, it should be the same in each one of the arms. We're not really concerned about bias here, and particularly in the post tarlatamab patients that enter the study because they're stratified, and again, they can only come in if they have progressed. I hope this answers your question.

在這方面，我認為每個組別的表現會相當。至於進展後治療（post-progression therapies），同樣的原則也適用。我們顯然無法控制進展後治療。有些患者可能會用 tarlatamab，有些可能會用 lerwi，有些可能會用其他療法。但由於這是一項樣本量足夠大的研究，這些治療在兩個組別中應該會以相近的比例使用。無論 tarlatamab 在生存方面可能帶來什麼優勢，在兩個組別中都應該是一樣的。我們並不太擔心這裡的偏倚，特別是對於進入研究的 post tarlatamab 患者，因為已經做了分層，而且再次強調，他們只有在出現進展後才能入組。希望這回答了你的問題。

Thank you. Just to quickly clarify that you're saying that you're not really concerned about bias between the two arm, can you share a bit more? I would say if the patients use zoci in the second line, would the physician still wish to use tarlatamab after zoci?

謝謝。我想快速釐清一下：你說你們不太擔心兩個組別之間的偏倚，能否再多分享一點？我想問的是，如果患者在第二線使用 zoci，醫師是否仍會希望在 zoci 之後使用 tarlatamab？

The physician may use tarlatamab after zoci, but so could they after topotecan, for instance, or lurbinectedin. I guess what I was saying is that tarlatamab is a post-progression therapy, which again, in survival studies, in any study, we cannot control. They should be used equally frequently in both arms, because once they progress, it's up to the investigator to decide what therapy to use.

醫師可能會在 zoci 之後使用 tarlatamab，但例如在使用 topotecan 或 lurbinectedin 之後也同樣可能使用。我想我剛才的意思是，tarlatamab 屬於進展後治療；而在生存研究中、在任何研究中，我們都無法控制進展後治療。它們在兩個組別中應該會以相同的頻率被使用，因為一旦患者進展，使用何種治療將由研究者決定。

Got it. Thank you so much.

了解。非常感謝。

Thank you for the question. We have come to the end of the question and answer session. With that, I would like to hand the call back to Samantha Tu for closing remarks.

謝謝你的提問。問答環節到此結束。接下來我想把電話交回給 Samantha Tu 作結語。

Thank you, operator. Thanks, everyone, for taking the time to join us on the call. We appreciate all your support and look forward to updating you again after the first quarter of 2026. Operator, you may now disconnect this call.

謝謝，接線員。也謝謝各位撥冗參加本次電話會議。我們感謝各位的支持，並期待在 2026 年第一季之後再次向各位更新。接線員，您現在可以斷線。

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

謝謝。今天的電話會議到此結束。感謝各位參與。您現在可以掛斷您的線路。