Zai Lab Ltd (ZLAB) 2026 Q1 法說會逐字稿

Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab First Quarter 2026 Financial Results Conference Call (Operator Instructions)

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 2026 年第一季度財務業績電話會議。(接線員指示)

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, madam.

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者關係高級副總裁 Christine Chiou。女士，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 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.

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、執行長兼董事長杜莹博士（Dr. Samantha Du）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；以及財務長陳雅靜博士（Dr. Yajing Chen）。

Dr. Shan He, our Chief Business Officer, will also be available to answer questions during the Q&A portion of the call.

我們的首席商務官何珊博士（Dr. Shan He）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.

提醒各位，在今天的電話會議中，我們將基於目前的預期發表若干前瞻性陳述。這些陳述受到多項風險與不確定性影響，可能因各種因素導致實際結果與我們的預期存在重大差異，包括我們向美國證券交易委員會（SEC）提交文件中所討論的因素。

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 May 7, 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.

我們也將提及經調整的營運虧損（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 5 月 7 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莹博士。

Thank you, Christine. Good morning and good evening, everyone. Thank you for joining us today.

謝謝你，Christine。各位早安、晚安。感謝大家今天加入我們。

Zai Lab is at a pivotal moment. Since our funding, we have built a fully integrated R&D engine. Capable of taking assets from discovery through global registrational studies, with the ability to design and execute multiple central trials globally.

再鼎醫藥正處於關鍵時刻。自我們獲得資金以來，我們已建立起一個完整整合的研發引擎。具備將資產從早期發現推進至全球註冊性研究的能力，並能在全球範圍內設計與執行多項關鍵性試驗。

The impact of these investments is beginning to emerge. Our pipeline is expanding, our global assets are generating meaningful data, and our lead asset is in global pivotal stage.

這些投入的成效正開始顯現。我們的產品管線正在擴展，我們的全球資產正在產出具意義的數據，而我們的核心資產已進入全球關鍵性階段。

We're also leveraging AI and data-driven approaches across the organization to enhance speed, precision, and efficiency, strengthening overall execution and corporate productivity, which we expect will drive further results.

我們也在全公司範圍內運用 AI 與數據驅動的方法，以提升速度、精準度與效率，強化整體執行力與企業生產力，我們預期這將帶來進一步成果。

Last month at AACR, we presented new data for Josie that reinforced our conviction. Including strong efficacy both systemically and in the brain in patients with small cell lung cancer alongside a best-in-class safety profile.

上個月在 AACR 大會上，我們公布了 Josie 的最新數據，進一步強化了我們的信心。在小細胞肺癌患者中，該藥物在全身與腦部均展現強勁療效，同時具備同類最佳的安全性特徵。

We also announced global collaborations with Amgen and Boehringer Ingelheim to explore ASOSI as a potential backbone therapy in small cell lung cancer and neuroendocrine carcinomas. Two cancer types with significant medical need.

我們也宣布與安進（Amgen）及勃林格殷格翰（Boehringer Ingelheim）展開全球合作，探索 ASOSI 作為小細胞肺癌與神經內分泌癌潛在基石療法的可能性。這兩種癌症類型均存在顯著未被滿足的醫療需求。

In late 2027, we expect to submit our first global BLA to the FDA, a defining milestone that marks our successful transformation to a global biotech company.

我們預期在 2027 年底前向 FDA 提交我們第一份全球 BLA，這將是一個里程碑式的關鍵節點，標誌著我們成功轉型為全球生物科技公司。

Beyond DOSI, we're building a growing portfolio of global clinical programs. Including ZL-1503 for atopic dermatitis, now in a Phase 1/1b study. This reflects the strength of our R&D engine, which combines rigorous science with operational speed and efficiency to advance differentiated assets into global development.

除 DOSI 之外，我們也正在建立日益壯大的全球臨床項目組合。其中包括用於異位性皮膚炎的 ZL-1503，目前已進入 1/1b 期研究。這反映了我們研發引擎的實力：以嚴謹科學為基礎，結合營運速度與效率，推動具差異化的資產進入全球開發。

Our visible business remains commercially profitable with a strong balance sheet. We are focused on strengthening our commercial capabilities and execution. And I'm pleased to welcome Dr. Isa Wang as an operating partner to work with me to drive commercial performance and readiness ahead of upcoming launches.

我們現有業務仍維持商業獲利，且資產負債表穩健。我們專注於強化商業化能力與執行。我也很高興歡迎王怡莎博士（Dr. Isa Wang）以營運合夥人身分與我合作，推動商業表現，並為即將到來的新產品上市做好準備。

The recent policy developments in the region, including the State Council Derivative, signal meaningful government support. For innovative medicines, and we believe Zai Lab is well-positioned to benefit over the medium to long-term, given our first and best-in-class portfolio.

近期區域內的政策發展，包括國務院相關衍生政策，顯示政府對創新藥物提供實質支持。我們相信，憑藉我們同類首創與同類最佳的產品組合，再鼎醫藥在中長期具備良好受益條件。

We're confident in Zai's future, which will be defined by our growing global and regional pipeline of differentiated assets.

我們對再鼎的未來充滿信心；未來將由我們不斷成長的全球與區域差異化資產管線所定義。

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

接下來，我把電話會議交給 Rafael。

Thank you, Samantha. Over the past years, we have built a globally integrated R&D engine that spans from discovery through global registrational development, while also delivering on regional development across therapy areas. Our ability to design and execute high-quality global studies with speed and discipline is a core strength that positions us well for development across regulatory geographies.

謝謝你，Samantha。過去幾年，我們建立了一個全球整合的研發引擎，涵蓋從早期發現到全球註冊性開發，同時也在多個治療領域推進區域性開發。我們能以速度與紀律設計並執行高品質的全球研究，這是我們的核心優勢，使我們能在不同監管地區順利推進開發。

We are embedding AI in R&D, including drug discovery and clinical trial design, to enhance the quality of our decisions and to more efficiently advance our pipeline.

我們正將 AI 深度嵌入研發流程，包括藥物發現與臨床試驗設計，以提升決策品質，並更有效率地推進我們的產品管線。

The data we presented at ASCR last month highlights the output of this engine across our global pipeline that included both externally sourced and internally discovered products. Let me start with Zozi. In extensive-stage small-cell lung cancer, at the go-forward dose of 1.6 milligrams per kilogram, DOSI demonstrated a confirmed intracranial overall response rate of 62.5% and a best overall intracranial response rate approaching 69%, including four complete responses. Grade 3 or higher treatment-related adverse events were approximately 16%.

我們上個月在 ASCR 會議上公布的數據，凸顯了這一研發引擎在全球管線上的產出，其中既包括外部引進的產品，也包括內部自主發現的產品。我先從 Zozi 談起。在廣泛期小細胞肺癌中，以後續推進劑量 1.6 毫克/公斤計，DOSI 顯示經確認的顱內總體客觀緩解率為 62.5%，最佳顱內總體緩解率接近 69%，其中包括 4 例完全緩解。3 級或以上治療相關不良事件約為 16%。

Responses of this magnitude inside the brain in one of the most treatment-resistant tumor types in oncology are meaningful signals of differentiation.

在腫瘤學中最具治療抗性的腫瘤類型之一，於腦內觀察到如此幅度的反應，是具有意義的差異化訊號。

The safety data reinforced what we have consistently observed. This is a best-in-class profile.

安全性數據也強化了我們一貫的觀察結果。這是一個同類最佳的特徵。

A registrational Phase III DELEVATE study is enrolling well and is on track to complete enrollment in the first half of 2027, positioning us for an interim analysis and potential accelerated approval submission next year.

註冊性 3 期 DELEVATE 研究入組進展良好，並按計畫將於 2027 年上半年完成入組，這將使我們能在明年進行期中分析，並有望提交加速核准申請。

In extrapulmonary neuroendocrine carcinoma, a setting where there is no established standard of care in the second line and beyond, SOSI demonstrated a confirmed ORR of 38.2%.

在肺外神經內分泌癌中，該領域在二線及後線治療尚無既定標準療法，SOSI 顯示經確認的 ORR 為 38.2%。

This compares favorably to currently used regimens, which typically show response rates of approximately 18% with limited durability. We're actively engaging with regulators on a potential registrational path and are well on our way recruiting into an extension single-arm study.

相較之下，目前常用方案的反應率通常約為 18%，且持久性有限。我們正積極與監管機構就潛在註冊路徑進行溝通，同時也正順利推進延伸單臂研究的受試者招募。

Depending on the outcomes of regulatory discussions, we could initiate a registrational or confirmatory study by year end.

視監管討論結果而定，我們可能在年底前啟動一項註冊性或確認性研究。

Now, on the collaborations with Amgen and Boehringer and Ingelheim, exploring ZOCI in combination with T-cell engagers. The scientific rationale is straightforward ZOCI delivers rapid tumor debulking through targeted cytotoxicity, while T-cell engagers drive antigen-dependent immune-mediated killing.

接著談與安進及勃林格殷格翰的合作：我們正在探索 ZOCI 與 T 細胞接合劑（T-cell engagers）的聯合治療。其科學依據很直接：ZOCI 透過標靶細胞毒性快速減少腫瘤負荷，而 T 細胞接合劑則驅動抗原依賴的免疫介導殺傷。

The mechanisms are complementary. The toxicity profiles are expected to have limited overlap, and together, they have the potential to deepen and extend responses in ways neither mechanistic approach achieves alone.

兩者機制互補。預期毒性特徵的重疊有限；合併使用有潛力以單一機制無法達成的方式，加深並延長治療反應。

A phase one with Amgen, which includes a cohort of untreated patients with triple combination of [Zozi in Delta and Infinzi], is already enrolling, and the BI study is expected to follow in the coming months.

與安進合作的 1 期研究已開始入組，其中包括一個未治療患者隊列，採用 [Zozi 與 Delta 及 Infinzi 的三聯合療法]；而 BI 的研究預期將在未來數月內跟進啟動。

We're also evaluating [Zozi] in combination with [PD-L1] with or without chemotherapy in a phase one study in first-line small cell lung cancer, with data expected later this year.

我們也正在第一線小細胞肺癌的一項第一期研究中，評估[Zozi]與[PD-L1]合併使用（可合併或不合併化療），預計今年稍晚將有數據出爐。

A chemosparing approach may allow for extended treatment duration compared to chemotherapy alone, where patients typically discontinue after four cycles. This is the basis of our phase three strategy with IO, which we are actively discussing with regulators.

相較於單用化療（患者通常在四個療程後停用），採取減少化療（chemosparing）的策略可能可延長治療期間。這也是我們以IO為核心的第三期策略基礎，我們正積極與監管機關討論。

Beyond SOSI, our global oncology pipeline continues to advance. ZL6201, our LRRC15ADC, is already in the clinic. ZL1311, our wholly owned MUC17 targeting T-cell engager, is expected to enter the clinic by year end.

除SOSI之外，我們的全球腫瘤產品線也持續推進。我們的LRRC15 ADC——ZL6201——已進入臨床。我們全資擁有、以MUC17為標的的T細胞銜接器（T-cell engager）ZL1311，預計將於年底前進入臨床。

We will provide updates as later matures.

我們將在後續數據更成熟時提供更新。

On the regional oncology side, we submitted a marketing authorization application for tumor treating fields in locally advanced pancreatic cancer and expect an approval for this medication by year end and for TPAC for cervical cancer in the coming months.

在區域腫瘤方面，我們已就局部晚期胰臟癌的腫瘤電場治療（tumor treating fields）提交上市許可申請，並預期該療法可於年底前獲批；另TPAC用於子宮頸癌則預計在未來數月內獲批。

Turning to immunology, we recently presented preclinical data for ZL-1503, our IL-13/IL-31 receptor alpha bispecific at Immunology 2026. The data show rapid and durable inhibition of both IL-13-driven inflammation and IL-31-mediated pruritus across disease models in non-human primates with sustained effects following single dose.

轉向免疫學方面，我們近期在Immunology 2026發表了ZL-1503（我們的IL-13/IL-31受體α雙特異性抗體）的臨床前數據。數據顯示，在非人靈長類的多種疾病模型中，ZL-1503可快速且持久地抑制由IL-13驅動的發炎與由IL-31介導的搔癢，且單次給藥後仍可維持效果。

We believe this data supports the potential for differentiated efficacy, less frequent dosing, and broad application across multiple atopic diseases, including asthma, rhinitis, and conjunctivitis.

我們認為這些數據支持其具備差異化療效、更低給藥頻率，以及在多種異位性疾病（包括氣喘、鼻炎與結膜炎）中的廣泛應用潛力。

Initial Phase 1 data in healthy volunteers and atopic dermatitis patients are expected in the second-half of this year.

預計今年下半年將取得健康受試者與異位性皮膚炎患者的第一期初步數據。

Finally, in our regional immunology portfolio, our partner Vertex reported positive Phase III interim results from the RAINIER study of povetacicept in IgA nephropathy, achieving approximately a 50% reduction in proteinuria versus placebo and meeting both the primary and all secondary endpoints.

最後，在我們的區域免疫學產品組合中，合作夥伴Vertex公布了povetacicept用於IgA腎病（IgA nephropathy）的RAINIER研究第三期期中結果為正向：相較安慰劑，蛋白尿約降低50%，並達成主要與所有次要終點。

I want to close with a broader point. The progress I've described today reflects a pipeline strategy built on biological rationale, clinical differentiation, and execution, and an organization that now has the infrastructure to advance multiple programs simultaneously at speed and across geographies.

我想以一個更宏觀的觀點作結。我今天所描述的進展，反映了我們以生物學理據、臨床差異化與執行力為基礎所建立的產品線策略；同時，我們的組織如今也具備基礎設施，能在不同地理區域以速度並行推進多個專案。

We have significant data emerging throughout the year, and I look forward to providing those updates.

今年將有大量數據陸續釋出，我期待向各位提供這些更新。

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

接下來，我把時間交給Josh。

Thank you, Raphael, and hello, everyone.

謝謝你，Raphael，各位大家好。

Let me start with our first quarter performance, which reflected Chinese New Year seasonality as well as near-term product-specific dynamics. Starting with ZEJULA, performance in the quarter was impacted by a shift in hospital utilization patterns following volume-based procurement for generic olaparib and some incremental competitive pressure in the PARP inhibitor class.

我先從第一季表現談起，該表現反映了農曆新年季節性因素，以及短期的產品特定動態。先看ZEJULA，本季表現受到在學名藥olaparib採行帶量採購後，醫院使用型態轉變的影響，並且PARP抑制劑類別也出現一些額外的競爭壓力。

Our first-line positioning remains intact, supported by our label advantage, and we are working hard on stabilizing and driving demand.

我們在第一線的定位仍然穩固，並受惠於標籤（適應症/仿單）優勢的支持；我們也正全力以赴穩定並帶動需求。

On VYVGART, physician confidence remains strong, and our share within Biologics is stable. We delivered double-digit volume growth year-on-year in the quarter, offset by a 12% price discount related to NRDL renewal.

在VYVGART方面，醫師信心依然強勁，我們在生物製劑中的市占維持穩定。本季我們的銷量年增達雙位數，但被與NRDL續約相關的12%價格折讓所抵銷。

On a full-year basis, we expect a similar level of volume growth as we continue to shape GMG treatment dynamics.

以全年來看，隨著我們持續塑造GMG治療動態，我們預期將維持類似水準的銷量成長。

The long-term opportunity stays significant. Biologic penetration in the GMG maintenance setting remains around 15%, suggesting a runway for growth. Plus, upcoming Phase III readouts in new indications such as IIM and Sorgren's add potential upside.

長期機會仍然可觀。在GMG維持治療情境中，生物製劑滲透率仍約為15%，顯示仍有成長跑道。此外，IIM與Sorgren's等新適應症即將公布的第三期讀出，也帶來潛在上行空間。

For XACDURO, patient demand was strong, and hospital adoption continued to expand. Performance was constrained by supply, and we expect those constraints may persist through the remainder of the year. That said, the underlying demand is encouraging. And local manufacturing expected in 2027 should alleviate supply pressure and support meaningful growth and margin expansion over time.

就XACDURO而言，患者需求強勁，醫院採用也持續擴大。表現受到供應限制，我們預期這些限制可能會持續到今年剩餘期間。不過，基本需求面令人鼓舞。而預計於2027年啟動的在地製造，應可緩解供應壓力，並隨時間推進支持顯著成長與毛利率擴張。

Looking ahead, we see a strong set of commercial catalysts.

展望未來，我們看到一系列強勁的商業催化劑。

KarXT launches in the second quarter and represents the first novel mechanism for schizophrenia in decades, a significant moment for the approximately 8 million patients living with this disease in China.

KarXT將於第二季上市，這是數十年來治療思覺失調症的首個新作用機轉，對中國約800萬名罹患此疾病的患者而言，是一個重要時刻。

KarXT's inclusion in national treatment guidelines ahead of launch reflect strong clinical confidence in this therapy.

KarXT在上市前即被納入國家治療指引，反映臨床端對此療法的高度信心。

Our focus this year is on physician education and market development, building a strong foundation for the brand.

我們今年的重點在於醫師教育與市場開發，為品牌建立堅實基礎。

We also anticipate potential regulatory approval for TIVDAC this year and intend to leverage our existing Zejula infrastructure to drive commercial synergies and accelerate uptake.

我們也預期TIVDAC今年可能獲得監管核准，並計畫運用既有Zejula的基礎設施來推動商業協同效應、加速滲透。

More broadly, our late-stage pipeline provides multiple additional growth opportunities in the region.

更廣泛而言，我們的後期產品線在區域內提供多項額外的成長機會。

Recent positive Phase III readouts for COVID testiscept in IGAN and olegrobart in thyroid eye disease add further depth to our long-term growth profile, and we see both as meaningful future contributors.

近期在IGAN中COVID testiscept以及在甲狀腺眼病（thyroid eye disease）中olegrobart的第三期正向讀出，進一步增厚我們的長期成長輪廓，我們認為兩者都將成為未來重要的貢獻來源。

Lastly, we are applying AI to sharpen commercial execution, from position targeting and field force optimization to real-time competitive insights, enabling more agile and informed go-to-market decisions.

最後，我們正運用AI來提升商業執行力，從目標客群定位與業務團隊最佳化，到即時競品洞察，讓上市策略決策更敏捷且更有依據。

2026 is about execution, delivering on key launches, stabilizing the portfolio, and building momentum.

2026年的重點在於執行：落實關鍵上市、穩定產品組合並建立動能。

And with that, I will now pass the call over to Yaojing to take us through our financial results. Yaojing.

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

Thank you, Josh. Our quarter one results reflect the near-term dynamics Josh described. First quarter total product revenue declined 6% year-over-year to $99.6 million, driven by lower Vajira sales, partially offset by continued growth from Zacdura and Newzira.

謝謝你，Josh。我們第一季的結果反映了Josh所描述的短期動態。第一季產品總營收年減6%至9,960萬美元，主要由Vajira銷售下滑所致，部分被Zacdura與Newzira持續成長所抵銷。

While we expect total product revenue to improve sequentially over the next nine months as underlying demand continues to build.

我們預期在未來九個月，隨著基本需求持續累積，產品總營收將逐季改善。

We anticipate near-term pressure for 2026 four-year total product revenues with a return to growth in 2027.

我們預期2026年短期內四年期產品總營收將承受壓力，並在2027年恢復成長。

Turning now to our expenses, our commitment to financial discipline is reflected in continued execution against our R&D and commercial priorities.

接著談費用面，我們對財務紀律的承諾，體現在持續落實我們的研發與商業優先事項。

And we will expand AI utilization from process automation to agentic execution to further improve cost efficiencies.

我們也將擴大AI的使用範圍，從流程自動化延伸至代理式（agentic）執行，以進一步提升成本效率。

R&D expenses for the first quarter increased 8% year-over-year, driven by increased license fees and the clinical trial-related expenses, partially offset by lower personnel compensation expenses due to resource prioritization and efficiency efforts.

第一季研發費用年增8%，主要由授權費增加與臨床試驗相關費用增加所帶動；部分被因資源優先排序與效率提升而降低的人員薪酬費用所抵銷。

HGMA expenses increased slightly year-over-year, mainly due to higher general selling expenses.

HGMA費用年增幅度不大，主要因一般銷售費用較高。

As a result. Loss from operations increased by 23% for the quarter to $69.4 million.

因此。本季營業虧損增加23%至6,940萬美元。

We ended this quarter with a cash position of $761.3 million. Our regional business is commercially profitable.

本季末我們的現金部位為7.613億美元。我們的區域業務在商業上已實現獲利。

Our global pipeline continues to progress steadily.

我們的全球產品線持續穩步推進。

Our focus this year remains on the strengthening the regional business, executing cross-global pipeline, and deploying capital softly to support both near-term launches and long-term growth plans.

我們今年的重點仍是強化區域業務、推進跨全球產品線執行，並以審慎方式部署資本，以同時支持短期上市與長期成長規劃。

With a strong balance sheet, we are well positioned to execute against these priorities.

憑藉強勁的資產負債表，我們已做好充分準備來落實這些優先事項。

Operator, please open up the line for questions.

接線員，請開放提問線路。

Thank you, dear participants. (Operator Instructions) Jonathan Chang, Leerink Partners. Your line is open. Please ask your question.

謝謝各位與會者。(接線員指示) Jonathan Chang，Leerink Partners。您的線路已開通。請提出您的問題。

Hey, guys. Thanks for taking my questions.

嗨，各位。謝謝讓我提問。

First question, on the ZOSI collaborations, evaluating the combinations with DLL3T cell engagers, how do these facilitate your longer-term strategy? And are there other combinations and collaborations that make sense to explore?

第一個問題，關於 ZOSI 的合作，在評估與 DLL3 T 細胞接合器的聯合方案時，這些如何促進你們的長期策略？另外，是否還有其他值得探索的聯合方案與合作？

And then second question, on the commercial business in China, can you give us a sense for how to think about revenues over the course of the year?

第二個問題，關於中國的商業化業務，能否請你們談談如何看待全年收入的走勢？

Hey, good morning, Jonathan. It's Josh.

嗨，早安，Jonathan。我是 Josh。

Thank you. I'll ask Rafael to take the first one and then Ya Jing can take the second.

謝謝。我先請 Rafael 回答第一題，然後 Ya Jing 回答第二題。

Yes.

好的。

Thanks for the question. This combination, I spoke about the rationale of it during the prepared remarks.

謝謝你的提問。我在事先準備的發言中已談到這項組合的科學理據。

And the expectation is that we would get better efficacy in terms of responses, durability, and eventually, better survival than with each agent alone.

我們的預期是，相較於單一藥物，該組合在反應率、持久性，並最終在存活方面都能帶來更佳療效。

We're testing it in second line in talatomab-naive patients, talatomab-experienced patients, but importantly, also in first line.

我們正在二線治療中測試：包含未使用過 talatomab 的患者、使用過 talatomab 的患者，但更重要的是，也在一線治療中測試。

Our first-line study will not include tarlatamab, the pivotal trial to begin with until we get more data. But if the data are positive, we may consider progressing this and developing it as a best-in-class regimen. So it's really improving the baseline treatment of this disease with two really very active mechanisms.

我們的一線研究一開始不會納入 tarlatamab 作為關鍵性試驗的一部分，直到我們取得更多數據。但如果數據呈現正面，我們可能會考慮推進並將其開發為同類最佳（best-in-class）的治療方案。因此，這實際上是透過兩種非常活躍的作用機制，來提升此疾病的基礎治療。

Thanks, Raphael. Yajing.

謝謝，Raphael。Yajing。

Yes. Hi, Jonathan. Thanks for the question. As I mentioned before, our revenue in the next nine months, you're going to expect to see some sequential growth. But for the four-year revenue, we are going to continue to experience some short-term pressure. So we are seeing the return to growth in 2027.

好的。嗨，Jonathan。謝謝你的提問。如我先前提到的，接下來九個月的收入，你們會看到一些逐季成長。但就全年收入而言，我們仍將面臨一些短期壓力。因此，我們看到在 2027 年恢復成長。

Thanks, Yajing.

謝謝，Yajing。

Next question.

下一個問題。

Yes, of course.

好的，當然。

Now we're going to take our next question.

現在我們來接下一個問題。

Michael Yee, UBS

Michael Yee，瑞銀（UBS）

Hey, guys. Thanks for taking our questions. This is Kyle Yang for Michael Yee from UBS. Two for us. So the first question is.

嗨，各位。謝謝讓我們提問。我是瑞銀（UBS）的 Kyle Yang，代 Michael Yee 提問。我們有兩個問題。第一個問題是。

For your upcoming data readout for IL-13 and 31, what is the expectation for data?

關於你們即將公布的 IL-13 與 31 的數據讀出，對數據有何預期？

And how do you expect the data set in healthy volunteers to de-risk the asset?

以及你們預期健康受試者的數據集將如何降低該資產的風險？

And when do we expect data from moderate to severe atopic dermatitis patients?

另外，我們何時能看到中度至重度異位性皮膚炎患者的數據？

The second question is that for your data set in frontline small cell lung cancer in the second-half.

第二個問題是，關於你們在下半年將公布的一線小細胞肺癌數據集。

What is the expectation for that? And also, what's good data?

對此有何預期？另外，什麼樣的數據才算好？

How do you pick the go-forward regimen in terms of a double it versus triple it?

在選擇後續推進的治療方案時，你們如何在雙聯與三聯之間做取捨？

Thank you.

謝謝。

Thanks, Kyle. Go ahead, Rafael.

謝謝，Kyle。Rafael，請。

Yeah. So with the first question in terms of expectations for 1,603.

好的。先回答第一個問題，關於 1,603 的預期。

The healthy volunteers data, I think, is going to be very useful. We actually have progressed the study quickly with those cohorts. And we would be looking at safety, obviously, pharmacokinetics to evaluate dosing interval, which we expect to be prolonged dosing, pharmacodynamics such as phosphostat and others.

我認為健康受試者的數據會非常有用。我們其實已快速推進該研究並完成這些隊列。我們將觀察安全性，當然也會看藥物動力學以評估給藥間隔，我們預期會是較長的給藥間隔；以及藥效學指標，例如 phosphostat 等。

An anti-drug antibody. So all of these, I think, will inform the basic parameters that will allow us to continue the development of the product.

以及抗藥物抗體。我認為這些都將有助於確立基本參數，使我們能持續推進該產品的開發。

And with regards to what to expect, obviously, it depends on how much data we have on atopic dermatitis, but we should have data on healthy volunteers by the end of the year and at least some of the cohorts with atopic dermatitis. So our expectation is that we may publish this data before the end of the year.

至於可預期的內容，當然取決於我們在異位性皮膚炎上累積了多少數據；但我們應可在年底前取得健康受試者數據，以及至少部分異位性皮膚炎隊列的數據。因此，我們預期可能在年底前發表這些數據。

And then with regards to first line, the question was what do we consider as go forward.

接著關於一線治療，你的問題是我們會考量什麼作為後續推進。

Well that the chemotherapy plus checkpoint inhibitor, which would be the control of our study, has a PFS of about five months or so.

化療加上免疫檢查點抑制劑（也就是我們研究的對照組）其無惡化存活期（PFS）大約是五個月左右。

Our response rate in second line with 1.6 milligrams per kilogram is in the order of 68%. So obviously, there's still room for improvement there. So we will be looking for higher response rates and also longer PFS than that we believe is clinically significant.

我們在二線治療中以每公斤 1.6 毫克的反應率約為 68%。因此，顯然仍有進一步改善的空間。所以我們會尋求更高的反應率，以及更長、且我們認為具有臨床意義的 PFS。

And we plan to present this data towards the fall or so.

我們計畫在秋季左右發表這些數據。

And by then, we should have sufficient follow-up to really be able to evaluate that. But we're currently planning to proceed with this study before the end of the year and in discussions with regulators.

到那時，我們應該會有足夠的追蹤期，能夠真正加以評估。但我們目前規劃在年底前推進這項研究，並正與監管機構討論中。

Thank you.

謝謝。

Thank you.

謝謝。

Anupam Rama, JP Morgan.

Anupam Rama，摩根大通（JP Morgan）。

Hey, guys. Thanks so much for taking the question.

嗨，各位。非常感謝讓我提問。

Just with the recent positive data for povitagisept and IGAN, what are the plans to submit in regional China? And just remind us, is there going to be any bridging work required? Thanks so much.

關於近期 povitagisept 在 IGAN 的正面數據，接下來在中國區域的申報計畫是什麼？另外請提醒我們，是否需要做任何橋接研究？非常感謝。

Thanks, Anupam. Okay, Rafael.

謝謝，Anupam。好的，Rafael。

Yes, we were very pleased to see the results of the RINIER study, really a good advance for Eigen, the filing of our partner has taken place and we will discuss with CDE what.

是的，我們很高興看到 RINIER 研究的結果，這確實是對 Eigen 的一項重大進展；我們合作夥伴已完成申報，我們將與 CDE 討論

The regulatory requirements for filing, but we expect that we would be able to proceed because we did include patients from China in the study, and that Bridgen study is not expected to be required. So as our partner, we would discuss with CDE our approach to an accelerated approval with this product.

申報的監管要求，但我們預期可以推進，因為研究中納入了來自中國的患者，且預期不需要橋接研究。因此，作為合作夥伴，我們將與 CDE 討論以該產品申請加速核准的策略。

Great. Thanks so much for taking our question.

很好。非常感謝回答我們的問題。

Thank you. Now, we're going to take our next question.

謝謝。現在我們來接下一個問題。

Li Watsek, Cantor

Li Watsek，Cantor

Good morning. This is Vinh on for Li So, question about ZL-1503, the bispecific antibody. So, it seems like data is going to come in the second-half of this year.

早安。我是 Vinh，代 Li 提問，問題關於雙特異性抗體 ZL-1503。看起來數據會在今年下半年出爐。

But so there's a lot of bispecific antibody out there in AD. So we'd like to know what's your base assumption on the market differentiation for this drug and the and also your strategy there?

不過在 AD 領域已經有很多雙特異性抗體在開發中。所以我們想了解，您對這款藥物在市場差異化方面的基本假設是什麼？以及您在這方面的策略是什麼？

Are you planning to run a Phase 2 Trial or are you potentially going to put new cells?

您是打算進行一項第二期試驗，還是可能會導入新的細胞？

Rafael, why don't you address that and I can make a couple of commercial comments.

Rafael，你要不要先回答這個問題，我也可以補充幾點商業面的看法。

Sure. Yes, in terms of differentiation, as I mentioned, I think long-term dosing is important and. We still have to evaluate how often that would be, but we expect that that would be the case for 1,503.

當然。是的，就差異化而言，如我提到的，我認為長期給藥很重要，而且。我們仍需評估給藥頻率會是多久，但我們預期 1,503 會是這樣的情況。

And in terms of activity.

至於療效方面。

The key activity is obviously a decrease in pruritus because our product inhibits the IL-31 receptor.

關鍵療效顯然是搔癢的降低，因為我們的產品抑制 IL-31 受體。

And so we expect using the numeric rating scale that we would have a meaningful decrease in pruritus that's also occurring early on in the treatment, because I think that's really important and differentiating from other products.

因此我們預期使用數字評分量表（NRS）時，搔癢會有具臨床意義的下降，而且會在治療早期就出現，因為我認為這點非常重要，也能與其他產品形成差異。

The same for skin pain, which is something that affects the quality of life of patients. And of course, the main endpoint, which tends to be EC75, which you know what the benchmark out there is in the 40% range. So surpassing these numbers would be, together with the extended dosing, something that we would consider.

皮膚疼痛也是一樣，這會影響病人的生活品質。當然還有主要終點，通常是 EC75；你也知道目前外部的基準大約在 40% 左右。因此，若能超越這些數字，再加上延長給藥間隔，將是我們會考量的方向。

Very positive for us to move forward with Phase II. And as of the question of whether or not we plan to do that, the answer is yes, we plan to do our Phase II study and evaluate these parameters, as I mentioned before.

這對我們推進到第二期會是非常正面的訊號。至於你問我們是否計畫這麼做，答案是肯定的：我們計畫進行第二期研究，並如我先前提到的評估這些參數。

Yeah, and I think just a comment, it's Josh.

是的，我想補充一下，我是 Josh。

Obviously, it's a competitive class, but there's lots of room for differentiation, still very undertreated. So I think as Raphael said, what we know about patients is dose and convenience makes a difference, relief on itch and speed of onset are all important things that will elucidate over the course of the clinical development program. So we're quite excited about the opportunity here.

顯然這是一個競爭激烈的類別，但仍有很大的差異化空間，而且目前仍有大量未被充分治療的需求。所以我認為如 Raphael 所說，我們對病人的了解是：劑量與便利性會帶來差異，止癢效果與起效速度也都很重要；這些都會在整個臨床開發計畫過程中逐步釐清。因此我們對這個機會感到相當興奮。

Thank you. (Operator Instructions)

謝謝。(接線員指示)

Ziyi Chen, Goldman Sachs.

高盛，Ziyi Chen。

Great. Thank you for taking my questions. I got two questions. The first one is on ZOC. We noticed that Amgen has an initiative phase one study. For telanumab plus ZOC with and without PD-L1 in small cell lung cancer. So could you share a bit more about your thoughts on potential dose levels you're going to explore, particularly considering for telanumab, FDA actually has a black box in their label, and what are the potential dose levels you're going to be exploring for ZOC and also for telanumab?

很好，謝謝讓我提問。我有兩個問題。第一個是關於 ZOC。我們注意到安進正在進行一項第一期研究。在小細胞肺癌中評估 tarlatamab 加上 ZOC，並包含有或沒有 PD-L1 的組合。所以您能否多分享一些您對將要探索的潛在劑量水準的想法？特別是考量到 tarlatamab 的標籤上 FDA 其實有黑框警語；那麼您將探索的 ZOC 以及 tarlatamab 的潛在劑量水準會是哪些？

And also, have you. Consider to test a sequential use of those two drugs or instead you are going to be more focusing on administrate those two drugs together to patients? And my second question is regarding the afratizmod in China.

另外，您是否。考慮測試這兩個藥物的序貫使用？還是您會更專注於將這兩個藥物同時給藥給病人？我的第二個問題是關於 afratizmod 在中國。

Could you please comment on the evolving landscape given that now Ramagen's telitasumcept has been also enrolled into NRDL? Particularly in the first quarter, have you seen any of the change to the market dynamics?

鑑於目前 Ramagen 的 telitasumcept 也已被納入國家醫保藥品目錄（NRDL），您能否評論一下競爭格局的演變？特別是在第一季，您是否看到市場動態有任何變化？

Thank you.

謝謝。

Thanks. Rafael, do you want to start on Zosi and then I'll comment on VYVGART?

謝謝。Rafael，你要不要先談 Zosi，然後我再評論 VYVGART？

Sure. Thanks for the question.

好的。謝謝你的問題。

Yeah, the study is actually enrolling now.

是的，這項研究目前其實正在收案中。

In terms of the dose levels, we wanted to have a Q3 weekly regimen with both drugs. And the dose of tarlatamab will be fixed.

就劑量水準而言，我們希望兩個藥物都採用每 3 週一次（Q3 weekly）的給藥方案。而 tarlatamab 的劑量將會固定。

And we will do, hopefully, a rapid dose escalation with Zozi up to 1.6 mixture kit, which is the go-to dosing that we have for DELEVATE, our Phase III study in second line.

而我們會希望對 Zozi 進行快速劑量遞增，最高到 1.6 mg/kg；這是我們在 DELEVATE（第二線的第三期研究）中採用的主要劑量。

So, as I mentioned before, this will be in various clinical settings, including the triplet combination with checkpoint inhibitors, as you mentioned, in frontline untreated patients.

因此，如我先前提到的，這將會在不同的臨床情境中進行，包括你提到的在一線未治療病人中，與免疫檢查點抑制劑的三聯合併治療。

So, in terms of whether it's sequential versus together, there's, given the mechanism of action, we want.

至於是序貫還是同時給藥，基於其作用機轉，我們希望。

The rapid debulking to be present when the T-cell engager is given. So they're given in fast sequence. We're not going to test alternating sequences or other schedules. So I hope that helps. Thanks for the question.

在給予 T 細胞接合劑時能夠有快速減瘤效果。因此它們會以快速的序列給予。我們不會測試交替順序或其他給藥時程。希望這能解答你的問題。謝謝你的提問。

Thanks, Rafael. And on Vibcart, first, as we mentioned, we're seeing double-digit volume increases in Q1 as a function both of new patients continuing to come in and get started and extending duration of therapy.

謝謝，Rafael。至於 Vibcart，首先，如我們提到的，我們在第一季看到用量出現雙位數成長，原因同時包括新病人持續進入並開始治療，以及治療持續時間延長。

That being said, there's still only about 15% of patients that would qualify for biologic therapy and GMG are getting it. So I think having additional competition is fine. We don't really see an impact from.

話雖如此，在符合生物製劑治療資格的 GMG 病人中，目前實際接受治療的仍只有約 15%。所以我認為有更多競爭是可以的。我們並沒有看到有任何影響。

To any measurable degree in Q1. And again, we would expect as we get through the year that continuing to emphasize getting patients with GMG on to biologic therapy and getting them the benefits of longer-term maintenance is going to help everybody. So that's what we're focused on. Thanks.

在第一季沒有觀察到任何可衡量程度的影響。同樣地，我們預期隨著今年推進，持續強調讓 GMG 病人接受生物製劑治療，並讓他們獲得較長期維持治療的效益，將會對所有人都有幫助。所以這就是我們的重點。謝謝。

Thank you.

謝謝。

Thank you.

謝謝。

(Operator Instructions)

(接線員指示)

Dear speakers, there are no further questions for today. I would now like to hand the conference over to your speaker, Samantha Du, for any closing remarks.

各位講者，今天沒有進一步的提問。我現在想把會議交回給貴方講者 Samantha Du，請她做結語。

Samantha, please go ahead.

Samantha，請開始。

Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate. My support and look forward to updating you again after the second quarter of 2026.

謝謝，接線員。我要感謝各位今天撥冗參與本次電話會議。我們非常感謝。我的支持，並期待在 2026 年第二季之後再次向各位更新。

Operator, you may now disconnect this call. Thank you.

接線員，您現在可以中斷本次通話。謝謝。

This concludes this conference call.

本次電話會議到此結束。

Thank you for participating. Man I'll all disconnect. Have a nice day.

感謝各位參與。我們將全部中斷連線。祝您有美好的一天。