Zai Lab Ltd (ZLAB) 2026 Q2 法說會逐字稿

Hello, ladies and gentlemen. Thank you for standing by and welcome to Zai Lab's second-quarter 2026 financial results conference call. (Operator Instructions) As a reminder, today's call is being recorded.

各位女士、先生，大家好。感謝各位撥冗等候，歡迎參加再鼎醫藥 2026 年第二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。

It is now my pleasure to turn the floor over to Christine Chiou, Senior Vice President of the Investor Relations. Please go ahead, ma'am.

現在我很榮幸把會議交給投資者關係資深副總裁 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 Dr. Rafael Amado, President and Head of Global Research and Development; and Dr. Yajing Chen, Chief Financial Officer. Dr. Shan Hu, our Chief Business Officer; and Dr. Yu Jo 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、執行長兼董事長杜珊博士（Dr. Samantha Du）主持。她將與全球研發總裁兼負責人 Rafael Amado 博士，以及財務長陳雅靜博士一同出席。我們的首席商務官胡珊博士，以及我們的營運合夥人王宇喬博士，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. Please refer to our earnings release furnished with the SEC on August 6, 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（包括我們在向美國證券交易委員會（SEC）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。有關此非 GAAP 財務衡量指標的更多資訊，請參閱我們於 2026 年 8 月 6 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.

現在我很榮幸把電話會議交給杜珊博士。

Thanks, Christine. Good morning and good evening, everyone. Thank you for joining us today. Zai Lab has reached an important inflection point in its evolution from a original business into a global biopharmaceutical company. We built this company by bringing first or best-in-class medicines to patients in China.

謝謝 Christine。各位早安、晚安。感謝各位今天加入我們。再鼎醫藥已到達一個重要的轉折點，正從原本的業務模式演進為一家全球生物製藥公司。我們透過將首創或同類最佳藥物帶給中國患者而建立了這家公司。

Today, we are developing our own innovative medicines for patients worldwide with our first US regulatory submission expected next year. The transformation reflects the R&D capabilities we have built. We're conducting global multiple center registrational oncology trials, advancing additional clinical programs across oncology and immunology, and advancing our preclinical pipeline into INDs this year.

如今，我們正為全球患者開發自有創新藥物，並預計於明年完成首次美國監管申報。這一轉型反映了我們所建立的研發能力。我們正在進行全球多中心的腫瘤註冊性臨床試驗，推進腫瘤與免疫領域的更多臨床項目，並在今年將我們的臨床前管線推進至 IND 申報。

Zoci, our potential first and best-in-class DLL3 ADC demonstrates what Zai Lab is capable of. We advanced it from IND to global pivotal trials in less than two years, reflecting the speed and efficiency of the integrated development organization we have built.

Zoci——我們潛在的首創且同類最佳 DLL3 ADC——展現了再鼎醫藥的能力。我們在不到兩年的時間內將其從 IND 推進至全球關鍵性試驗，體現了我們所建立的一體化研發組織的速度與效率。

By the end of this year, we expect to have three registrational programs in small cell lung cancer and neuroendocrine carcinoma. We're also evaluating Zoci in combination with T- cell engagers through collaborations with Amgen and Boehringer Ingelheim.

到今年年底，我們預計將在小細胞肺癌與神經內分泌癌領域擁有三個註冊性項目。我們也正透過與安進（Amgen）及勃林格殷格翰（Boehringer Ingelheim）的合作，評估 Zoci 與 T 細胞接合器的聯合治療。

Our second major global opportunity is ZL-1503, a potential first-in-class long-acting IL-13/IL-31 bispecific for atopic dermatitis. We believe it has the potential to bring together multiple attributes in a single asset, robust skin clearance, rapid and durable reduction, and longer dosing interval. Later this year, we'll report the program's first human data.

我們第二個重大的全球機會是 ZL-1503，這是一款潛在首創的長效 IL-13/IL-31 雙特異性抗體，用於治療異位性皮膚炎。我們相信它有潛力在單一資產中結合多項特性：顯著的皮膚清除效果、快速且持久的改善，以及更長的給藥間隔。今年稍晚，我們將公布該項目的首次人體數據。

At the same time, we continue to strengthen our commercial business. This quarter, we sharpened our focus behind our highest priority brands. Net product revenue grew 11% versus previous quarter, and the business remained commercially profitable. We're setting a strong foundation and expect a return to meaningful year-on-year growth in 2027, followed by the potential for our first US product launch in 2028.

同時，我們持續強化商業化業務。本季度，我們進一步聚焦於最優先的品牌。產品淨收入較上一季度成長 11%，且業務仍維持商業化獲利。我們正在奠定堅實基礎，並預期於 2027 年恢復具意義的年對年成長，之後有望於 2028 年迎來我們在美國的首個產品上市。

Zai Lab's evolution into a global biopharmaceutical company is well underway with a growing portfolio of globally developed differentiated medicines and a profitable commercial business. We're confident in the path ahead and the long-term value we can create for shareholders and patients.

再鼎醫藥向全球生物製藥公司的演進正在順利推進：我們擁有日益擴大的、全球開發的差異化藥物組合，以及一個獲利的商業化業務。我們對前方道路充滿信心，並相信能為股東與患者創造長期價值。

With that, let me turn the call over to Rafael to further discuss our pipeline in greater detail. Thank you.

接下來，我把電話會議交給 Rafael，更詳細地討論我們的研發管線。謝謝。

Thank you, Samantha. Let me walk you through the pipeline and what to expect this year. Starting with Zoci, our DLL3 targeted ADC. Small cell lung cancer is one of the most difficult diseases in oncology, and Zoci has demonstrated what we believe is a potential best-in-class ADC profile. In patients who have failed frontline multiple lines of treatment, we're seeing strong responses, including high responses and control of brain metastases. That efficacy with a favorable safety profile positions Zoci as a backbone for future combination regimens across lines of therapy. This program is moving fast.

謝謝你，Samantha。我將帶各位了解研發管線以及今年的重點里程碑。先從 Zoci——我們的 DLL3 靶向 ADC——談起。小細胞肺癌是腫瘤領域最具挑戰性的疾病之一，而 Zoci 展現了我們認為具備潛在同類最佳的 ADC 特徵。在一線治療失敗、且接受過多線治療的患者中，我們觀察到強勁反應，包括較高的反應率以及對腦轉移的控制。在具備良好安全性特徵的同時展現此等療效，使 Zoci 有望成為未來跨治療線別聯合方案的基石。該項目推進速度很快。

Our global registration Phase 3 in second-line plus small cell lung cancer is expected to complete enrollment in the first half of 2027 with a US accelerated approval submission expected to follow later that year and approval anticipated in 2028. At ESMO in October, we will present combination data evaluating Zoci plus PD-L1 with or without chemo in first-line small cell lung cancer or during maintenance.

我們在二線及以上小細胞肺癌的全球註冊性第三期試驗，預計將於 2027 年上半年完成入組；隨後預計於當年稍晚提交美國加速核准申請，並預期於 2028 年獲批。在 10 月的 ESMO 會議上，我們將展示聯合治療數據，評估 Zoci 加 PD-L1（合併或不合併化療）在一線小細胞肺癌或維持治療期間的表現。

Today's standard of care of IO plus chemo delivers a 60% to 70% response rate, median PFS of about 5 months and grade 3 or higher treatment-related adverse events around 60%. NCCN guidelines recommend four cycles of platinum-based chemotherapy. A chemo-sparing regimen could offer better tolerability, allow longer treatment duration compared to systemic chemotherapy and improved control of brain metastases. This is the basis of our Phase 3 combination strategy with immunotherapy, which we have discussed with regulators. We anticipate initiating the trial in the coming months.

目前 IO 加化療的標準治療可帶來 60% 至 70% 的反應率，中位無惡化存活期（PFS）約 5 個月，且 3 級或以上治療相關不良事件約為 60%。NCCN 指南建議進行 4 個療程的含鉑化療。減少化療的治療方案可能具有更佳耐受性，與全身性化療相比可支持更長的治療持續時間，並改善對腦轉移的控制。這正是我們與免疫治療聯合的第三期組合策略基礎，我們已就此與監管機構進行討論。我們預計在未來數月內啟動該試驗。

And in extrapulmonary neuroendocrine carcinomas where there is no established standard of care in the second line and beyond, Zoci demonstrated a confirmed ORR of 38.2%, which is well above the roughly 18% seen with currently used regimens. We're engaging with regulators on a potential approval pathway using extended single-arm data from our ongoing second-line trial with a subsequent approval pathway in first line. So 3 registrational programs underway by year-end.

此外，在肺外神經內分泌癌中，二線及以上尚無既定標準治療；Zoci 顯示經確認的客觀緩解率（ORR）為 38.2%，明顯高於目前常用方案約 18% 的水準。我們正與監管機構就潛在核准路徑進行溝通，擬以正在進行的二線試驗之延伸單臂數據支持核准，並在一線治療中建立後續核准路徑。因此，到年底將有 3 個註冊性項目在推進中。

We're also collaborating with Amgen and Boehringer Ingelheim to combine Zoci with T-cell engagers. A global Phase 1b study with Amgen is already enrolling, including a cohort of untreated small cell lung cancer patients on a triple combination of Zoci, IMDELLTRA and Imfinzi. And the global Phase 1b/2 study with Boehringer Ingelheim in neuroendocrine carcinoma is expected to initiate in the coming months.

我們也正與安進（Amgen）及勃林格殷格翰（Boehringer Ingelheim）合作，將 Zoci 與 T 細胞接合劑（T-cell engagers）進行聯合。與安進合作的全球第 1b 期研究已在招募中，其中包含一個未治療小細胞肺癌患者隊列，採用 Zoci、IMDELLTRA 與 Imfinzi 的三聯組合。此外，與勃林格殷格翰在神經內分泌癌的全球第 1b/2 期研究，預計將於未來數月內啟動。

Beyond Zoci, our next wave of global assets is advancing quickly. ZL-1503 is a long-acting humanized IgG1 bispecific antibody targeting both interleukin-13 and interleukin-31 receptor alpha. It includes YTE amino acid modifications in the Fc region that extend serum half-life and support less frequent dosing. Through blocking both pathways at once, ZL-1503 is designed to break the itch scratch inflammation cycle with rapid durable efficacy and less frequent dosing in moderate to severe atopic dermatitis.

除 Zoci 之外，我們下一波全球資產也在快速推進。ZL-1503 是一款長效人源化 IgG1 雙特異性抗體，同時靶向白介素-13（interleukin-13）與白介素-31 受體 α（interleukin-31 receptor alpha）。其 Fc 區域包含 YTE 胺基酸修飾，可延長血清半衰期並支持較低頻率給藥。透過同時阻斷兩條途徑，ZL-1503 旨在以快速且持久的療效、並以較低頻率給藥，打破中重度異位性皮膚炎的搔癢—抓搔—發炎循環。

ZL-1503 is in the clinic now with first-in-human data in healthy volunteers to be presented in the second half of this year. This data set will include pharmacokinetic data following single dose administration and pharmacodynamic data, including inhibition of AD-related biomarkers such as pSTAT6, TARC and CCL26, a cytokine that recruits eosinophils during type 2 inflammation. We will also have an initial read on safety and immunogenicity, including assessment of antidrug antibodies. We're also currently enrolling patients with AD in the multiple ascending dose portion of the trial, and we will share this data at a major medical conference next year.

ZL-1503 目前已進入臨床，針對健康受試者的首次人體（first-in-human）數據將於今年下半年發表。該數據集將包含單次給藥後的藥物動力學（pharmacokinetic）數據，以及藥效學（pharmacodynamic）數據，包括對 AD 相關生物標誌物（biomarkers）的抑制，例如 pSTAT6、TARC 與 CCL26；CCL26 為一種在第 2 型發炎中招募嗜酸性球的細胞激素。我們也將取得初步的安全性與免疫原性（immunogenicity）結果，包括抗藥抗體（antidrug antibodies）的評估。我們目前也正在該試驗的多次遞增劑量（multiple ascending dose）部分招募 AD 患者，並將於明年在一場重要醫學會議上分享這些數據。

We believe ZL-1503 with a potentially differentiated profile can address unmet medical needs in one of the largest markets in immunology globally, and we are moving this program forward rapidly. Beyond its lead indication, ZL-1503 has the potential to expand into additional IL-13 and IL-31 mediated diseases, creating a broader development opportunity over time. We look forward to sharing updates as the program advances.

我們相信，ZL-1503 具備潛在差異化的特徵，可在全球免疫學最大市場之一中滿足未被滿足的醫療需求，我們正快速推進此計畫。除主要適應症外，ZL-1503 亦有潛力拓展至其他由 IL-13 與 IL-31 介導的疾病，隨時間推進可形成更廣泛的開發機會。我們期待在該計畫推進過程中分享最新進展。

I would highlight just 2 more programs, ZL-6201, our internally discovered LRRC15 targeting ADC. We are actively enrolling patients in the global Phase 1 study and expect to complete enrollment in the dose escalation portion with initial data expected in the first half of next year. By year-end, we expect to submit an IND for ZL-1311, a next-generation T-cell engager targeting mucin 17, a promising target for gastrointestinal cancers.

我再重點提及另外兩個計畫：ZL-6201，為我們內部發現、靶向 LRRC15 的 ADC。我們正在全球第 1 期研究中積極招募患者，並預期於明年上半年完成劑量遞增部分的招募並取得初步數據。至今年底，我們預計為 ZL-1311 提交 IND；ZL-1311 是新一代 T 細胞接合劑，靶向黏蛋白 17（mucin 17），為胃腸道癌症的一個具前景靶點。

In summary, we have the infrastructure and capacity to advance multiple global programs at different stages of development simultaneously at speed and efficiency and across geographies while also advancing our regional pipeline. We have significant data emerging throughout the year on our most advanced products, and I look forward to sharing it with you in the coming months.

總結而言，我們具備基礎設施與產能，能以速度與效率在不同地理區域同步推進多個處於不同開發階段的全球計畫，同時也推進我們的區域性產品管線。我們最先進產品在全年將有大量數據陸續釋出，我期待在未來數月與各位分享。

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

接下來，我把時間交給雅靜。

Thank you, Rafael. As Samantha and Rafael described, Zai Lab is entering the next phase of its evolution. From a financial perspective, our objective is straightforward, build on our commercially profitable business while investing with discipline behind the innovation that will drive our next stage of growth. In the second quarter, net product revenue grew 11% sequentially to $105.8 million, and the business remained commercially profitable. ZEJULA was steady. VYVGART volumes grew double digits sequentially. XACDURO demand remains strong despite supply constraints and KarXT's launch is off to an excellent start.

謝謝你，Rafael。如 Samantha 與 Rafael 所述，Zai Lab 正進入其演進的下一階段。從財務角度來看，我們的目標很明確：在既有商業獲利的業務基礎上持續發展，同時以紀律性投資支持將推動下一階段成長的創新。第二季產品淨營收較前一季成長 11% 至 1.058 億美元，且業務仍維持商業獲利。ZEJULA 表現穩定。VYVGART 銷量較前一季呈雙位數成長。儘管供應受限，XACDURO 需求仍然強勁，而 KarXT 的上市開局非常出色。

In the second half of the year, we expect to further stabilize product sales while laying the foundation for a return to a meaningful growth in 2027. KarXT is expected to be a key driver of that growth as the first new mechanism of action for schizophrenia in decades with efficacy across positive and negative symptoms, no boxed warning and inclusion in national treatment guidelines, we believe KarXT is well positioned to address a significant unmet need. Early physician interest and positive patient experiences are encouraging, and we are building good momentum ahead of potential NRDL inclusion in 2027.

在今年下半年，我們預期將進一步穩定產品銷售，同時為 2027 年重回具意義的成長奠定基礎。KarXT 預期將成為該成長的關鍵驅動力；作為數十年來首個治療思覺失調症的新作用機轉，對陽性與陰性症狀皆具療效、無黑框警語（boxed warning），且已納入國家治療指引，我們相信 KarXT 具備良好定位，可滿足顯著的未被滿足需求。早期醫師興趣與患者正向使用經驗令人鼓舞，我們也正在為 2027 年可能納入 NRDL 之前建立良好動能。

For the VYVGART franchise, we intend to seek NRDL inclusion for VYVGART Hytrulo and are preparing for a gradual transition from IV to subcu. As a result, reported revenue in the second half may not fully reflect underlying demand due to timing of NRDL-related commercial dynamics.

就 VYVGART 產品系列而言，我們計畫爭取 VYVGART Hytrulo 納入 NRDL，並正為從靜脈注射（IV）逐步轉換至皮下注射（subcu）做準備。因此，由於 NRDL 相關商業動態的時點因素，下半年所報告的營收可能無法完全反映實際的內在需求。

Looking ahead to 2027, we are confident in a return to meaningful growth, supported by new product launches, potential NRDL product inclusion and continued demand growth across our key brands. Beyond 2027, we expect our internally developed pipeline to become an increasingly important contributor to both revenue and margins.

展望 2027 年，我們對重回具意義的成長充滿信心，成長將由新產品上市、產品可能納入 NRDL，以及我們核心品牌需求持續成長所支撐。在 2027 年之後，我們預期內部研發管線將在營收與毛利率方面扮演愈來愈重要的貢獻者。

On expenses, we remain disciplined, prioritizing our highest value programs while improving productivity through streamlining the organization and the use of AI across clinical development, regulatory, commercial and corporate functions. As a result, we expect operating expenses to remain broadly stable through the remainder of the year.

在費用方面，我們仍維持紀律，優先投入最高價值的計畫，同時透過組織精簡與在臨床開發、法規、商業與公司職能中導入 AI 來提升生產力。因此，我們預期今年剩餘期間的營運費用將大致維持穩定。

We ended the quarter with $717.5 million in cash, providing the financial flexibility to continue investing in the highest value opportunities. Pulling this together, we have a commercially profitable business, disciplined capital allocation and a global innovative pipeline that will increasingly shape the company's future growth and drive substantial value for patients and shareholders alike.

本季末我們持有 7.175 億美元現金，提供持續投資於最高價值機會的財務彈性。綜合而言，我們擁有商業獲利的業務、具紀律的資本配置，以及具全球創新性的研發管線；這些將日益塑造公司未來成長，並為患者與股東共同創造可觀價值。

With that, I will open it up for questions.

接下來，我們開放提問。

(Operator Instructions) Anupam Rama, JPMorgan.

(接線員指示) Anupam Rama，摩根大通（JPMorgan）。

Just looking to ESMO, can you walk us through what you're looking for in the first-line small cell study of Zoci plus IO plus or minus chemo? Like what's going to be the size and scope of that data set? And how are you defining a win scenario?

我想就 ESMO 請教一下：能否帶我們了解你們在 Zoci 加 IO、加或不加化療的一線小細胞研究中，主要在尋找什麼？例如該數據集的規模與範圍會是如何？以及你們如何定義「勝出」的情境？

Thank you, Anupam. This is Christine. Rafael, could you take that question, please?

謝謝你，Anupam。我是 Christine。Rafael，能請你回答這個問題嗎？

Sure. So at ESMO, we expect to present about 60 patients worth of data. This will include doublet and triplet, but most patients will be in the doublet with a checkpoint inhibitor at the highest dose of 1.6 milligrams per kilogram. We have been monitoring that data. We think we'll be fairly mature by the time of ESMO with a median follow-up between eight or nine months. So we will be able to report on a meaningful data set by then.

當然。因此在 ESMO，我們預期將發表約 60 位患者的數據。這將包含雙聯與三聯方案，但多數患者將在雙聯組，並在最高劑量 1.6 毫克/公斤下合併一種檢查點抑制劑。我們一直在監測這些數據。我們認為到 ESMO 時數據會相當成熟，中位隨訪時間約為 8 或 9 個月。因此屆時我們將能報告一個具代表性的數據集。

In terms of what to look for, I think the benchmark with the checkpoint inhibitor studies have shown responses in the 60% to 70% with chemotherapy and median follow-up -- sorry, progression-free survival of about five months. So there's still room for improvement in the about 80% response rate or so and a 50% increase in median PFS would be, I think, clinically meaningful. So those are sort of the parameters that we're looking for.

就我們應該關注什麼而言，我認為以檢查點抑制劑研究作為基準，與化療合併時的反應率已顯示在 60% 到 70%，而中位隨訪——抱歉，是無進展存活期（PFS）約為五個月。因此，在大約 80% 左右的反應率以及中位 PFS 提升 50% 方面仍有改進空間，我認為這在臨床上會具有意義。所以這些就是我們正在觀察的參數。

We're obviously at the same time that we're preparing this data set moving forward with operationalizing the study. And it's going to be a chemo-sparing study, not because we saw any DLTs with the triplet, but because we think it's more convenient, and we will be able to give higher dose intensity of Zoci than chemotherapy does.

很明顯地，在我們準備這份資料集的同時，也在推進研究的落地執行。而這將是一項減少化療使用（chemo-sparing）的研究，不是因為我們在三聯療法中看到任何劑量限制性毒性（DLT），而是因為我們認為這樣更便利，且我們能夠給予 Zoci 較化療更高的劑量強度。

Michael Yee, UBS.

Michael Yee，瑞銀（UBS）。

This is Kyle Yang for Michael. Two for us, the first one on the higher level, the company previously guided toward profitability by end of 2025. So how should we think about that? And at what point do you think investors can start to revisit the profitability goal?

我是代替 Michael 的 Kyle Yang。我們有兩個問題，第一個是較高層次的：公司先前指引在 2025 年底實現獲利。那我們應該如何看待這件事？以及你認為投資人何時可以開始重新檢視這個獲利目標？

The second question is on IL-13/IL-31. The atopic dermatitis landscape is getting increasingly competitive. And we recently saw additional investor interest in the space, including a new IPO this week also has -- that also has an IL-13/IL-31. So how should we think about the differentiation of your asset versus your competitors?

第二個問題是關於 IL-13/IL-31。異位性皮膚炎的競爭格局正變得愈來愈激烈。我們最近也看到該領域新增的投資人興趣，包括本週一個新的 IPO 也有——也同樣有一個 IL-13/IL-31。那我們應該如何看待你們資產相較於競品的差異化？

Thank you, Kyle. Yajing, can you please take the one on profitability and Rafael, a question on the 1503 differentiation, please?

謝謝你，Kyle。Yajing，請你回答關於獲利能力的問題；Rafael，請回答關於 1503 差異化的問題，好嗎？

All right. Thanks for the question. So I'm really looking at the profitability through the lens of our capital allocation. So we already have a commercially profitable business today. Our local manufacturing is on track for XACDURO and KarXT that will continue to improve our profitability. However, at the same time, we have multiple global competitive programs that we believe have the potential to create substantially greater long-term value.

好的。謝謝你的提問。我主要是從資本配置的角度來看獲利能力。我們今天已經擁有一個在商業上可獲利的業務。我們的在地製造正按計畫推進，用於 XACDURO 和 KarXT，這將持續改善我們的獲利能力。然而同時，我們也有多個具全球競爭力的專案，我們相信它們有潛力創造顯著更高的長期價值。

So right now, our responsibility is to invest where the returns justify it. We do maintain a very high bar for every investment decision. So in summary, we are kind of growing revenue with our potential global approval in 2028, which will improve margin and drive operating efficiencies across the organization at the same time. So we believe those factors adding together will naturally lead to the profitability over time and continue to improve the profitability over time as well.

因此目前，我們的責任是在回報足以支撐的地方進行投資。我們對每一項投資決策都維持非常高的門檻。總結來說，隨著我們在 2028 年可能取得全球核准而帶動營收成長，這將改善毛利，並同時在整個組織推動營運效率。因此我們相信，這些因素加總起來，會隨時間自然帶來獲利，並且也會持續隨時間改善獲利能力。

Yes. This is Rafael. I'll just make a few comments about 1503. So the drug, as you know, is designed to have three highly desirable attributes. The first one was robust skin clearance.

是的。我是 Rafael。我簡單就 1503 補充幾點。如你所知，這個藥物的設計目標是具備三個非常理想的特性。第一個是強勁的皮膚清除效果。

And I think this is through Th2 suppression, but by breaking the cycle of itching, scratching and inflammation that we see. I think by inhibiting the receptor, the 31 receptor, we should see brisk reduction in pruritus. We also have a molecule that is YTE modified, the extended dosing interval that's going to be tested in the current study that is ongoing, both in healthy volunteers and MADs, but we expect that it will be superior to the standards at the moment with every one month and dupi every two weeks. So we expect to go beyond that.

我認為這是透過 Th2 抑制來達成，但也藉由打破我們所看到的搔癢、抓癢與發炎的循環。我認為透過抑制受體，也就是 31 受體，我們應該會看到搔癢（pruritus）快速下降。我們也有一個做了 YTE 修飾的分子，延長給藥間隔，這會在目前正在進行的研究中測試，包含健康受試者與多次遞增劑量（MAD），我們預期它會優於目前的標準療法：每月一次以及 dupi 每兩週一次。因此我們預期能超越現有方案。

And there are a few agents that actually have the three simultaneous attributes. Some of them are preclinical. Some of them are targeting the ligand, some of them are targeting the receptor. We believe that targeting IL-13 ligand and targeting 31 receptor, the YTE modification will result in both better reported outcomes with regards to pruritus, which is really morbid in these patients, but also improvement in inflammation. And also, this is an underpenetrated market where there isn't really a winner takes all, if you will.

而實際上同時具備這三項特性的藥物並不多。其中一些仍在臨床前階段。有些是針對配體（ligand），有些是針對受體。我們相信，同時靶向 IL-13 配體並靶向 31 受體，再加上 YTE 修飾，將在搔癢相關的病人回報結果上帶來更好的表現——搔癢對這些病人確實非常折磨——同時也能改善發炎。此外，這是一個滲透率仍偏低的市場，並不存在所謂「贏者通吃」。

So I think any improvement in quality of life, dose extension and more importantly, inflammation and patient symptoms will allow for these drugs to have a role in atopic dermatitis. So we're also moving very fast with the Phase 1 study, and we expect to, as we've guided before, present healthy volunteers data this year and then next year, the MAD data in atopic dermatitis. So we are a bit ahead of some of the competitors.

所以我認為，任何在生活品質、延長給藥間隔，更重要的是在發炎與病人症狀上的改善，都會讓這些藥物在異位性皮膚炎中扮演角色。我們也正非常快速地推進第一期研究；如同我們先前所指引的，我們預期今年公布健康受試者資料，並在明年公布異位性皮膚炎的 MAD 資料。因此我們在進度上比部分競爭對手稍微領先。

Li Watsek, Cantor.

Li Watsek，Cantor。

I have one pipeline and one commercial question. For 1503, the bispecific antibody, just wondering what is the potential dosing profile that you're looking for? And how would the SAD data later this year inform you on the drug profile? Any early trends on ADA from the MAD cohort?

我有一個管線問題和一個商業問題。關於 1503 這個雙特異性抗體，我想了解你們期望的潛在給藥特徵（dosing profile）是什麼？以及今年稍晚的單次遞增劑量（SAD）資料將如何幫助你們判斷藥物特徵？在 MAD 隊列中，是否有任何關於抗藥抗體（ADA）的早期趨勢？

And the second question is on the commercial side. Just at a high level, how do you envision the China business to evolve in the coming quarters? What are the metrics that are most important to you?

第二個問題是商業面。整體而言，你們如何看待未來幾季中國業務的演變？對你們而言最重要的衡量指標是哪些？

Thank you, Li. Rafael, can you take the question on the dosing profile for 1503 and how the upcoming data will inform on the profile and on ADA. And then Yizhe, if you can address the commercial question.

謝謝你，Li。Rafael，你能否回答關於 1503 的給藥特徵、即將公布的資料將如何影響對其特徵的判斷，以及 ADA 的問題。然後 Yizhe，請你回應商業面的問題。

Yes. So in the healthy volunteers data, it's a single IV injection, and we have six cohorts. We're testing four doses. The single injections and the patients are being followed long term. This will inform us mostly on tolerability and PK, including half-life and then the biomarkers that I mentioned in the prepared remarks, including immunogenicity of antidrug antibodies. The MAD has two cohorts with two doses, also IV, and it's a larger cohort. I think to hone into the dose, we will need to do a bit more experimentation.

好的。在健康受試者資料中，這是單次靜脈注射（IV），共有六個隊列。我們在測試四個劑量。單次注射後，受試者會被長期追蹤。這主要會讓我們了解耐受性與藥物動力學（PK），包括半衰期，以及我在事先準備的發言中提到的生物標記，包含抗藥抗體的免疫原性。MAD 有兩個隊列、兩個劑量，也都是 IV，且是較大的隊列。我認為要更精準地確定劑量，我們還需要做更多的試驗探索。

There's a bioequivalence study that will compare the IV to the subcu and then we will do more dose experimentation with the subcutaneous dose. We expect that there will be a short induction course followed by a longer maintenance dosing, but it's premature to speculate on the actual dose. So -- and on the question about antibody drug conjugates, obviously, we're looking at this, and we will be reporting on this suffice it to say that the study continues.

目前有一項生體相等性研究，將比較靜脈注射（IV）與皮下注射（subcu），之後我們會針對皮下劑量進行更多劑量探索。我們預期會先有一個較短的誘導療程，接著是較長的維持給藥，但現在就推測實際劑量仍為時過早。所以——至於您問到抗體藥物複合體（ADC），很明顯我們也在評估，並會對外更新；總之，研究仍在持續進行。

Okay. Li, and hi, everybody. This is Yizhe here, and I'm speaking with you in China right now. Can you hear me okay? Good signal?

好的。Li，大家好。我是Yizhe，我現在在中國和各位通話。你們聽得到我嗎？訊號還好嗎？

Yes.

是的。

Very good. Great. Okay. So commercial. So first of all, I just want to say three months in a row, I look at commercial, it's not just a China business only, right?

非常好。太好了。好的。那談商業面。首先我想說，連續三個月我在看商業表現時，這不只是中國業務而已，對吧？

If you look out three -year horizon, we have the potential to launch our first US assets, our global assets, very exciting. That is Zoci. But that being said, the near term, absolutely, our focus should be focusing on our regional business, which is primarily our China business. So my view is this, we actually have a pretty sizable business, okay, but with a diverse, right, mixSome are CSO products, some are promoted by our own sales.

如果把時間拉到三年的視野，我們有機會推出我們在美國的第一批資產、我們的全球資產，非常令人振奮。那就是Zoci。但即便如此，短期內，我們的重點絕對應該放在區域性業務上，而這主要就是我們的中國業務。所以我的看法是，我們其實有相當可觀的業務規模，但組合很多元——有些是CSO產品，有些則由我們自有銷售團隊推廣。

So from my perspective, it's very important going forward to be very focused focus on three key brands. That is return ZEJULA to growth and continue growth on the volume growth, underlying demand on efgart and also launch excellence for KarXT, okay? From execution front, we must go back to the basics. We have to be very good at, I call it brilliant at the basics, really drive the metrics.

因此從我的角度來看，未來非常重要的是要高度聚焦在三個關鍵品牌上。也就是讓ZEJULA重回成長、持續推動efgart的量增與底層需求成長，以及把KarXT做到卓越上市表現，好嗎？在執行面，我們必須回到基本功。我們要把基本功做到非常好——我稱之為「把基本功做到出色」——真正去拉動各項指標。

So you asked me about what are some of the potential KPIs. So it's all about underlying demand. So for example, for each of these brands, new patient start will be critically important. We like to see the signal continue. For those who flatten, we want to return to growth.

你問我一些可能的KPI是什麼。核心就是底層需求。例如，對這些品牌而言，新病人啟動（new patient start）會是至關重要的指標。我們希望看到這個訊號持續。對於那些已經趨於持平的，我們希望讓它回到成長。

And for those has been growing, we want to continue to grow or potentially accelerate. We have seen these signals, right? And that will lead to, I think, in the next couple of quarters, a consolidation or solidification of our stabilization of revenue and eventually turning to a very meaningful growth in 2027, okay? So that is where we are.

而對於已在成長的，我們希望持續成長，甚至可能加速。我們已經看到這些訊號，對吧？我認為這將在接下來幾個季度帶來我們營收穩定的鞏固或強化，並最終在2027年轉為非常有意義的成長，好嗎？所以這就是我們目前的位置。

So in the second -- in the upcoming quarter, I look for is -- as you see the second quarter, we actually delivered an 11% sequential quarter-over-quarter growth. So in the upcoming quarter, we -- I see quite confidently we can solidify that. And then really -- in the meantime, really improving our underlying demand and setting ourselves up for a very good next year. And during this period, we also will focus on a couple of NRDL, right, negotiations. We want to make sure we win and we win at a good price.

所以在第二——在接下來的季度，我的觀察是——如你們在第二季所見，我們實際上繳出季對季（QoQ）11%的連續成長。因此在接下來的季度，我相當有信心我們可以把這個趨勢鞏固下來。同時，真正去改善我們的底層需求，為明年打下非常好的基礎。在這段期間，我們也會聚焦幾項NRDL（國家醫保目錄）談判。我們要確保我們能贏，而且要以好的價格贏。

Yigal Nochomovitz, Citi.

Citi的Yigal Nochomovitz。

This is [Caroline] on for Yigal. We're wondering as your MUC17 T-cell engager approaches the clinic, what aspects of the preclinical profile give you the greatest confidence it can overcome historical challenges associated with T-cell engagers in solid tumors?

我是[Caroline]，代替Yigal提問。我們想請教，隨著你們的MUC17 T細胞接合器（T-cell engager）即將進入臨床，前臨床資料中哪些面向讓你們最有信心它能克服T細胞接合器在實體腫瘤上歷來面臨的挑戰？

Rafael, if you can take the MUC17 T-cell.

Rafael，你可以回答MUC17 T細胞的問題嗎？

Sure. Yes. This is MUC17 T-cell engager. It's an interesting target. It's in GI tumors, more prominently in gastric, pancreas and other tumors of the GI tract.

當然。是的。這是MUC17 T細胞接合器。這是一個有趣的標的。它存在於腸胃道（GI）腫瘤中，較明顯的是胃癌、胰臟癌以及其他GI道腫瘤。

It is engineered to be biparatopic. So it targets more than one epitope. So hopefully, the avidity will be higher. But the CD3 is balanced by higher on and off rate. And we believe that, that hopefully, in the clinic will ameliorate cytokine release syndrome, which is really the Achilles heel of these products and that they need to be given in the hospital because of the emergence of CRS.

它被工程化設計為雙位點（biparatopic）。因此它會鎖定不只一個表位（epitope）。所以希望其親和力（avidity）會更高。但CD3端則透過較高的結合與解離速率（on/off rate）來取得平衡。我們相信這在臨床上有望減輕細胞激素釋放症候群（CRS），而CRS確實是這類產品的致命弱點，因為CRS出現時往往需要在醫院給藥。

So a lot of the innovation in this field, as you probably know, is directed to increasing efficacy, but also decreasing the potential toxicity related to CRS so that eventually one day, these products can be given in the community. We can say that preclinically, as we prepare to the IND, the product looks really to have great properties compared to other potential products in this target, including competitors. So we're pretty excited about it, and we're moving forward with the goal of having this IND out by the year's end.

因此，正如你可能知道的，這個領域的許多創新方向，一方面是提升療效，另一方面是降低與CRS相關的潛在毒性，讓這些產品終有一天可以在社區端給藥。我們可以說，就前臨床而言，在我們準備提交IND的過程中，這個產品相較於同一標的的其他潛在產品（包括競品）展現出非常好的特性。所以我們相當興奮，並正朝著今年底前提交IND的目標推進。

Daina Graybosch, Leerink Partners.

Leerink Partners的Daina Graybosch。

I wonder if you can talk about the combination of your DLL3 ADC with the DLL3 targeted T-cell engager and sort of mechanistically and biologically why that has value or differentiation relative to combining a DLL3 T-cell engager with the B7-H3 ADC?

我想請你談談你們的DLL3 ADC與DLL3標靶T細胞接合器的組合；從機制與生物學角度，為什麼這樣的組合具有價值或差異化？以及相較於把DLL3 T細胞接合器與B7-H3 ADC合併，差異在哪裡？

Thank you, Daina. It's great to have you on the call. Rafael, can you address the question on the combo of DLL3 plus TCE and why it may have value and differentiation versus the B7-H3 combo?

謝謝你，Daina。很高興你加入這通電話。Rafael，你能回應一下DLL3加上TCE的組合，以及為什麼相較於B7-H3的組合可能更有價值與差異化嗎？

Yes. I mean the more simplistic reason is that the mechanisms of action are orthogonal. They are very different. One is a cytotoxic that can debulk tumors, particularly small cell lung cancer that can present with a high-volume disease and then allow T-cells to eliminate residual disease and maintain immune surveillance. As the ADC kills the tumor cells, it liberates other antigens that are neoantigens.

可以。我想最簡單的原因是，兩者的作用機制是正交的。它們非常不同。其中一個是細胞毒性藥物，能夠縮減腫瘤負荷（debulk tumors），特別是小細胞肺癌，常以高腫瘤量疾病呈現；接著讓T細胞清除殘存病灶並維持免疫監視。當ADC殺死腫瘤細胞時，會釋放其他抗原，也就是新抗原（neoantigens）。

And the T-cells, even though they're directed to DLL3, can respond to these neoantigens, particularly when they're combined with PD-1. So this is a combination which is really targeted to bring in cytotoxicity as well as IO into the tumor.

而T細胞即使是以DLL3為導向，也能對這些新抗原產生反應，特別是在與PD-1合併時。因此，這個組合的目標是把細胞毒性以及免疫腫瘤（IO）一起帶入腫瘤之中。

In the case of Zoci and IMDELLTRA, for instance, the epitopes are different. So both drugs can actually bind in the same cell. And it's known that the density of receptors are required for ADCs and TCEs are different. ADCs combine even if there are lower receptors because there's also a bystander effect that can affect T-cells that have low DLL3 expression. So this is something, obviously, that still needs to be proven. We're doing the studies and the studies are aimed to look at tolerability. The good news is that there aren't really overlapping toxicities, except for potentially myelosuppression.

以 Zoci 和 IMDELLTRA 為例，兩者的表位是不同的。因此，這兩種藥物實際上可以在同一個細胞上結合。而且已知 ADC 與 TCE 所需的受體密度是不同的。即使受體較少，ADC 也能結合，因為還存在旁觀者效應，可能影響 DLL3 表達較低的 T 細胞。所以這顯然仍需要被證實。我們正在進行研究，而這些研究旨在評估耐受性。好消息是，除了可能的骨髓抑制之外，基本上沒有真正重疊的毒性。

And with regards to whether DLL3 is the same -- is the best target because it's the same target, there's a B7-H3 study that Amgen was conducting. It is on pause at the moment with IMDELLTRA as well. B7-H3 is not a tumor-specific target. It's present in normal tissue, including the lung epithelium. So there's a potential for more toxicity and in small cell lung cancer patients, lung toxicity can be problematic because of the incidence of ILD with ADCs, so we think that having a safer target that is more tumor specific is probably a better option.

至於 DLL3 是否是同一個——也就是因為是同一個標的而成為最佳標的，Amgen 曾在進行一項 B7-H3 的研究。目前該研究也與 IMDELLTRA 一樣處於暫停狀態。B7-H3 並非腫瘤特異性標的。它也存在於正常組織中，包括肺上皮。因此可能帶來更高的毒性風險；而在小細胞肺癌患者中，肺毒性可能會成為問題，因為 ADC 具有 ILD 的發生率，所以我們認為選擇更安全、且更具腫瘤特異性的標的，可能是更好的選項。

So we're looking forward to seeing the results of these combinations. Amgen obviously has data with B7-H3, but that hasn't been released. And we look forward to looking at the dual -- DLL3 dual mechanism approach. And hopefully, we'll have that data early next year.

因此我們期待看到這些聯合治療的結果。Amgen 顯然有 B7-H3 的數據，但尚未公布。我們也期待評估 DLL3 的雙重——DLL3 雙機制策略。並希望能在明年初取得相關數據。

(Operator Instructions) Linhai Zhao, Goldman Sachs.

(接線員指示) 高盛，Linhai Zhao。

This is Linhai from Goldman. Just a follow-up question on the Zoci and DLL3-TCE combinations, we've seen that both Amgen and BI have initiated the Phase 1/2 trials, including different cohorts for both the late line and first line. And for the RP2D in first-line triplet exploration, wondering if the RP2D will still remain as 1.6 mg or there will be a dose titration to a different dose level? And for the two Phase 1/2 trials, what might be the expected time that we will see some data?

我是高盛的 Linhai。關於 Zoci 與 DLL3-TCE 聯合治療有個追問：我們看到 Amgen 和 BI 都已啟動第 1/2 期試驗，並針對後線與一線設置了不同的隊列。就一線三聯方案探索的 RP2D 而言，想請問 RP2D 是否仍會維持在 1.6 mg，還是會進行劑量滴定到不同的劑量水平？另外，對於這兩項第 1/2 期試驗，我們大概何時能看到一些數據？

Thank you, Linhai. Rafael, could you address the question on the RP2D dose for the Zoci plus T-cell engagers study?

謝謝你，Linhai。Rafael，你能否回應一下關於 Zoci 加 T 細胞接合器研究之 RP2D 劑量的問題？

Yes. So the two immunotherapies, the PD-L1 as well as the T-cell engager will be used as standard doses. There may be some accommodation to be able to dose every three weeks just because Zoci is dosed every three weeks. With regards to Zoci, we're only exploring two doses and moving very fast. We're exploring 1.2 and 1.6 milligrams per kilogram.

可以。因此，兩種免疫治療——PD-L1 以及 T 細胞接合器——將採用標準劑量。可能會做一些調整，以便能每三週給藥一次，因為 Zoci 是每三週給藥。至於 Zoci，我們只探索兩個劑量，並且推進得非常快。我們正在探索每公斤 1.2 與 1.6 毫克。

We don't have any reason to think that 1.6 won't be well tolerated. So we hope that, that will be the dose that we go on to expand. So that's as much as we can say. The study is ongoing. The Amgen one is ongoing and accruing well.

我們沒有任何理由認為 1.6 不會有良好的耐受性。因此我們希望那會是我們接下來用於擴展的劑量。所以我們目前能說的大概就這些。研究仍在進行中。Amgen 的那項研究也在進行中，且入組情況良好。

And it's got a cohort of patients that are untreated, which I think is probably the most exciting cohort. As you know, the response rate with T-cell engagers is relatively modest. It's in the 30% to 40%, whereas the response rate with ADCs is very high.

而且其中有一個未接受治療的患者隊列，我認為這可能是最令人興奮的隊列。如你所知，T 細胞接合器的反應率相對溫和。大約在 30% 到 40%，而 ADC 的反應率則非常高。

So you combine also differential response rates, differential durability of response and then a potential immune surveillance that in Phase 3 studies with T-cell engagers, particularly with IMDELLTRA in second line has led to a 6-month difference in survival. So again, mechanistically, this makes a lot of sense. And in terms of the doses, we hope that we won't have to modify our target dose that we have chosen across the development plan for Zoci, which is 1.6 mgs per kg.

因此，當你把不同的反應率、不同的反應持久性，再加上潛在的免疫監視結合起來——在第 3 期 T 細胞接合器研究中，特別是 IMDELLTRA 的二線治療，已帶來 6 個月的生存差異。所以再次強調，從機制上看這非常合理。而在劑量方面，我們希望不必修改我們在 Zoci 整體開發計畫中所選定的目標劑量，也就是每公斤 1.6 毫克。

And when will we see the data readouts from the trial?

那我們何時會看到該試驗的數據讀出？

With the drug being operationalized by Amgen, so even though we obviously work very closely with them, it will be probably a joint decision, but they will take the lead as to when those results will be presented. My sense is that it will be next year, but I can't tell you exactly when it will happen. I would probably guide towards the end of the second half of the year.

由於該藥物的試驗運作由 Amgen 主導，因此即便我們顯然與他們密切合作，何時發表結果可能仍會是共同決定，但他們將主導何時呈現這些結果。我的感覺會是在明年，但我無法告訴你確切時間。我大概會指引到下半年後段。

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

我這邊顯示沒有進一步的提問。現在我把會議交回給 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 third quarter of 2026.

謝謝你，接線員。我要感謝各位今天撥冗參加本次電話會議。我們感謝各位的支持，並期待在 2026 年第三季之後再次向各位更新。

Operator, you may now disconnect this call.

接線員，您現在可以中斷本次通話。

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電話會議。本節目到此結束。您現在可以掛斷電話線。