Zai Lab Ltd (ZLAB) 2025 Q3 法說會逐字稿

Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab's Third Quarter 2025 Financial Results Conference Call. [Operator Instructions]. As a reminder, today's call is being recorded.

各位女士、先生們，大家好。感謝您的耐心等待，歡迎參加再鼎醫藥2025年第三季財務業績電話會議。[操作說明]。再次提醒，今天的通話將會被錄音。

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

現在我很高興將發言權交給投資者關係高級副總裁克里斯汀邱。請繼續。

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.

謝謝接線生。大家好，歡迎各位。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珊博士主持。她將與總裁兼營運長 Josh Smiley、總裁兼全球研發主管 Rafael Amado 博士以及財務長 Yajing Chen 博士一同出席。

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 also refer to adjusted loss from operations, which is a non-GAAP financial measure. Please refer to our earnings release furnished with the SEC on November 6, 2025, 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.

再次提醒大家，在今天的電話會議中，我們將根據目前的預期做出一些前瞻性陳述。這些聲明受到許多風險和不確定因素的影響，可能導致實際結果與我們的預期有重大差異，具體原因包括我們在提交給美國證券交易委員會的文件中討論的因素。我們也提到了調整後的營業虧損，這是一個非GAAP財務指標。有關此非GAAP財務指標的更多信息，請參閱我們於2025年11月6日向美國證券交易委員會提交的收益報告。此時，我很高興將電話轉交給杜珊莎醫生。

Thank you, Christine. Good morning, and good evening, everyone. Thank you for joining us today. Before we discuss the quarter, I want to take a moment to reflect on who we are, where we are headed.

謝謝你，克里斯汀。各位早安，各位晚上好。感謝您今天蒞臨。在討論本季之前，我想花點時間思考我們是誰，我們要去哪裡。

Zai Lab was built on a clear vision to bring the best global innovation to patients in China and to discover and develop new innovations that can compete on the world stage. That vision remains unchanged. Today, our global pipeline is stepping to the forefront, becoming the next key chapter in Zai's growth story. Zoci or ZL-1310 has now entered the pivotal stage less than 2 years from Phase 1/1b, an extraordinary pace at any standard in our industry. And we're on the path for our first global approval by 2027 or early 2028.

再鼎醫藥秉持著清晰的願景，致力於將全球最佳創新成果帶給中國患者，並發現和開發能夠在世界舞台上競爭的新創新成果。這願景始終未變。今天，我們的全球產品線正走向前沿，成為再鼎集團發展歷程中的下一個關鍵篇章。Zoci 或 ZL-1310 從 1/1b 期到進入關鍵階段僅花了不到 2 年時間，這在我們行業中是一個非同尋常的速度。我們預計在 2027 年或 2028 年初獲得首個全球批准。

Beyond Zoci, we're expanding our global portfolio with other highly differentiated programs, including our IL-13xIL-31R bispecific atopic dermatitis, IL-12 PD-1 bispecific and LRRC15 ADC for solid tumors. More importantly, we have built a global R&D organization that combines speed, scientific rigor and quality expected of a global biopharma.

除了 Zoci 之外，我們還在透過其他高度差異化的項目來擴展我們的全球產品組合，包括我們的 IL-13xIL-31R 雙特異性異位性皮膚炎、IL-12 PD-1 雙特異性和 LRRC15 ADC 實體瘤。更重要的是，我們建立了一個全球研發組織，該組織兼俱全球生物製藥公司所期望的速度、科學嚴謹性和品質。

On our commercial business in China, we are commercially profitable today and on a steady, profitable growth path. However, the pace has been slower than we expected. The environment is complex and dynamic. But at the same time, there are encouraging signs of progress. Regulatory reviews are faster and NRDL negotiations are more transparent.

目前，我們在中國的商業業務已經實現盈利，並走上了穩定、盈利的成長道路。然而，進展速度比我們預期的要慢。環境複雜多變。但同時，也出現了令人鼓舞的進展跡象。監管審查速度更快，NRDL談判更透明。

We have one of the strongest commercial teams in the industry, backed by a portfolio of differentiated, high potential assets, and we remain confident in the long-term potential of this business.

我們擁有業內最強大的商業團隊之一，並擁有差異化、高潛力的資產組合，我們對這項業務的長期潛力充滿信心。

This next chapter will take focus and persistence, but we have the right science, the right team and the right vision. Together, we are building a company that will make a lasting difference for patients and create long-term value for our 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?

接下來的篇章需要專注和堅持，但我們擁有正確的科學、正確的團隊和正確的願景。我們將共同打造一家能為患者帶來持久改變並為股東創造長期價值的公司。接下來，我將把電話交給拉斐爾，他將為大家介紹我們研發流程的進度。拉斐爾？

Thank you, Samantha. I will begin with a few highlights from our global pipeline, starting with ZL-1310 or Zoci. Two weeks ago, at the triple meeting conference, we presented updated Phase I data in previously treated extensive stage small cell lung cancer. This global study enrolled 115 patients across the U.S., Europe and China.

謝謝你，薩曼莎。我將首先介紹我們全球產品線中的幾個亮點，首先是 ZL-1310 或 Zoci。兩週前，在三方會議上，我們公佈了先前接受過治療的廣泛期小細胞肺癌的最新 I 期數據。這項全球性研究招募了 115 名來自美國、歐洲和中國的患者。

At baseline, 90% of patients had received a PD-1 or PD-L1 therapy, nearly 1/3 had brain metastases and several had progressed on a prior DLL3 targeted therapy, including tarlatamab, making this a very difficult to treat heavily pretreated patient population. At the 1.6 milligrams per kilogram dose, we observed an overall response rate of 68% and a disease control rate of 94%, among the strongest efficacy signals reported in the second line setting. Importantly, we also saw robust activity in patients with brain metastases, including an 80% overall response rate in lesions, which had received no prior treatment of any kind, suggesting that Zoci may offer a new way to control both systemic as well as intracranial disease without interrupting therapy, a potential game changer in terms of speed to treatment for these patients whose tumors tend to be growing very fast.

在基線時，90% 的患者接受過 PD-1 或​​ PD-L1 治療，近三分之一的患者有腦轉移，一些患者在先前的 DLL3 標靶治療（包括 tarlatamab）中病情進展，這使得該患者群體成為治療難度極大的重度預處理患者群體。在每公斤 1.6 毫克的劑量下，我們觀察到整體緩解率為 68%，疾病控制率為 94%，這是二線治療中報告的最強療效訊號之一。重要的是，我們還觀察到腦轉移患者的療效顯著，其中未接受過任何治療的病灶總體緩解率達到 80%，這表明 Zoci 可能提供了一種新的方法來控制全身性疾病和顱內疾病，而無需中斷治療，這對於腫瘤生長速度往往非常快的這些患者來說，在治療速度方面可能具有顛覆性意義。

Across all doses and lines, the median duration of response was 6.1 months, and the median progression-free survival was 5.4 months, which is highly encouraging for a monotherapy in this refractory population across doses and lines of therapy. Data from the 1.2 and 1.6 milligrams per kilogram cohort continue to mature as enrollment continues and patients remain on treatment. Zoci also continues to demonstrate a best-in-class safety profile. At the 1.6 milligrams per kilogram dose, grade 3 or higher treatment-related adverse events were observed in only 13% of patients, far below the 35% to 50% rate seen with other ADCs in this setting.

在所有劑量和治療線中，中位緩解持續時間為 6.1 個月，中位無惡化存活期為 5.4 個月，對於這種難治性人群的單藥治療而言，無論劑量和治療線如何，這都是非常令人鼓舞的。隨著入組人數的增加和患者繼續接受治療，每公斤體重 1.2 毫克和 1.6 毫克組的數據也在不斷改進。Zoci 也持續展現一流的安全性能。在每公斤 1.6 毫克的劑量下，只有 13% 的患者觀察到 3 級或更高級別的治療相關不良事件，遠低於其他 ADC 在這種情況下觀察到的 35% 至 50% 的發生率。

There were no drug-related discontinuations or deaths and only 2 Grade 1 interstitial lung disease cases across both expansion doses of 1.2 and 1.6 milligrams per kilogram. This combination of deep efficacy and favorable tolerability positions Zoci as an ideal candidate for the first-line combination where safety is paramount. We've now begun enrollment in our registrational Phase III trial in extensive stage small cell lung cancer with the potential for an accelerated approval submission. We're also advancing our first-line strategy with plans to initiate a Phase III study next year following results of our ongoing combination study evaluating Zoci plus PD-L1 with and without chemotherapy. In addition, we see significant opportunity for Zoci as a backbone therapy in novel mechanism combinations.

在每公斤 1.2 毫克和 1.6 毫克的兩種擴展劑量中，沒有發生與藥物相關的停藥或死亡，只有 2 例 1 級間質性肺病病例。Zoci 兼具高效性和良好的耐受性，是安全性至關重要的一線聯合治療的理想選擇。我們目前已開始招募廣泛期小細胞肺癌患者參與註冊性 III 期試驗，並有可能獲得加速審批。我們也在推進第一線治療策略，計劃明年啟動 III 期研究，此前我們正在進行一項聯合研究，評估 Zoci 加 PD-L1 聯合或不聯合化療的療效，該研究結果將公佈。此外，我們認為 Zoci 作為新型機制組合療法的基礎療法具有巨大的發展潛力。

We plan to initiate studies with agents with ethanol and complementary mechanisms of action, and we will share details once the studies are posted on clinicaltrials.gov. Beyond small cell lung cancer, Zoci is being evaluated in Neuroendocrine Carcinomas or NAC, which have poor prognosis and no targeted therapy despite high DLL3 expression. Early data with ZL-1310 are encouraging, and we plan to present results in the first half of next year and to move into a registrational study thereafter. Beyond Zoci, our next wave of innovative global assets continue to advance rapidly. ZL-1503, our internally discovered IL-13/IL-31 bispecific antibody for atopic dermatitis recently entered Phase I. Its dual mechanism targets both itch and inflammation and its extended half-life offers potential for less frequent dosing. A subcutaneous formulation is being developed. Preclinical results support its use in other inflammatory diseases.

我們計劃啟動含有乙醇且作用機制互補的藥物的研究，一旦研究結果發佈在clinicaltrials.gov網站上，我們將分享詳細資訊。除了小細胞肺癌之外，Zoci還在神經內分泌癌（NAC）中進行評估，NAC預後不良，儘管DLL3表達量高，但目前尚無標靶治療。ZL-1310 的早期數據令人鼓舞，我們計劃在明年上半年公佈結果，並隨後進行註冊研究。除了 Zoci 之外，我們的下一批創新全球資產也正在快速發展。ZL-1503 是我們內部研發的用於治療異位性皮膚炎的 IL-13/IL-31 雙特異性抗體，最近進入了 I 期臨床試驗。它的雙重作用機制可同時靶向瘙癢和炎症，並且其延長的半衰期使其有可能減少給藥頻率。正在研發皮下注射劑型。臨床前研究結果支持其用於治療其他發炎性疾病。

First-in-human data are expected in 2026. ZL-6201 is an internally discovered LRRC15 targeted antibody with a next-generation payload linker. It remains on track for a U.S. IND submission by year-end and a global Phase I study initiation early next year for patients with cancer that have tumor cell or tumor stroma expressing this target. ZL-1222 is another internally discovered asset. It is a next-generation PD-1 IL-12 immunocytokine designed to deliver cytokine signaling directly into the tumor microenvironment while preserving PD-1 checkpoint blockade. IND-enabling work is underway, and we expect to move quickly towards an IND once data are available.

預計 2026 年獲得首次人體試驗數據。ZL-6201 是一種內部發現的 LRRC15 標靶抗體，具有新一代有效載荷連接子。該藥物仍有望在年底前向美國提交IND申請，並於明年初啟動針對腫瘤細胞或腫瘤基質表達該標靶的癌症患者的全球I期研究。ZL-1222 是另一項內部發現的資產。它是一種新一代 PD-1 IL-12 免疫細胞因子，旨在將細胞激素訊號直接傳遞到腫瘤微環境中，同時保持 PD-1 檢查點阻斷作用。IND申報工作正在進行中，一旦數據可用，我們預計會迅速推進IND申報工作。

Now turning to our key late-stage regional programs in immunology and neuroscience. The Efgartigimod continues to expand across multiple autoimmune indications. The ADAPT SERON study in seronegative gMG was positive, the first global Phase III trial to show clinically meaningful improvements across all 3 gMG subtypes, MuSK+, LRP4+, and triple seronegative. Three additional Phase III readouts in Ocular myasthenia gravis, Myositis and Thyroid eye disease are expected next year with China contributing to global enrollment. For Povetacicept, our partner, Vertex recently received FDA breakthrough therapy designation for IgAN. Enrollment of the global RAINIER Phase 3 is complete with an interim analysis planned for the first half of 2026, where patients from China are included and potentially supporting an accelerated approval submission next year. The global pivotal Phase II/III study in primary membranous nephropathy was initiated in October, and we're on track to enroll patients in China this quarter.

現在讓我們來看看我們在免疫學和神經科學領域的關鍵後期區域計畫。Efgartigimod 的應用範圍持續擴大，涵蓋多種自體免疫疾病。ADAPT SERON 研究在血清陰性 gMG 患者中取得了積極成果，這是首個全球 III 期試驗，顯示所有 3 種 gMG 亞型（MuSK+、LRP4+ 和三重血清陰性）均有臨床意義的改善。預計明年將公佈眼肌型重症肌無力、肌炎和甲狀腺眼疾這三項 III 期臨床試驗的額外結果，中國將為全球招募做出貢獻。對於 Povetacicept，我們的合作夥伴 Vertex 最近獲得了 FDA 授予的 IgAN 突破性療法認定。全球 RAINIER 3 期試驗的入組工作已經完成，計劃於 2026 年上半年進行中期分析，屆時將納入來自中國的患者，並有可能支持明年提交加速審批申請。針對原發性膜性腎病變的全球關鍵性 II/III 期研究已於 10 月啟動，我們預計在本季在中國招募患者。

Together, these achievements reflect the depth and quality of our pipeline, one that is advancing with speed and efficiency and with a clear focus on novel mechanisms and clinical differentiation. In summary, over the next 12 months, we expect to reach several important milestones across our global portfolio. For Zoci, we expect a catalyst-rich year with updated intracranial data, first-line small cell lung cancer combination data and results in neuroendocrine carcinoma in the first half. In parallel, we plan to initiate registrational studies in first-line small cell lung cancer and other neuroendocrine carcinomas as well as starting studies with novel combinations across line of therapy.

這些成就共同體現了我們研發管線的深度和質量，該管線正以快速且有效率的方式推進，並明確專注於新型機制和臨床差異化。總而言之，在接下來的 12 個月裡，我們預計我們的全球投資組合將實現幾個重要的里程碑。對 Zoci 而言，我們預計今年將是充滿催化劑的一年，上半年將有更新的顱內數據、一線小細胞肺癌聯合治療數據以及神經內分泌癌的治療結果。同時，我們計劃啟動針對一線小細胞肺癌和其他神經內分泌癌的註冊研究，並開始針對不同治療線的新型聯合療法的研究。

Beyond Zoci, we expect first-in-human data for ZL-1503 or IL-1331 and to advance ZL-6201 or LRRC15 into global Phase I development. We're also progressing ZL-1222 or anti-PD-1/ IL-12 agonist and look forward to sharing additional data in the coming year. And with that, I'll hand it over to Josh. Joshua SmileyExecutive Thank you, Rafael, and hello, everyone. Before we turn to our third quarter results, I'd like to start by welcoming Dr. Yajing Chen, he as our new Chief Business Officer. Chen brings both deep scientific expertise and investment experience and will play a central role in expanding our portfolio and unlocking value through partnerships and out-licensing.

除了 Zoci 之外，我們期待獲得 ZL-1503 或 IL-1331 的首次人體試驗數據，並將 ZL-6201 或 LRRC15 推進到全球 I 期開發階段。我們也正在推進 ZL-1222（抗 PD-1/IL-12 激動劑）的研發，並期待在未來一年分享更多數據。然後，我就把麥克風交給喬許了。Joshua SmileyExecutive 謝謝 Rafael，大家好。在介紹第三季業績之前，我首先要歡迎陳亞京博士加入我們，擔任首席商務官。陳先生擁有深厚的科學專業知識和投資經驗，將在擴大我們的投資組合、透過合作和對外授權釋放價值方面發揮核心作用。

I'd also like to sincerely thank Jonathan Wang for his many contributions over the past decade in helping build the strong foundation that now supports our next phase of growth. Now turning to our commercial performance. Total revenues were $116 million, representing 14% growth year-over-year. VYVGART and VYVGART Hytrulo contributed $27.7 million, which includes a $2.4 million reduction following a voluntary price adjustment on Hytrulo to align with NRDL guidelines ahead of national pricing negotiations. While this adjustment affected reported sales, the underlying fundamentals of the launch remain very strong. VYVGART continues to be one of the most successful immunology launches ever in China, ranking as the #1 innovative drug by sales among all new launches in the past 2 years.

我還要衷心感謝 Jonathan Wang 在過去十年中所做的許多貢獻，幫助我們奠定了堅實的基礎，為我們的下一階段發展提供了支持。現在來談談我們的商業表現。總收入為 1.16 億美元，年增 14%。VYVGART 和 VYVGART Hytrulo 貢獻了 2,770 萬美元，其中包括在全國定價談判之前，為配合 NRDL 指導方針而自願調整 Hytrulo 價格後減少的 240 萬美元。雖然這項調整影響了公佈的銷售額，但此次新品發布的基本面依然非常強勁。VYVGART 持續保持著中國免疫學領域最成功的上市記錄之一，在過去兩年所有新上市藥物中，其銷售額位居創新藥物榜首。

More importantly, the trends beneath the headline numbers point to durable long-term growth. There are 2 key growth drivers underpinning the trajectory of VYVGART in gMG, patient demand and treatment duration, the latter of which is particularly important given the chronic nature of the disease. First, on demand. We continue to see steady new patient additions each month with nearly 21,000 patients treated to date. VYVGART penetration in gMG remains only around 12%, meaning we are still in the early stages of market development with significant room for expansion.

更重要的是，主要數據背後的趨勢表明，長期成長將持續下去。VYVGART 在 gMG 的發展軌跡主要受兩個關鍵因素驅動：患者需求和治療持續時間，考慮到疾病的慢性性質，後者尤其重要。首先，按需供應。每個月都有穩定的新患者加入，迄今已治療了近 21,000 名患者。VYVGART 在 gMG 的滲透率仍只有 12% 左右，這意味著我們仍處於市場發展的早期階段，還有很大的擴張空間。

Second, on treatment duration. The updated MG guidelines published in July have been a meaningful catalyst to emphasize both the importance of rapid symptom control, where VYVGART has demonstrated strong efficacy and a minimum of 3 treatment cycles to reduce the risk of relapse and maintain durable disease control. Since publication, we have seen clear signs of positive impact in real-world practice. Physicians are becoming receptive to maintaining patients on therapy even after achieving symptom control, signaling a shift from episodic to maintenance use.

其次，關於治療持續時間。7 月發布的最新 MG 指南具有重要的推動作用，它強調了快速控制症狀的重要性（VYVGART 已證明具有很強的療效），以及至少 3 個治療週期以降低復發風險並維持持久的疾病控制。自出版以來，我們已經看到其在實際應用中產生了明顯的正面影響。醫生開始接受即使在症狀控制後也讓患者繼續接受治療，這標誌著治療方式從間歇性使用轉向維持性使用。

As a result of our efforts, the average vials per patient have increased over 30% year-to-date versus last year, with a notable acceleration in Q3. And VYVGART volumes have grown sequentially in the mid-teens. We see this level of growth as realistic and sustainable as we head into 2026. Now admittedly, the pace of market build for this first-in-class therapy for chronic disease has been more measured than we initially anticipated. With VYVGART, we are shaping this new market thoughtfully, focusing not only on driving adoption, but also on redefining how gMG is managed over the long term.

由於我們的努力，今年迄今每位患者的平均用藥量比去年同期增長了 30% 以上，第三季度增長尤為顯著。VYVGART 的銷量在十幾歲左右開始逐年成長。我們認為，展望 2026 年，這種成長水準是現實且可持續的。誠然，這種針對慢性疾病的首創療法的市場擴張速度比我們最初預期的要緩慢得多。借助 VYVGART，我們正在深思熟慮地塑造這個新市場，不僅專注於推動普及，還專注於重新定義 gMG 的長期管理方式。

Through physician education and real-world experience, we aim to change long-standing treatment patterns. While the ramp is slower than expected, the long-term potential of VYVGART in gMG is substantial. Beyond gMG, we're making progress in CIDP, expanding access across both supplemental and commercial health insurance plans. We will continue to add new layers of growth with new indications and formulations with the most immediate being seronegative gMG and the prefilled syringe. Looking ahead, our next major launch opportunity is KarXT, currently under regulatory review. KarXT has the potential to redefine schizophrenia treatment in China, introducing the first new mechanism of action in more than 70 years. Notably, it has already been included in the China Schizophrenia Prevention and Treatment Guidelines 2025 Edition, the first national guideline globally to do so, underscoring its strong differentiation and anticipated clinical impact.

我們旨在透過對醫生的教育和實際經驗，改變長期以來的治療模式。雖然成長速度比預期慢，但 VYVGART 在 gMG 的長期潛力是巨大的。除了 gMG 之外，我們在 CIDP 方面也取得了進展，擴大了補充醫療保險和商業醫療保險計劃的覆蓋範圍。我們將繼續透過新的適應症和配方增加新的成長層次，其中最直接的進展是血清陰性gMG和預充式註射器。展望未來，我們下一個重要的產品發布機會是 KarXT，目前正在接受監管審查。KarXT 有可能重新定義中國的精神分裂症治療，引進 70 多年來的第一個新作用機制。值得注意的是，它已被納入《中國精神分裂症防治指南 2025 年版》，這是全球首個將精神分裂症防治指南納入其中的國家級指南，凸顯了其顯著的差異化優勢和預期的臨床影響。

Across the company, we remain disciplined in our operations, scaling efficiently while investing strategically in commercial execution and pipeline innovation. And with that, I will now pass the call over to Yajing to take us through our financial results. Yajing? Yajing ChenExecutive Thank you, Josh. Now I will review highlights from our third quarter 2025 financial results compared to the prior year period. Total revenue grew 14% year-over-year to $116.1 million in the third quarter, primarily driven by higher sales of NUZYRA supported by increasing market coverage and penetration.

公司上下在營運方面都保持嚴謹，高效擴張，同時在商業執行和產品線創新方面進行策略性投資。接下來，我將把電話交給雅靜，讓她為我們介紹我們的財務表現。雅靜？陳雅靜 執行官 謝謝你，喬許。現在我將回顧我們2025年第三季財務業績與去年同期相比的亮點。第三季總營收年增 14% 至 1.161 億美元，主要得益於 NUZYRA 銷售成長，而 NUZYRA 的市場覆蓋率和滲透率不斷提高。

Demand for XACDURO remains robust, and we aim to normalize supply by year-end. ZEJULA grew sequentially but declined year-over-year amid evolving competitive dynamics within the PARP class. Given this trend as well as VYVGART dynamics discussed earlier, we are updating our full year total revenue guidance to at least $460 million. Our continued focus on financial discipline and efficiency was evident in our cost structure with both R&D and SG&A as a percentage of revenue declining significantly year-over-year. R&D expenses for the third quarter decreased 27% year-over-year, mainly due to a decrease in licensing fees in connection with upfront and milestone payments. SG&A expenses for the third quarter increased 4% year-over-year, mainly due to higher general selling expenses to support the growth of NUZYRA and VYVGART, partially offset by lower selling expenses for ZEJULA.

對 XACDURO 的需求依然強勁，我們的目標是在年底前使供應恢復正常。ZEJULA 逐年成長，但隨著 PARP 類產品競爭格局的演變，其年比有所下降。鑑於這一趨勢以及先前討論過的 VYVGART 動態，我們將全年總收入預期更新為至少 4.6 億美元。我們持續注重財務紀律和效率，這點在我們的成本結構中顯而易見，研發費用和銷售、管理及行政費用佔收入的比例均較去年同期大幅下降。第三季研發費用年減 27%，主要原因是預付款和里程碑付款相關的許可證費用減少。第三季銷售、一般及行政費用年增 4%，主要原因是為支持 NUZYRA 和 VYVGART 的成長而增加的一般銷售費用，部分被 ZEJULA 的銷售費用降低所抵銷。

As a result, loss from operations improved 28% in the third quarter to $48.8 million and adjusted loss from operations, which excludes certain noncash items, depreciation, amortization and share-based compensation, was $28 million in the third quarter, a 42% improvement from the prior year. While we expect meaningful quarter-over-quarter improvement in adjusted operating loss, we now expect profitability to shift beyond the fourth quarter, reflecting the lower revenue base this year. Importantly, our fundamentals remain strong. Our China business is already commercially profitable and growing, and we are executing strong financial discipline and investing strategically in R&D. We are on a path to profitability, and we'll provide updated 2026 financial guidance when we report our full year 2025 earnings.

因此，第三季營業虧損改善了 28%，達到 4,880 萬美元；經調整後的營業虧損（不包括某些非現金項目、折舊、攤提和股份支付）為 2,800 萬美元，比去年同期改善了 42%。雖然我們預計調整後的營業虧損將較上季顯著改善，但鑑於今年的營收基數較低，我們現在預計獲利能力將在第四季之後才能實現。重要的是，我們的基本面依然強勁。我們在中國的業務已經實現商業盈利並不斷增長，我們正在執行嚴格的財務紀律，並在研發方面進行策略性投資。我們正走在實現盈利的道路上，我們將在公佈 2025 年全年收益時提供更新後的 2026 年財務預期。

Zai Lab is at a major value inflection point with a rapidly advancing global pipeline, a commercially profitable China business and a path to profitability. We also maintain a strong financial foundation, ending the quarter with $817 million in cash, which provides us with the flexibility to invest in both innovation and disciplined execution. And with that, I would now like to turn the call back over to the operator to open up the line for questions.

再鼎醫藥正處於一個重要的價值轉折點，其全球產品線快速發展，中國業務已實現商業盈利，並走上了盈利之路。我們也保持著強勁的財務基礎，本季末現金餘額為 8.17 億美元，這使我們能夠靈活地投資於創新和嚴謹的執行。那麼，我現在要把電話轉回給接線生，以便大家提問。

[Operator Instructions] We will now take our first question from the line of Jonathan Chang, Leerink Partners.

【操作員說明】現在我們將接受來自 Leerink Partners 的 Jonathan Chang 的第一個問題。

First question, on the revised revenue guidance, how should we be thinking about the key drivers for growth and the path to profitability?

首先，關於修訂後的營收預期，我們應該如何看待成長的關鍵驅動因素和實現獲利的路徑？

And then second question on ZL-1503. Can you help set expectations for the initial data readout expected in 2026? And how are you guys seeing the opportunity in atopic dermatitis?

然後是關於 ZL-1503 的第二個問題。您能否幫我們設定一下預計在 2026 年發布的首批數據讀數的預期？你們如何看待異位性皮膚炎領域的機會？

Thanks, Jonathan. It's Josh Smiley. Thanks for the questions. I'll take the first one on revenue drivers, and then Rafael will talk about 1503. I think as we think about revenue headed into the fourth quarter here, drivers will continue to be VYVGART, we expect continued good sequential growth driven by new patient additions and continued growth and durability in terms of the number of doses patients get.

謝謝你，喬納森。是喬許·斯邁利。謝謝大家的提問。我先講講收入驅動因素，然後拉斐爾會講講 1503。我認為，展望第四季度的收入，VYVGART 將繼續成為驅動因素，我們預計在新增患者數量的推動下，以及患者接受的劑量數量持續增長和保持穩定，將帶來良好的環比增長。

We are seeing, as I mentioned in the opening remarks, we're seeing good progress as a result of the national guidelines that were issued in July, which focus on getting patients into at least 3 courses of therapy. So, we'll see, we expect to see continued growth there. ZEJULA, we are seeing a return to growth. As we've mentioned throughout the year, the quarterly numbers, I think, will be a little bit choppy because of the generic entries for Lynparza, but we do expect VBP to kick in, in the fourth quarter here, and that gives us a chance to gain share in this class, and we're confident we will. So, we'd expect to see some growth there. rest of the portfolio continues to do well. We are excited about the progress we're seeing with XACDURO, but still face supply constraints.

正如我在開場白中提到的，我們看到，由於7月份發布的國家指導方針，我們取得了良好的進展，這些指導方針的重點是讓患者至少接受3個療程的治療。所以，我們拭目以待，我們預計那裡會繼續成長。ZEJULA，我們看到成長勢頭正在恢復。正如我們全年所提到的，由於 Lynparza 的通用條目，我認為季度數據會有些波動，但我們預計 VBP 將在第四季度發揮作用，這將給我們一個機會在這個類別中獲得市場份額，我們有信心做到這一點。因此，我們預計這部分會有一些成長。投資組合的其他部分繼續表現良好。我們對 XACDURO 的進展感到興奮，但仍面臨供應限制。

So, we'll be somewhat limited as we come into the fourth quarter here or there. But overall, good momentum in the portfolio and good growth drivers. We'll give more specific guidance for 2026 as we get into next year. But obviously, we're looking forward to the launch of KarXT, the potential approval of TIVDAK and continued growth in these, in the core part of the portfolio. As it relates to profitability, again, our profitability will be driven by growth in the business in China.

所以，到了第四季度，我們會受到一些限制。但整體而言，投資組合發展勢頭良好，成長動力強勁。進入明年後，我們將給予2026年的更具體指引。但顯然，我們期待 KarXT 的上市、TIVDAK 的潛在批准以及這些產品組合核心部分的持續成長。至於獲利能力，同樣，我們的獲利能力將取決於中國業務的成長。

The China business, of course, is profitable today. And as we continue to drive top line growth, that profitability will be enough to cover the R&D and corporate costs that we have. So, we're still on that path. It's just, we just need the growth to continue in the portfolio. With that, I'll turn it to Rafael to talk about 1503. Rafael AmadoExecutive Thanks, Josh. Thanks, Jonathan. So, 1503, we're really excited about this molecule.

當然，目前中國市場的業務是獲利的。隨著我們持續推動營收成長，獲利能力將足以涵蓋我們的研發和公司營運成本。所以，我們仍在沿著這條路走。只是，我們需要投資組合繼續保持成長。接下來，我將把麥克風交給拉斐爾，讓他談談 1503 年的情況。Rafael AmadoExecutive 謝謝，Josh。謝謝你，喬納森。所以，1503，我們對這個分子感到非常興奮。

As you know, it's both dual IL-13/31 inhibitors. It traps IL-13, and we know that, that is a proven pathway. And 31 is a very potent pathway in initiating pruritus. So, we think the combination plus the long half-life is going to translate into a really brisk effect, which is very fast and sustained. We have initiated the IND already. We plan to do a multi-country study. And obviously, it's a first-in-human study. We will do single ascending dose in normal volunteers and then multiple doses in patients with atopic dermatitis. In the lab, we've been looking at other models of TH2 diseases, and we are very encouraged with what we're seeing on asthma, rhinitis and other disorders that affect [TH2].

如您所知，它們都是IL-13/31雙重抑制劑。它能捕獲 IL-13，我們知道，這是一條已被證實的途徑。而 31 是引發搔癢的非常有效的途徑。所以，我們認為這種組合加上較長的半衰期將會帶來非常迅速且持久的效果。我們已經啟動了IND程式。我們計劃進行一項多國研究。顯然，這是首次進行人體試驗。我們將對健康志願者進行單次遞增劑量試驗，然後對異位性皮膚炎患者進行多次劑量試驗。在實驗室裡，我們一直在研究其他TH2疾病模型，我們對在氣喘、鼻炎和其他相關疾病方面觀察到的成果感到非常鼓舞。[TH2]

So, in addition to this, we're going to be looking at efficacy endpoints given the half-life that is long, we think that we will be able to see effects on EASI scores as well as IgA/ID [Audio Gap] and so this is going to be measured very frequently. We hope to have the data available by the middle of next year, but it will obviously accumulate throughout next year, and we will present when we have sufficient data. It's a placebo-controlled trial. So, we'll be able to have comparisons.

因此，除此之外，鑑於其半衰期較長，我們將關注療效終點，我們認為我們將能夠看到對 EASI 評分以及 IgA/ID（聽力差距）的影響，因此我們將非常頻繁地測量這些指標。我們希望在明年年中之前獲得相關數據，但顯然數據將在明年全年陸續積累，我們將在獲得足夠的數據後進行公佈。這是一項安慰劑對照試驗。這樣，我們就可以進行比較了。

And obviously, we know what the landmarks are here with other products. So again, a very large opportunity. This is a very common disease, even a fraction percentage of capturing in AD would be a large opportunity. And also, the possibility of expanding into other TH2 diseases, I think make this a very promising product.

顯然，我們都知道其他產品在這裡的標誌性特徵是什麼。所以，這又是一個非常大的機會。這是一種非常常見的疾病，即使只在阿茲海默症患者中發現一小部分病例，也是一個巨大的機會。而且，我認為該產品還有可能擴展到其他 TH2 疾病領域，這使它成為一款非常有前途的產品。

We will now take our next question from the line of Anupam Rama, JPMorgan.

接下來，我們將回答摩根大通的 Anupam Rama 提出的問題。

This is Joyce on for Anupam. The press release today really led with progress on your own internal global development programs. Is this a shift in how you're thinking about the resource allocation in terms of your prior focus on external BD versus now the internal pipeline?

這裡是喬伊斯替阿努帕姆報道。今天的新聞稿主要介紹了貴公司內部全球發展項目的進展。這是否意味著您在資源分配方面的想法發生了轉變，從之前專注於外部業務拓展轉向現在專注於內部管道？

Thanks. It's Josh. I'll start. First, we are very excited about the pipeline that we have today with the global emphasis. And of course, that will be a priority to invest in and Rafael outlined our near-term focus in terms of 1310 and getting the registration trial up and running and expanding into first line and into neuroendocrine tumors. So that's going to be a focus.

謝謝。是喬許。我先來。首先，我們對目前擁有的、具有全球視野的研發管線感到非常興奮。當然，這將是我們優先投資的項目，拉斐爾概述了我們近期在 1310 方面的重點，包括啟動註冊試驗、擴展到一線治療以及神經內分泌腫瘤治療。所以這將是我們的重點。

We've got a really exciting global portfolio behind that. We think we have the capacity here to fully invest in those programs. We have a strong balance sheet with plenty of cash to continue to pursue on a targeted basis, the right kind of external opportunities to bring in, both on a global and regional basis.

我們背後有著非常令人振奮的全球投資組合。我們認為我們有能力全力投入這些項目。我們擁有強勁的資產負債表和充足的現金，可以繼續有針對性地尋求合適的外部機會，無論是在全球還是區域範圍內。

And we have the capacity within the income statement on the R&D side to, I think, fully invest behind these exciting opportunities and still manage, I think, an R&D budget that's within the range of what we've seen the last few years. So, priorities are advance the pipeline, continue to build the pipeline and continue to drive the commercial business in China, which is profitable today and will be increasingly profitable over time.

我認為，我們在研發方面的損益表上有能力全力投入這些令人興奮的機遇，同時也能將研發預算控制在過去幾年所達到的範圍內。因此，當務之急是推進管道建設，繼續建造管道，並繼續推動在中國的商業業務發展，該業務目前盈利，隨著時間的推移，盈利能力將越來越強。

We will now take our next question from the line of Yigal Nochomovitz, Citi.

接下來，我們將回答花旗集團的 Yigal Nochomovitz 提出的問題。

This is Caroline on for Yigal. We were wondering where you're seeing the greatest opportunity and greatest likelihood for success for your internal global pipeline among LRRC and PD-1, IL-2 and others. I have a second question, if okay.

這裡是卡洛琳，為您報道伊加爾。我們想知道，在您內部的全球研發管線中，LRRC、PD-1、IL-2 等藥物中，您認為哪些藥物最有機會、最有可能成功。如果可以的話，我還有第二個問題。

Rafael, jump in on this one, please.

拉斐爾，請你也參與進來。

Sure. Obviously, the most immediate one is 1310. I mean, it clearly is quite active. It is well tolerated, very few related grade 3 and above treatment effects. treatment side effects, strong brisk effect on brain metastases in untreated brain metastases.

當然。顯然，最直接的例子是 1310 年。我的意思是，它顯然非常活躍。此藥耐受性良好，3級以上相關治療副作用極少，且對未治療的腦轉移瘤有顯著的快速療效。

And again, very high percent of patients responding. We are starting up the Phase III study for second line. We've had recent discussions with FDA, and we're sharpening the design to the point that it's already started. We will continue to do some work on the dose, but I think that is going to finish pretty quickly. With regards to the rest of the products, obviously, 1503, I mean, these are proven pathways. So, the bar for activity is pretty low.

再次強調，患者的應答率非常高。我們即將啟動二線治療的III期臨床試驗。我們最近與FDA進行了討論，並且正在完善設計，目前該計畫已經啟動。我們將繼續研究劑量問題，但我認為這項工作很快就會完成。至於其他產品，顯然，1503，我的意思是，這些都是經過驗證的途徑。所以，參與活動的門檻相當低。

And also, the characteristics of the product with FC modification for long half-life makes it very ideal for patients with these chronic diseases. And then with regards to some of the other ones, LRRC15 is particularly interesting because it will be the first time where a tumor is being targeted where the target is not necessarily in the tumor. So, there will be these 2 groups of patients like sarcoma patients where the tumor does express LRRC15, but others in which the tumor only expresses the target in fibroblasts.

此外，該產品經 FC 修飾後具有半衰期長的特點，非常適合患有這些慢性疾病的患者。至於其他一些靶點，LRRC15 特別有趣，因為它是首次以腫瘤為靶點，而標靶不一定在腫瘤內部。因此，會有兩類患者，例如肉瘤患者，他們的腫瘤會表達 LRRC15，但另一些患者的腫瘤只會在纖維母細胞中表達該標靶。

And if that is the case, if we can actually abrogate tumors where the tumor is negative, but the tumor microenvironment is positive, then it opens a whole host of tumor types. So pretty excited about this. And I think we are with others leading in ADC, which is one of our focus in oncology. And then I'll finish with PD-1 IL-12. It's been very hard to target IL-12 because it's toxic.

如果是這樣，如果我們能夠消除腫瘤本身為陰性但腫瘤微環境為陽性的腫瘤，那麼這將為多種腫瘤類型打開大門。我對此感到非常興奮。我認為我們在ADC領域與其他領先者並駕齊驅，ADC也是我們在腫瘤學領域的研究重點之一。最後，我將介紹 PD-1 IL-12。由於IL-12具有毒性，因此很難對其進行標靶治療。

So, we've been able to engineer an IL-12 stimulated moiety, which actually is attenuated. So, it doesn't really cause side effects of T cell activation. And at the same time, with full blockade of PD-1. So, in animal models, we can see that we can actually restore PD-1 resistant tumors, which would be pretty exciting to see. And we are seeing, as you know, more enhancements on PD-1 as a checkpoint with other molecules. And we think that an IL-12 would be one of them.

因此，我們已經能夠設計出一種IL-12刺激部分，但實際上它的作用減弱了。所以，它其實並不會引起T細胞活化的副作用。同時，完全阻斷 PD-1。因此，在動物模型中，我們可以看到我們實際上可以恢復 PD-1 抗藥性腫瘤，這真是令人興奮。如您所知，我們看到 PD-1 作為檢查點與其他分子進行了更多改進。我們認為IL-12就是其中之一。

So, I'll just finish by saying that we can move these things pretty quickly. We'll have 2 INDs this year. One of them will enroll this year. The other one will start enrolling in January. And PD-1 IL-12 is a candidate that will have an IND next year and hopefully, the first patient as well in the second half. So yes, we're excited about all of them. But obviously, our strongest focus right now is making sure that we cover the lives on 1310.

最後，我想說的是，我們可以很快地推進這些事情。今年我們將有2位獨立球員。他們之中有一人今年會入學。另一所學校將於一月開始招生。PD-1 IL-12 是一種候選藥物，明年將提交 IND 申請，希望下半年也能迎來首例患者。是的，我們對所有這些項目感到興奮。但很顯然，我們目前的首要任務是確保我們能夠報道 1310 上的生命。

Got it. And on my second question, we're wondering what you're doing to set yourself up for a strong KarXT launch? And what more have you learned about the schizophrenia market in China to best position KarXT in the marketplace?

知道了。我的第二個問題是，我們想知道您正在採取哪些措施來為 KarXT 的強勢上市做好準備？為了更好地將 KarXT 定位在市場上，您對中國精神分裂症市場還有哪些新的了解？

It's Josh. Yes, we're quite excited about the opportunity with KarXT. Regulatory reviews are going well. So, we are hopeful for an approval sometime in the near term here. First, I think if you look in China, there's a huge opportunity. Of course, there haven't been any new mechanisms approved in severe melan illness or schizophrenia in more than 70 years.

是喬許。是的，我們對與 KarXT 的合作機會感到非常興奮。監管審查進展順利。因此，我們希望在不久的將來能夠獲得批准。首先，我認為如果你看看中國，你會發現那裡蘊藏著巨大的機會。當然，在過去70多年裡，還沒有任何新的療法被批准用於治療嚴重的黑變病或精神分裂症。

So, the opportunity for a mechanism like KarXT that provides both efficacy on positive symptoms, negative symptoms and cognition is, I think, well anticipated and thought leaders are anxious for this drug to come. So, we'll launch with a targeted sales force. I think the difference in China versus what we see in some of the Western markets, certainly in the US is it's a more concentrated approach. Patients tend to be in bigger institutions.

因此，我認為，像 KarXT 這樣既能有效緩解陽性症狀、陰性症狀又能改善認知功能的藥物的出現，是大家所翹首以盼的，思想領袖們也迫切希望這種藥物能夠問世。所以，我們將以一支目標明確的銷售團隊作為啟動方案。我認為中國與一些西方市場（尤其是美國）的不同之處在於，中國採取的是一種更集中的方式。患者往往在規模較大的醫療機構接受治療。

So, with a relatively targeted sales force and education program, we should be able to touch a significant portion of the market at launch. And again, just to remind people that the opportunity here is quite significant with millions of patients today suffering from schizophrenia. Obviously, it's a lifelong disease. So, we're anxious to get the approval first to get up and running in 2026 and then move toward NRDL listing in 2027.

因此，憑藉一支目標明確的銷售團隊和教育計劃，我們應該能夠在產品上市時觸及相當大的市場份額。再次提醒大家，鑑於目前有數百萬精神分裂症患者，這是一個非常重要的機會。顯然，這是一種終身疾病。因此，我們急於先獲得批准，以便在 2026 年啟動運營，然後在 2027 年爭取列入 NRDL 名單。

Our next question comes from the line of Li Watsek, Cantor Fitzgerald.

我們的下一個問題來自李·瓦特塞克（Li Watsek）和康托·菲茨杰拉德（Cantor Fitzgerald）的著作。

I have one commercial, one pipeline question. I guess just given some of the complex commercial dynamics in China and your revised guidance, can you provide your updated views on the $2 billion revenue target by 2028? And then second is for ZL1310, sounds like you're expanding to neuroendocrine tumors next year. I wonder if you can just talk a little bit about the pathway to approval and what would be the bar?

我有一個關於商業和管道方面的問題。鑑於中國複雜的商業環境以及您修訂後的業績指引，您能否就 2028 年實現 20 億美元的營收目標提供一些最新的看法？其次是關於 ZL1310 的，聽起來你們明年打算將研究領域擴展到神經內分泌腫瘤。我想請您簡單談談審批流程以及門檻是什麼？

Thanks, Li. It's Josh. I think first on the $2 billion 2028 goal, we will look at all the moves that we had in the portfolio, and we'll provide a more fulsome update next year, maybe starting at JPMorgan. But to comment, we feel really good about the portfolio we have today. As Samantha mentioned upfront, I think the most exciting piece is the opportunity for sales outside of China in 2028. We mentioned that 1310, we see a path for an approval as early as late 2027.

謝謝，李。是喬許。我認為，首先要實現 20 億美元的 2028 年目標，我們將審視我們在投資組合中採取的所有舉措，明年我們將提供更全面的更新，也許會從摩根大通開始。但就我們目前擁有的投資組合而言，我們感到非常滿意。正如薩曼莎一開始提到的那樣，我認為最令人興奮的是 2028 年在中國以外地區銷售的機會。我們提到過，1310號法案最快可能在2027年底獲得批准。

So, to have some significant sales in 2028 coming from the US in small cell lung cancer, I think, quite exciting and certainly represents a new inflection point and phase of growth for us. The portfolio in China continues to grow. And we've talked about the dynamics with VYVGART, which we expect over the course of the next number of years to continue to grow at a good and steady rate, supplemented by additional indications.

因此，我認為，2028 年在美國小細胞肺癌領域取得顯著的銷售額，非常令人興奮，這無疑代表著我們新的轉捩點和成長階段。在中國的業務組合持續成長。我們已經討論過 VYVGART 的發展動態，我們預計在未來幾年內，隨著更多適應症的出現，VYVGART 將繼續保持良好且穩定的成長速度。

Since we have talked about that revenue goal, we've added Pove and Veli, both of which can launch in the 2028-time frame. So, we're quite excited about the long-term growth potential of the portfolio and most excited this year about the progress on 1310 and what it means for sales, not just in China, but outside of China within this time frame. Yes, Rafael, if you can jump in, please.

自從我們討論過營收目標以來，我們又增加了 Pove 和 Veli，這兩款產品都可以在 2028 年左右推出。因此，我們對該產品組合的長期成長潛力感到非常興奮，今年最令人興奮的是 1310 的進展及其對銷​​售的意義，不僅在中國，而且在這一時期內對中國以外的銷售也意義重大。是的，拉斐爾，如果你方便的話，請上來。

Yes. Thanks, Caroline. So, I'll talk a bit about NEC. So, the study that we have has 2 cohorts of carcinoma. So, these are highly proliferative tumors that have a poor prognosis. One is gastroenteropancreatic tumors or GEP, and the others are other NECs that can arise from other sites, other organs. We are seeing responses in both groups. It's still early days, obviously, and we're accumulating more and more evidence of activity.

是的。謝謝你，卡洛琳。那麼，我將簡單談談NEC公司。所以，我們這項研究有 2 個癌症隊列。所以，這些是高度增生性腫瘤，預後不良。其中一種是胃腸胰腫瘤（GEP），其他的則是其他部位、其他器官可能出現的神經內分泌癌（NEC）。我們看到兩組人群都有反應。顯然，現在還處於早期階段，我們正在累積越來越多的活動證據。

These are patients that have had more than one line of therapy, which tends to be platinum-based therapy. And there really isn't any standard for these patients. The tumors tend to grow fast and actually mortality is quite high. So, in terms of how we want to proceed with this, the idea would be to sort of circumscribe the tumors that have similar natural history like GEP, large cell non-small cell lung cancer and also tumors of a non-primary and do a study, a single-arm trial and try to characterize the response rate.

這些患者接受過不只一種治療方案，其中以鉑類藥物為主。對於這些患者，其實並沒有任何標準。這些腫瘤往往生長迅速，而且死亡率相當高。所以，就我們想如何推進這項工作而言，我們的想法是，將具有相似自然史的腫瘤（如 GEP、大細胞非小細胞肺癌以及非原發性腫瘤）進行範圍界定，然後進行一項研究，一項單臂試驗，並嘗試描述反應率。

I think anything above 30% to 40% would be of great interest because there really isn't any therapy. Many of these patients go to clinical trials with reasonable durability. So, we would plan to have discussions with regulatory authorities to see whether given the unmet need single-arm trial with these kinds of results could result in an accelerated approval. The alternative is to do a physician choice comparator, which also we will be prepared to launch.

我認為任何高於 30% 到 40% 的情況都會引起人們的極大興趣，因為目前還沒有有效的治療方法。這些患者中許多人都能以相當的持久性參與臨床試驗。因此，我們計劃與監管機構進行討論，看看鑑於目前尚未滿足的需求，這種單臂試驗取得此類結果是否可以加速獲得批准。另一種方法是進行醫生選擇比較，我們也準備推出這項服務。

And given the activity that we are seeing, if it continues, it wouldn't be a very large study, particularly given the large unmet need and the fact that this is an orphan indication. So pretty excited about what the agency will see and opine once we have sufficient follow-up and sufficient patients to characterize the activity.

鑑於我們目前看到的活動情況，如果這種情況繼續下去，這項研究的規模不會很大，特別是考慮到巨大的未滿足需求以及這是一個罕見適應症。所以，一旦我們有足夠的後續研究和足夠的患者來描述這種活動，我很期待該機構會看到什麼並發表意見。

Our next question comes from the line of Lai Chen, Goldman Sachs.

我們的下一個問題來自高盛的賴晨。

Two questions. The first one is regarding the guidance. We try to understand a bit more about compared to the expectations set in any guidance previously, in which areas has the company encountered deeper than anticipated challenges in China environment, particularly for VYVGART and ZEJULA. Could you elaborate a bit more? And also, I think beginning of the year, in terms of the guidance, not only about the top line, but also you mentioned about fourth quarter cash breakeven target. Is that still intact? That's my first one.

兩個問題。第一個問題是關於指導方針的。我們試圖更了解與先前任何指導方針中設定的預期相比，公司在中國環境中遇到了哪些比預期更深的挑戰，特別是 VYVGART 和 ZEJULA。能再詳細說明一下嗎？而且，我認為年初的業績指引，不僅是營收方面，還有您提到的第四季現金損益平衡目標。它還完好無損嗎？這是我的第一個。

Second is regarding the R&D because Zai Lab is really pivoting towards a global R&D company. So, in terms of the pipeline buildup, particularly for the early-stage pipeline buildup, now we got oncology ADCs, we have 2 different ADCs. We have PD-1, IL-12, and we also have immunology. So we're trying to understand a bit more about the strategy, the portfolio strategy when you're deciding what to go after and what not to do. So, could you provide a bit more color on that?

其次是關於研發方面，因為再鼎醫藥正在向全球研發公司轉型。所以，就產品線建設而言，特別是早期產品線建設，現在我們有了腫瘤ADC，我們有2種不同的ADC。我們有 PD-1、IL-12，我們還有免疫學。所以我們正在嘗試更多地了解策略，也就是在決定追求什麼和不追求什麼時所採取的投資組合策略。那麼，您能再詳細解釋一下嗎？

Sure. Thanks. First, on the performance this year, I would say, relative to our initial expectations, VYVGART, while growing well, and we're pleased with the underlying dynamics, as we've mentioned throughout the call, it's just taking longer to get to the rate that we, of treatment that we see in the US market, for example. So, we're focused now on getting patients up to at least 3 cycles of treatment, and we're seeing progress there. It's just slow.

當然。謝謝。首先，關於今年的業績，我想說，相對於我們最初的預期，VYVGART 雖然增長良好，我們對基本面的動態感到滿意，正如我們在電話會議中提到的那樣，只是需要更長的時間才能達到我們在美國市場看到的治療速度。所以，我們現在的重點是讓患者完成至少 3 個療程的治療，而我們在這方面已經看到了進展。就是慢。

So, I would say that's our sort of on the VYVGART piece, that's the piece that has been the slowest relative to our expectations. Again, I think this is what we're realizing is it's a long-term build the market opportunity. We have the long term with this product, and we're seeing good response to things like the national guidelines and our continued promotional and educational efforts.

所以，我想說，VYVGART 這件作品的進展速度比我們預期的要慢一些。我認為，我們現在意識到的是，這是一個長期的市場建設機會。我們對這款產品抱持長期的信心，我們看到，國家指導方針以及我們持續的推廣和教育努力都得到了良好的反響。

So just a slower ramp to get to the kind of treatment duration that we see in the Western markets. On ZEJULA, we expect to gain share as a function of Lynparza going generic, and we saw some delays there in terms of, relative to our initial expectations relative to VBP.

所以，治療持續時間需要循序漸進地達到我們在西方市場看到的水平。在 ZEJULA 上，我們預計隨著 Lynparza 成為仿製藥，市場份額將會增長，但就 VBP 而言，我們看到了一些延遲，與我們最初的預期相比有所延遲。

Again, we expect that to kick in beginning in the fourth quarter and set us up well for next year. Certainly, again, there are dynamics related to affordability and hospital purchasing and otherwise that may make that a bit choppy. But I think the underlying opportunity for ZEJULA is to gain share from what had been Lynparza as it goes to generic.

我們預計這種情況將從第四季開始顯現，並為明年奠定良好的基礎。當然，與支付能力、醫院採購等相關的動態因素可能會使情況變得有些不穩定。但我認為 ZEJULA 的根本機會在於，隨著 Lynparza 成為仿製藥，ZEJULA 將從 Lynparza 手中奪取市場份額。

The third piece for us is then just we've talked about this through the year. It's a great product and our partner, Pfizer, is seeing really great response and demand in the hospital setting for this drug. And we've had more supply constraints than we anticipated at the beginning of the year. We're working through those, and we're hopeful that as we come into 2026, those will be resolved, and we'll be able to fully meet the demand that we're seeing in the marketplace.

第三點是我們今年一直在討論的。這是一款很棒的產品，我們的合作夥伴輝瑞公司在醫院環境中對這種藥物的反應和需求都非常旺盛。而且，我們遇到的供應限制比年初預想的還要多。我們正在努力解決這些問題，並希望在 2026 年，這些問題都能得到解決，我們將能夠完全滿足我們在市場上看到的需求。

Those things together, of course, will help and drive profitability. I think if you look at our path to profitability and focus on the noncash, I mean, on the cash sort of earnings, which is our non-GAAP number, you see continued good progress in that regard. And that progress should continue. We'll give you an update for 2026. But really, it's just going to be a function of continued growth on the top line.

當然，這些因素加在一起，將有助於提高獲利能力。我認為，如果你審視我們實現盈利的路徑，並專注於非現金收益，也就是我們的非GAAP財務數據，你會發現我們在這一方面持續取得良好進展。而這種進步應該會繼續下去。我們將於 2026 年為您提供最新資訊。但實際上，這最終取決於營收能否持續成長。

And I think at the numbers that we're suggesting here for the fourth quarter, we probably won't quite get there, but we'll still show good improvement, and we'll be on that path as we head into 2026. Rafael, if you can talk about how we think about the portfolio and the next opportunities.

我認為，根據我們預測的第四季度數據，我們可能無法完全實現目標，但我們仍然會取得良好的進步，並且我們將在邁向 2026 年的道路上繼續保持這一勢頭。拉斐爾，你能談談我們對投資組合和未來機會的看法嗎？

Sure. So, the portfolio will continue to grow as a blend of both internal as well as external opportunities. I'm really proud of the fact that many of the products that are now in development came from our protein science laboratories, which have been very productive. But in terms of strategy in oncology, we will continue with antibody drug conjugates, and we will continue to innovate there.

當然。因此，投資組合將繼續成長，這既包括內部機會，也包括外部機會。我非常自豪的是，目前正在研發的許多產品都來自我們高效率的蛋白質科學實驗室。但在腫瘤學策略方面，我們將繼續使用抗體藥物偶聯物，並將繼續在該領域進行創新。

There are other antibodies that we haven't mentioned that are in the pipeline at the moment, and we spend a lot of time trying to characterize the antibody vis-a-vis the target. and then use the right payload linker. So that's going to continue to grow. We also have an interest in immunocytokines, which I mentioned before.

還有一些我們尚未提及的抗體正在研發中，我們花費大量時間研究這些抗體與標靶的相互作用，然後選擇合適的有效載荷連接子。所以這個數字還會繼續增加。我們也對免疫細胞激素感興趣，我之前也提到過。

We have other immunocytokines that will come after the PD-1 IL-12. And then T cell engagers, we've made an effort in T cell engagers, and we will be reporting with time some of these candidates entering the clinic. Outside of oncology, you are right. I mean, we have been focusing on autoimmunity, neuroscience and immunology. In autoimmunity, we are focusing on cytokines, both antibodies or bispecifics perhaps cell depletion as well and then signal transduction of some of these cytokine pathways, which involve small molecules as well.

PD-1 IL-12 之後還會有其他免疫細胞激素。然後是 T 細胞銜接器，我們在 T 細胞銜接器方面也投入了精力，我們將陸續報告其中一些候選藥物進入臨床試驗的情況。除了腫瘤科以外，你的說法是對的。我的意思是，我們一直專注於自體免疫、神經科學和免疫學。在自體免疫中，我們關注的是細胞因子，包括抗體或雙特異性抗體，或許還有細胞耗竭，以及其中一些細胞激素路徑的訊號傳導，其中也涉及小分子。

And so overall, we will remain opportunistic, obviously, for either regional or global opportunities that have novel mechanisms of action, have differentiation and really make a big difference for patients. But the guardrails, if you will, are the ones that I just described to you. So, thanks for the question.

因此，總的來說，我們顯然會繼續抓住機會，尋找具有新穎作用機制、具有差異化優勢並能真正為患者帶來重大改變的區域性或全球性機會。但是，如果你要說有什麼防護措施的話，那就是我剛才向你描述的那些。謝謝你的提問。

Yes. I think, Joe, just like Rafael was saying, we, even though our pipeline in China, regional pipeline has oncology, autoimmune and neuro and anti-infectious. But for our global pipeline, we are focusing on oncology and autoimmune and anti-inflammatory specifically that Rafael was saying. So internally for global development pipelines, we are only focused on those 2 areas.

是的。我認為，喬，就像拉斐爾說的那樣，儘管我們在中國的區域產品線涵蓋腫瘤、自體免疫和神經以及抗感染領域。但就我們的全球產品線而言，我們正專注於腫瘤學、自體免疫和抗發炎領域，正如拉斐爾所說。因此，在內部，對於全球開發流程，我們只專注於這兩個領域。

Our last question today comes from the line of Clara Dong, Jefferies.

今天最後一個問題來自傑富瑞的克拉拉·董女士。

This is Jenna on for Clara. We have 2 questions, if we may. First, on VYVGART. I think previously, we were under the impression that sales will be back half loaded. So, I was just curious what kind of visibility or leading indicators you may have for Q4 and 2026? And more specifically, can you comment on, for example, pace, number of cycles on average patients are getting today? What does the pace look like over the next few years to reach the 3 average doses?

這裡是珍娜，替克拉拉報道。我們有兩個問題，可以嗎？首先，在 VYVGART 上。我認為之前我們都以為銷售額會恢復一半。所以，我只是好奇您對第四季和 2026 年的情況有什麼預測或領先指標？更具體地說，您能否談談治療進度，例如，目前患者平均接受的治療週期數？未來幾年內，達到平均 3 劑劑量的速度會是怎麼樣的呢？

And then our second question is on Bema in the context of the Amgen announcement. I was just curious if it's still possible to have a path forward for just China based on the trials you're running or the data you have in hand?

那麼我們的第二個問題是關於安進公司公告中的 Bema 問題。我只是好奇，根據你們正在進行的試驗或掌握的數據，是否有可能只針對中國市場制定前進方向？

I'll start with VYVGART and then Rafael can talk about Bema. I think on VYVGART, what we're seeing is good underlying growth in terms of duration or number of vials or cycles patients get. I think as we started the year, on average, we were probably close to 1 cycle per year or per patient per year, and that represented the fact that at launch, we were getting lots of the acute patients and VYVGART, of course, works really well in an acute setting, but to get the full benefit for patients with gMG that allows them to work and live their lives fully, you need to get the maintenance benefits, which kick in at least 3 cycles.

我先從 VYVGART 開始，然後 Rafael 可以談談 Bema。我認為在 VYVGART 方面，我們看到的是良好的潛在增長，無論是在治療持續時間還是患者接受的治療劑量（例如，治療瓶數或治療週期數）。我認為，年初的時候，平均下來，我們可能接近每年每個患者 1 個療程，這反映出在產品上市初期，我們接收了很多急性患者，而 VYVGART 在急性期當然效果很好，但要讓重症肌無力患者獲得充分的益處，使他們能夠工作和充分地生活，就需要獲得維持治療的益處，這至少需要 3 個療程才能生效。

Through this year, we're seeing progress towards an average of 2 cycles per year. And as you mentioned in your question, the goal is to get to at least 3 and over time, aspirations toward 5, where we see the full benefits in clinical trial and real-world setting, so I think as we look into next year, we'd expect the underlying growth to continue probably at this, what we're seeing in terms of volume, so sort of number of vials in total is sequential quarterly growth in the sort of low teens.

今年以來，我們看到朝著平均每年 2 個週期的目標取得了進展。正如您在問題中提到的，我們的目標是至少達到 3，並隨著時間的推移，力爭達到 5，屆時我們將在臨床試驗和真實世界環境中看到全部益處。因此，我認為展望明年，我們預計潛在的成長可能會繼續保持目前的水平，就銷量而言，也就是藥瓶總數，季度環比增長幅度在 10% 左右。

And I think that's reasonable to expect as we head into next year and continue to sort of climb towards that on average, 3 cycles of use; again, supplemented by, or accelerated by the national guidelines that were issued in July and our efforts to educate physicians in that regard. So, we're looking forward to the continued underlying growth here, and I think expect that to continue on a good basis as we head into 2026. Rafael, do you want to talk about Bema?

我認為，隨著我們進入明年並繼續朝著平均 3 個使用周期的目標邁進，這是合理的預期；此外，7 月份發布的國家指南以及我們在這方面對醫生的教育工作也對此進行了補充或加速。因此，我們期待這裡能夠繼續保持潛在的成長，而且我認為，隨著我們邁入 2026 年，這種成長勢頭有望繼續保持良好。拉斐爾，你想談談貝瑪嗎？

Sure. So, we're still digesting the data. You saw the data at ESMO that was presented with the primary analysis of 096 and then the final analysis with this attenuated treatment effect. And then Amgen announced that 098 was a negative study in terms of not meeting statistical significance. So, we're looking at with Amgen and our partner at translational markers and subgroups, and we will be doing this in the upcoming weeks and make a decision.

當然。所以，我們還在消化這些數據。您在 ESMO 上看到了 096 的主要分析數據，以及隨後的最終分析數據，其中治療效果有所減弱。然後安進公司宣布，098 研究結果為陰性，因為它沒有達到統計意義。所以，我們正在與安進公司和我們的合作夥伴一起研究轉化標誌物和亞組，我們將在接下來的幾週內完成這項工作並做出決定。

But our opinion is that it will be very challenging to get an approval in China with this data set. So as such, we're thinking about how to deploy these resources to the rich pipeline that we've been discussing today and try to capitalize on the fact that we will have this opportunity of time, people, resources and effort to advance the current pipeline.

但我們認為，憑藉這套數據集，在中國獲得批准將非常困難。因此，我們正在考慮如何將這些資源部署到我們今天討論的豐富的流程中，並努力利用我們擁有的時間、人力、資源和精力來推進當前流程。

Thank you, we have come to the end of the question-and-answer session. Thank you all very much for your questions. I'll now turn the conference back to Dr. Samantha Du for her closing comments.

謝謝大家，問答環節到此結束。非常感謝大家的提問。現在我將把會議交還給薩曼莎·杜博士，請她作總結發言。

Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support and look forward to updating you again after the fourth quarter of 2025. Operator, you may now disconnect this call.

謝謝接線生。感謝大家今天抽空參加我們的電話會議。感謝您的支持，我們期待在 2025 年第四季之後再次向您報告最新情況。操作員，您可以掛斷電話了。

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

感謝您參加今天的會議。節目到此結束。現在您可以斷開線路了。