Zai Lab Ltd (ZLAB) 2025 Q2 法說會逐字稿

Hello, ladies and gentlemen. Thank you for standing by and welcome to Zai Lab's second-quarter 2025 financial results conference call. (Operator Instructions) As a reminder, today's call is being recorded.

女士們、先生們，大家好。感謝您的支持，歡迎參加再鼎醫藥 2025 年第二季財務業績電話會議。（操作員指示）提醒一下，今天的通話正在被錄音。

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

現在我很高興將發言權交給投資者關係高級副總裁 Christine Chiou。請繼續，女士。

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

謝謝您，接線生。大家好，歡迎大家。今天的財報電話會議將由再鼎醫藥創辦人、執行長兼董事長杜嘉班納博士主持。與她一同出席的還有總裁兼營運長 Josh Smiley、總裁兼全球研發主管 Rafael Amado 博士以及財務長 Yajing Chen 博士。我們的商務長 Jonathan Wang 也將在電話會議的問答環節回答問題。

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.

提醒一下，在今天的電話會議中，我們將根據我們目前的預期做出某些前瞻性的陳述。這些聲明受到眾多風險和不確定性的影響，這些風險和不確定性可能導致實際結果與我們的預期有重大差異，原因包括我們向美國證券交易委員會提交的文件中討論的因素。

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 August 7, 2025, for additional information on this non-GAAP financial measure.

我們也會參考調整後的營業虧損，這是一項非公認會計準則財務指標。有關此非 GAAP 財務指標的更多信息，請參閱我們於 2025 年 8 月 7 日向美國證券交易委員會 (SEC) 提交的收益報告。

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

現在，我很高興將電話轉給 Samantha Du 博士。

Thank you, Christine. Good morning and good evening, everyone. Thank you for joining us today. As we've reached the midpoint of 2025, Zai Lab is entering a pivotal phase. killing our commercial business, advancing our global pipeline, and executing on the goals we outlined at the beginning of the year. Our long-term vision of becoming a leading global biopharma remains strong, grounded on consistent execution and meaningful progress across the business.

謝謝你，克里斯汀。大家早安，晚上好。感謝您今天加入我們。2025年已過半，再鼎醫藥正進入一個關鍵階段。我們將終止商業業務，推進全球產品線，並執行我們在年初制定的目標。我們成為全球領先生物製藥公司的長期願景依然堅定，並以持續執行和整個業務的有意義的進步為基礎。

We are reaffirming our full-year revenue guidance of USD560 million to USD590 million. We remain on track to achieve profitability in the fourth quarter, a milestone made possible by the efficient, scalable model we have built over the years.

我們重申全年營收預期為 5.6 億美元至 5.9 億美元。我們仍有望在第四季度實現盈利，這一里程碑的實現得益於我們多年來建立的高效、可擴展的模式。

In our original business, momentum is building as we head into a period of significant growth supported by multiple new term launches. This includes pipeline product opportunities, like VYVGART in multiple autoimmune indications, and povitacacept, a dual BAFF inhibitor with broad potential.

在我們原有的業務中，隨著我們進入在多個新術語推出的支持下的顯著增長期，發展勢頭正在增強。這包括管道產品機會，如用於多種自體免疫適應症的 VYVGART 和具有廣泛潛力的雙重 BAFF 抑制劑 povitacacept。

We also anticipate approvals for KarXT in schizophrenia and Tivdak in cervical cancer, both currently under regulatory views in China. We're preparing for submissions for other later stage assets, including bemarituzumab for gastric cancer, and tumor treating fields for pancreatic cancer. Combined with our broader regional pipeline, these programs position us well for long-term growth.

我們也預計用於治療精神分裂症的 KarXT 和用於治療子宮頸癌的 Tivdak 也將獲得批准，目前這兩種藥物都在中國接受監管批准。我們正在準備提交其他後期資產的申請，包括用於治療胃癌的貝馬利珠單抗和用於治療胰腺癌的腫瘤治療領域。結合我們更廣泛的區域管道，這些項目為我們實現長期成長奠定了良好的基礎。

On the global R&D front, we're advancing a pipeline of innovative, globally competitive programs. ZL-1310, our DLL3 ADC, continues to demonstrate first-in-class -- best-in-class potential in small cell lung cancer, as illustrated by the updated data presented at ASCO. We also see encouraging early signals in other difficult-to-treat tumors such as neuroendocrine carcinomas. Beyond that, we're advancing our next wave of innovative global programs into the clinics, including ZL-1503, a bi-specific IL-13/IL-31 study for atopic dermatitis; and ZL-6201, our LRRC15 ADC for solid tumors.

在全球研發方面，我們正在推動一系列創新的、具有全球競爭力的項目。我們的 DLL3 ADC ZL-1310 繼續在小細胞肺癌領域展現出一流的潛力，正如 ASCO 上展示的最新數據所示。我們也在其他難以治療的腫瘤（如神經內分泌癌）中看到了令人鼓舞的早期訊號。除此之外，我們正在將下一波創新全球計畫推進到臨床階段，包括針對異位性皮膚炎的雙特異性 IL-13/IL-31 研究 ZL-1503；以及用於實體腫瘤的 LRRC15 ADC ZL-6201。

This development continues to be a core pillar of our growth strategy. As global interest in China-originated innovation rises, Zai Labs is uniquely positioned to act as a bridge between China's thriving bio ecosystem and global markets. Our deep local know-how and global R&D expertise allow us to source and develop high-potential assets emerging from China and the rest of the world, while continuing to expand our internally discovered global pipeline. We're also leveraging AI across the organization.

這一發展持續成為我們成長策略的核心支柱。隨著全球對中國創新的興趣日益濃厚，再鼎醫藥擁有獨特的優勢，可以作為中國蓬勃發展的生物生態系統與全球市場之間的橋樑。我們深厚的本地知識和全球研發專業知識使我們能夠尋找和開發來自中國和世界其他地區的高潛力資產，同時繼續擴大我們內部發現的全球管道。我們也在整個組織中利用人工智慧。

For example, optimizing clinical trials, accelerating timelines, and sharpening our commercial analytics. These ongoing efforts are already improving our speed, precision, and efficiency. Going forward, we will apply more AI tools to accelerate our future growth.

例如，優化臨床試驗、加快時間表以及加強我們的商業分析。這些持續的努力已經提高了我們的速度、精確度和效率。未來，我們將應用更多的人工智慧工具來加速我們未來的成長。

We remain disciplined in our operations, scaling efficiently while investing strategically in both commercial execution and pipeline innovation. The progress we have made this quarter reinforces our conviction. Seeing what Zai Lab is becoming, a profitable high-growth company with global impact, powered by innovation, disciplined execution, and a deep commitment to delivering long-term values for patients and shareholders alike.

我們在營運中保持紀律，高效擴展，同時在商業執行和管道創新方面進行策略性投資。本季我們的進展增強了我們的信念。看看再鼎醫藥正在成為一家具有全球影響力、盈利能力強、高成長的公司，其動力來自創新、嚴謹的執行以及為患者和股東提供長期價值的堅定承諾。

Now I turn the call over to Josh. Josh?

現在我把電話轉給喬希。喬希？

Thank you, Samantha, and hello, everyone. Let me start with VYVGART, where strong commercial execution continues to drive momentum in gMG. In the second quarter, we saw record levels of patient utilization supported by a steady flow of new patient starts and increasing treatment duration. We are seeing a meaningful shift toward maintenance use, a reflection of growing physician confidence in VYVGART's long-term benefits.

謝謝你，薩曼莎，大家好。首先從 VYVGART 開始，其強大的商業執行力繼續推動 gMG 的發展勢頭。在第二季度，由於新患者數量的穩定增長和治療時間的延長，我們的患者利用率達到了創紀錄的水平。我們看到了向維持性使用的重大轉變，這反映出醫生對 VYVGART 的長期益處的信心日益增強。

These positive trends are supported by ongoing physician education and patient support programs aimed at extending treatment duration. We expect this momentum to further accelerate following the July update to China's national gMG guidelines, which meaningfully elevate VYVGART's positioning. The new guidelines recognize minimal symptom expression, or MSE, as the primary treatment goal in gMG and highlight VYVGART's ability to achieve MSE rapidly and durably.

這些積極趨勢得到了旨在延長治療時間的持續醫生教育和患者支持計劃的支持。我們預計，隨著中國國家基因改造生物指南於 7 月更新，這一勢頭將進一步加速，這將顯著提升 VYVGART 的定位。新指引將最小症狀表現（MSE）視為 gMG 的主要治療目標，並強調 VYVGART 快速且持久地實現 MSE 的能力。

VYVGART has the highest MSE rates, ranging from 40% to 73% across clinical studies. And stands out for its rapid onset and deep and sustained efficacy. VYVGART is now recommended for early use in mild to moderate and highly active patients and for sustained long-term treatment to maximize benefit, marking a major step forward for biological adoption for treating gMG in China.

VYVGART 的 MSE 率最高，在臨床研究中範圍從 40% 到 73%。並因其起效迅速、療效深遠持久而脫穎而出。目前，VYVGART 被推薦用於輕度至中度及高度活躍患者的早期治療，並進行長期持續治療以最大程度地提高療效，這標誌著中國在生物製劑用於治療 gMG 方面邁出了重要一步。

We see significant long-term potential for VYVGART. Physicians are initiating treatment earlier and shifting away from steroids, yet VYVGART penetration in gMG is only 10%. We are well positioned to drive broader adoption and to capture the substantial opportunity that lies ahead. Once listed on NRDL, we believe that subcutaneous formulation will further accelerate uptake by driving deeper market penetration and expanding patient access.

我們看到 VYVGART 具有巨大的長期潛力。醫生們正在更早開始治療並逐漸停止使用類固醇，但 VYVGART 在 gMG 的滲透率僅為 10%。我們已做好準備，推動更廣泛的採用，並抓住未來的巨大機會。一旦被列入國家健保目錄，我們相信皮下製劑將進一步加速市場滲透，擴大病患用藥管道，加速普及。

The launch in CIDP is also underway, with efforts focused on increasing supplemental health insurance coverage and driving awareness. Our planned submission of the prefilled syringe remains on track and will further differentiate the brand through added convenience and improved adherence.

CIDP 的啟動工作也正在進行中，重點是增加補充醫療保險的覆蓋範圍並提高人們的認識。我們計劃提交的預充式註射器仍在按計劃進行，並將透過增加便利性和提高依從性來進一步區分品牌。

Beyond gMG and CIDP, we are actively pursuing label expansion opportunities across a range of immunology indications with significant unmet need, including seronegative gMG, ocular MG, myositis, lupus nephritis, and sjogren’s. Taken together, these efforts reinforce our view that VYVGART can exceed $1 billion in peak sales and become a foundational immunology brand in China.

除了 gMG 和 CIDP 之外，我們還在積極尋求一系列具有重大未滿足需求的免疫學適應症的標籤擴展機會，包括血清陰性 gMG、眼部 MG、肌炎、狼瘡性腎炎和乾燥綜合徵。總的來說，這些努力強化了我們的觀點，VYVGART的峰值銷售額可以超過10億美元，並成為中國的基礎免疫學品牌。

Turning to the broader commercial portfolio, ZEJULA had a softer quarter due to evolving competitive dynamics within the PARP class. That said, we were already seeing signs of stabilization entering the second half of the year. We anticipate continued volume expansion across the PARP class and expect ZEJULA's sales to strengthen in first-line ovarian cancer, where it maintains a differentiated safety and efficacy profile supported by strong China patients' data and first-to-market advantage. We are confident in ZEJULA's return to growth later this year.

轉向更廣泛的商業投資組合，由於 PARP 類別內不斷變化的競爭動態，ZEJULA 本季表現較為疲軟。話雖如此，我們已經看到下半年穩定的跡象。我們預計 PARP 類藥物的銷售將繼續擴大，並預計則樂在卵巢癌一線治療領域的銷售將增強，在該領域，則樂保持著差異化的安全性和有效性，這得益於強大的中國患者數據和先發優勢。我們對 ZEJULA 今年稍後恢復成長充滿信心。

XACDURO continues to see robust demand and highly positive feedback from physicians treating CRAB infections, a serious and underserved public health threat in China, with approximately 300,000 Acinetobacter cases annually. As we work to localize manufacturing, supply constraints may modestly limit near-term growth in 2025, but underlying demand remains strong.

XACDURO 持續受到治療 CRAB 感染的醫生的強勁需求和高度積極的回饋，CRAB 感染是中國嚴重且服務不足的公共衛生威脅，每年約有 30 萬例不動桿菌病例。隨著我們努力實現製造業在地化，供應限制可能會適度限制 2025 年的短期成長，但潛在需求仍然強勁。

With AUGTYRO, we are taking a focused, efficient approach to commercialization. While near-term revenue is expected to be limited, we believe its best-in-class clinical profile in ROS1-positive non-small-cell lung cancer, including strong CNS activity and durability in both TKI-naive and pretreated patients, positions AUGTYRO as an important treatment option for patients. We will continue to pursue efficient ways to broaden our reach to realize the full value of its long-term potential.

透過 AUGTYRO，我們採取了專注、高效的方法來實現商業化。雖然預計短期收入有限，但我們相信其在 RO​​S1 陽性非小細胞肺癌中的最佳臨床特徵，包括強大的中樞神經系統活性和對 TKI 初治患者和預處理患者的持久性，使 AUGTYRO 成為患者的重要治療選擇。我們將繼續尋求有效的方式來擴大我們的業務範圍，以充分發揮其長期潛力的價值。

Turning to our financial position, we continued to execute against our profitability plan, maintaining disciplined spending while investing in growth. For the second quarter of 2025, operating loss improved by 28% to $54.9 million. On an adjusted basis, which excludes certain non-cash expenses, operating loss was reduced by 37% to $34.2 million, keeping us firmly on track to reach profitability on an adjusted basis in the fourth quarter.

談到我們的財務狀況，我們繼續執行獲利計劃，在投資成長的同時保持有紀律的支出。2025 年第二季度，營業虧損改善 28% 至 5,490 萬美元。經過調整後（不包括某些非現金支出），營業虧損減少了 37%，至 3,420 萬美元，使我們穩固地走在第四季度實現調整後盈利的軌道上。

We also expect a strong set of near-term regulatory milestones ahead. KarXT and Tivdak are under review by the NMPA, and we plan to submit applications for VYVGART's pre-filled syringe for gMG and CIDP, bemarituzumab for gastric cancer, and TTFields for pancreatic cancer in the coming months. To support these potential near-term launches, we are leveraging a scalable, resource-efficient commercial model, repurposing teams where possible, and targeting field force deployment in high-impact areas.

我們也預期近期監管方面將出現一系列重大里程碑。KarXT 和 Tivdak 正在接受 NMPA 的審查，我們計劃在未來幾個月內提交 VYVGART 用於 gMG 和 CIDP 的預充式註射器、用於胃癌的貝馬利珠單抗和用於胰腺癌的 TTFields 的申請。為了支援這些潛在的近期發布，我們正在利用可擴展、資源高效的商業模式，盡可能地重新調整團隊，並針對高影響區域部署現場部隊。

For example, our ZEJULA team will support Tivdak, our QINLOCK team will lead efforts for bemarituzumab, and we plan to cover 85% of the schizophrenia market with a highly focused team of approximately 150 representatives for KarXT. At the same time, we are advancing several operational efficiencies, including scaling support forVYVGART, localizing manufacturing for key products, and improving cost leverage across the portfolio, all of which will drive both strong top-line growth and margin expansion.

例如，我們的 ZEJULA 團隊將支持 Tivdak，我們的 QINLOCK 團隊將領導 bemarituzumab 的工作，我們計劃透過一支由約 150 名代表組成的高度專注的 KarXT 團隊覆蓋 85% 的精神分裂症市場。同時，我們正在提高多項營運效率，包括擴大對VYVGART的支援、實現關鍵產品的在地化製造以及提高整個產品組合的成本槓桿，所有這些都將推動強勁的收入成長和利潤率擴張。

Business development remains a strategic priority. We are focused on three core areas, strengthening our global pipeline with externally sourced innovation, expanding our China portfolio with best-in-class assets, and pursuing out licensing and global partnerships to unlock the full value of our pipeline on the global stage. With continued commercial momentum, an innovative and advancing pipeline, and a path to profitability, we are confident in our ability to deliver meaningful long-term growth and value.

業務發展仍然是我們的策略重點。我們專注於三個核心領域：透過外部創新加強我們的全球產品線；透過一流的資產擴大我們的中國產品組合；以及尋求許可和全球合作夥伴關係，以在全球舞台上釋放我們產品線的全部價值。憑藉持續的商業動能、創新和進步的管道以及獲利之路，我們有信心實現有意義的長期成長和價值。

And with that, I will now pass the call over to Rafael to discuss the great progress within our pipeline.

現在，我將把電話轉給拉斐爾，討論我們管道內的巨大進展。

Thank you, Josh. I'll start with highlights from our global pipeline since our last earnings call and then cover upcoming milestones. Let's start with ZL-1310, or Zocilurtatug pelitecan or zoci for short, our first-in-class DLL3 targeting ADC for small cell lung cancer and other neuroendocrine tumors.

謝謝你，喬希。我將首先介紹自上次財報電話會議以來我們全球管道的亮點，然後介紹即將到來的里程碑。讓我們從 ZL-1310（簡稱 Zocilurtatug pelitecan 或 zoci）開始，這是我們針對小細胞肺癌和其他神經內分泌腫瘤的首創 DLL3 靶向 ADC。

At ASCO this year, we presented dose-finding results in patients with previously treated extensive-stage small cell lung cancer. Across all dose levels in the second-line setting, the unconfirmed response rate was 67% and the disease control rate was 97%. The most promising combination of response and tolerability was observed at 1.6 milligrams per kilogram, which showed a 79% unconfirmed overall response rate and 100% control rate of the disease, which is among the strongest efficacy response signals seen in this setting today. At a median follow-up of 3.4 months, median duration of response had not yet been reached, and 29 of 38 responders remain on study.

在今年的 ASCO 上，我們展示了針對先前接受過治療的廣泛期小細胞肺癌患者的劑量探索結果。在二線治療的所有劑量水準中，未經證實的反應率為 67%，疾病控制率為 97%。在劑量為 1.6 毫克/公斤時觀察到了最有希望的反應和耐受性組合，顯示出 79% 的未經證實的總體反應率和 100% 的疾病控制率，這是當今在此環境下看到的最強療效反應信號之一。經過 3.4 個月的中位隨訪，尚未達到中位反應持續時間，38 名反應者中仍有 29 名仍在研究中。

Importantly, we observed compelling intracranial activity, an important unmet need in small cell lung cancer, where up to 70% of patients developed brain metastasis. Among these patients, the ORR was 68% and it was 86% in patients without prior cranial irradiation. Again, the highest intracranial response was reported.

重要的是，我們觀察到明顯的顱內活動，這是小細胞肺癌中一個重要的未滿足需求，多達 70% 的患者出現腦轉移。在這些患者中，ORR 為 68%，而先前未接受過顱腦照射的患者中 ORR 為 86%。再次報告了最高的顱內反應。

Zoci also demonstrated a well-tolerated and differentiated safety profile. At target doses below 2 milligrams per kilogram, there were no Grade 2 or higher interstitial lung disease cases and Grade 3, and above treatment-related adverse events occur in just 6% of patients with no drug-related discontinuation. These data support the potential of zoci as a clinically meaningful treatment for patients in second-line small cell lung cancer and other lines of therapy, either as monotherapy or in combination.

Zoci 也表現出了良好的耐受性和差異化的安全性。當目標劑量低於每公斤 2 毫克時，沒有出現 2 級或更高級別的間質性肺病病例，且只有 6% 的患者出現 3 級及以上的治療相關不良事件，且沒有因藥物相關原因停藥。這些數據支持 zoci 作為二線小細胞肺癌患者和其他療法的臨床意義的治療方法的潛力，無論是作為單一療法還是聯合療法。

We are pleased to receive a fast-track designation from the FDA in small cell lung cancer adding to the orphan drug designation granted earlier this year and are pursuing breakthrough therapy designation. We have aligned with the FDA on the accelerated approval pathway and are finalizing details on the pivotal study design in second-line small cell lung cancer. We remain on track to initiate the registration of study later this year.

我們很高興獲得 FDA 在小細胞肺癌治療方面的快速通道資格，這補充了今年早些時候授予的孤兒藥資格，並且我們正在尋求突破性治療資格。我們已與 FDA 就加速審批途徑達成一致，並正在敲定二線小細胞肺癌關鍵研究設計的細節。我們仍將按計劃在今年稍後啟動學習註冊。

Given its favorable safety profile at 1.6 milligrams per kilogram, zoci is also well-suited for use in the frontline setting. We are rapidly enrolling patients in the combination dose escalation portion of the study, which will be followed by dose optimization and then a pivotal computation trial after the defined follow-up period. We expect to provide a clinical trial update of zoci in combination with a resolution map in the next year. Beyond small cell lung cancer, zoci is also being studied in other neuroendocrine carcinomas where enrollment is ongoing in a global Phase 1/2 study which may have registration potential pending regulatory discussions. We plan to present preliminary data at a medical conference in the first half of the next year.

由於 zoci 的安全性良好（每公斤 1.6 毫克），因此也非常適合在前線環境中使用。我們正在迅速招募患者參與研究的聯合劑量遞增部分，隨後將進行劑量優化，然後在規定的追蹤期後進行關鍵的計算試驗。我們預計明年將提供 zoci 的臨床試驗更新以及解析度圖。除了小細胞肺癌之外，zoci 還在其他神經內分泌癌中進行研究，其中全球 1/2 期研究正在進行招募，該研究可能具有註冊潛力，等待監管討論。我們計劃在明年上半年的醫學會議上展示初步數據。

Moving to ZL-1503, our internally developed IL-13/IL-31 bispecific antibody for atopic dermatitis. In June, we presented preclinical data showing durable dual inhibition of both itch and inflammation pathways. While IL-4, IL-13 inhibitors have marginally improved outcomes in atopic dermatitis, symptoms mediated by IL-31 often remain only partially alleviated, contributing to limited and incomplete clinical responses to currently available medications for many patients. ZL-1503 dual mechanism and extended half-life may enable less frequent dosing and more comprehensive disease control. We are on track to initiate a Phase 1 study for moderate to severe atopic dermatitis later this year with both IV and subcutaneous formulations progressing as planned.

轉向 ZL-1503，我們內部開發的用於治療異位性皮膚炎的 IL-13/IL-31 雙特異性抗體。6 月份，我們公佈了臨床前數據，顯示對搔癢和發炎途徑具有持久的雙重抑製作用。雖然 IL-4、IL-13 抑制劑略微改善了異位性皮膚炎的治療效果，但 IL-31 介導的症狀通常僅部分緩解，導致許多患者對目前可用的藥物的臨床反應有限且不完全。ZL-1503 的雙重機制和延長的半衰期可以減少給藥頻率並實現更全面的疾病控制。我們計劃在今年稍後啟動針對中度至重度異位性皮膚炎的 1 期研究，靜脈注射和皮下注射製劑的研發均按計畫進行。

Importantly, 1503 exhibits immunomodulatory properties that are extending beyond atopic dermatitis, with potential applications across a range of interleukin-driven diseases, laying the foundation for a pipeline of future indications. More broadly, across our global portfolio, we're advancing our internal discovery efforts in parallel. We are actively pursuing external opportunities to expand our pipeline with early-stage compounds from China and beyond.

重要的是，1503 表現出的免疫調節特性不僅限於異位性皮膚炎，還可能應用於一系列白細胞介素驅動的疾病，為未來一系列的適應症奠定了基礎。更廣泛地說，在我們的全球投資組合中，我們正在同步推動我們的內部發現工作。我們正在積極尋求外部機會，利用來自中國及其他地區的早期化合物來擴大我們的產品線。

Now turning to our regional programs, let's start with oncology. Bemarituzumab, our first-in-class FGFR2b-targeting therapy for gastric cancer. In June, we announced positive top-line results from the global Phase 3 FORTITUDE-101 study in first-line FGFR2b-positive gastric, gastroesophageal junction cancer.

現在談談我們的區域項目，讓我們從腫瘤學開始。Bemarituzumab 是我們首創的針對胃癌的 FGFR2b 標靶療法。6 月，我們發表了全球 3 期 FORTITUDE-101 研究在一線治療 FGFR2b 陽性胃癌、胃食道交界處癌症的正面頂線結果。

Bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival as compared to placebo plus chemotherapy in patients with unreceptible, locally advanced, or metastatic gastric or gastroesophageal junction cancer with FGFR2b overexpression and who are known as HER2-positive. FGFR2b overexpression was defined as 2 plus or 3 plus staining greater than 10% of tumor cells by centrally performed immunohistochemistry.

對於患有 FGFR2b 過度表達且已知為 HER2 陽性的不可切除、局部晚期或轉移性胃癌或胃食道連接部癌的患者，與安慰劑聯合化療相比，Bemarituzumab 聯合化療在總體生存率方面表現出統計學上顯著且具有臨床意義的改善。FGFR2b 過度表現被定義為透過集中進行的免疫組織化學檢測，2 加或 3 加染色超過 10% 的腫瘤細胞。

The most common treatment effects adverse events in patients treated with bemarituzumab with chemotherapy were reduced visual acuity, keratitis, anemia, neutropenia, nausea, corneal epithelium defect, and dry eye. While ocular events were consistent with the Phase 2 experience and observed in both arms, they occurred with greater frequency and severity in the Phase 3 bemarituzumab arm.

接受貝馬利珠單抗合併化療治療的患者最常見的治療效果不良事件是視力下降、角膜炎、貧血、嗜中性球減少、噁心、角膜上皮缺損和乾眼症。雖然眼部事件與第 2 階段的經驗一致，並且在兩組中均觀察到，但在第 3 階段 bemarituzumab 組中發生的頻率和嚴重程度更高。

These data, which our partner Amgen plans to present at an upcoming medical meeting, support a regulatory submission in China. Meanwhile, we look forward to the top-line results from our second global Phase 3 study, FORTITUDE-101, a Phase 1b/3 study of the bemarituzumab plus chemotherapy and nivolumab in patients with first-line gastric cancer. Phase 3 data readout is anticipated in the second half of 2025 for the first half of 2026.

我們的合作夥伴安進計劃在即將舉行的醫學會議上展示這些數據，以支持在中國提交監管申請。同時，我們期待第二項全球 3 期研究 FORTITUDE-101 的頂線結果，這是一項針對第一線胃癌患者使用 bemarituzumab 聯合化療和 nivolumab 的 1b/3 期研究。預計第 3 階段資料讀取將於 2025 年下半年及 2026 年上半年進行。

In pancreatic cancer, our partner Novocure announced positive results from the Phase 3 PANOVA-3 trial evaluating tumor-treating fields with chemotherapy in newly diagnosed patients with unreceptible, locally advanced pancreatic adenocarcinoma. The study met its primary endpoint of overall survival, representing the first Phase 3 study success in this setting. We believe this therapy could meaningfully expand treatment options for patients with limited alternatives in pancreatic cancer, and we expect to submit in China this year.

在胰臟癌領域，我們的合作夥伴 Novocure 宣布了 3 期 PANOVA-3 試驗的積極結果，該試驗評估了腫瘤治療場與化療聯合治療新診斷的無法接受治療的局部晚期胰腺腺癌患者。該研究達到了整體存活率的主要終點，代表了在該環境下首次 3 期研究的成功。我們相信這種療法可以顯著擴大胰臟癌患者的治療選擇，我們預計今年將在中國提交申請。

Now moving to our key late-stage regional programs in immunology. For efgartigimod, we continue to explore its potential to treat other IgG-mediated autoimmune indications, including thyroid eye disease or TED, myositis, seronegative gMG, ocular MG, sjogren's disease, and lupus nephritis

現在轉向我們免疫學領域的關鍵後期區域計畫。對於 efgartigimod，我們繼續探索其治療其他 IgG 介導的自體免疫疾病的潛力，包括甲狀腺眼疾或 TED、肌肉炎、血清陰性 gMG、眼部 MG、乾燥症和狼瘡性腎炎

In the second half of this year, we expect top-line results from the global Phase 3 study of seronegative gMG and the Phase 2 study of lupus nephritis. In addition, we will join the registrational UNITY study of efgartigimod to subcutaneously administered by prefilled syringe in sjogren's disease in Greater China in the third quarter of this year.

今年下半年，我們預計將獲得血清陰性 gMG 全球 3 期研究和狼瘡性腎炎 2 期研究的頂線結果。此外，我們將於今年第三季加入efgartigimod在大中華區用於乾燥症患者預充式註射器皮下給藥的註冊性UNITY研究。

Povetacicept is a dual antagonist of the BAFF and APRIL pathways. China has already joined the global Phase 3 RAINIER trial in IgA nephropathy, and enrollment of the interim analysis cohort is now completed. Our partner, Vertex, will conduct an interim analysis once this cohort reaches 36 weeks of treatment, with the potential to file for accelerated approval in the US in the first half of 2026. We also plan to join the global Pivotal Phase 2, 3 study in primary membranous nephropathy expected to start in the second half of this year.

Povetacicept 是 BAFF 和 APRIL 路徑的雙重拮抗劑。中國已加入IgA腎病變全球3期RAINIER試驗，中期分析隊列的招募工作已完成。我們的合作夥伴 Vertex 將在該組患者完成 36 週的治療後進行中期分析，並有可能在 2026 年上半年在美國申請加速批准。我們也計劃加入預計今年下半年啟動的原發性膜性腎病變全球關鍵性 2、3 期研究。

Moving to VRDN-003, an anti-IGF-1R antibody, a potentially best-in-class therapy in thyroid eye disease. It has the same binding domain as veligrotug and it is administered subcutaneously. Veligrotug has consistently demonstrated reductions in proptosis, diplopia, and clinical activity score across both active and chronic thyroid eye disease in Phase 3 studies. The infrequent dosing regimen of every four weeks or every eight weeks presents significant potential as a transformative option for patients with TED.

轉向 VRDN-003，一種抗 IGF-1R 抗體，可能是治療甲狀腺眼疾的最佳療法。它具有與 veligrotug 相同的結合域，並且是皮下給藥。在第 3 期研究中，Veligrotug 已持續證明可降低活動性和慢性甲狀腺眼疾患者的眼球突出、複視和臨床活動評分。每四週或每八週一次的低頻率給藥方案對於 TED 患者來說具有巨大的潛力，可以作為轉變選擇。

The two global registration of REVEAL-1 and REVEAL-2 studies are enrolling and our partner Viridian is expected to provide top-line results in the first half of 2026. We are working on initiating Phase 1 PK study in China and a Phase 3 registrational study in TED upon CDE agreement expected in the fourth quarter of 2025.

REVEAL-1 和 REVEAL-2 兩項全球註冊研究正在招募中，我們的合作夥伴 Viridian 預計將在 2026 年上半年提供頂線結果。我們正在努力在中國啟動 1 期 PK 研究，並根據 CDE 協議在 TED 啟動 3 期註冊研究，預計將於 2025 年第四季完成。

These updates underscore our continuous focus on pipeline renewal as well as discovery and development innovation and execution across oncology and immunology. I look forward to sharing further progress updates in the coming quarters.

這些更新強調了我們對管道更新以及腫瘤學和免疫學領域的發現和開發創新和執行的持續關注。我期待在接下來的幾個季度分享進一步的進展更新。

And now Yajing will give an overview of our financial results. Yajing?

現在雅靜將概述我們的財務表現。雅靜？

Thank you, Rafael. Now I will discuss highlights from our second quarter 2025 financial results compared to the prior year period. Total revenue grew 9% year over year to $110 million in the second quarter, primarily driven by higher sales of VYVGART, supported by duration of therapy extension and increasing market penetration, as well as XACDURO, which was launched since the fourth quarter of 2024. Our focus on financial discipline and efficiency efforts was also reflected on the expenses side.

謝謝你，拉斐爾。現在，我將討論我們 2025 年第二季財務業績與去年同期相比的亮點。第二季總營收年增 9%，達到 1.1 億美元，主要得益於 VYVGART 銷售額的成長、治療時間的延長和市場滲透率的提高，以及自 2024 年第四季推出的 XACDURO。我們對財務紀律和效率努力的關注也體現在支出方面。

R&D and SG&A as a percentage of revenue declined significantly year over year. R&D expenses for the second quarter decreased 18% year over year, mainly due to decreased personnel costs and clinical trial costs as a result of resource prioritization and efficiency efforts. SG&A expenses for the second quarter decreased 11% year over year, mainly due to the strategic resource allocation and the efficiency improvement. As a result of operating leverage we're building into our business, our large fund operations decreased 28% for the second quarter to $54.9 million.

研發和銷售、一般及行政費用佔收入的百分比較去年同期大幅下降。第二季研發費用較去年同期下降18%，主要由於資源優先化和效率提升導致人員成本和臨床試驗成本下降。第二季銷售、一般及行政費用較去年同期下降11%，主要得益於策略資源分配及效率提升。由於我們在業務中建立的經營槓桿，我們的大型基金營運在第二季下降了 28%，至 5,490 萬美元。

When you adjust our loss from operations to exclude certain noncash items, specifically depreciation, amortization, and share-based compensation, we had adjusted loss from operations of $34.2 million in the second quarter, reflecting year-over-year improvement of 37%. Based on our operating plan and our anticipated revenue growth, we expect to achieve profitability on the adjusted basis by the fourth quarter of this year.

當您調整我們的營業虧損以排除某些非現金項目（特別是折舊、攤提和股權激勵）時，我們第二季的調整營業虧損為 3,420 萬美元，年成長 37%。根據我們的營運計劃和預期的收入成長，我們預計今年第四季將實現調整後的利潤。

Looking ahead, we expect to deliver quarter over quarter total revenue growth in 2025 with a meaningful acceleration anticipated in the later part of the year. We remain confident in reaffirming our full year 2025 total revenue guidance of $560 million to $590 million. This revenue forecast reflects strong growth for VYVGART franchise, continued growth for our base business, and contributions from newly launched products. We are in a strong financial position, ending the quarter with a cash position of $832.3 million.

展望未來，我們預計 2025 年總收入將逐季成長，並預計在今年下半年將顯著加速。我們仍然有信心重申我們對 2025 年全年總收入的預期，即 5.6 億美元至 5.9 億美元。這項收入預測反映了 VYVGART 特許經營的強勁成長、我們基礎業務的持續成長以及新推出產品的貢獻。我們的財務狀況良好，本季末現金狀況為 8.323 億美元。

And with that, I would now like to turn the call back over to the operator to open up the line for questions. Operator?

現在，我想將電話轉回給接線生，以便大家可以提問。操作員？

(Operator Instructions) Jonathan Chang, Leerink Partners.

（操作員指示）Jonathan Chang，Leerink Partners。

First question, congrats on the positive FORTITUDE-101study results. Can you help us understand the potential opportunity for bema in frontline gastric cancer? What biomarker status and FGFR2b threshold would patients need for treatment with bema? And can you help us characterize the safety profile observed in the 101 study?

第一個問題，祝賀 FORTITUDE-101 研究取得了積極的成果。您能幫助我們了解 bema 在第一線胃癌療程中的潛在機會嗎？患者需要什麼樣的生物標記狀態和 FGFR2b 閾值才能接受 bema 治療？您能幫我們描述一下在 101 項研究中觀察到的安全性特徵嗎？

Good morning, Jonathan. It's Josh. Thanks for the message. I'll start on commercial and then turn it over to Rafael to talk a little bit more about the profile.

早安，喬納森。我是喬希。謝謝你的留言。我先從商業開始，然後交給拉斐爾進一步談論簡介。

First, there's over 450,000 patients with gastric cancer in China, about a third of whom overexpress FGFR2b. So very significant patient population. I think given what we know of the clinical benefits of this product and potential treatment duration, we're quite excited and confident that there's over time, a $1 billion sales potential opportunity in this potential indication.

首先，中國有超過45萬胃癌患者，其中約三分之一過度表現FGFR2b。因此患者人數非常多。我認為，鑑於我們對該產品的臨床益處和潛在治療持續時間的了解，我們非常興奮並有信心，隨著時間的推移，這種潛在適應症將帶來 10 億美元的潛在銷售機會。

We're already in this space with QINLOCK. We've got about 100 sales reps who promote QINLOCK today. We'll use that sales force and build on it to take advantage of the opportunity here. And again, we're quite excited by this product. It's going to deliver significant benefit to a very big patient population in China.

我們已經透過 QINLOCK 進入了這個領域。今天我們有大約 100 位銷售代表推廣 QINLOCK。我們將利用這支銷售團隊並在此基礎上抓住機會。再次，我們對這款產品感到非常興奮。它將為中國龐大的患者群體帶來巨大的利益。

And I'll ask Rafael to make some more comments.

我會請拉斐爾發表更多評論。

Yeah, thanks, Josh. And thanks for the question. As I said in the prepared remarks, this is a drug for patients with overexpression of FGFR2b, and that's about a third of patients, 30% or so. The cutoff is 2-plus to 3-plus, at least 10% of the cells. So in terms of patient numbers, it's close to 140,000, 150,000 new cases in China per year, which is very sizable, and we are preparing to launch this product with diagnostic as well.

是的，謝謝，喬希。感謝您的提問。正如我在準備好的演講中所說，這是一種針對 FGFR2b 過度表達患者的藥物，約佔患者的三分之一，即 30% 左右。截止值為 2+ 至 3+，至少 10% 的細胞。因此，就患者數量而言，中國每年新增病例接近 14 萬至 15 萬，這是一個非常大的數字，我們也正準備推出這款具有診斷功能的產品。

In terms of the toxicity, as I mentioned, the key toxicity was mild suppression, which is probably more related to chemotherapy, and then ocular toxicity, which was expected and it was seen in the Phase 2 study, the FIGHT trial.

就毒性而言，正如我所提到的，關鍵毒性是輕度抑制，這可能與化療更相關，然後是眼部毒性，這是預料之中的，並且在第 2 階段研究 FIGHT 試驗中也觀察到了這一點。

So, toxicity greater than 25% included mostly corneal toxicity that affected visual acuity. So, either punctic keratitis or epithelial defects as well as dry eyes. And we saw this actually in the placebo arm as well. but it's more pronounced in the treatment arm and more common in the 101 study than it was seen in the Phase 2 study and that may be because we included a more comprehensive and standardized ocular monitoring in that trial.

因此，大於 25% 的毒性主要包括影響視力的角膜毒性。因此，要嘛是點狀角膜炎，要嘛是上皮缺損，還有乾眼症。我們實際上也在安慰劑組中看到了這種情況。但它在治療組中更為明顯，在 101 研究中比在第 2 階段研究中更為常見，這可能是因為我們在該試驗中納入了更全面和標準化的眼部監測。

And this is expected, as I said, the receptor is expressed in epithelial cells in the cornea. It can be monitored by ocular consultation. Patients can be prophylaxed. It happens well into the treatment, so it doesn't happen right away. And at least in the Phase 2 study, they were reversible. So the details of all the safety will be presented at an upcoming meeting that Amgen has guided towards.

這是意料之中的，正如我所說，該受體在角膜上皮細胞中表達。可以透過眼科會診進行監測。患者可以得到預防。它會在治療過程中發生，所以不會立即發生。至少在第二階段的研究中，它們是可逆的。因此，所有安全細節將在安進指導的即將召開的會議上公佈。

And then in terms of how this will play out with regards to benefit-risk, well, it depends on the benefit that you will see when the presentation comes up. But these are patients that have a particularly poor prognosis, and there is a meaningful treatment effect that needs to be taken into account with this very aggressive form of cancer that has very limited treatment options.

然後，就收益風險而言，這將如何發揮作用，這取決於您在演示時將看到的收益。但這些患者的預後特別差，對於這種治療選擇非常有限的惡性癌症，需要考慮有意義的治療效果。

Understood. And maybe second question, if I may. Can you discuss your confidence levels in achieving your 2025 revenue guidance and profitability goal by year end? And how should we think about the contribution of VYVGART in achieving these goals? Thank you.

明白了。如果可以的話，也許還有第二個問題。您能否談談您對在年底前實現 2025 年收入指引和獲利目標的信心程度？而我們又該如何看待VYVGART在實現這些目標中所做出的貢獻呢？謝謝。

Thanks, Jonathan. It's Josh. First, we reaffirmed our top line guidance of $560 million to $590 million in sales, so obviously we're confident in that range. And on profitability, we also have reconfirmed that we see us achieving profitability on a non-GAAP basis in Q4. So I think full speed ahead on both of those.

謝謝，喬納森。我是喬希。首先，我們重申了 5.6 億美元至 5.9 億美元的銷售額預期，因此我們顯然對這一範圍充滿信心。在獲利能力方面，我們也再次確認，我們將在第四季度實現非公認會計準則下的獲利。所以我認為這兩項工作都會全速推進。

As it relates to the sales, We do expect accelerating growth in the second half of this year, driven certainly by VYVGART as one of the big drivers here. We're pleased with our performance in the second quarter. Saw, you know, record patient numbers in terms of patient starts and we're seeing, you know, every month we're seeing an increase in patient duration or numbers of doses or cycles per patient.

就銷售而言，我們確實預計今年下半年將加速成長，其中 VYVGART 無疑是主要推動力之一。我們對第二季的表現感到滿意。你知道，我們記錄了患者開始治療的人數，我們發現，每個月患者的治療持續時間或每個患者的劑量或週期數都在增加。

We expect that to accelerate in the second half of the year, both as we continue to build experience with physicians and patients but also leveraging the new national guidelines for gMG that were issued in July. So you should expect to see the kind of quarter-over-quarter acceleration or growth in sales for VYVGART that we saw in the second quarter, and again, we're quite happy with those trends.

我們預計這一進程將在下半年加速，因為我們將繼續累積與醫生和患者的經驗，同時也利用 7 月發布的新的 gMG 國家指南。因此，您應該會看到 VYVGART 銷售額出現像我們在第二季看到的那種環比加速或成長，而且，我們對這些趨勢感到非常滿意。

ZEJULA, we expect growth in the second half of the year. We did see some declines in the second quarter, but I would say that's mostly related to the choppiness and disruption that comes with a major competitor going off patent, that's LYNPARZA, and new competitors coming on. But we're quite confident in our position with ZEJULA as market leader in first line ovarian cancer. And again, we are already seeing good recovery in the third quarter, so we'd expect to see sales growth there.

ZEJULA，我們預計下半年將成長。我們確實看到了第二季度的一些下滑，但我認為這主要與主要競爭對手 LYNPARZA 專利到期以及新競爭對手出現所帶來的波動和混亂有關。但我們對 ZEJULA 作為一線卵巢癌治療市場的領導者地位充滿信心。而且，我們已經看到第三季的良好復甦，因此我們預計那裡的銷售額將會成長。

So again, confident about the trajectory and the shape of the growth for the second half of the year. With that growth then, if you look at our overall operating expenses, that growth drives us towards profitability. And if you look historically quarter over quarter, we continue to see good improvement each quarter and have good confidence that we'll get there in the fourth quarter of this year. So thanks.

因此，我們對下半年的成長軌跡和形態充滿信心。有了這種成長，如果你看看我們的整體營運費用，你會發現這種成長推動著我們獲利。如果從歷史上看，我們每季都會看到良好的改善，並且我們有信心在今年第四季實現這一目標。所以謝謝。

Anupam Rama, JPMorgan.

摩根大通的 Anupam Rama。

You talked about the second-half growth levers with VYVGART, and you talked about the stabilization of ZZEJULA looking to the second half. But just wondering if there's any outsized growth expected from the broader commercial franchise in terms of NUZYRA or XACDURO that might contribute meaningfully to getting to guidance and profitability by the end of the year.

您談到了 VYVGART 下半年的成長槓桿，也談到了 ZZEJULA 下半年的穩定性。但我只是想知道，就 NUZYRA 或 XACDURO 而言，更廣泛的商業特許經營是否有望實現超額增長，從而可能對在年底前獲得指導和盈利能力做出有意義的貢獻。

Thanks, Anupam. It's Josh. Yeah, I think first, if you look at XACDURO and AUGTYRO, both products are in the beginnings of the launch phases. We're really excited about the potential of both products.

謝謝，Anupam。我是喬希。是的，我認為首先，如果你看一下 XACDURO 和 AUGTYRO，這兩種產品都處於發布階段的開始階段。我們對這兩款產品的潛力感到非常興奮。

I think with XACDURO, should expect to see continued good growth, as we mentioned in the beginning of the call. I think the demand is strong. We're still working through supply and making sure we can fill as much of that demand as possible. So the more product we can get into the country, the better off we'll be, and we should expect to see continued good growth there. are somewhat limited, I think, in the second half of the year by supply constraints, but I think long-term for this product, we're quite excited.

我認為，正如我們在電話會議開始時提到的那樣，XACDURO 應該會繼續保持良好的成長。我認為需求很強。我們仍在努力解決供應問題，確保盡可能滿足需求。因此，我們向該國銷售的產品越多，我們的狀況就越好，我們應該期望看到那裡繼續保持良好的成長。我認為，由於供應限制，下半年的銷售量會受到一定限制，但我認為，從長遠來看，我們對這款產品感到非常興奮。

I think with AUGTYRO, we're taking a focused approach to the launch here, but also would expect to see good growth in the second half of the year. We have good pricing on NRDL. Of course, this is a product for patients with the mutation that provides really significant benefits.

我認為，對於 AUGTYRO，我們正採取一種專注的方式進行發布，但也預計今年下半年將實現良好的成長。我們的國家健保目錄定價合理。當然，對於發生突變的患者來說，這是一種能帶來真正顯著益處的產品。

So, yeah, I think as you look at your models, having more growth in the second half of the year from those products is important. AUGTYRO continues to be a strong driver of growth for us and expect that to continue in the second half as well.

所以，是的，我認為當你看你的模型時，這些產品在下半年實現更多的成長是很重要的。AUGTYRO 繼續成為我們強勁的成長動力，預計下半年也將持續這一勢頭。

Yigal Nochomovitz, Citigroup.

花旗集團的 Yigal Nochomovitz。

Yeah, hi. Thank you very much. I had a bunch of questions on the bema topic. So obviously you can't tell us the data, but you have said that it's statistically significant and clinically meaningful. And obviously in FIGHT, in the Phase 2 FIGHT trial, the OS delta was over 13 months. So can you just help put in perspective what the expectations should be around the OS data for FORTITUDE-101 in terms of the expected delta?

是的，你好。非常感謝。我對 bema 主題有很多疑問。所以顯然你不能告訴我們數據，但你說過它具有統計意義和臨床意義。顯然，在 FIGHT 第 2 階段試驗中，OS 增量超過 13 個月。那麼，您能否幫助我們從預期增量的角度來分析 FORTITUDE-101 的 OS 資料的預期應該是什麼？

And then for 102, given that it's with nivo, I'm also curious whether you would expect that the delta would be less because you have nivo on both sides of the equation. And then Also, in China, what's going to be the regimen that is more likely to get the uptake in gastric? Is it with the chemo or also with the nivo? Thank you.

然後對於 102，考慮到它與 nivo 有關，我也很好奇您是否會預期 delta 會更小，因為等式兩邊都有 nivo。那麼，在中國，哪種療法更有可能在胃部獲得應用？是和化療一起進行還是也和 nivo 一起進行？謝謝。

And then I have another one on DLL3. Thank you.

然後我在 DLL3 上還有另一個。謝謝。

I'll ask Rafael to jump in here on the question, Yigal. Thanks.

我會請拉斐爾來回答這個問題，伊加爾。謝謝。

Yeah, I mean, I think with regards to the magnitude of the treatment effect, I'm afraid I can't comment, because it's embargoed until the presentation, obviously. But I think other than the qualitative statements that (inaudible) announced -- made with regards to the clinical meaningfulness of the differences between placebo and bema, I can't really say very much more. And so stay tuned for that.

是的，我的意思是，我認為關於治療效果的大小，恐怕我無法評論，因為顯然在演示之前它是被禁止的。但我認為，除了（聽不清楚）宣布的關於安慰劑和 bema 之間差異的臨床意義的定性陳述之外，我真的不能再多說了。請繼續關注。

I think with regards to the differences in survival between what is seen in 101 and 102, again, I would be speculating. The difference in survival of neoGASTRIC and GE junction tumors is not very pronounced. As you know, it's about a couple of months or so. You know, if one maintains, you know, the same sort of survival difference with bema you could potentially have an additive effect to those two months, but again, difficult to speculate, and we will know when we see the data.

我認為，關於 101 和 102 之間的生存差異，我會再次進行推測。新胃癌和胃食道連接處腫瘤的存活差異並不十分明顯。如您所知，這大約需要幾個月的時間。你知道，如果一個人維持與 bema 相同的生存差異，那麼你可能會對這兩個月產生附加效應，但同樣很難推測，當我們看到數據時我們就會知道。

And then in terms of uptake in China, it's difficult to tell, but the 101 is a particularly important study for us in China. The use of nivo is relatively low, but there are other PD-1 inhibitors, and many patients are treated without PD-1 as well.

至於在中國的接受程度，目前還很難說，但 101 對我們中國來說是一項特別重要的研究。nivo 的使用率相對較低，但還有其他 PD-1 抑制劑，許多患者也在沒有 PD-1 的情況下接受治療。

And so chemotherapy plus bema, if it's perceived to be a very important advance, it will be used. So it remains to be seen how much traction the PD-1 inhibitor will have, but there will be a difference in time also of the launch of one versus the other, which may affect as well uptake of a potential PD-1. So I'm afraid I can't really give you a concise and accurate answer, but this is sort of my qualitative statement.

因此，如果化療加貝瑪療法被認為是一項非常重要的進步，那麼就會被採用。因此，PD-1 抑制劑將產生多大的吸引力還有待觀察，但兩者的推出時間也會有所不同，這也可能影響潛在 PD-1 的吸收。所以恐怕我無法給你一個簡潔而準確的答案，但這是我的定性陳述。

Okay, alright. And then for the DLL3, so it looks like you're somewhere in the 1.6 mgs per kg for the dose that you've done so far. So with the combo with atezo, how are you thinking about the combo dose for DLL3? Do you think you can stay at the 1.6 or may you need to be a little lower potentially for combo tox or do you see that it's not -- you're not going to have overlapping toxin. It's fine just to go with what you saw already in the monotherapy?

好的，好的。然後對於 DLL3，看起來您到目前為止的劑量大約是每公斤 1.6 毫克。那麼，對於與阿特唑的組合，您如何考慮 DLL3 的組合劑量？您認為您可以保持在 1.6 嗎？或者您可能需要稍微低一點以用於組合毒素，或者您是否認為它不是 - 您不會有重疊的毒素。只按照單一療法中已經看到的效果就可以了嗎？

It's a bit premature to say with certainty, but the toxicity of these two agents are very different, and actually a 1.6 touching 10 is very well tolerated. We only had 6% Grade 3 and above. And so, with the non-overlapping toxicities, we believe that the combinability with 1.6 is very possible, and we're working towards that.

現在下定論還為時過早，但這兩種藥物的毒性非常不同，實際上 1.6 到 10 的耐受性非常好。我們只有 6% 的學生達到 3 級及以上。因此，由於毒性不重疊，我們相信與 1.6 的結合是非常有可能的，我們正在朝著這個目標努力。

And then, in addition to that, we're also trying to do an etoposide sparing regimen as well, and we continue to study the with carbo. All this data will, as it matures in terms of follow-up and response and safety, we will present it most likely in the first half of next year.

除此之外，我們也正在嘗試實施依托泊苷節約方案，並持續研究卡鉑。所有這些數據，隨著後續行動、回應和安全性的不斷成熟，我們很可能會在明年上半年公佈。

Okay. And if I could have one for Josh. Josh, obviously there's a lot of momentum with efgar, but you have these four new trials, the lupus, seronegative gMG, myasthenia gravis, sjogren's disease. I'm just kind of curious, when you put all those together, How does that change your perspective on the potential overall peak for this drug relative to the initial rollout of indications? Can you just kind of frame that so we can get sort of a zip code of how much more that's going to drive the overall franchise long-term? Thank you.

好的。如果我可以給喬希一個的話。喬希，顯然 efgar 的發展勢頭強勁，但您還有四項新試驗：狼瘡、血清陰性 gMG、重症肌無力、乾燥綜合症。我只是有點好奇，當你把所有這些放在一起時，這會如何改變你對該藥物相對於最初推出的適應症的潛在整體高峰的看法？您能否簡單概括一下，以便我們了解這將對長期推動整個特許經營產生多大作用？謝謝。

Sure. Thanks, Yigal. We've said consistently that over time we see a greater than $1 billion sales potential on an annual basis in China for VYVGART when you look at the various indications, and I think we're certainly on the way there. Of course, today the opportunity is to drive penetration usage and duration in gMG. But I think if you look at the indications you mentioned, certainly those that are complementary in the gMG space can add somewhere in the range of 25% or more patient opportunity within gMG, so this would be ocular and seronegative.

當然。謝謝，伊加爾。我們一直說，隨著時間的推移，從各種跡象來看，VYVGART 在中國每年的銷售潛力將超過 10 億美元，我認為我們肯定正在朝著這個目標邁進。當然，今天的機會是推動 gMG 的滲透使用和持續時間。但我認為，如果您看一下您提到的適應症，那麼那些在 gMG 領域具有互補性的適應症肯定可以在 gMG 中增加 25% 或更多的患者機會，因此這將是眼部和血清陰性的。

Lupus, we're excited to see the data. That's a very big potential indication, but still more to come. I think myositis and sjogren's, again, also pretty big indications. So I think if you look at the total patient population, then add in thyroid eye disease, we go from a starting point of about 170,000 patients with gMG in China to something well over 500,000 when you start to put these indications together. So, as we've said, the $1 billion type of opportunity. You don't have to assume huge penetration rates or otherwise.

狼瘡，我們很高興看到這些數據。這是一個非常大的潛在跡象，但未來還會有更多跡象。我認為肌炎和乾燥症也是相當大的指徵。因此，我認為，如果看一下總體患者人數，然後再加上甲狀腺眼病，那麼當我們把這些指徵加在一起時，中國患有 gMG 的患者人數將從最初的約 170,000 人增加到 500,000 多人。正如我們所說，這是一個價值 10 億美元的機會。您不必假設巨大的滲透率或其他情況。

And again, I think the data that we've seen so far that have been released give us a lot of confidence that there's going to be significant benefits across the various indications here. But for us today, it's drive, penetration, and gMG, look forward to the supplementary indications that can build out that patient population for 2026. Get Hytrulo approved through NRDL. We think that'll bring significant patient benefits. Then supplement that with the pre-filled syringe, which we'll work towards submitting later this year.

而且，我認為迄今為止我們所看到的已發布的數據讓我們非常有信心，這將為各種跡象帶來顯著的益處。但對我們今天來說，它的動力、滲透力和 gMG，期待補充適應症能夠在 2026 年擴大患者群體。透過 NRDL 獲得 Hytrulo 批准。我們認為這將為患者帶來巨大的利益。然後用預充式註射器進行補充，我們將在今年稍後提交。

So a lot to come in VYVGART and a lot to be excited about in terms of the current performance and things to look forward to.

因此，VYVGART 還有很多事情要做，就目前的表現和值得期待的事情而言，有很多值得興奮的事情。

(Operator Instructions) Yi Chen, Goldman Sachs.

（操作員指示）高盛的陳毅。

Two questions for me. The first one is for VYVGART. I understand that management mentioned in first quarter, there has been some inventory management that lead to weaker sales. And I'm wondering, was VYVGART still under this type of inventory management in the second quarter? And how should we look into the second half, and particularly in July, what has been the momentum versus previous months in the first half? And also, we look at Argenx, they observed very strong subQ formulation uptake. And what will be the strategy in China between subQ and IV formulation for VYVGART from your perspective.

我有兩個問題。第一個是 VYVGART。據我了解，管理階層在第一季提到，一些庫存管理措施導致銷售疲軟。我很好奇，VYVGART 在第二季是否仍採用這種庫存管理？我們該如何看待下半年，特別是7月份，與上半年前幾個月相比，發展動能如何？此外，我們觀察了 Argenx，他們觀察到了非常強烈的 subQ 配方吸收。從您的角度來看，VYVGART 在中國的皮下注射和靜脈注射製劑策略是什麼？

And my second question is regarding the DLL3 ADC. Now the asset's going to be moving to pivotal study pretty soon. So at this juncture, we're trying to understand a bit more about the competition strategy in the US market. Are you still actively looking for a partner for clinical development? Or the strategy is going to be pivoting towards self-sponsoring the pivotal study and potentially the future commercialization to capture all the economics. Thank you.

我的第二個問題是關於 DLL3 ADC 的。現在，該資產很快就要進入關鍵研究階段。因此，在這個時刻，我們正試圖更了解美國市場的競爭策略。您是否仍在積極尋找臨床開發的合作夥伴？或者該策略將轉向自我贊助關鍵研究並可能實現未來商業化以獲得所有經濟利益。謝謝。

Thanks. I'll start on VYVGART and then turn it to Rafael for the discussion on DLL3.

謝謝。我將從 VYVGART 開始，然後轉向 Rafael 討論 DLL3。

I think first on the inventory piece, I just would remind you that in 2024 was our first year of launch and as you would in any new launch product on NRDL. We built inventory through the year to keep up with demand, and at the end of Q4, stocked the channel for the approval of Hytrulo. So you do have some inventory build in the 2024 numbers, again, as you would expect.

我認為首先關於庫存部分，我只想提醒您，2024 年是我們推出產品的第一年，就像 NRDL 上任何新推出的產品一樣。我們全年都在建立庫存以滿足需求，並在第四季度末為 Hytrulo 的批准儲備了庫存。因此，正如您所預料的那樣，2024 年的數字中確實有一些庫存累積。

I think first half of this year for VYVGART, we tried to manage that inventory closely. And I would say in the second half of the year, you should expect normal types of build to prepare for 2026 and what we presume will be robust sales, including, as I mentioned in the last discussion or question, our expectation that Hytrulo will be added to NRDL.

我認為今年上半年對於 VYVGART 來說，我們嘗試密切管理庫存。我想說，在下半年，你應該期待正常類型的建築為 2026 年做好準備，我們預計銷售將會強勁，包括我在上次討論或問題中提到的，我們預計 Hytrulo 將被添加到 NRDL。

And then I think to your question, I think from what we see around the world where Hytrulo is available, it becomes a very important treatment option and treatment choice relative to IV. So, I think we would expect over time that Hytrulo would become a very meaningful formulation for patients with gMG, and again, we'll pursue NRDL appropriately in that regard.

然後我思考一下你的問題，我認為從我們在世界各地看到的 Hytrulo 的使用情況來看，它成為了一種相對於 IV 而言非常重要的治療選擇。因此，我認為隨著時間的推移，我們期望 Hytrulo 將成為 gMG 患者非常有意義的製劑，並且我們將在這方面適當地追求 NRDL。

So I think as you get into 2026, you should expect to see, you know, a shift from of course, today almost exclusively IV use to significant Hytrulo and then, certainly followed in the coming years by the PFS version as well.

所以我認為，當你進入 2026 年時，你應該會看到，當然，從今天幾乎完全使用 IV 到重要的 Hytrulo，然後，在未來幾年肯定也會有 PFS 版本。

I'll ask Rafael to comment then on DLL3.

我會請 Rafael 對 DLL3 進行評論。

Yeah, so with regards to the pivotal trial, we have said before that we've been in discussions with the FDA, and this accelerated approval pathway is still viable. It will be a randomized trial, and we're on track to initiate this trial before the end of the year. We have to align on the dose, but as we presented at ASCO, 1.6 mgs per kilogram is looking very strong and probably the best sort of combination and benefit-risk. We will continue to generate data. We will present some data as well on the durability. But our goal is to get agreement on the dose and initiate this trial.

是的，關於關鍵試驗，我們之前說過，我們一直在與 FDA 進行討論，這種加速審批途徑仍然可行。這將是一次隨機試驗，我們預計在今年年底前啟動這項試驗。我們必須調整劑量，但正如我們在 ASCO 上所展示的，每公斤 1.6 毫克的劑量看起來非常強勁，可能是最佳的組合和效益風險。我們將繼續產生數據。我們還將提供一些有關耐用性的數據。但我們的目標是就劑量達成一致並啟動這項試驗。

And with regards to partnership, initial pursuit is going to be to go ahead and launch this trial ourselves. And these discussions, I think, may remain open, but we're pretty committed to moving this forward by ourselves, and this study will be launched by us.

關於合作，我們最初的追求是我們自己繼續進行這項試驗。我認為這些討論可能會繼續進行，但我們非常致力於自行推動這項進程，這項研究將由我們啟動。

Li Watsek, Cantor.

李·瓦特塞克，領唱。

I have two pipeline questions. First on bema, just wondering what steps are left to file in China, and is it possible to get NRDL listing in 2027, or should we assume it's more of a 2028 event?

我有兩個管道問題。首先關於 bema，我只是想知道在中國提交申請還剩下哪些步驟，以及是否有可能在 2027 年獲得 NRDL 上市，或者我們是否應該假設它更像是 2028 年的事件？

And then for DLL3 ADC, how are you guys thinking about the data from [Hungary] DLL3 program next month? Any research you're on program? And for data update later this year, what additional information do you hope to share relative to the ASCO update? Thank you.

那麼對於 DLL3 ADC，你們如何看待下個月 [匈牙利] DLL3 計畫的數據？您正在進行任何研究計劃嗎？今年稍後的數據更新，您希望分享與 ASCO 更新相關的哪些附加資訊？謝謝。

Thanks, Li. I think first on bema -- and Rafael can provide some more comments here, but our focus now is to get the file submitted and approved. And NRDL timing is dependent on when you're approved during the year and that always changes and everything else. So we're just focused right at this point on getting that product approved as quickly as possible and then moving as quickly as possible into NRDL listing. So we'll have more to come there as we move through the regulatory process.

謝謝，李。我認為首先在 bema 上——Rafael 可以在這裡提供更多評論，但我們現在的重點是提交和批准文件。國家健保目錄的生效時間取決於您在一年中何時獲得批准，而批准時間以及其他所有因素總是會發生變化。因此，我們目前只專注於盡快獲得該產品的批准，然後儘快將其列入國家醫療保健目錄。因此，隨著監管程序的推進，我們將會有更多進展。

I think, Rafael, if you could jump in on both of the questions.

拉斐爾，我想你能否回答一下這兩個問題。

Yeah, so with regards to bema, we have breakthrough designation, and we will be working with Amgen, our partner, in potential registration in China expeditiously. We obviously will have to do a pre-BLA meeting and get feedback from (inaudible), and so this is a priority for us, and again, we're in discussions with Amgen as to the initiation of the submission.

是的，關於 bema，我們擁有突破性稱號，我們將與我們的合作夥伴安進公司合作，盡快在中國註冊。顯然，我們必須召開 BLA 前會議並獲得（聽不清楚）的回饋，因此這是我們的優先事項，而且，我們正在與安進討論啟動提交事宜。

With regards to the competition from Hungary, we know, I think, what everybody knows, which is that they're presenting at (inaudible) later on next month, and I would just only highlight the fact that products, especially ADCs, can be differentiated by many factors, including the type of antibody, the epitope, the ability, the payload, the linker, et cetera. We think that we have the best-in-class antibody, as we showed at ASCO a couple of months ago, with 79% response rate, which is, yes, confirmed and unconfirmed. But among the highest that has ever been seen and great activity in the brain as well.

關於來自匈牙利的競爭，我想大家都知道，他們將在下個月晚些時候（聽不清楚）進行展示，我只想強調一個事實，即產品，尤其是 ADC，可以透過許多因素來區分，包括抗體的類型、表位、能力、有效載荷、接頭等等。我們認為我們擁有一流的抗體，正如我們幾個月前在 ASCO 上展示的那樣，其反應率高達 79%，是的，無論這是已證實的還是未證實的。但它的強度是迄今為止最高的，而且大腦活動也很活躍。

And we are really advanced already with regards to getting the dose ready for execution of the Phase 3 study, as I mentioned before. So we have a good time difference with regards to the competition. And in terms of what we will present, there will be another four months' worth of data which will include updated response and time-to-event endpoints, both durability of response as well as progression-free survival.

正如我之前提到的，我們在準備執行第三階段研究的劑量方面已經取得了很大進展。因此，我們在比賽方面擁有良好的時間差。就我們將要展示的內容而言，將會有另外四個月的數據，其中包括更新的反應和事件發生時間終點、反應持久性以及無進展生存期。

And importantly, we will also work characterizing these responses in the brain because they are really unprecedented and it's something that we're hearing a lot from our investigators in terms of the high incidence and the durability. So what you will see with (inaudible), which is the way that brain metastasis are assessed as well as response for the brain metastasis in the totality of the population. And we may present some data on biomarker as well. But I think the principal update will be updated responses on the dose optimization as well as durability.

重要的是，我們還將致力於描述大腦中的這些反應，因為它們確實是前所未有的，而且我們從研究人員那裡聽到了很多關於其高發病率和持久性的信息。因此，您將看到（聽不清楚），這是評估腦轉移的方式以及整個人群對腦轉移的反應。我們也可能提供一些有關生物標記的數據。但我認為主要的更新將是對劑量優化和耐用性的更新反應。

Jack Lin, Morgan Stanley.

摩根士丹利的傑克林。

I have two brief questions. First one regarding the DLL3. I just would hope to, I think, clarify a bit on the catalyst with data timeline. So if I could confirm again in terms of when we might expect the next data update from the second-line treatment, and especially, I think, on the expenditure covert. And also, I think it was mentioned previously at the ASCO call, we also have first line data upcoming. I'd just like to reconfirm the timeline to expect for that.

我有兩個簡短的問題。第一個關於 DLL3。我只是希望能夠透過數據時間軸稍微澄清一下催化劑。因此，如果我可以再次確認我們何時可以預期二線治療的下一次數據更新，特別是關於支出隱性數據。而且，我認為之前在 ASCO 電話會議上提到過，我們即將獲得第一線數據。我只是想再次確認預計的時間表。

And the second one, I think, briefly on whether the company has review or update in terms of some of the policy news update regarding the commercial insurance ramp-up, and if there's any implications or changes to our commercial strategy for products like OPTUNE. Just these two questions. Thank you.

第二，我想簡要地談談公司是否對商業保險成長的一些政策新聞更新進行了審查或更新，以及這是否對我們的 OPTUNE 等產品的商業策略有任何影響或變化。就這兩個問題。謝謝。

Rafael, why don't you go ahead?

拉斐爾，你為什麼不繼續？

Yeah, so for DLL3, 1310, we expect to provide this update before the end of the year on the second line, as you mentioned, and I explained before what the nature of the update will be. We had 89 patients at ASCO. Here we will have upwards of 110 patients and obviously four more months of follow-up, as I mentioned.

是的，對於 DLL3,1310，我們預計在第二行在今年年底之前提供此更新，正如您所提到的，我之前解釋過更新的性質。我們在 ASCO 有 89 位病人。正如我所提到的，我們將有 110 多名患者，顯然還需要四個月的追蹤。

With regards to first line, because we are prioritizing this second-line study, we continue to enroll in the first-line cohorts, both with [adeso] and carbo. If we have meaningful data, then perhaps it will be this year, but most likely it will be next year, early next year, that we will provide that information. We are spending time enrolling in the second line and standing up the Phase 3 study. So I hope this helps with the cadence of of data.

關於一線治療，由於我們優先考慮這項二線研究，我們繼續招募一線隊列，包括 [adeso] 和 carbo。如果我們有有意義的數據，那麼也許今年就會提供，但最有可能的是明年，也就是明年初，我們會提供這些資訊。我們正在花時間招募第二線患者並進行第三階段研究。所以我希望這有助於數據的節奏。

And then just to mention that we are doing well on the neuroendocrine carcinoma, neuroendocrine tumors. These are distinct cohorts, and we will provide an update as soon as we have meaningful information on that. But so far, the accrual has been very favorable, so we think that it will be relatively quickly. We want to wait until we see enough durability before we actually -- until we can present a meaningful update.

然後要說的是，我們在神經內分泌癌、神經內分泌腫瘤方面做得很好。這些是不同的群體，一旦我們獲得有意義的信息，我們將立即提供更新。但到目前為止，應計情況一直非常有利，因此我們認為這將相對較快。我們希望等到看到足夠的耐用性後才能真正提出有意義的更新。

And Jack, I think on the commercial insurance policy changes, we're quite encouraged by the trend here. You know, keep in mind, I know you know this, you know, the reimbursement or funding for innovative drugs in China through a commercial insurance channel is considerably less than 10% today.

傑克，我認為，就商業保險政策的變化而言，我們對這一趨勢感到非常鼓舞。你知道，請記住，我知道你知道這一點，你知道，目前中國透過商業保險管道對創新藥物的報銷或資助遠低於 10%。

So I think as we look at the policy changes to try to drive that number higher, it certainly benefits us as we launch new innovative products, not just OPTUNE or TTFields, but any of the products we've discussed today, there's always a lag between when they're approved through NMPA and when they are eligible for NRDL listings. So I think that time period, as commercial insurance expands, gives us a really good opportunity as we get drugs like bema approved or KarXT or others to leverage these channels and drive good experience and sales in that sub-period between approval and NRDL listing. So I think that's important.

因此，我認為，當我們考慮政策變化以試圖提高這一數字時，這肯定會對我們有利，因為我們推出新的創新產品，不僅僅是 OPTUNE 或 TTFields，而且我們今天討論的任何產品，在它們通過國家藥品監督管理局批准和有資格列入國家醫保目錄之間總是存在一個滯後。因此，我認為，隨著商業保險的擴大，這段時間為我們提供了一個非常好的機會，因為我們可以獲得 Bema 或 KarXT 等藥物的批准，從而利用這些管道，在批准和國家醫療保健目錄列出之間的這段時間內推動良好的體驗和銷售。所以我認為這很重要。

Certainly, as it relates to OPTUNE and as we think about PANOVA or the opportunity in pancreatic cancer, I think that's one that we'll certainly be able to time that well with some of these policy changes. So again, I think it's positive for all companies who are bringing innovative drugs to market in China. And we look forward to participating and taking advantage of those policy changes.

當然，由於它與 OPTUNE 相關，並且當我們考慮 PANOVA 或胰腺癌的機會時，我認為我們一定能夠利用其中一些政策變化來很好地把握時機。所以，我認為這對所有將創新藥物推向中國市場的公司來說都是正面的。我們期待參與並利用這些政策變革。

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

問答環節現已結束。非常感謝大家的提問。現在我想請 Samantha Du 博士發表閉幕演講。

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 2025.

謝謝您，接線生。我要感謝大家今天抽出時間來參加我們的電話會議。我們感謝您的支持，並期待在 2025 年第三季之後再次向您更新資訊。

Operator, you may now disconnect this call.

接線員，您現在可以掛斷此通話了。

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

感謝大家參加今天的會議。這確實結束了程序，您現在可以斷開線路。