Group 1 - The core viewpoint of the article highlights a collective decline in Hong Kong's innovative drug concept stocks on September 4, with significant drops in various companies [1] Group 2 - Zai Lab experienced a decline of over 10% [1] - Hengrui Medicine, Genscript Biotech, and Cloudmed fell by more than 5% [1] - WuXi AppTec dropped over 4%, while Innovent Biologics, WuXi Biologics, and Hansoh Pharmaceutical decreased by more than 3% [1]

Core Insights - The final analysis of the FORTITUDE-101 Phase III clinical study for bemarituzumab combined with mFOLFOX6 in first-line gastric cancer treatment has been completed, showing a reduction in previously observed survival benefits compared to the interim analysis [1] Group 1: Clinical Study Results - The interim analysis indicated significant statistical and clinical improvement in overall survival for the bemarituzumab plus chemotherapy compared to chemotherapy alone [1] - The final analysis revealed a weakening of the survival benefit previously observed in the interim analysis [1] Group 2: Future Plans - The company plans to wait for the results of the FORTITUDE-102 study, which evaluates bemarituzumab combined with nivolumab and chemotherapy for the same patient population, before submitting a registration application [1] - Data from the FORTITUDE-102 study is expected to be available by the end of 2025 or the first half of 2026 [1]

Group 1 - The core point of the article is that the final analysis of the FORTITUDE-101 Phase III clinical study for bemarituzumab combined with chemotherapy (mFOLFOX6) in first-line gastric cancer treatment shows a reduction in previously observed survival benefits compared to the interim analysis [1] - The interim analysis indicated a statistically and clinically significant improvement in overall survival for the bemarituzumab combination therapy compared to chemotherapy alone [1] - The results from both the interim and final analyses will be presented at an upcoming major medical conference [1] Group 2 - The company plans to wait for the results of the FORTITUDE-102 study, which aims to evaluate bemarituzumab combined with nivolumab and chemotherapy for the same patient population, before submitting a registration application [1] - Data from the FORTITUDE-102 study is expected to be available by the end of 2025 or the first half of 2026 [1]

Core Viewpoint - The final analysis of the FORTITUDE-101 Phase III clinical study for Bemarituzumab combined with mFOLFOX6 in first-line gastric cancer treatment shows a reduction in previously observed survival benefits compared to the interim analysis [1] Group 1: Clinical Study Results - The interim analysis indicated significant statistical and clinical improvement in overall survival for the combination therapy compared to chemotherapy alone [1] - The final analysis revealed a weakening of the survival benefit previously observed in the interim analysis [1] Group 2: Future Plans - The company plans to wait for the results of the FORTITUDE-102 study, which evaluates Bemarituzumab combined with Nivolumab and chemotherapy for the same patient population, before submitting a registration application [1] - Data from the FORTITUDE-102 study is expected to be available by the end of 2025 or the first half of 2026 [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不會對因本公告全部或任何部分內容而產生或因 倚賴該等內容而引致的任何損失承擔任何責任。 根據 FORTITUDE-101 研究的更新結果，本公司計劃在提交註冊申請之前等待 FORTITUDE-102 研究（其旨在評估貝瑪妥珠單抗聯合納武利尤單抗及化療用於相同的 患者人群）的結果。預計 FORTITUDE-102 研究的數據將在 2025 年底或 2026 年上半年 公佈。 承董事會命 再鼎醫藥有限公司 Zai Lab Limited 再鼎醫藥有限公司* （於開曼群島註冊成立的有限公司） （股份代號：9688） 內幕消息 安進貝瑪妥珠單抗 FORTITUDE-101 III 期臨床研究最新進展 本公告乃由再鼎醫藥有限公司（「本公司」）根據香港聯合交易所有限公司證券上市 規則（「上市規則」）第 13.09(2)(a)條及香港法例第 571 章證券及期貨條例第 XIVA 部 項下內幕消息條文（定義見上市規則）而作出。 據安進公司，本公司的合作夥伴和該項研究的申辦方，評估貝瑪妥珠單抗聯合化療 （ ...

Group 1: Hong Kong Stocks - Photovoltaic stocks rose in the morning, with Xinyi Solar (00968) up over 3%, Fuyao Glass (03606) up over 3%, and GCL-Poly Energy (00451) up over 3%. Domestic leading polysilicon companies have raised prices, and the market is focused on the restructuring progress in the polysilicon industry [1] - Heng Rui Medicine (01276) increased by over 5% after announcing the approval of HRS-7172 tablets for clinical trials by the National Medical Products Administration on September 2 [1] - Qingdao Bank (03866) rose over 2% as its major shareholder plans to increase holdings by 233 million to 291 million shares, recognizing the long-term investment value of the bank's stock [1] - Zhaojin Mining (01818) increased by over 1%, with a total market value exceeding HKD 100 billion, and the company is accelerating overseas project construction, indicating future growth potential [1] - Zhongsheng Holdings (00881) rose over 4%, with management optimistic about the new car market and smooth progress in the company's new energy business [1] - Innovent Biologics (09969) increased by over 5% after disclosing its interim performance report, with core products driving growth and accelerating multiple self-immune phase III clinical trials [1] - United Laboratories (03933) rose over 6% after announcing a 27% year-on-year increase in profit attributable to shareholders in its half-year results, with key progress in several products in the formulation segment [1] Group 2: U.S. Stocks - NIO (NIO.US) rose 3.13%, with vehicle deliveries in August 2025 reaching 31,305 units, a year-on-year increase of 55.2%, and total deliveries since 2025 reaching 166,472 units, up 30.0% [3] - Hesai Technology (HSAI.US) fell 2.91% as it plans to list in Hong Kong after passing the hearing [3] - Eli Lilly (LLY.US) rose 0.36% after Novo Nordisk's weight loss drug Wegovy outperformed it in a real-world comparative study [3] - Zai Lab (ZLAB.US) increased by 0.73% after announcing that its drug was approved in Hong Kong for treating recurrent or metastatic cervical cancer [3] - Beike (BEKE.US) rose 4.89% after reporting a 11.3% year-on-year increase in net income for the second quarter, leading multiple institutions to reaffirm a "buy" rating [3] - Gold stocks rose against the trend, with Gold Resource (GORO.US) up 15.80%, Harmony Gold (HMY.US) up 7.53%, and Kinross Gold (KGC.US) up 2.68%, driven by expectations of U.S. interest rate cuts and a weak dollar [3] - Corning (GLW.US) rose 2.15% after UBS raised its target price from $65 to $84 and upgraded its rating from "neutral" to "buy" [4] - Li Auto (LI.US) rose 4.50% as the founder announced plans to fully enter the high-end pure electric SUV market [4]

Group 1 - Zai Lab (ZLAB.US) shares rose 1% in pre-market trading, reaching $33.43 [1] - The Hong Kong Department of Health has approved TIVDAK® (tisotumab vedotin) for the treatment of recurrent or metastatic cervical cancer in adult patients who have disease progression during or after chemotherapy [1] - Tisotumab vedotin is currently under review for a biological product license application by the National Medical Products Administration (NMPA) in China, with the application accepted in March 2025 [1] Group 2 - The closing price on August 29 was $33.10, with a pre-market price of $33.43 on September 2 [1] - The stock's highest price was $33.51, and the lowest was $32.59, with a trading volume of 378,300 shares [1] - The total market capitalization of Zai Lab is approximately $3.64 billion [1]

Core Viewpoint - The Hong Kong government has approved TIVDAK® (tisotumab vedotin) for the treatment of recurrent or metastatic cervical cancer in adult patients who have experienced disease progression during or after chemotherapy [1] Company Summary - The approval by the Hong Kong Department of Health marks a significant milestone for the company, as it expands the availability of TIVDAK® in the region [1] - TIVDAK® is currently undergoing the biological product license application review process with the National Medical Products Administration (NMPA) in China, with the application accepted in March 2025 [1]

於開曼群島註冊成立的有限公司 香港聯交所：9688 納斯達克：ZLAB 公司資料 董事會 執行董事 杜瑩博士 （董事長兼首席執行官） 2025 中期報告 獨立董事 John Diekman博士 （首席獨立董事） Richard Gaynor博士 梁頴宇女士 William Lis先生 Scott W. Morrison先生 Leon O. Moulder, Jr.先生 Michel Vounatsos先生 Peter Wirth先生 中國內地總部及主要營業地點 目錄 | 公司資料 | 2 | | --- | --- | | 前瞻性陳述 | 4 | | 管理層討論及分析 | 7 | | 其他資料 | 26 | | 未經審計簡明合併資產負債表 | 58 | | 未經審計簡明合併經營表 | 60 | | 未經審計簡明合併綜合虧損表 | 61 | | 未經審計簡明合併股東權益表 | 62 | | 未經審計簡明合併現金流量表 | 63 | | 未經審計簡明合併財務報表附註 | 65 | | 詞彙表 | 83 | 中國 上海市浦東新區 金科路4560號 金創大廈 1號樓4樓 郵編：201210 （直至2025年6月30日 ...

Core Viewpoint - Zai Ding Medical (09688) reported a total revenue of $216 million for the first half of 2025, representing a year-on-year increase of 15.35% [1] Financial Performance - The company recorded a net loss of $89.165 million, which is a 33.33% reduction compared to the previous year [1] - Earnings per share stood at a loss of $0.08 [1] Revenue Breakdown - Product revenue increased by $27.5 million (or 15%) to $215 million, driven by sales growth of Weiwei Jia due to extended treatment duration and improved market penetration [1] - Sales of Niu Zai Le also grew due to enhanced market coverage and penetration [1] - The newly launched Ding You Le, which started sales in Q4 2024, contributed to revenue growth [1] R&D Expenditure - Research and development expenses decreased by $4.9 million (or 4%) to $111 million, primarily due to ongoing resource optimization and efficiency improvements that reduced personnel and clinical trial costs [1] - This decrease was partially offset by an increase in licensing fees [1]