Core Viewpoint - Zai Ding Pharmaceutical (09688) shares rose over 5%, currently up 5.38% at HKD 25.48, with a trading volume of HKD 224 million [1] Group 1: Clinical Research Updates - Recently, Zai Ding Pharmaceutical announced that its partner Amgen has completed the final analysis of the FORTITUDE-101 Phase III clinical study, which evaluates the efficacy of Bemarituzumab combined with chemotherapy (mFOLFOX6) for first-line treatment of gastric cancer [1] - The interim analysis showed significant statistical and clinical improvement in overall survival with the Bemarituzumab combination compared to chemotherapy alone; however, the survival benefit observed in the interim analysis weakened in the final analysis [1] - Amgen stated that the results of both the interim and final analyses will be presented at an upcoming major medical conference [1] Group 2: Future Research Plans - Based on the updated results from the FORTITUDE-101 study, 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 released by the end of 2025 or in the first half of 2026 [1]

Core Viewpoint - Zai Ding Pharma (09688) shares rose over 5%, reaching HKD 25.48 with a trading volume of HKD 224 million following the announcement of the final analysis of the FORTITUDE-101 Phase III clinical trial for Bemarituzumab combined with mFOLFOX6 in first-line gastric cancer treatment [1] Group 1: Clinical Trial Results - The FORTITUDE-101 trial showed significant statistical and clinical improvement in overall survival when comparing Bemarituzumab combined with chemotherapy to chemotherapy alone during the pre-set interim analysis [1] - However, the final analysis indicated a reduction in the previously observed survival benefit [1] - Amgen, the partner and sponsor of the study, plans to present the results of both the interim and final analyses at an upcoming major medical conference [1] Group 2: Future Plans - The company intends 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]

Core Viewpoint - Zai Lab Limited is under investigation for potential securities fraud following the release of disappointing final results from a Phase 3 clinical trial for its drug bemarituzumab, leading to a significant drop in its stock price [1][3]. Group 1: Company Overview - Zai Lab Limited is a biopharmaceutical company listed on NASDAQ under the ticker ZLAB [1]. - The company is currently facing claims of securities fraud or unlawful business practices, prompting an investigation by Pomerantz LLP [1]. Group 2: Clinical Trial Results - On September 3, 2025, Zai Lab announced the completion of the final analysis of the Phase 3 FORTITUDE-101 trial for bemarituzumab in combination with chemotherapy for first-line gastric cancer [3]. - The interim analysis had shown a significant improvement in overall survival compared to chemotherapy alone, but the final analysis indicated that this survival advantage had diminished [3]. - Zai Lab plans to await results from the FORTITUDE-102 trial before proceeding with regulatory filing, with data readout expected by the end of 2025 or the first half of 2026 [3]. Group 3: Market Reaction - Following the announcement of the final trial results, Zai Lab's American Depositary Receipt (ADR) price fell by $2.04, or 6.12%, closing at $31.30 per ADR on September 3, 2025 [3].

Summary of Zai Lab (ZLAB) 2025 Conference Call Company Overview - Zai Lab has been operational for ten years, focusing on two main business segments: a robust commercial business in China and a global clinical pipeline [3][4] Key Business Segments 1. **Commercial Business in China** - Partnerships with Western biotechs to develop and commercialize products in China - Portfolio includes over 10 products, with Zejula and Vivgard expected to drive profitability by Q4 2025 [4] - Anticipated sales growth from Vivgard, targeting approximately $1 billion in annual sales by 2028, up from $94 million last year [7][8] 2. **Global Pipeline** - Lead asset is a DLL3 targeted ADC for small cell lung cancer, with a registration trial expected to start imminently [5] - Potential for sales in the US as early as late 2027 [5] Financial Projections - Zai Lab aims to achieve $2 billion in sales by 2028, a significant increase from approximately $560 million projected for this year [6][7] - Growth drivers include: - Vivgard for myasthenia gravis, expected to trend towards $500 million by 2028 [9] - Cobemfi for schizophrenia, with potential for billion-dollar sales [11] - Zejula for ovarian cancer, expected to contribute significantly through patent protection until 2029 [12] Market Dynamics - The myasthenia gravis market in China has about 180,000 patients, with Zai Lab aiming to increase patient exposure to Vivgard significantly [8] - New treatment guidelines in China have positioned Vivgard as a frontline therapy, which is expected to enhance patient adoption and sales [30][31] Regulatory and Competitive Landscape - Zai Lab is involved in the bemiratuzumab program for gastric cancer, with recent data indicating a potential delay in submission due to updated survival benefit analysis [19][24] - The company is preparing for a competitive landscape in small cell lung cancer, with plans to start a registration trial for DLL3 ADC [58] Pricing Strategy - Zai Lab is approaching a two-year price renegotiation for Vivgard, expecting a single-digit price reduction based on simplified renewal processes [42][44] - Anticipated pricing adjustments will be disclosed in December, with net pricing effective from January 2026 [47] Conclusion - Zai Lab is positioned for significant growth driven by a strong product pipeline and strategic partnerships, with a focus on expanding its market presence in China and the US. The company is optimistic about achieving its sales targets while navigating regulatory challenges and competitive pressures in the biotech industry [6][24][58]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | | | 致：香港交易及結算所有限公司 公司名稱: 再鼎醫藥有限公司 呈交日期: 2025年9月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09688 | 說明 | 普通股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.000006 USD | | 30,000 | | 增加 / 減少 (-) | | | | | | USD | | | | 本月底結存 | | | 5,000,000,000 | USD | | 0.000006 USD | | 30,000 | 本月底法定/註冊股本總額： USD 30,000 FF301 第 1 頁 共 11 頁 v ...

每经AI快讯，9月4日，港股创新药概念股集体下跌，再鼎医药跌超10%，恒瑞医药、歌礼制药、云顶新 耀跌超5%，药明康德跌超4%，信达生物、药明合联、翰森制药跌超3%。 ...

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]

根据FORTITUDE-101研究的更新结果，公司计划在提交注册申请前等待FORTITUDE-102研究(其旨在评 估贝玛妥珠单抗联合纳武利尤单抗及化疗用于相同的患者人群)的结果。预计FORTITUDE-102研究的数 据将在2025年底或2026年上半年公布。 在该研究预设的中期分析(即主要分析)时，贝玛妥珠单抗联合化疗方案对比单独化疗在总生存期方面显 示出具有显著统计学意义和临床意义的改善。然而，在最终分析中，此前观察到的生存获益幅度减弱。 安进表示中期分析和最终分析的结果将在即将举行的主要医学会议上公布。 格隆汇9月3日丨再鼎医药(09688.HK)公告，据安进公司，公司的合作伙伴和该项研究的申办方，评估贝 玛妥珠单抗联合化疗(mFOLFOX6)用于一线胃癌治疗的FORTITUDE-101III期临床研究已完成最终分 析。 ...

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 （ ...