格隆汇9月9日丨再鼎医药(09688.HK)公告，于2025年9月8日(美国东部时间)，公司根据2024年股权激励 计划向2名承授人授出可认购合共6,600股美国存托股份的购股权并向4名承授人涉及合共9,893股美国存 托股份的受限制股份单位。 ...

Core Viewpoint - Zai Ding Pharmaceutical (09688) announced the grant of stock options and restricted stock units under its 2024 equity incentive plan, indicating a strategic move to incentivize key personnel and align their interests with the company's performance [1] Summary by Category - **Stock Options Granted** - The company granted a total of 6,600 American Depositary Shares (ADS) stock options to 2 grantees [1] - **Restricted Stock Units** - Additionally, the company awarded a total of 9,893 ADS restricted stock units to 4 grantees [1] - **Plan Implementation Date** - The grants are set to take effect on September 8, 2025, Eastern Time [1]

Group 1 - The company, Zai Lab (09688), announced the granting of stock options and restricted stock units under its 2024 equity incentive plan [1] - A total of 6,600 American Depositary Shares (ADS) options were granted to 2 grantees [1] - Additionally, 9,893 ADS restricted stock units were granted to 4 grantees [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。 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） 授出購股權及受限制股份單位 本公告乃根據上市規則第17.06A、17.06B以及17.06C條作出。董事會謹此宣佈，於2025 年9月8日（美國東部時間），本公司根據2024年股權激勵計劃向2名承授人授出可認購 合共6,600股美國存託股份的購股權並向4名承授人涉及合共9,893股美國存託股份的受限 制股份單位。 授出2024年股權激勵計劃項下的購股權 本公司根據2024年股權激勵計劃條款向2名承授人授出6,600份購股權（以美國存託股份 計）。 購股權授出詳情如下： | 授出日期： | 2025年9月8日（美國東部時間） | | --- | --- | | 承授人數目： | 2 | | 承授人類型： | 本集團僱員參與者 | | 所授出購股權數目 | 6,600 | | （以美國存託股份計） ...

根据FORTITUDE-101研究的更新结果，公司计划在提交注册申请之前等待 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。 再鼎医药盘中涨超5%，截至发稿，股价上涨4.30%，现报25.22港元，成交额2.84亿港元。 近日，再鼎医药发布公告，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-101 III 期临床研究已完成最终分析。 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。 责任编辑：栎树 ...

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 ...