Core Viewpoint - The news highlights the potential impact of a proposed executive order by the Trump administration aimed at restricting experimental drugs and clinical data from China, which has led to a decline in the stock prices of several Chinese innovative pharmaceutical companies listed in both A-shares and H-shares markets [1][2]. Group 1: Market Reaction - Following the news, stocks of Chinese innovative drug companies such as BeiGene and I-Mab experienced varying degrees of decline in the U.S. market [1]. - The proposed executive order is seen as a response to concerns over China's rise in biotechnology and its implications for the U.S. industry [1][2]. Group 2: Regulatory Implications - The draft order suggests that U.S. pharmaceutical companies will face stricter scrutiny for acquiring drug rights from Chinese firms, requiring mandatory reviews by the Committee on Foreign Investment in the United States (CFIUS) [2]. - The FDA would impose stricter reviews and higher regulatory fees, potentially hindering reliance on clinical trial data from Chinese patients [2][3]. Group 3: Industry Perspectives - Experts indicate that if the order is enacted, it could create higher barriers for licensing agreements between Chinese drug companies and large U.S. pharmaceutical firms, increasing transaction costs and uncertainty [2][3]. - The proposed measures may also disrupt the supply chain and increase R&D costs for U.S. pharmaceutical companies, which rely on innovations developed in China [3][4]. Group 4: Global Context - China has emerged as a significant player in global pharmaceutical innovation, with projections indicating that 93 innovative drugs will be approved in China in 2024, marking a ten-year high [4]. - The country surpassed Japan and Europe in the number of innovative drug approvals, becoming the second-largest region for such approvals globally [4][5]. Group 5: Future Outlook - Despite potential uncertainties due to geopolitical risks, the trend of Chinese innovative drug companies expanding into international markets is expected to continue [5][6]. - Companies are encouraged to enhance their global clinical data capabilities to adapt to changing policies and maintain the value of their innovative drugs [6].

Company Overview - Zai Lab was founded in 2014 and went public on NASDAQ and dual listed on the Hong Kong Stock Exchange in 2019 [1] - The company has approximately 1,700 employees globally, with the majority based in China [1] - Zai Lab is involved in the discovery, development, and commercialization of pharmaceutical products, primarily in China [1] Product Portfolio - Currently, Zai Lab has launched 8 commercial products [1]

Company Overview - Zai Lab was founded in 2014 and went public on NASDAQ and dual listed on the Hong Kong Stock Exchange in 2019 [1] - The company has approximately 1,700 employees globally, with the majority based in China [1] - Zai Lab is involved in the discovery, development, and commercialization of pharmaceutical products, primarily in China [1] Product Portfolio - Currently, Zai Lab has launched 8 commercial products [1]

Zai Lab (NasdaqGM:ZLAB) FY Conference September 09, 2025 02:35 PM ET Company ParticipantsKi Chul Cho - CFOSamantha Du - Founder, Chairperson, and CEOJosh Smiley - President and CEOConference Call ParticipantsJacqueline - China Biotech AnalystJacquelineOkay, so we're good.Samantha Duyeah. OkayJacquelineSounds good. Good afternoon, everyone. Thank you for joining us today. My name is Jacqueline. I'm the China Biotech Analyst for Morgan Stanley. Today it is a pleasure to invite Zai Lab Ki Chul Cho to join us i ...

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]