| 股份代號: | 01276 | | --- | --- | | 上市法國名稱: | 江蘇恒瑞醫藥股份有限公司 - H股 | | 日期 (日 / 月 / 年): | 16/08/2025 - 16/09/2025 | 格隆汇9月16日丨根据联交所最新权益披露资料显示，2025年9月11日，恒瑞医药(01276.HK)获GIC Private Limited在场内以每股均价81.9747港元增持251.9万 股，涉资约2.06亿港元。 增持后，GIC Private Limited最新持股数目为5053.42万股，持股比例由18.60%上升至19.57%。 | 表格序號 | 大股東/董事/最高行政人員名 作出披露的 買入 / 費出或涉及的 每股的平均價 | | | | | 持有權益的股份數目 佔已發行的 有關事件的日期 相 | | --- | --- | --- | --- | --- | --- | --- | | | 월 | 原因 | 股份數目 | | | ( 請參閱上述 * 註 有投票權股 (日 / 月 / 年) | | | | | | | | 월 份百分比 | | | | | | | | ( % ) ...

查看完整报告 特别申明： 本订阅号中所涉及的证券研究信息由光大证券研究所编写，仅面向光大证券专业投资者客户，用作新媒体形势下研究 信息和研究观点的沟通交流。非光大证券专业投资者客户，请勿订阅、接收或使用本订阅号中的任何信息。本订阅号 难以设置访问权限，若给您造成不便，敬请谅解。光大证券研究所不会因关注、收到或阅读本订阅号推送内容而视相 关人员为光大证券的客户。 报告摘要 行情回顾： 上周，A股医药生物指数下跌0.36%，跑输沪深300指数1.75pp，跑输创业板综指2.37pp，在31个子行业中 排名第28。H股恒生医疗健康指数上周收跌1.43%，跑输恒生国企指数4.83pp。 点击注册小程序 上市公司研发进度跟踪： 上周，恒瑞医药的HRS9531注射液的NDA申请新进承办；智翔金泰的泰利奇拜单抗注射液、康宁杰瑞的安 尼妥单抗注射液的上市申请新进承办；益方生物的D-2570片的IND申请新进承办；康诺亚的CM383注射液 的临床申请新进承办。舒泰神的韦洛利单抗正在进行三期临床；海创药业的HP515、诺诚健华的 mesutoclax正在进行二期临床；荃信生物的QX029N正在进行一期临床。 本周观点：创新药IN ...

【深圳商报讯】（记者 陈燕青）今年以来，港股IPO市场火爆。根据统计，截至9月14日，今年共有60 家新股登陆港股，合计募资1386.7亿港元，勇夺全球交易所冠军。业内预计，未来港股IPO市场有望继 续保持火热，其中A股公司将是港股重要的上市来源。 数据显示，2023年共有70家公司登陆港股，合计募资463.3亿港元；2024年共有67家公司登陆港股，合 计募集881.5亿港元。也就是说，今年不到9个月时间，港股IPO募资已超过过去两年募资总和。 记者注意到，今年港股IPO募资大增与内地龙头企业纷纷赴港上市有较大关系。 对此，北方一家券商投行高管分析称，"今年港股IPO市场火爆主要有两方面原因，一是港股二级市场 持续走强，恒生指数今年大涨三成且市场流动性明显改善，吸引了部分内地企业；二是港交所的IPO政 策包容性较高，上市速度较快。" 从具体募资金额来看，今年港股IPO募资金额排名前3名的新股分别是宁德时代（300750）、恒瑞医药 （600276）、三花智控（002050），分别募资410.1亿港元、113.7亿港元、107.4亿港元，3家公司合计 募了627亿港元，占今年港股IPO募资总额近五成。其中，宁 ...

HRS9531此次提交上市申请，拟定适应症为在控制饮食和增加运动基础上，初始体重指数（BMI）符合特定要求的成人的长期体重管理，即BMI≥28 kg/m² （肥胖），或≥24 kg/m²（超重）并伴有至少一种体重相关合并症（例如高血糖、高血压、血脂异常、阻塞性睡眠呼吸暂停、脂肪肝等）。 从作用机制来看，HRS9531通过同时激活GLP - 1和GIP受体信号通路发挥降糖减重作用。GIP参与胰岛素分泌，并在中枢神经系统中调节能量平衡，有助于 促进热量消耗；GLP - 1则抑制胃排空、增强饱腹感，同时促进胰岛素分泌和降低胰高血糖素水平。这种"协同增效"机制，使HRS9531在减重效果上潜力巨 大，被业内认为是恒瑞医药在研管线中"最重磅品种"之一。 9月1日，恒瑞医药发布公告，其子公司福建盛迪医药有限公司自主研发的GLP - 1R/GIPR双靶点激动剂HRS9531的药品上市申请，已获国家药监局受理。目 前，全球范围内获批上市的GLP - 1/GIP双受体激动剂仅有礼来的替尔泊肽，恒瑞医药凭借HRS9531 III期临床的全面成功，正式向这一市场霸主发起挑战。 恒瑞早已布局HRS9531的海外市场。2024年5月， ...

Group 1 - The proposed sanctions by the Trump administration on innovative drugs have caused significant turmoil in the capital market, with the Hong Kong Hang Seng Biotechnology Index dropping by 7% at the opening, affecting leading companies like BeiGene and CSPC Pharmaceutical [1] - The National Medical Products Administration (NMPA) announced a reduction in the review and approval time for clinical trial applications to 30 working days, nearly halving the previous timeline, which has provided reassurance to the anxious market [1][8] - The U.S. aims to cut off the core profit path for Chinese innovative drugs through enhanced CFIUS reviews and increased FDA regulatory costs, while China is responding with accelerated approval processes and synchronized global research submissions [1][4] Group 2 - The Trump administration's draft executive order includes two main provisions targeting the key aspect of BD licensing for Chinese innovative drugs [2] - The first provision expands CFIUS reviews, requiring U.S. pharmaceutical companies to undergo mandatory safety reviews for acquiring rights to Chinese drugs in development, which could lead to longer transaction cycles and increased costs [3] - The second provision mandates more detailed FDA reviews of Chinese clinical data and higher regulatory fees for companies submitting trial data from China, raising the entry barriers for Chinese innovative drugs into the U.S. market [4] Group 3 - Data shows that the success rate for Chinese innovative drugs progressing from Phase I clinical trials to FDA approval is only 1.7%, highlighting the stringent nature of FDA approvals [4][6] - Currently, only two PD-1 inhibitors developed in China have received FDA approval, indicating the challenges faced by Chinese companies in the U.S. market [6] - The proposed U.S. measures may inadvertently strengthen the position of multinational corporations (MNCs) that are increasingly interested in Chinese innovative drugs due to their cost-effectiveness and high return on investment [7] Group 4 - The NMPA's recent policy to expedite clinical trial reviews is expected to significantly shorten the R&D cycle, enhancing China's attractiveness in the global R&D network and improving the bargaining power of local companies in international transactions [9][11] - The policy aims to create a more reliable domestic market as a "base" for innovative drug companies, especially when facing potential obstacles in international markets [9] - By 2025, the number of approved innovative drugs in China is projected to reach 43, with domestic drugs accounting for 93%, indicating a robust growth trajectory in the innovative drug sector [9][10] Group 5 - The Chinese government continues to support the development of innovative drugs through various policies, including the establishment of a comprehensive support system for R&D and payment mechanisms [10] - The introduction of a commercial health insurance directory for innovative drugs aims to provide new payment channels for high-value drugs, addressing the challenges of reimbursement under basic medical insurance [10] - The overall policy framework is designed to create a closed-loop system for the high-quality development of innovative drugs, enhancing clinical accessibility and stabilizing enterprise expectations [10][11]

9月15日，药捷安康（南京）科技股份有限公司（药捷安康，2617.HK）盘中最高涨超124%，收涨115.58%，报415港元/股，市值1647.1亿港元。 药捷安康成立于2014年，2025年6月23日在港股上市，9月8日被纳入港股通标的名单。港股上市时，该公司的每股发行价为13.15港元。按照9月15 日的收盘价来计算，上市三个月不到，药捷安康的股价涨幅已经达到3055.89%，并顺利跻身港股千亿市值俱乐部。 招股书显示，替恩戈替尼是一款MTK抑制剂，靶向三个关键通路，包括FGFR/VEGFR、JAK及Aurora，可靶向治疗若干耐药性、复发性或难治性 肿瘤。药捷安康在招股书中称，该产品是世界首个且唯一已进入注册临床阶段治疗FGFR抑制剂复发或难治性CCA（胆管癌）患者的研究药物。 药捷安康提到，在美国的一项临床研究汇总分析，截至2024年3月28日， 其中43名先前已使用FGFR抑制剂治疗但发生疾病进展的CCA患者，以 Tinengotinib进行了治疗，并进行了至少一次肿瘤扫描，客观缓解率（ORR）为30%，疾病控制率（DCR）为93%，中位无进展生存期（PFS）为6 个月。在中国进行的临床试验中亦观 ...

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry as of September 15, 2025 [1] Core Insights - The trend of Chinese innovative drugs going overseas continues, with a focus on selective opportunities. The report highlights that the global pharmaceutical transaction volume reached 456 deals in the first half of 2025, a 32% year-on-year increase, with upfront payments totaling $11.8 billion, a 136% surge, and total transaction value hitting $130.4 billion, up 58% year-on-year [2] - The report emphasizes the promising clinical data from Chinese innovative drugs presented at the World Lung Cancer Conference, particularly in the ADC (Antibody-Drug Conjugate) field, showcasing significant efficacy advantages [3] - The report discusses the potential of small nucleic acid drugs and innovative delivery systems, indicating new market opportunities arising from strategic collaborations between Chinese companies and multinational corporations [4] - The CXO (Contract Research Organization) sector is expected to gradually recover, with a notable increase in orders anticipated in the third quarter of 2025, driven by improved innovation environments and funding from license-out transactions [5] - The 2025 medical insurance negotiation and commercial insurance innovative drug directory work has commenced, with a focus on orphan drugs and breakthrough treatment varieties [6] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry underperformed the CSI 300 index by 1.75% in the past week, with a recent one-month increase of 3.32%, lagging behind the CSI 300 by 5.81% [22][26] - The medical device sector showed the highest weekly increase of 2.23%, while the chemical pharmaceutical sector experienced a decline of 2.57% [31] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical industry index's current PE (TTM) stands at 40.60, above the five-year historical average of 31.60 [46] - The report notes that the pharmaceutical sector has shown a 15.06% increase over the past three months, outperforming the CSI 300 by 16.11% [43] 3. Recent Research Achievements - The report outlines recent research achievements by the Huaxin pharmaceutical team, including various in-depth and commentary reports on innovative drug developments and market trends [50] 4. Recent Industry Policies and News - The report details recent policy updates from the National Healthcare Security Administration regarding the 2025 drug directory adjustments and the approval of new drug applications [52][55]

研究报告 Research Report 15 Sep 2025 香港医疗 Hong Kong Health Care 医药行业周报（2025.09.08-2025.09.12）特朗普计划对中国创新药出海采取限制，但实际影响预计有限 Weekly Report (2025.09.08–2025.09.12): Potential restrictions by Trump on Chinese innovative drug globalization are expected to have a manageable impact Healthcare Weekly (2025.08.25-2025.08.29): ST Volatility in the Market; LT Positive Outlook for Innovative Drugs Unchanged (1 Sep 2025) (Please see APPENDIX 1 for English summary) 医药行业表现回顾 本周（2025.09.08-2025.09.12）恒生医疗保健指数下跌 1.4%，恒生 指数上涨 3.8% ...

"旧账"未了，又谋输血 9月10日晚，贝达药业发布公告称，为进一步提升公司资本实力和综合竞争力，深入推进公司国际化进程，公 司拟发行境外上市股份（H股）并申请在香港联合交易所有限公司主板挂牌上市，本次发行的H股股数不超过 发行后公司总股本的15%（超额配售权行使前）。值得一提的是，贝达药业曾于2021年2月8日首次向港交所递 交上市申请，并于同年5月30日通过聆讯，但未启动招股，申请随后失效；2021年12月2日公司再度递表但无疾 而终。 目前，贝达药业正与相关中介机构推进发行上市的具体工作，细节尚未最终确定。《华夏时报》记者就上市计 划致函公司询问，截至发稿未获回复。 有分析认为，贝达药业此次重启H股上市，或与其面临的流动性压力有关。2025年上半年，公司业绩表现不尽 如人意：实现营业收入17.31亿元，同比增长15.37%；而归母净利润为1.4亿元，同比下滑37.53%，系2022年以 来首次半年度利润下降。贝达药业将其归因于"计入当期损益的折旧摊销等费用升高"，但扣非后归母净利润亦 同比下降11.97%。其中第二季度业绩滑坡更为显著：营业收入8.14亿元，同比微增6.39%；归母净利润仅3980.8 万 ...

贝达药业于9月10日晚再次披露拟发行H股赴港上市的计划，引发市场对其经营现状与融资动机的关 注。公司表示此次募资将用于支持在研管线与营销网络建设等项目，但在上半年归母净利润同比下降 37.53%的背景下，该行为也被市场视为缓解资金压力的举措。 从业务结构来看，贝达药业目前仍高度依赖早期产品凯美纳和贝美纳支撑收入，新获批产品贝福替尼销 售额未达披露门槛，且面临国内多款三代EGFR抑制剂的激烈竞争。与此同时，公司2025年上半年销 售、管理及财务费用均呈双位数增长，而研发投入却延续自2022年以来的收缩态势。此次H股募资能否 有效推进研发管线并改善财务状况，仍受到业内关注。 "旧账"未了，又谋输血 9月10日晚，贝达药业发布公告称，为进一步提升公司资本实力和综合竞争力，深入推进公司国际化进 程，公司拟发行境外上市股份（H股）并申请在香港联合交易所有限公司主板挂牌上市，本次发行的H 股股数不超过发行后公司总股本的15%（超额配售权行使前）。值得一提的是，贝达药业曾于2021年2 月8日首次向港交所递交上市申请，并于同年5月30日通过聆讯，但未启动招股，申请随后失效；2021年 12月2日公司再度递表但无疾而终。 目 ...