本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-200 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司瑞石生物医 药有限公司收到国家药品监督管理局（以下简称"国家药监局"）核准签发关于 RSS0343 片的《药物临床试验批准通知书》，将于近期开展临床试验。现将相关 情况公告如下： 一、药物的基本情况 药物名称：RSS0343 片 剂 型：片剂 申请事项：临床试验 受 理 号：CXHL2501022、CXHL2501023、CXHL2501024、CXHL2501025 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 9 月 22 日、23 日受理的 RSS0343 片临床试验申请符合药品注册的有关要求， 同意本品开展两项临床试验。申请的适应症为慢性鼻窦炎不伴鼻息肉和慢性阻塞 性肺疾病。 二、药物的其他情况 RSS0343 是公司自主研发的一款口服、强效和高选择 ...

恒瑞医药12月12日公告，公司子公司瑞石生物医药有限公司收到国家药品监督管理局核准签发关于 RSS0343片的《药物临床试验批准通知书》，将于近期开展临床试验。申请的适应症为慢性鼻窦炎不伴 鼻息肉和慢性阻塞性肺疾病。 ...

每经AI快讯，12月12日，恒瑞医药(600276.SH)公告称，子公司苏州盛迪亚生物医药有限公司收到国家 药品监督管理局核准签发关于SHR-A1811(sc)注射液的《药物临床试验批准通知书》，将于近期开展临 床试验。SHR-A1811(sc)是在注射用SHR-A1811的基础上开发的皮下制剂，目前全球尚无同类产品的皮 下制剂上市。经查询EvaluatePharma数据库，2024年以上同类产品全球销售额合计约为65.57亿美元。 ...

RSS0343是公司自主研发的一款口服、强效和高选择性的小分子1类新药，在动物模型中具有很强的抑 制炎症和缓解呼吸道相关组织损伤的作用。针对慢性鼻窦炎不伴鼻息肉和慢性阻塞性肺疾病，国内外目 前暂无同类药物获批上市。 格隆汇12月12日丨恒瑞医药(600276.SH)公布，公司子公司瑞石生物医药有限公司收到国家药品监督管 理局核准签发关于RSS0343片的《药物临床试验批准通知书》，将于近期开展临床试验。 ...

南财智讯12月12日电，恒瑞医药公告，恒瑞医药收到国家药品监督管理局核准签发的关于SHR- A1811(sc)注射液的《药物临床试验批准通知书》，同意该药品单药在晚期实体瘤患者中开展临床试 验。SHR-A1811(sc)注射液为公司开发的皮下制剂，是在已获批上市的注射用瑞康曲妥珠单抗（SHR- A1811）基础上优化而来，旨在缩短给药时间、提升便捷性。目前全球尚无同类皮下制剂产品上市。此 前，注射用瑞康曲妥珠单抗已获批用于治疗存在HER2激活突变且既往接受过至少一种系统治疗的不可 切除的局部晚期或转移性非小细胞肺癌成人患者。 ...

恒瑞医药公告称，子公司苏州盛迪亚生物医药有限公司收到国家药监局核准签发关于SHR - A1811(sc)注 射液的《药物临床试验批准通知书》，将于近期开展临床试验。公司注射用瑞康曲妥珠单抗（SHR - A1811）已于2025年5月在国内获批上市。SHR - A1811(sc)是皮下制剂，全球尚无同类产品上市。截至 目前，注射用瑞康曲妥珠单抗相关项目累计研发投入约157,417万元。药品研发上市存在不确定性，公 司将推进项目并披露进展。 ...

恒瑞医药公告称，子公司瑞石生物医药收到国家药监局关于RSS0343片的《药物临床试验批准通知 书》，将于近期开展临床试验。该药申请的适应症为慢性鼻窦炎不伴鼻息肉和慢性阻塞性肺疾病。 RSS0343是公司自主研发的小分子1类新药，国内外暂无同类药物获批上市，相关项目累计研发投入约 7228万元。药品研发上市周期长、环节多，存在不确定性，公司将推进项目并披露进展。 ...

恒瑞医药公告称，子公司山东盛迪医药收到国家药监局核准签发的HRS - 1780片《药物临床试验批准通 知书》，将于近期开展临床试验。该药物用于治疗左室射血分数≥40%的成人心力衰竭患者。截至目 前，HRS - 1780片相关项目累计研发投入约6780万元。药品从研制到投产周期长、环节多，存在不确定 性，公司将推进项目并及时披露进展。 ...

Summary of the Conference Call on China Healthcare and Pharmaceuticals Industry Overview - The conference focused on the **China healthcare and pharmaceuticals** sector, specifically discussing the **2025 National Reimbursement Drug List (NRDL)** and the **Commercial Health Insurance Innovative Drug Directory (CHIIDD)** [1][2]. Key Points NRDL and CHIIDD Updates - Approximately **70 innovative drugs** were included in the NRDL, with a **success rate of 88%** for new drug negotiations, an increase from **76% in 2024** [2]. - A total of **114 new drugs** were added to the NRDL, including **50 type 1 innovative drugs**, while **29 drugs** were removed, bringing the total to **3,253 drugs** [2]. - The CHIIDD features **19 expensive innovative drugs** out of **24 candidates**, covering treatments for oncology, Alzheimer’s disease, and rare diseases [2]. Implementation Timeline - The new NRDL and CHIIDD will be implemented on **January 1, 2026**, with new prices for most newly included drugs to be revealed at that time [3]. Company-Specific Insights 1. **Hengrui (600276 CH/1276 HK)**: - Included **10 new drugs** in the NRDL for the first time, such as trastuzumab rezetecan and ivarmacitinib [4]. 2. **Hansoh (3692 HK)**: - Added two new indications for almonertinib to the NRDL [4]. 3. **Sinobio (1177 HK)**: - Three new drugs added: garsorasib, recombinant human coagulation factor VIIa, and penpulimab [5]. 4. **Innovent (1801 HK)**: - New additions include teprotumumab, limertinib, and fulzerasib among others [5]. 5. **BeOne (6160 HK/ONC US)**: - Newly added dinutuximab and zanidatamab in the CHIIDD [5]. 6. **Kelun Biotech (6990 HK)**: - Included sacituzumab tirumotecan and cetuximab N01 in the NRDL [5]. 7. **Akeso (9926 HK)**: - Added new indications for ivonescimab and cadonilimab, along with ebdarokimab and ebronucimab in the NRDL [6]. 8. **Tirzepatide**: - Included in the NRDL for type 2 diabetes, but not for obesity [6]. Market Outlook - The higher success rate and supportive policy trends suggest a **bright sales outlook** for innovative drugs, which are expected to drive growth for the related companies in **2026** [7]. Additional Insights - The report emphasizes the positive implications of the NRDL updates for the growth of covered companies, indicating a favorable environment for innovative drug sales in the Chinese healthcare market [4][7].

Group 1 - The Hong Kong IPO market has raised funds amounting to 2.1 times the total for the entire year of 2024, with expectations for the Hong Kong Stock Exchange to regain the top position in IPO financing by 2025, projecting over HKD 300 billion in IPO fundraising for next year [1] - The trading volume of placement and convertible bond products has significantly increased year-on-year, with major blue-chip companies such as BYD, Xiaomi, Alibaba, China Pacific Insurance, Ping An Insurance, Chow Tai Fook Jewelry, and NIO completing large-scale transactions exceeding USD 1 billion [1] Group 2 - The primary market for Hong Kong stocks is showing a strong recovery, with influential companies actively responding to the national strategy to develop Hong Kong's capital market, leading to the execution of large-scale financing projects [2] - CATL's IPO raised USD 5.3 billion, becoming the largest IPO globally in 2023, and has facilitated other leading companies like Zijin Mining, Sany Heavy Industry, Seres, Hansoh Pharmaceutical, Sanhua Intelligent Controls, Haitian Flavoring and Food, and Chery Automobile to complete financing exceeding USD 1 billion, occupying four spots in the global top ten IPOs [2]