Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-1894 injection, which is expected to begin soon [1] Group 1: Product Development - SHR-1894 injection is a self-developed therapeutic biological product aimed at treating atopic dermatitis, expected to protect the skin barrier and suppress inflammation [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] - The total research and development investment for the SHR-1894 injection project has reached approximately 40.1 million yuan (unaudited) [1]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-021 江苏恒瑞医药股份有限公司 关于药品上市许可申请获受理的提示性公告 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。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）收到国家药品监督 管理局（以下简称"国家药监局"）下发的《受理通知书》，公司 HR091506 片 的上市许可申请获国家药监局受理。现将相关情况公告如下： 一、药品的基本情况 受理号：CXHS2600022、CXHS2600023 申报阶段：上市 申请人：江苏恒瑞医药股份有限公司 拟定适应症（或功能主治）：用于痛风患者高尿酸血症的长期治疗。 二、药品的临床试验情况 此次申报上市，是基于两项随机、双盲、非布司他片阳性对照的关键Ⅲ期临 床研究（研究编号 HR091506-301、HR091506-302）。HR091506-301 研究是一项 评价 HR091506 片在需尿酸深度达标的痛风伴高尿酸血症患者中的有效性和安全 性Ⅲ期研究，由复旦大学附属华山医院邹和建、薛愉教授担任主要研究者，全国 ...

近日，江苏恒瑞医药股份有限公司（以下简称"公司"）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（以下简称"国家药监局"）核准签 发关于 SHR-1894 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。现将相关情况公告如下： 一、药物的基本情况 药物名称：SHR-1894 注射液 剂 型：注射剂 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-022 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 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。 二、药物的其他情况 SHR-1894 注射液是公司自主研发的一种治疗用生物制品，预期可在特应性 皮炎治疗过程中，发挥保护皮肤屏障和抑制炎症的作用。经查询，目前国内外尚 无同类药物获批上市。截至目前，SHR-1894 注射液相关项目累计研发投入约为 4,010 万元(未经审计)。 三、风险提示 根据我国药品注册相关的法律法规要求，药物在获得药物临床试验批准通知 书后，尚需开展临床试验并经国家药监局审评、审批通过后方可生产上市。药 ...

Core Viewpoint - The company announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-1894 injection, a self-developed therapeutic biological product aimed at treating atopic dermatitis [1] Group 1 - SHR-1894 injection is expected to protect the skin barrier and suppress inflammation during the treatment of atopic dermatitis [1] - The total research and development investment for this project has reached approximately 40.1 million yuan [1] - Following the approval of the clinical trial notification, the drug must undergo clinical trials and receive further review and approval from the National Medical Products Administration before it can be produced and marketed [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-1894 injection, a self-developed therapeutic biological product aimed at treating atopic dermatitis [1] Group 1 - SHR-1894 injection is expected to protect the skin barrier and inhibit inflammation during the treatment of atopic dermatitis [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] - The total research and development investment for the SHR-1894 injection project has reached approximately 40.1 million yuan (unaudited) [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received the acceptance notice from the National Medical Products Administration for the listing application of HR091506 tablets, intended for the long-term treatment of hyperuricemia in gout patients [1] Group 1: Product Development - HR091506 tablets are developed using gastric retention formulation technology and feature a pulsatile release characteristic, consisting of both immediate-release and delayed-release components [1] - The immediate-release part quickly releases in the stomach to achieve effective blood drug concentration, while the delayed-release part remains in the stomach to sustain the release, aiming to prolong the maintenance time of effective blood drug concentration and improve the rate of achieving uric acid reduction targets [1] - The total R&D investment for the HR091506 project has reached approximately 126.7 million yuan (unaudited) [1]

Core Viewpoint - The company has received acceptance from the National Medical Products Administration for the marketing authorization application of HR091506 tablets, a novel oral sustained-release formulation of febuxostat [1] Group 1: Product Development - HR091506 tablets are developed using gastric retention formulation technology and feature a pulsatile release characteristic [1] - The product consists of a rapid-release component and a delayed-release component, designed to quickly achieve effective blood drug concentration and maintain it over an extended period [1] Group 2: Market Implications - The sustained-release nature of HR091506 aims to improve the rate of achieving target uric acid levels in patients [1]

Core Viewpoint - The announcement indicates that the subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. of Heng Rui Medicine has received approval from the National Medical Products Administration for the clinical trial of SHR-1894 injection, which is expected to play a role in treating atopic dermatitis by protecting the skin barrier and inhibiting inflammation [1] Group 1: Product Development - SHR-1894 injection is a self-developed therapeutic biological product by the company [1] - The clinical trial for SHR-1894 injection will commence shortly following the approval [1] - The total research and development investment for the SHR-1894 injection project has reached approximately 40.1 million yuan [1] Group 2: Market Context - Currently, there are no similar drugs approved for market release domestically or internationally [1]

2025年，香港金融市场展现出令人瞩目的复苏动能与战略韧性。 在这背后，除了上市新股数量与募资额大增外，九成新股溢价发行、基石投资者认购数额创历史新高、打新的人数持续回升等一系列细节，也 成为过去一年港股IPO"王者归来"最好的"注脚"。 近日，沙利文、捷利交易宝、头豹联合发布的《2025年香港IPO市场及二级市场白皮书》(简称《白皮书》)显示，2025年香港IPO市场火热，多 维度发行数据足以证明： 90%的新股选择溢价发行；大多数新股采取招股区间的上限价定价；新股首日破发率降至三成以下；上市后股价翻倍者比比皆是；参与港股打 新的人数持续回升；百倍认购、千倍认购不再稀奇，甚至创下新股万倍认购的记录。 同时，基石投资者参与新股的金额也创出历史新高。2025年，78.07%的IPO新股引入了基石投资者，较上一年提升11.07个百分点，基石投资总 额约1065.96亿港元，创下历史新高。瑞银、Jane Street、GIC Private Limited、施罗德等外资机构尤为活跃。 九成新股溢价发行 据LiveReport大数据统计，2025年114家IPO公司中，72家有上市前估值数据，占比63.16%。 从发 ...

Industry Overview - The report highlights the recent release of the "Implementation Regulations of the Drug Administration Law of the People's Republic of China" and the issuance of opinions by nine departments to promote high-quality development in the drug retail industry [21][23][25] - The sixth batch of national procurement for high-value medical consumables has been opened for bidding, indicating ongoing efforts to regulate and enhance the medical supply chain [21][22] Industry Data - In December, the Consumer Price Index (CPI) for healthcare was 101.8, with a year-on-year increase of 1.8% and a month-on-month increase of 0.1% [26] - The Producer Price Index (PPI) for pharmaceutical manufacturing was 96.1, showing a year-on-year decrease of 3.9% and a month-on-month decrease of 0.2% [37] - For the entire year of 2025, the cumulative operating income of the pharmaceutical manufacturing industry was 24,870.0 billion, a year-on-year decrease of 1.2%, while the cumulative total profit was 3,490.0 billion, a year-on-year increase of 2.7% [39] Company Announcements - Hengrui Medicine received drug registration approval and had several drugs included in the list of breakthrough therapy designations, indicating a strong pipeline and regulatory progress [62][67] - Zai Lab entered a global strategic cooperation and licensing agreement with AbbVie for the development and commercialization of ZG006, which includes significant upfront and milestone payments [68] - Rongchang Bio signed an exclusive licensing agreement with AbbVie for RC148, a dual-specific antibody drug, which includes substantial upfront and potential milestone payments [69] Market Performance - In January, the Shanghai Composite Index rose by 3.76%, while the Shenzhen Component Index increased by 5.03%. The SW Pharmaceutical and Biological Index rose by 3.14%, with all sub-sectors showing positive growth [74] - The SW Pharmaceutical and Biological Industry's price-to-earnings ratio (TTM) was 50.97, with a valuation premium of 258% relative to the CSI 300 [77] Monthly Strategy - The report suggests focusing on investment opportunities in innovative drugs, CXO, and upstream life sciences, particularly in light of recent developments in brain-computer interfaces and AI applications [84] - The report maintains a "neutral" rating for the industry and recommends a "buy" rating for Hengrui Medicine and an "accumulate" rating for WuXi AppTec [84]