Financial Performance - The company reported a revenue of 8.6676 million, representing a year-on-year increase of 119.88%, with losses narrowing compared to the previous year [2] Business Development - The NDA review for the core product SY-707 (Shouyaoze) for ALK-positive non-small cell lung cancer is progressing steadily, with supplementary materials submitted in November 2025 [3] - The NDA for SY-5007 (Shouyize) for RET fusion-positive non-small cell lung cancer was accepted in October 2025 and is currently under review, with clinical data presented at the 2025 ESMO annual meeting [3] - The key clinical trial for SY-3505 (Ficonalkib), a third-generation ALK inhibitor, has completed patient enrollment, and the company plans to submit the NDA after data readout [3] Product Development - The company is strengthening its early-stage projects, including MAT2A, ALK-4G, and p53Y220C, to advance more candidate drugs into clinical stages [4]

Core Insights - The company Shouyao Holdings announced the retirement of its core technical personnel, Luo Hong, due to age reasons [2] - Following his retirement, Luo Hong will no longer hold any position within the company and will not be recognized as a core technical personnel [2]

首药控股（北京）股份有限公司 关于核心技术人员退休离任的公告 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个别及连带责任。 相关内容提示： 证券代码：688197 证券简称：首药控股 公告编号：2026-003 二、相关影响及公司应对措施 罗鸿先生出生于1959年9月。因年龄缘故，其于近日向公司提请退休，退休 后将不再担任公司任何职务。 罗鸿先生拥有美国、加拿大国籍，以及加拿大萨省大学药学院药代动力学 博士学位。其于2010年8月至2019年5月期间，在公司全资子公司北京赛林泰医 药技术有限公司担任高级总监；于2019年6月至退休前，在公司历任副总经理、 董事、总经理、国际事务首席代表兼药代药动部高级总监等职务。截至本公告 披露日，罗鸿先生未直接或者间接持有公司股份，亦不存在任何应履行而未履 行的承诺事项。 （一）参与的研发项目和专利技术情况 1 罗鸿先生任职期间，主要分管公司在研新药的药物代谢和毒理研究及其临 床申请，并曾参与多项国家"重大新药创制"专项课题。罗鸿先生作为发明人 之一，申请新药发明专利10项，取得授权6项，均为职务成 ...

公司已与罗鸿先生签署了相关协议，对其应承担的保密义务和竞业限制义务作出了约定，其与公司不存 在涉及职务成果、知识产权纠纷或者潜在纠纷的情形。目前公司的技术研发和日常运营均正常稳健进 行，公司研发团队结构完整，后备人员充足，现有研发团队及核心技术人员能够支持公司核心在研管线 及创新产品的持续开发。本次核心技术人员的调整不会影响公司所拥有的核心技术及知识产权权属的完 整性，亦不会对公司的技术优势、核心竞争力和持续经营能力造成重大不利影响。 格隆汇2月12日丨首药控股(688197.SH)公布，公司核心技术人员HONGLUO(下称"罗鸿先生")近日因年 龄缘故提请退休。退休后，罗鸿先生将不再担任公司任何职务，公司不再认定其为核心技术人员。 ...

公司已与罗鸿先生签署了相关协议，对其应承担的保密义务和竞业限制义务作出了约定，其与公司不存 在涉及职务成果、知识产权纠纷或者潜在纠纷的情形。目前公司的技术研发和日常运营均正常稳健进 行，公司研发团队结构完整，后备人员充足，现有研发团队及核心技术人员能够支持公司核心在研管线 及创新产品的持续开发。本次核心技术人员的调整不会影响公司所拥有的核心技术及知识产权权属的完 整性，亦不会对公司的技术优势、核心竞争力和持续经营能力造成重大不利影响。 格隆汇2月12日丨首药控股(688197.SH)公布，公司核心技术人员HONGLUO(下称"罗鸿先生")近日因年 龄缘故提请退休。退休后，罗鸿先生将不再担任公司任何职务，公司不再认定其为核心技术人员。 ...

Core Viewpoint - The article discusses the performance of the A-share market, highlighting the fluctuations in major indices and the notable movements in specific sectors such as media and pharmaceuticals. Market Performance - The Shanghai Composite Index decreased by 0.02% to 4122.34, while the Shenzhen Component Index also fell by 0.02% to 14206.26. The ChiNext Index dropped by 0.14% to 3328.02, and the Sci-Tech Innovation Board Index rose by 0.19% to 1800.35 [4][12]. - The total trading volume in the Shanghai and Shenzhen markets reached 1.4 trillion yuan, with over 2800 stocks declining [6]. Sector Highlights - The media sector experienced significant gains, with multiple stocks such as Light Media and China Film hitting the daily limit, and Huace Film and Happiness Blue Sea rising over 15% [5][6]. - The innovative drug concept saw a surge, with stocks like Guangsheng Tang increasing by over 13% [6]. - The semiconductor sector also performed well, with stocks like Chipone Technology rising over 8% [10]. New Listings - Three new stocks were listed, with N Electric Technology opening at a remarkable increase of 750.05% on its first day [11]. Other Market Movements - The precious metals, shipping, and liquor sectors showed weakness, contrasting with the strong performance of the media and innovative drug sectors [5][6].

Core Viewpoint - The company, Shouyao Holdings (688197.SH), has received approval from the National Medical Products Administration for a clinical trial of SY-9453 capsules, aimed at treating locally advanced or metastatic solid tumors with homozygous deletion of methylthioadenosine phosphorylase (MTAP) [1] Group 1 - The clinical trial approval is specifically for the use of SY-9453 as a monotherapy [1] - The targeted condition for the trial involves patients with MTAP homozygous deletion [1] - This development indicates a significant step forward in the company's research and development efforts in oncology [1]

证券代码：688197 证券简称：首药控股 公告编号：2026-002 首药控股（北京）股份有限公司 自愿披露关于MAT2A抑制剂SY-9453 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个别及连带责任。 首药控股（北京）股份有限公司（以下简称"公司"）于近日收到国家药 品监督管理局（以下简称"国家药监局"）核准签发的《药物临床试验批准通 知书》，SY-9453胶囊单药用于治疗甲基硫腺苷磷酸化酶（MTAP）纯合缺失的 局部晚期或转移性实体瘤的临床试验申请获得批准。现将有关情况公告如下： 一、药品基本情况 药品名称：SY-9453 剂型：胶囊 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12月2日受理的SY-9453胶囊符合药品注册的有关要求，同意本品单药在 甲基硫腺苷磷酸化酶（MTAP）纯合缺失的局部晚期或转移性实体瘤患者中开 展临床试验。 二、其他相关信息 已有的研究显示，近15%的人类癌症存在MTAP基因缺失，MTAP缺失可导 致肿瘤细胞内5′-甲硫腺苷（MTA）积 ...

Core Viewpoint - The company Shouyao Holdings (688197.SH) has received approval from the National Medical Products Administration for a clinical trial of SY-9453 capsules, aimed at treating locally advanced or metastatic solid tumors with homozygous deletion of methylthioadenosine phosphorylase (MTAP) [1] Group 1 - The clinical trial approval is specifically for the use of SY-9453 as a monotherapy [1] - The targeted condition for the trial involves patients with a specific genetic mutation, indicating a focused approach in oncology [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of SY-9453 capsules, aimed at treating locally advanced or metastatic solid tumors with homozygous deletion of methylthioadenosine phosphorylase (MTAP) [1] Group 1: Clinical Trial Approval - The clinical trial application for SY-9453 capsules has been approved for use in treating specific types of tumors [1] - This approval is a significant step in the drug development process, although it is noted that it will not have a major short-term impact on the company's financial status or operational results [1] Group 2: Uncertainties in Drug Development - The clinical research of innovative drugs carries substantial uncertainty, and there are various factors that may prevent the candidate drug from demonstrating the desired safety and efficacy in clinical trials [1] - The company cannot guarantee that any preclinical research or clinical trial data will predict the final clinical outcomes of the candidate drug [1] - Future clinical trial results may not support the submission of a drug application for market approval, and the timing of any potential approval remains uncertain [1]