证券代码：688197 证券简称：首药控股 公告编号：2025-028 RET基因异常在多种肿瘤中均有发生，其中，约1%-2%的非小细胞肺癌患 者发生RET基因融合。在我国，RET融合阳性非小细胞肺癌患者确诊时大多已 1 处于疾病晚期，且基础化疗方案对此类患者疗效有限、疗效持续时间短，免疫 疗法对该类患者不敏感，部分RET阳性非小细胞肺癌患者最终会发生脑部转移。 相关研究表明，相比于非选择性抑制剂，选择性RET抑制剂能够更加有效抑制 RET的激酶活性，阻断其下游的信号传导，破坏肿瘤细胞的多种生理功能，抑 制一系列RET阳性肿瘤细胞（不同的RET融合形式、不同的突变形式）的生长， 从而更能使RET基因异常的非小细胞肺癌等实体瘤患者显著获益，同时降低毒 副作用的发生，提高患者的耐受性，其诊疗价值和商业潜力较为可观。 首药控股（北京）股份有限公司 自愿披露关于RET抑制剂索特替尼片（SY-5007） 新药上市申请获得受理的公告 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（下称"公司"）于近日收 ...

Core Viewpoint - The company, Shouyao Holdings (688197.SH), has received a notice of acceptance from the National Medical Products Administration for its new drug application (NDA) for SY-5007, a treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are positive for RET gene fusion [1] Group 1: Drug Development - SY-5007 is a fully self-developed drug that has shown significant and durable efficacy in both treatment-naive and previously treated patients with RET fusion-positive NSCLC [1] - The drug demonstrates good safety and tolerability, validating its clinical potential as a highly selective RET inhibitor [1] Group 2: Market Implications - The approval of SY-5007 is expected to provide a new treatment option for patients in China with RET fusion-driven non-small cell lung cancer [1]

Core Viewpoint - The company has received acceptance for the new drug application (NDA) of its self-developed drug, SY-5007, which is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are positive for RET gene fusion [1] Group 1 - SY-5007 is a highly selective small molecule RET tyrosine kinase inhibitor and is the first of its kind to enter clinical research in China [1] - It is one of the fastest progressing domestically produced selective RET inhibitors in clinical development [1] - The primary endpoints of key Phase II and III clinical trials have been met, demonstrating a high and durable objective response rate in patients with RET gene fusion positive locally advanced or metastatic NSCLC [1] Group 2 - Efficacy data shows that the product achieves a high proportion of objective responses in the target patient population [1] - Most high-grade adverse reactions can be managed through dose adjustment, safety monitoring, and necessary symptomatic treatment [1]

Core Viewpoint - The company, Shouyao Holdings, has received acceptance for its new drug application for SY-5007, a selective RET inhibitor, aimed at treating adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are positive for RET gene fusion [1] Group 1 - The National Medical Products Administration has issued an acceptance notice for the new drug application of SY-5007 [1] - SY-5007 has demonstrated significant and durable efficacy in both treatment-naive and previously treated patients with RET fusion-positive NSCLC [1] - The drug shows good safety and tolerability, confirming its clinical potential as a highly selective RET inhibitor [1]

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [1] Core Insights - The pharmaceutical and biotechnology industry index declined by 3.65% during the reporting period, ranking 21st among 31 primary industries, underperforming the CSI 300 index which fell by 2.73% [4][16] - The valuation of the pharmaceutical and biotechnology industry as of October 17, 2025, is a PE (TTM overall method, excluding negative values) of 30.08x, down from 31.23x in the previous period, indicating a downward trend and below the average [4][21] - Key sub-industries include vaccines (55.76x), hospitals (39.64x), and medical devices (38.84x), with the lowest valuation in pharmaceutical circulation (14.29x) [4][21] - The report highlights significant innovations presented at the 2025 ESMO conference, indicating a shift in global oncology drug development from "single-agent breakthroughs" to "combination therapy strategies" [6][8] - The newly released regulations by the State Council aim to standardize clinical research pathways, promoting innovation while ensuring safety [7][25][26] Industry Overview - The report notes that 26 listed companies in the pharmaceutical and biotechnology sector experienced a net reduction in shareholder holdings amounting to 501 million yuan, while 4 companies increased their holdings by 519 million yuan [4] - The report emphasizes the importance of monitoring third-quarter earnings to validate the fundamentals of companies, particularly those with innovative product launches and significant performance improvements [8] Important Industry News - The approval of the first domestic PDE4 inhibitor by He Mei Pharmaceutical marks a significant milestone in the industry [6][34] - The approval of a new indication for GSK's recombinant shingles vaccine expands its application to adults at increased risk due to immunodeficiency [6][36] - The U.S. Senate passed a revised version of the Biosecurity Act, which continues to impose restrictions on certain Chinese biotechnology companies [6][44] - The collaboration between Bai Li Tian Heng and BMS on the iza-bren project has reached a milestone, triggering a payment of 250 million USD [6][47] - The IPO of Xuan Zhu Biotechnology on the Hong Kong Stock Exchange saw a significant oversubscription and a substantial increase in share price during the dark trading period [6][49]

（编辑 任世碧） 证券日报网讯 10月17日晚间，首药控股发布公告称，公司分别于2025年8月26日、2025年9月15日召开 第二届董事会第十次会议、第二届监事会第九次会议及2025年第一次临时股东大会，会议审议通过了 《关于变更注册地址、取消监事会、修订并办理工商变更登记的议案》。近日，公司完成了上述事项的 工商变更登记及备案手续，并取得了北京经济技术开发区市场监督管理局核准换发的《营业执照》。 ...

证券代码：688197 证券简称：首药控股 公告编号：2025-027 首药控股（北京）股份有限公司 一、名称：首药控股（北京）股份有限公司 二、类型：股份有限公司（上市、自然人投资或控股） 三、统一社会信用代码：91110108MA004WFJ71 关于完成工商变更登记及备案并换发《营业执照》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"）分别于2025年8月26 日、2025年9月15日召开第二届董事会第十次会议、第二届监事会第九次会议及 2025年第一次临时股东大会，会议审议并通过了《关于变更注册地址、取消监 事会、修订<公司章程>并办理工商变更登记的议案》。具体内容详见公司于 2025年8月28日、2025年9月16日在《上海证券报》及上海证券交易所网站 （www.sse.com.cn）披露的相关公告。 近日，公司完成了上述事项的工商变更登记及备案手续，并取得了北京经 济技术开发区市场监督管理局核准换发的《营业执照》。本次变更后的《营业 执照》登记事项信息如 ...

Group 1 - The article highlights the stock price target increases for various companies as of October 16, with notable recommendations from different securities firms [1][2] - Haiguang Information received the highest target price increase of 50.38% with a target price of 350.40 yuan, while Xiaogongmiao City and Jiuzhou Pharmaceutical also received significant recommendations [1] - A total of 20 listed companies were recommended by securities firms on October 16, with Haiguang Information receiving 4 recommendations, Xiaogongmiao City 3, and Jiuzhou Pharmaceutical 2 [1] Group 2 - The article lists the number of securities firms recommending specific companies, with Haiguang Information leading with 4 firms, followed by Xiaogongmiao City with 3 and Jiuzhou Pharmaceutical with 2 [2] - Six companies received initial coverage on October 16, including Baiya Co. with a "Buy" rating from Jianghai Securities and Juhua Co. with an "Increase" rating from Tianfeng Securities [2][3] - The sectors represented among the newly covered companies include personal care products, chemical products, and IT services [3]

Investment Rating - The report initiates coverage with a "Buy" rating for the company [29] Core Insights - The company is set to commercialize its second-generation ALK inhibitor, SY-707, and has promising clinical value for its third-generation ALK inhibitor, SY-3505, which is expected to capture a significant market share [4][10][21] - The company has a differentiated pipeline of innovative drugs, focusing on ALK mutation NSCLC, with several candidates showing strong clinical efficacy and safety profiles [5][22] - Revenue projections for 2025 to 2027 are estimated at 0.15 billion, 0.96 billion, and 2.85 billion yuan, with growth rates of 280.5%, 537.7%, and 197.8% respectively [29] Summary by Sections 1. Profit Forecast - Revenue is projected to be 0.04 billion yuan in 2024, increasing to 0.15 billion in 2025, 0.96 billion in 2026, and 2.85 billion in 2027, with respective growth rates of -24.6%, 280.5%, 537.7%, and 197.8% [2][29] - Net profit attributable to shareholders is forecasted to be -2.12 billion yuan in 2024, -1.83 billion in 2025, -2.08 billion in 2026, and -1.12 billion in 2027 [2][29] - The earnings per share (EPS) is expected to improve from -1.43 yuan in 2024 to -0.75 yuan in 2027 [2][29] 2. Innovative Drug Pipeline - The company has multiple differentiated innovative drug candidates, including SY-707 (a second-generation ALK inhibitor) and SY-3505 (a third-generation ALK inhibitor), both targeting ALK-positive NSCLC [5][10] - SY-5007, a selective RET inhibitor, is expected to submit a New Drug Application (NDA) in the second half of 2025, showing strong clinical efficacy compared to existing treatments [22][23] - SY-5933, a KRAS (G12C) inhibitor, has demonstrated significant anti-tumor activity in early clinical trials, with a focus on combination therapies [24][28] 3. Market Position and Competitive Advantage - The company is positioned to capture market share in the ALK-TKI market with its innovative therapies, particularly with the anticipated approval of SY-707 and the promising clinical data for SY-3505 [10][21] - The report highlights the competitive advantages of SY-5007 and SY-5933 in terms of clinical efficacy and safety compared to existing therapies [22][24]

Group 1 - The core viewpoint of the news is that Shouyao Holdings experienced a decline in stock price and trading volume, indicating potential liquidity issues and investor sentiment concerns [1] - On October 13, Shouyao Holdings' stock price fell by 2.86%, with a trading volume of 43.49 million yuan, and a net financing buy of -48,200 yuan [1] - As of October 13, the total margin balance for Shouyao Holdings was 287 million yuan, accounting for 11.04% of its market capitalization, which is above the 80th percentile of the past year [1] Group 2 - As of June 30, the number of shareholders for Shouyao Holdings increased by 5.33% to 4,526, while the average circulating shares per person decreased by 5.06% to 14,141 shares [2] - For the first half of 2025, Shouyao Holdings reported a revenue of 2 million yuan, a year-on-year decrease of 47.37%, and a net profit attributable to shareholders of -104 million yuan, a decrease of 1.48% year-on-year [2] - Among institutional holdings, as of June 30, 2025, Penghua Medical Technology Stock A was the largest shareholder with 5.41 million shares, unchanged from the previous period, while China Europe Medical Health Mixed A entered as the tenth largest shareholder with 1.17 million shares [2]