登录新浪财经APP 搜索【信披】查看更多考评等级 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、准确性和完整性依法承担法律责任。 近日，科兴生物制药股份有限公司（以下简称"公司"）全资子公司深圳科兴药业有限公司（以下简 称"深圳科兴"）收到国家药品监督管理局（以下简称"国家药监局"）签发的《药物临床试验批准通知 书》，国家药监局批准同意深圳科兴自主研发的靶向BDCA2（血树突状细胞抗原2）的创新药物"GB19 注射液"开展临床试验。 现将相关情况公告如下： 一、《药物临床试验批准通知书》基本情况 二、药品相关介绍 GB19注射液项目靶向浆细胞样树突状细胞（pDC）表面特异性表达的BDCA2靶点，其作用机制与现有 靶向B细胞通路的临床药物存在显著差异；GB19通过与BDCA2特异性结合，可抑制pDC细胞产生I型干 扰素，从而干预先天性免疫与适应性免疫间的异常活化环路。GB19注射液临床前研究展现出良好的体 外活性、免疫原性，生物利用度高，对靶点抑制时间维持超90天，安全性表现优异，如研发成功有望为 多种干扰素通路异常相关的SLE等自身免疫性疾病患者提供新的 ...

北京商报讯（记者 丁宁）2月25日晚间，科兴制药（688136）发布公告称，公司全资子公司深圳科兴药 业有限公司（以下简称"深圳科兴"）收到国家药品监督管理局（以下简称"国家药监局"）签发的《药物 临床试验批准通知书》，国家药监局批准同意深圳科兴自主研发的靶向BDCA2（血树突状细胞抗原2） 的创新药物"GB19注射液"开展临床试验。 科兴制药表示，公司GB19注射液的临床试验获得国家药监局的批准，是公司基于自主技术平台在单抗 药物研发领域扎实积淀的成果，是公司在自身免疫性疾病创新药领域的重要布局。若该药品研发未来实 现成功上市，能够为满足市场需求提供更加多元的产品，有利于丰富公司产品布局，进一步提高公司市 场竞争力。 ...

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、准确性和完整性依法承担法律责任。 近日，科兴生物制药股份有限公司（以下简称"公司"）全资子公司深圳科兴 药业有限公司（以下简称"深圳科兴"）收到国家药品监督管理局（以下简称 "国 家药监局"）签发的《药物临床试验批准通知书》，国家药监局批准同意深圳科 兴自主研发的靶向BDCA2（血树突状细胞抗原2）的创新药物"GB19注射液"开展 临床试验。 现将相关情况公告如下： 一、《药物临床试验批准通知书》基本情况 证券代码：688136 证券简称：科兴制药 公告编号：2026-011 科兴生物制药股份有限公司 自愿披露关于 GB19 注射液获得药物临床试验批准通知书的公告 1 三、对公司的影响 本次 GB19 注射液的临床试验获得国家药监局的批准对公司近期的财务状 况、经营业绩不会产生重大影响。 公司 GB19 注射液的临床试验获得国家药监局的批准，是公司基于自主技术 平台在单抗药物研发领域扎实积淀的成果，是公司在自身免疫性疾病创新药领域 的重要布局。若该药品研发未来实现成功上市，能够为满足市场需求提供更加多 元的产 ...

新京报贝壳财经讯 2月25日，科兴制药公告，近日，全资子公司深圳科兴药业有限公司收到国家药品监 督管理局签发的《药物临床试验批准通知书》，国家药监局批准同意深圳科兴自主研发的靶向 BDCA2(血树突状细胞抗原2)的创新药物"GB19注射液"开展临床试验。 ...

Core Viewpoint - The article highlights that Sinovac Biotech (688136.SH) has received approval from the National Medical Products Administration for its innovative drug "GB19 Injection," which targets BDCA2 for clinical trials, potentially offering new treatment options for autoimmune diseases [1] Group 1: Company Developments - Sinovac's wholly-owned subsidiary, Shenzhen Sinovac Biotech Co., Ltd., has been granted a Clinical Trial Approval Notice for GB19 Injection [1] - The drug targets plasmacytoid dendritic cells (pDC) by specifically binding to the BDCA2 target, differing significantly from existing clinical drugs that target B cell pathways [1] Group 2: Drug Mechanism and Potential - GB19 Injection works by inhibiting pDC cells from producing type I interferons, thereby intervening in the abnormal activation loop between innate and adaptive immunity [1] - Preclinical studies of GB19 have shown good in vitro activity, high immunogenicity, and a biological availability that maintains target inhibition for over 90 days, with excellent safety profiles [1] - If successfully developed, GB19 could provide new treatment options for patients with autoimmune diseases related to abnormal interferon pathways, such as systemic lupus erythematosus (SLE) [1]

科兴制药公告，近日，全资子公司深圳科兴药业有限公司收到国家药品监督管理局签发的《药物临床试 验批准通知书》，国家药监局批准同意深圳科兴自主研发的靶向BDCA2（血树突状细胞抗原2）的创新 药物"GB19注射液"开展临床试验。 ...

产品研发进展 经济观察网 科兴生物制药股份有限公司近期在H股上市进程、创新药管线关键进展及海外市场拓展等方 面有动态更新。 高管变动 科兴制药于2025年11月向港交所主板提交H股上市申请，后续需关注港交所的审核进展、聆讯时间及最 终上市时间表。若成功上市，将拓宽公司资本通道，支持国际化战略。 公司结构与治理 股东会议争议案庭审定于2026年4月下旬至5月初进行，涉及董事会职权归属，可能影响公司治理稳定 性。此事件关联科兴生物控股层面，可能间接波及上市公司。 以上内容基于公开资料整理，不构成投资建议。 GB18注射液（GDF15单抗）针对肿瘤恶病质的国内I期临床试验于2025年10月启动入组，未来将公布安 全性、耐受性及药代动力学数据，并可能推进至后续临床阶段。该药是潜在"First-in-Class"药物，瞄准 全球未满足临床需求。其他核心管线包括聚焦炎症性肠病的GB24（TL1A/LIGHT双靶点）、针对系统 性红斑狼疮的GB19，以及三抗药物GB26，均处于早期临床阶段，未来需关注其临床试验结果与国际化 申报进展。 海外市场拓展 白蛋白紫杉醇等产品已在欧盟、阿根廷、秘鲁等多国获批，2026年将继续在拉美 ...

Core Viewpoint - The recent surge in "A+H" listings has seen over 100 A-share companies at various stages of seeking listings in Hong Kong, with a notable presence of biopharmaceutical companies like Kexing Pharmaceutical, which has submitted its application for dual listing [1][2]. Company Overview - Kexing Pharmaceutical, established in 1989 and restructured into a joint-stock company in 2019, is headquartered in Jinan, Shandong [4][3]. - The actual controller of the company, Deng Xueqin, holds 56.27% of the voting rights as of October 2025 [5]. - The board of directors consists of eight members, including four executive directors [6]. Financial Performance - Kexing Pharmaceutical's revenue has fluctuated in recent years, with figures of 1.31 billion, 1.26 billion, 1.40 billion, and 700 million RMB reported for 2022, 2023, 2024, and the first half of 2025, respectively [25]. - The company achieved profitability in 2024, with net profits of 27.05 million RMB and 78.96 million RMB in the first half of 2025 [26]. - Sales expenses have been high, totaling 2.369 billion RMB over three and a half years, while R&D expenses were approximately 788 million RMB, accounting for 16.8% of total revenue [27]. Product Portfolio - Kexing Pharmaceutical has established a product matrix consisting of commercialized products, a research pipeline, and introduced products [9][12]. - The company has four main commercialized products, including SINOGEN, which holds a 55.2% market share in China's short-acting interferon α1b market [10][11]. - The revenue from these products for the years 2022, 2023, 2024, and the first half of 2025 was 1.314 billion, 1.254 billion, 1.392 billion, and 680 million RMB, respectively [12]. Research and Development - Kexing Pharmaceutical has a pipeline of 5 products in clinical stages and 10 in preclinical stages, focusing on oncology, autoimmune diseases, and degenerative diseases [13][18]. - The company has developed a "3KX technology platform" to enhance the R&D process, integrating various advanced technologies [14]. - The most advanced products in the pipeline are GB05 and GB-K02, both currently in Phase III clinical trials [19][20]. Market Position and Challenges - The company is facing challenges due to a lack of blockbuster products and a relatively weak R&D capability compared to other biotech firms [30]. - The sales team may struggle with centralized management due to a dispersed pipeline layout, leading to higher sales expenses [30].

Market Overview - The biopharmaceutical sector increased by 0.65% on February 4, with Weiguang Bio leading the gains [1] - The Shanghai Composite Index closed at 4102.2, up 0.85%, while the Shenzhen Component Index closed at 14156.27, up 0.21% [1] Individual Stock Performance - Weiguang Bio (002880) closed at 30.72, up 7.79% with a trading volume of 106,600 shares and a transaction value of 320 million yuan [1] - Kanglaweishi (920575) closed at 11.07, up 5.63% with a trading volume of 105,200 shares and a transaction value of 114 million yuan [1] - Kangchen Pharmaceutical (603590) closed at 41.61, up 5.61% with a trading volume of 50,700 shares and a transaction value of 208 million yuan [1] - Other notable performers include Zhifei Biological (300122) up 2.61%, Kanghong Pharmaceutical (002773) up 2.31%, and Watson Bio (300142) up 1.92% [1] Capital Flow Analysis - The biopharmaceutical sector experienced a net outflow of 159 million yuan from institutional investors, while retail investors saw a net inflow of 187 million yuan [2] - The overall retail investor net outflow was 28.35 million yuan [2] Detailed Capital Flow for Selected Stocks - Wanze Co. (000534) had a net inflow of 67.22 million yuan from institutional investors, while retail investors experienced a net outflow of 99.26 million yuan [3] - Kangtai Biological (300601) saw a net inflow of 15.17 million yuan from institutional investors, with retail investors also experiencing a net outflow [3] - Shanghai Laisai (002252) had a net inflow of 14.01 million yuan from institutional investors, while retail investors faced a net outflow [3]

一、回购股份的基本情况 证券代码：688136 证券简称：科兴制药 公告编号：2026-010 科兴生物制药股份有限公司 关于以集中竞价交易方式回购公司股份的进展公告 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。 重要内容提示： | 回购方案首次披露日 | 2025/3/19 | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 回购方案实施期限 | 年 月 月 2025 3 3 | 17 | 日~2026 | 年 | 16 | 日 | | 预计回购金额 | 3,000万元~6,000万元 | | | | | | | 回购用途 | □减少注册资本 √用于员工持股计划或股权激励 □用于转换公司可转债 | | | | | | | 累计已回购股数 | □为维护公司价值及股东权益 1,319,333股 | | | | | | | 累计已回购股数占总股本比例 | 0.66% | | | | | | | 累计已回购金额 | 4,924.18万元 | | | | | | | 实 ...