自愿披露关于 GB19 注射液获得美国 FDA 新药临床试验许可的公告 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"） 收到美国食品药品监督管理局（以下简 称 "FDA"）的通知，深圳科兴自主研发的创新药GB19注射液药品临床试验申 请已获得FDA批准，可在美国开展临床试验，适应症为治疗皮肤型红斑狼疮 （CLE）、系统性红斑狼疮（SLE）。 现将相关情况公告如下： 证券代码：688136 证券简称：科兴制药 公告编号：2026-017 科兴生物制药股份有限公司 一、许可基本情况 1、药品名称：GB19 注射液 2、申请事项：美国境内开展临床试验 3、申请编号：IND 180417 4、审评结论：本药品临床试验申请获得美国 FDA 批准，同意本药品按照提 交的方案开展临床研究。 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 ...

证券代码：688136 证券简称：科兴制药 公告编号：2026-016 科兴生物制药股份有限公司 关于开立募集资金专项账户并签订募集资金专户存储三方监管协议 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、准确性和完整性依法承担法律责任。 一、募集资金基本情况 经中国证券监督管理委员会出具的《关于同意科兴生物制药股份有限公司首 次公开发行股票注册的批复》（证监许可[2020]2655号）同意，科兴生物制药股 份有限公司（以下简称"科兴制药"或"公司"）首次公开发行人民币普通股 4,967.5300万股，每股面值人民币1.00元，每股发行价为人民币22.33元，本次 发 行 募 集 资 金 总 额 为 1,109,249,449.00 元 ， 扣 除 保 荐 承 销 等 发 行 费 用 114,608,529.84元，募集资金净额为994,640,919.16元。上述募集资金已全部到 位，经大华会计师事务所（特殊普通合伙）验资，并于2020年12月7日出具大华 验字[2020]000752号《验资报告》验证确认。 上述募集资金到账后，公司依照规定对上 ...

证券代码：688136 证券简称：科兴制药 公告编号：2026-014 科兴生物制药股份有限公司 关于股份回购进展及实施结果暨股份变动的公告 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。 重要内容提示： | 回购方案首次披露日 | 2025/3/19，由公司实际控制人、董事长提议 | | | | | | --- | --- | --- | --- | --- | --- | | 回购方案实施期限 | 年 月 日 2025 3 3 16 | 17 | 日~2026 | 年 | 月 | | 预计回购金额 | 3,000万元~6,000万元 | | | | | | 回购价格上限 | 46.75元/股 | | | | | | 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 | | | | | | | □为维护公司价值及股东权益 | | | | | | 实际回购股数 | 1,514,425股 | | | | | | 实际回购股数占总股本比例 | 0.75% | | | | ...

证券代码：688136 证券简称：科兴制药 公告编号：2026-015 科兴生物制药股份有限公司 自愿披露关于 GB19 注射液皮肤型红斑狼疮适应症 获得药物临床试验批准通知书的公告 1、产品名称：GB19 注射液 2、受理号：CXSL2501081 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 皮肤型红斑狼疮（CLE）适应症的临床试验。 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 3、适应症：皮肤型红斑狼疮（CLE） 4、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，GB19 注射液临床试验申请符合药品注册的有关要求，同意本品开展皮肤型红斑狼疮 （CLE）适应症临床试验。 二、药品相关介绍 ...

关于签署日常关联交易协议的公告 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、准确性和完整性依法承担法律责任。 证券代码：688136 证券简称：科兴制药 公告编号：2026-013 科兴生物制药股份有限公司 重要内容提示： 是否需要提交股东大会审议：否 日常关联交易对上市公司的影响：科兴生物制药股份有限公司（以下简 称"公司"、"本公司"）与关联方的日常关联交易是为了满足公司日常业务发展 需要，为正常的持续性合作。公司关联交易符合相关法律、法规的规定，关联交 易的定价主要遵循市场价格和公开、公平、公正及合理的原则，没有损害公司及 股东的利益，不会对公司的独立性产生影响，也不会对关联方形成较大的依赖。 一、日常关联交易基本情况 经公司第二届董事会第十三次会议审议，公司（含全资子公司及分公司，下 同）分别与关联方创益生物科技有限公司（以下简称"创益科技"）续签了写字 楼租赁合同、物业管理服务合同，承租创益科技大厦用于办公场所及研究实验室， 租赁期为 2024 年 3 月 1 日到 2026 年 2 月 28 日共两年。详见公司于 2024 年 3 月 7 ...

Group 1 - The core viewpoint of the news is that Sinovac Biotech reported a significant increase in revenue and net profit for the year 2025, driven by strong overseas market expansion [1] - The company's revenue reached 1.541 billion yuan, representing a year-on-year growth of 9.54%, while the net profit attributable to shareholders surged by 406.47% to 159 million yuan [1] - The growth was primarily attributed to the robust development in overseas markets, with products now covering approximately 70 countries and regions, particularly performing well in the European Union [1] Group 2 - On February 25, 2026, Sinovac Biotech announced that its wholly-owned subsidiary, Shenzhen Sinovac Pharmaceutical, received clinical trial approval for the GB19 injection, targeting systemic lupus erythematosus and other autoimmune diseases [2] - The GB19 injection is based on an innovative mechanism targeting BDCA2, with preclinical studies demonstrating excellent safety and bioavailability [2] - This approval marks an important strategic move for the company in the autoimmune disease sector, potentially enriching its product pipeline in the future [2] Group 3 - In the past week (as of February 27, 2026), Sinovac Biotech's stock price increased by 1.42%, with a trading range fluctuation of 2.52%, closing at 30.63 yuan, up by 0.56% on the day [3] - On February 27, there was a net inflow of 933,900 yuan in main funds, although the overall trend over the past five days showed a net outflow [3] - The turnover rate was 0.55%, with a trading volume of 33.7 million yuan, indicating relatively stable market activity [3]

Core Viewpoint - The company reported a significant increase in revenue and net profit for the fiscal year 2025, driven by strong overseas market expansion and non-recurring gains from investments [1] Financial Performance - The company achieved an operating revenue of 1.541 billion yuan, representing a year-on-year growth of 9.54% [1] - The net profit attributable to the parent company was 159 million yuan, with a substantial increase in net profit excluding non-recurring gains amounting to 59.7062 million yuan compared to the previous year [1] Market Expansion - The company actively expanded its overseas market, resulting in robust growth in overseas revenue, which contributed to the overall increase in operating revenue [1] Non-Recurring Gains - The increase in non-recurring gains was primarily due to changes in the fair value of private equity funds held by the company and profits from the disposal of subsidiaries [1]

Core Viewpoint - The company reported a significant increase in revenue and net profit for the fiscal year 2025, driven by strong overseas market expansion and non-recurring gains [1] Financial Performance - The company achieved an operating revenue of 1.541 billion yuan, representing a year-on-year growth of 9.54% [1] - The net profit attributable to the parent company was 159 million yuan, with a substantial increase in net profit excluding non-recurring gains at 59.7062 million yuan compared to the previous year [1] Market Expansion - The company actively expanded its overseas market, resulting in robust growth in overseas revenue, which contributed to the overall increase in operating revenue [1] Non-Recurring Gains - The increase in non-recurring gains during the reporting period was primarily due to changes in the fair value of private equity funds held by the company and profits from the disposal of subsidiaries [1]

Core Viewpoint - The company reported significant growth in its 2025 performance, driven by strong overseas market expansion and successful product launches [2] Financial Performance - In 2025, the company achieved total revenue of 1.541 billion yuan, representing a year-on-year increase of 9.54% [2] - The net profit attributable to the parent company reached 159 million yuan, a substantial increase of 406.47% compared to 31.48 million yuan in the same period of 2024 [2] Market Expansion - The company's overseas revenue saw significant growth, contributing to the overall increase in revenue and profit [2] - The company has established a global market presence in approximately 70 countries and regions, including the EU, Brazil, the Philippines, and Indonesia [2] - The company's core product, albumin paclitaxel, was approved for sale in the EU in 2024, with export volume in the first half of 2025 accounting for 47.7% of China's total exports of similar products [2] Innovation and R&D - The company's long-term commitment to innovation and R&D has entered a phase of成果转化 (results transformation), contributing to its explosive growth [2] - The company focuses on three potential areas: oncology, autoimmune diseases, and metabolic diseases, advancing a differentiated pipeline [2] - Several products with "first-in-class" (FIC) or "best-in-class" (BIC) potential have entered critical clinical stages, injecting new momentum for long-term value growth [2]

Investment Rating - The report maintains a "Market Perform" rating for the pharmaceutical and biotechnology industry, indicating that the industry index is expected to perform within ±10% of the market index over the next six months [3][26]. Core Insights - The SW pharmaceutical and biotechnology industry underperformed the CSI 300 index, declining by 0.95% from February 13 to February 26, 2026, which is approximately 1.1 percentage points lower than the index [11]. - Most sub-sectors within the industry recorded positive returns during the same period, with "Other Biological Products" and "Hospitals" leading with increases of 2.42% and 1.80%, respectively. Conversely, "Medical R&D Outsourcing" and "Offline Pharmacies" saw declines of 3.80% and 0.65% [12][24]. - Approximately 52% of stocks in the industry reported positive returns, with the highest gain being 14.44% for Erkang Pharmaceutical, while the largest decline was 13.28% for Zexing Pharmaceutical-U [13][16]. - The overall industry valuation remained stable, with a Price-to-Earnings (PE) ratio of approximately 51.16 times as of February 26, 2026, which is 3.82 times higher than the CSI 300 index [18][26]. Summary by Sections 1. Market Review - The SW pharmaceutical and biotechnology industry underperformed the CSI 300 index, with a decline of 0.95% from February 13 to February 26, 2026 [11]. - Most sub-sectors recorded positive returns, with "Other Biological Products" and "Hospitals" leading the gains [12]. - About 52% of stocks in the industry achieved positive returns, with notable performances from Erkang Pharmaceutical and Zexing Pharmaceutical-U [13][16]. - The industry valuation showed little change, with a PE ratio of 51.16 times [18]. 2. Industry News - The Zhejiang Medical Insurance Bureau announced a training session for the centralized procurement of two types of medical consumables, which includes cardiac pacemakers and peripheral vascular intervention micro-catheters [24]. - The average price reduction for cardiac pacemakers was reported at 43.09%, with the highest reduction reaching 76.13% for implantable pacemakers [24]. 3. Company Announcements - Sinovac Biotech announced the approval of a clinical trial for its innovative drug GB19 injection, which targets BDCA2 [25]. 4. Industry Outlook - The report suggests a focus on investment opportunities in the brain-computer interface sector, which is highlighted in the 14th Five-Year Plan [26]. - Recommended stocks for attention include leading companies in medical devices, pharmaceutical retail, aesthetic medicine, scientific services, and traditional Chinese medicine [28].