Group 1 - The core point of the announcement is that Shenzhen Kexing Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Kexing Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for the drug GB10 injection [1][2] Group 2 - The GB10 injection is a high-concentration ophthalmic protein drug formulation developed independently by Shenzhen Kexing, targeting both VEGF and Ang-2, with a concentration of 140 mg/mL, which is expected to improve patient compliance by allowing administration every four months [3] - Preclinical data indicates that GB10 injection's biological activity and animal efficacy meet international competitive standards, effectively inhibiting choroidal neovascularization in monkey models [3] Group 3 - The approval for the clinical trial of GB10 injection is a significant milestone in the company's innovative drug development process, marking key progress in its dual-antibody research strategy based on its proprietary technology platform [4] - If successfully developed and launched, GB10 injection could diversify the company's product offerings and enhance its market competitiveness [4]

根据公告，GB10注射液是抗VEGF/Ang-2双靶点抗体高浓度眼科专用蛋白药物制剂。GB10注射液浓度 达到 140mg/mL，可减少注射体积或提高给药量，延长给药周期，预期实现每4个月给药一次。 北京商报讯（记者 王寅浩 宋雨盈）12月8日，科兴制药发布公告称，公司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》，同意GB10注射液开展治疗新生血 管性年龄相关性黄斑变性（nAMD）的临床试验。 ...

Core Viewpoint - Company Kexing Pharmaceutical (688136.SH) has received approval from the National Medical Products Administration (NMPA) for clinical trials of its self-developed GB10 injection, a dual-target antibody drug for ophthalmic use [1] Group 1: Clinical Trial Approval - Kexing's wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., has been granted a Clinical Trial Approval Notice by the NMPA [1] - The approval allows Shenzhen Kexing to conduct clinical trials for the GB10 injection [1] Group 2: Product Details - GB10 injection is a high-concentration ophthalmic protein drug formulation targeting both VEGF and Ang-2, with a concentration of 140 mg/mL [1] - The formulation aims to reduce injection volume or increase dosage, allowing for administration every four months, which is expected to significantly enhance patient compliance [1] Group 3: Preclinical Data - Preclinical data indicates that GB10's biological activity and animal efficacy meet international competitive standards [1] - In a laser-induced monkey model of choroidal neovascularization (CNV), GB10 effectively inhibits retinal vascular neogenesis [1]

证券代码：688136 证券简称：科兴制药 公告编号：2025-099 科兴生物制药股份有限公司 自愿披露关于眼科制剂 GB10 注射液获得药物临床试验批准通知书的 公告 GB10 注射液是深圳科兴自主研发、拥有全球知识产权的抗 VEGF/Ang-2 双 靶点抗体高浓度眼科专用蛋白药物制剂。GB10 注射液浓度达到 140mg/mL，可 减少注射体积或提高给药量，延长给药周期，预期实现每 4 个月给药一次，极大 提高患者依从性。 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 圳科兴开展"GB10注射液"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 1、产品名称：GB10 注射液 2、受理号：CXSL2500841 3、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， ...

Core Viewpoint - The company announced that its wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for the GB10 injection, aimed at treating neovascular age-related macular degeneration (nAMD) [1] Group 1 - The NMPA has issued a "Clinical Trial Approval Notification" for the GB10 injection [1] - The clinical trial application for GB10 injection meets the relevant requirements for drug registration [1] - The clinical trial will focus on treating neovascular age-related macular degeneration (nAMD) [1]

格隆汇12月8日丨科兴制药(688136.SH)公布，近日，公司全资子公司深圳科兴收到国家药监局签发的 《药物临床试验批准通知书》，国家药监局批准同意深圳科兴开展"GB10注射液"的临床试验。产品名 称：GB10注射液，受理号：CXSL2500841。 GB10注射液是深圳科兴自主研发、拥有全球知识产权的抗VEGF/Ang-2双靶点抗体高浓度眼科专用蛋白 药物制剂。GB10注射液浓度达到140mg/mL，可减少注射体积或提高给药量，延长给药周期，预期实现 每4个月给药一次，极大提高患者依从性。 临床前数据显示，其生物活性和动物药效均达到国际竞品水平，在激光诱导的猴CNV（脉络膜新生血 管, choroidal neovascularization）药效模型中能够有效抑制眼底血管新生。 公司GB10注射液的临床试验获得国家药监局的批准，是公司创新药研发过程中的重要一步，标志着科 兴基于自主技术平台的双抗研发战略取得关键进展，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。 ...

Core Viewpoint - Company Sihuan Pharmaceutical (688136.SH) has received approval from the National Medical Products Administration (NMPA) for clinical trials of its self-developed GB10 injection, marking a significant step in its innovative drug development process [1] Group 1: Product Development - GB10 injection is a high-concentration ophthalmic protein drug formulation targeting both VEGF and Ang-2, with a concentration of 140 mg/mL, which can reduce injection volume or increase dosage, allowing for administration every four months [1] - Preclinical data indicates that GB10 injection's biological activity and animal efficacy meet international competitive standards, effectively inhibiting choroidal neovascularization in laser-induced monkey models [1] Group 2: Strategic Importance - The approval for GB10 injection's clinical trial represents a key advancement in the company's dual-antibody research strategy based on its proprietary technology platform [1] - Successful future commercialization of GB10 injection could diversify the product offerings in the market, enhancing the company's competitive position [1]

Core Viewpoint - The announcement indicates that the company’s wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for the GB10 injection, aimed at treating neovascular age-related macular degeneration [1] Group 1 - The product name is GB10 injection, and the acceptance number is CXSL2500841 [1] - The approval conclusion states that the product is allowed to proceed with clinical trials for the treatment of neovascular age-related macular degeneration [1]

Core Insights - Company Kexing Pharmaceutical has submitted its prospectus to the Hong Kong Stock Exchange, marking a significant step in its "A+H" dual-platform strategy following its listing on the STAR Market in December 2020 [3] - Kexing Pharmaceutical is distinct from Kexing Biotech, focusing on recombinant protein drugs and microbiome preparations, primarily in antiviral and oncology treatments, while Kexing Biotech specializes in preventive vaccines [3][4] - The company has faced declining growth momentum due to domestic price reductions and increased international competition, leading to a period of losses [3][10] - The actual controller, Deng Xueqin, has raised over 1 billion yuan through share reductions, raising market concerns about the company's stock price volatility [3][19] Company Background - Kexing Pharmaceutical and Kexing Biotech share a common origin dating back to 1989, but have since become completely independent entities with no substantial ties [4] - The company was established as a result of asset and business separations that began in 2001, with Kexing Pharmaceutical focusing on therapeutic biopharmaceuticals [4][5] Financial Performance - Kexing Pharmaceutical's revenue has fluctuated between 1.2 billion to 1.3 billion yuan from 2020 to 2023, with a net loss of 190 million yuan in 2023 [10][9] - The company expects revenue to recover to 1.4 billion yuan in 2024, with a net profit of 31 million yuan, and further growth in 2025 [9][10] - Approximately 90% of the company's revenue comes from four core products, all of which have been on the market for over 15 years, facing challenges such as price reductions and increased competition [10][11] Product Portfolio - The four main products contributing to revenue include Epoetin (依普定), Interferon (赛若金), Granulocyte Colony-Stimulating Factor (白特喜), and Clostridium Butyricum (常乐康), which collectively accounted for 89% of revenue in 2024 [10][11] - Despite strong historical performance, these products are now encountering growth ceilings, impacting overall revenue stability [10][12] Cost Management and Efficiency - The company has implemented cost-cutting measures, reducing R&D expenses by 51% and sales expenses by 13.4% in 2024 [15][14] - Employee numbers have decreased from 1,407 at the end of 2022 to 971 by mid-2025, indicating a significant reduction in workforce [15] Financial Health - Kexing Pharmaceutical's debt levels have increased, with a debt-to-asset ratio rising from 43% at the end of 2022 to 49% by mid-2025, alongside a significant increase in bank loans [17] - The company's liquidity position has also deteriorated, with the current ratio dropping from 2.6 in 2022 to 1.6 in mid-2025, indicating a tightening of short-term financial flexibility [17] Market Strategy - The submission for H-share listing aims to enhance the company's "innovation + internationalization" strategy and diversify financing channels [18] - The market is observing the implications of Deng Xueqin's share reductions, which may reflect either a lack of confidence or a strategic move to optimize the share structure ahead of the H-share issuance [19][22]

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 | 2025 年 3 月 3 月 | 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 | | | | | | 实际回购价格区间 | 23.14元/股~43.50元/股 | | | | | 一、回购股份的基本情况 科兴生物制药股份有限公司（以下简称" ...