洞察临床需求 瞄准全球蓝海市场 眼底血管增生疾病逐渐成为全球成年人"不可逆致盲"的重要病因之一。其中年龄相关性黄斑变性 （nAMD）、糖尿病黄斑水肿（DME）等视网膜新生血管疾病危害尤为突出。根据弗若斯特沙利文资 料，2024年中国眼底血管增生性疾病患者人数超过4000万，并且随着人口老龄化，患者人数还在不断上 升。然而当前临床主流的单靶点抗VEGF治疗方案存在显著未满足需求：部分患者对单靶点药物响应不 佳或出现疗效衰减，无法有效控制病情进展；同时，现有药物玻璃体腔注射半衰期较短，频繁给药不仅 降低患者治疗依从性，更有可能增加如眼内炎、视网膜脱离等并发症的发生风险。 12月8日晚，科兴制药（688136.SH）发布公告，公司自主研发、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，已正式获得国家药品监督管理局颁发的《药 物临床试验批准通知书》（受理号：CXSL2500841），同意开展治疗新生血管性年龄相关性黄斑变性 （nAMD）的临床试验。 瞄准这一临床痛点，科兴制药GB10项目采用"VEGF-Trap+抗Ang-2纳米抗体（VHH）"的创新融合蛋白 结构， ...

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]

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]

科兴制药公告，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开展"GB10注射液"的临床试验，产品名称为GB10注射液，受理号为 CXSL2500841，审批结论为同意本品开展治疗新生血管性年龄相关性黄斑变性的临床试验。 ...

Core Points - The company has received acceptance for its clinical trial application for GB10 injection, marking a significant step in its innovative drug development process [1][2][3] - GB10 injection is a high-concentration ophthalmic injection developed by the company, targeting age-related macular degeneration and diabetic macular edema [2] - Successful development and potential market launch of GB10 injection could enhance the company's product portfolio and market competitiveness [3] Summary by Sections Application Registration Details - Product Name: GB10 Injection [2] - Application Type: Domestic production drug registration clinical trial [2] - Acceptance Number: CXSL2500841 [2] - Indications: Treatment for neovascular diseases such as age-related macular degeneration (nAMD) and diabetic macular edema (DME) [2] - Dosage Form: Injection [2] - Product Overview: GB10 injection is a dual-target antibody with global intellectual property rights, showing efficacy in preclinical studies comparable to international competitors [2] Impact on the Company - The acceptance of the clinical trial application is a crucial milestone in the company's dual-antibody research strategy, indicating progress in its innovative drug development [3] - If successful, the drug could meet market demands with a more diverse product offering, thereby enhancing the company's competitive position [3]

Core Viewpoint - The acceptance of the clinical trial application for GB10 injection marks a significant milestone in the company's innovative drug development process, indicating progress in its dual-target antibody research strategy [3]. Group 1: Product Information - Product Name: GB10 Injection [2] - Application Type: Clinical trial registration for domestic drug production [2] - Indications: Treatment of age-related macular degeneration (nAMD) and diabetic macular edema (DME) [2] - Dosage Form: Injection [2] - Product Overview: GB10 injection is a high-concentration ophthalmic injection developed by Shenzhen Kexing, targeting both VEGF and Ang-2, with preclinical data showing efficacy comparable to international competitors [2]. Group 2: Impact on the Company - The acceptance of the clinical trial application is a crucial step in the company's drug development, potentially enhancing its product portfolio and market competitiveness if the drug successfully reaches the market [3].