此次GB10注射液临床试验申请的受理，是公司创新药研发过程中的重要一步，标志着公司基于自主技 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。 智通财经APP讯，科兴制药(688136.SH)发布公告，近日，公司全资子公司深圳科兴药业有限公司(简 称"深圳科兴")收到国家药品监督管理局(简称"国家药监局")行政许可文书《受理通知书》，公司申报 的"GB10注射液"临床试验申请已获得受理。 ...

证券代码：688136 证券简称：科兴制药 公告编号：2025-079 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"）行政许可文书《受理通知书》，公司申报的"GB10注射液"临 床试验申请已获得受理。 现将相关情况公告如下： 一、 申请注册药品的基本情况 1、产品名称：GB10 注射液 2、申请事项：境内生产药品注册临床试验 3、受理号：CXSL2500841 科兴生物制药股份有限公司 自愿披露关于 GB10 注射液临床试验注册申请获得受理的公告 GB 10 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注射剂。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 ...

Core Viewpoint - Company received acceptance notice for clinical trial application of GB10 injection from the National Medical Products Administration, marking a significant step in the development of innovative drugs [1] Group 1: Product Development - GB10 injection is a high-concentration ophthalmic injection targeting both VEGF and Ang-2, developed by the company's wholly-owned subsidiary, Shenzhen Kexing [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 - Acceptance of the clinical trial application represents a key advancement in the company's dual-antibody research and development strategy based on its proprietary technology platform [1] - Successful future commercialization of GB10 injection could diversify the product offerings and enhance the company's market competitiveness [1]

Group 1 - In the past five trading days, a total of 196 companies were investigated by institutions, with a significant focus on companies like Jingzhida, Xinlitai, and Enhua Pharmaceutical [1] - Among the companies investigated, 29 received attention from more than 20 institutions, with Jingzhida being the most popular, attracting 138 institutions [1] - The types of institutions involved in the investigations included 171 securities companies, 118 fund companies, and 57 private equity firms, indicating a strong interest from the securities sector [1] Group 2 - In terms of capital inflow, 8 out of the 29 companies that attracted more than 20 institutions saw net capital inflows, with Dangsheng Technology receiving the highest net inflow of 293 million yuan [1] - The performance of the investigated stocks showed that 12 companies experienced price increases, with Shen Gong Co., Jingzhida, and Xinlitai leading with gains of 31.80%, 17.68%, and 15.81% respectively [2] - Conversely, 17 companies saw declines, with Han Zhong Precision, Kexing Pharmaceutical, and Gao Weida experiencing the largest drops of 13.31%, 9.84%, and 9.25% respectively [2] Group 3 - The most frequently investigated company was Binglun Environment, which was surveyed 4 times, while Hu Dian Co. and Fule New Materials were investigated 3 and 2 times respectively [1] - The detailed list of companies investigated includes various sectors such as machinery, pharmaceuticals, and electronics, highlighting a diverse interest from institutions [2][3]

Market Overview - The biopharmaceutical sector experienced a decline of 0.21% on September 25, with Nossland leading the drop [1] - The Shanghai Composite Index closed at 3853.3, down 0.01%, while the Shenzhen Component Index closed at 13445.9, up 0.67% [1] Stock Performance - Notable gainers in the biopharmaceutical sector included: - Aopu Mai (688293) with a closing price of 62.85, up 7.42% and a trading volume of 30,600 [1] - Rongchang Biotech (688331) closed at 108.50, up 3.43% with a trading volume of 89,200 [1] - Baipusais (301080) closed at 62.16, up 3.43% with a trading volume of 43,500 [1] - Major decliners included: - Nossland (430047) closed at 22.99, down 3.69% with a trading volume of 57,000 [2] - Wufan Biotech (301393) closed at 53.12, down 3.42% with a trading volume of 24,600 [2] - Kexing Pharmaceutical (688136) closed at 38.75, down 3.34% with a trading volume of 53,500 [2] Capital Flow - The biopharmaceutical sector saw a net outflow of 207 million yuan from institutional investors, while retail investors contributed a net inflow of 45.07 million yuan [2] - Notable capital flows included: - Rongchang Biotech (688331) with a net inflow of 1.021 billion yuan from institutional investors [3] - Junshi Biosciences (688180) with a net inflow of 35.36 million yuan from institutional investors [3] - Aopu Mai (688293) with a net inflow of 9.41 million yuan from institutional investors [3]

Core Insights - The company’s inhalation solution of human interferon α1b has been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration, indicating its potential significant clinical benefits in antiviral treatment [1] - The product is a key research pipeline in the antiviral field and has progressed to Phase III clinical trials, having received FDA approval for clinical trials earlier this year [1][2] Group 1: Product Development - The GB05 project, which is the inhalation solution of human interferon α1b, is specifically designed for pediatric use to treat lower respiratory tract infections caused by respiratory syncytial virus (RSV) [2] - There is a significant market demand for antiviral drugs targeting RSV infections in infants and young children, and this product aims to fill that gap, potentially becoming the first inhalation formulation for treating pediatric RSV globally [2] - The inhalation solution offers advantages over traditional administration methods, such as faster onset of action and improved patient compliance, particularly for young children who may be averse to injections [2] Group 2: Innovation and Strategy - The company has been focusing on high-quality drug development and internationalization, particularly in the fields of oncology, autoimmune diseases, and antiviral treatments [3] - The inclusion of the GB05 project in the breakthrough therapeutic varieties list is a result of the company's strategic emphasis on innovation and international expansion [3] - The company aims to enhance its global market competitiveness and achieve its goal of becoming an innovative multinational biopharmaceutical enterprise by continuously driving innovation [3]

Core Viewpoint - The recent strategic partnership between 联康生物科技集团 and 科兴生物制药 is aimed at expanding the commercialization of a novel osteoporosis treatment across six countries in the Middle East and Latin America [1] Group 1: Shareholder Activity - On September 23, shareholders of 联康生物科技集团 deposited shares worth HKD 113 million into HSBC Hong Kong, representing 12.33% of the total shareholding [1] Group 2: Strategic Partnership - 联康生物科技集团's wholly-owned subsidiary, 北京博康健基因科技有限公司, has signed a strategic cooperation agreement with 科兴生物制药股份有限公司 [1] - The agreement grants 科兴制药 exclusive commercialization rights for the innovative osteoporosis treatment 博固泰® in six countries: Saudi Arabia, Egypt, Morocco, Colombia, Argentina, and Mexico [1]

Core Viewpoint - The company announced that its inhaled human interferon α1b solution has been included in the list of breakthrough therapeutic drugs by the National Medical Products Administration (NMPA) of China, marking a significant advancement in its antiviral drug development [1][2]. Group 1: Drug Information - The inhaled human interferon α1b solution is designed for pediatric patients suffering from respiratory syncytial virus (RSV) infections, which are a leading cause of acute respiratory infections in children [2]. - RSV infections accounted for over 60% of acute respiratory infections in children, with 33 million cases reported globally in 2019 among children under five years old [2]. - In China, approximately 3.5 million cases of RSV infections were reported in 2019, representing over 10% of the global total, with hospitalization rates between 620,000 to 950,000, accounting for 18-27% of global hospitalizations [2]. Group 2: Clinical Development Status - As of the date of the announcement, the inhaled human interferon α1b solution is in the Phase III clinical trial stage [3]. Group 3: Impact on the Company - The inclusion of the inhaled human interferon α1b solution in the breakthrough therapy list will not have a significant immediate impact on the company's financial performance [5]. - The company acknowledges the long and uncertain nature of drug development, which involves substantial investment and multiple stages, and will continue to communicate progress in accordance with regulatory requirements [5].

Group 1: Company Announcements - Ganli Pharmaceutical signed a technology transfer and supply agreement with FZ and BIOMM, with a total supply framework agreement amount expected to be no less than 3 billion RMB [1] - Upwind New Materials completed the transfer of 121 million shares, changing its controlling shareholder to Zhiyuan Hengyue, associated with Zhiyuan Robotics [2] - Poly Developments plans to publicly issue corporate bonds not exceeding 15 billion RMB for various purposes including debt repayment and project construction [3] Group 2: Shareholder Actions - Lenovo Holdings reduced its stake in Lakala by 8.0781 million shares, decreasing its ownership from 25.00% to 23.97% [4] - Fenghuo Communication plans to repurchase shares with a budget between 75 million and 150 million RMB, with a maximum repurchase price of 40.53 RMB per share [5] - Hualing Cable intends to acquire control of San Bamboo Intelligent for no more than 270 million RMB to enhance its capabilities in robotics and high-frequency transmission [6] Group 3: Market Developments - Guiguang Network clarified that rumors regarding major collaborations with Huawei Cloud and restructuring with state-owned enterprises are untrue [7] - Dongshan Precision is planning to issue H-shares and list on the Hong Kong Stock Exchange to enhance its international presence [8] - Wolong Nuclear Materials' subsidiary plans to invest up to 1 billion RMB in a new materials project in Suzhou [9] Group 4: Other Corporate Activities - Chao Xun Communication's management completed their share reduction plan, with specific shares sold by board members [10] - Various companies are involved in significant project bids and collaborations, including China Electric Research and others [15]

Core Viewpoint - The company has announced that its subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., has developed an inhalation solution of human interferon α1b, which has been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration's Drug Review Center [1] Group 1 - The inhalation solution is indicated for pediatric respiratory syncytial virus lower respiratory tract infections, including pneumonia and bronchiolitis [1]