证券代码：000661 证券简称：长春高新 公告编号：2025-137 长春高新技术产业（集团）股份有限公司 关于子公司 GenSci142 胶囊国内生产药品注册临床试验申请 获得受理的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记 载、误导性陈述或重大遗漏。 近日，长春高新技术产业（集团）股份有限公司（以下简称"公司"）子公 司——长春金赛药业有限责任公司（以下简称"金赛药业"）收到国家药品监督 管理局核准签发的《受理通知书》，金赛药业的 GenSci142 胶囊境内生产药品注 册临床试验申请获得受理，现将相关情况公告如下： 一、药品的基本情况 产品名称：GenSci142 胶囊 申请事项：境内生产药品注册临床试验 受理号：CXSL2500910、CXSL2500911、CXSL2500912 申请人：长春金赛药业有限责任公司 审批结论：经审查，决定予以受理 适应症：细菌性阴道病 二、药品的其它情况 细菌性阴道病（BV）是育龄期女性中最常见的阴道感染性疾病之一，其病 理机制主要表现为正常产生过氧化氢的乳酸杆菌数量大量减少，取而代之的是兼 性及专性厌氧菌，尤其以加德纳菌的过度增殖最 ...

Core Viewpoint - Changchun Gaoxin's subsidiary, Jinsai Pharmaceutical, has received the acceptance notice for the clinical trial application of GenSci142 capsules from the National Medical Products Administration, indicating a significant step in expanding the company's product offerings and enhancing its competitive edge in the pharmaceutical industry [1] Group 1: Company Developments - Jinsai Pharmaceutical's GenSci142 capsules target Gardnerella bacteria and are characterized by rapid action, precise bactericidal effects, high efficiency in biofilm clearance, low risk of resistance, and local safety [1] - The acceptance of the clinical trial application is expected to help the company broaden its business structure and optimize its product lineup [1] Group 2: Industry Context - The pharmaceutical products involved are noted for their high technology, high risk, and high added value, indicating the complexities and challenges associated with drug development [1] - There remains uncertainty regarding the progress of the clinical trial, reflecting the inherent risks in the pharmaceutical industry [1]

Core Points - The Medical Health R Index (480016) closed at 7852.45 points, up 1.04%, with a trading volume of 22.052 billion yuan and a turnover rate of 0.74% [1] - Among the index constituents, 40 stocks rose while 9 fell, with WuXi AppTec leading the gainers at 4.27% and Pian Zai Huang leading the decliners at 0.91% [1] Index Constituents Summary - The top ten constituents of the Medical Health R Index include: - WuXi AppTec (603259) with a weight of 14.37%, latest price at 102.04, and a market cap of 304.463 billion yuan [1] - Hengrui Medicine (600276) with a weight of 11.45%, latest price at 66.00, and a market cap of 438.055 billion yuan [1] - Mindray Medical (300760) with a weight of 8.07%, latest price at 223.57, and a market cap of 271.066 billion yuan [1] - United Imaging Healthcare (688271) with a weight of 4.32%, latest price at 143.03, and a market cap of 117.879 billion yuan [1] - Pian Zai Huang (600436) with a weight of 3.59%, latest price at 185.38, and a market cap of 111.843 billion yuan [1] - Aier Eye Hospital (300015) with a weight of 3.21%, latest price at 12.33, and a market cap of 114.982 billion yuan [1] - Kelun Pharmaceutical (002422) with a weight of 2.54%, latest price at 36.05, and a market cap of 57.610 billion yuan [1] - Changchun High & New Technology (000661) with a weight of 2.35%, latest price at 120.28, and a market cap of 49.067 billion yuan [1] - Fosun Pharma (600196) with a weight of 2.28%, latest price at 29.28, and a market cap of 78.190 billion yuan [1] - Sinopharm (002001) with a weight of 2.22%, latest price at 23.27, and a market cap of 71.519 billion yuan [1] Capital Flow Analysis - The net inflow of main funds into the Medical Health R Index constituents totaled 634 million yuan, while retail funds saw a net outflow of 105 million yuan [1] - Detailed capital flow for key stocks includes: - WuXi AppTec with a net inflow of 353.9 million yuan from main funds [2] - Sinopharm with a net inflow of 90.036 million yuan from main funds [2] - Hengrui Medicine with a net inflow of 76.418 million yuan from main funds [2] - Other stocks like Changchun High & New Technology and Fosun Pharma also experienced varying levels of net inflow and outflow [2]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Jinsai Pharmaceutical, received approval from the National Medical Products Administration for a clinical trial of GenSci139 in patients with advanced solid tumors, which may enhance the company's business scope and core competitiveness [1]. Group 1 - Jinsai Pharmaceutical has been granted a clinical trial approval for GenSci139, a dual-specific antibody-drug conjugate targeting EGFR and HER2 [1]. - GenSci139 is developed independently by Jinsai Pharmaceutical and possesses its own intellectual property rights [1]. - Successful progress in the clinical trial application could help the company expand its business range and optimize its product structure [1].

Core Viewpoint - Changchun Gaoxin announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration to conduct clinical trials for the injection of GenSci139 in patients with advanced solid tumors [1] Group 1 - The approval includes a clinical trial notification for the drug GenSci139 [1] - The clinical trial will focus on patients suffering from advanced solid tumors [1]

Core Viewpoint - Changchun Gaoxin's subsidiary, Changchun Jinsai Pharmaceutical, has received approval from the National Medical Products Administration to conduct clinical trials for GenSci139 in patients with advanced solid tumors, which may enhance the company's business scope and product structure [1] Group 1 - The approval allows for the clinical trial of GenSci139, a drug intended for advanced solid tumor patients [1] - Successful progress in the clinical trial application is expected to broaden the company's business range and optimize its product structure [1] - The initiative aims to enrich and improve the strategic product line layout, thereby enhancing the company's core competitiveness [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received approval from the National Medical Products Administration for clinical trials of GenSci139 in patients with advanced solid tumors [1] Group 1: Product Development - GenSci139 is a dual-specific antibody-drug conjugate (BsADC) independently developed by Jinsai Pharmaceutical, targeting EGFR and HER2 [1] - The product utilizes a proprietary, highly stable, and hydrophilic cleavable linker, covalently connected to a potent topoisomerase I inhibitor as an effective payload [1] - GenSci139 specifically recognizes and binds to tumor cells expressing EGFR and/or HER2, blocking the signaling pathways of EGFR homodimers, HER2 homodimers, and EGFR-HER2 heterodimers, thereby inhibiting tumor cell growth [1] Group 2: Mechanism of Action - The drug can internalize upon binding to tumor cells expressing EGFR and/or HER2, releasing the effective payload to kill tumor cells [1]

Group 1 - The core point of the article is that Changchun High-tech (000661) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received approval from the National Medical Products Administration for a clinical trial of GenSci139 injection in patients with advanced solid tumors [1] Group 2 - The approval allows Jinsai Pharmaceutical to conduct clinical trials, indicating progress in the development of GenSci139 as a potential treatment option [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received the approval from the National Medical Products Administration for the clinical trial of GenSci139 injection in patients with advanced solid tumors [1] Group 1 - The approval allows Jinsai Pharmaceutical to conduct clinical trials for GenSci139, indicating progress in the company's drug development pipeline [1] - This development may enhance the company's position in the oncology market, potentially leading to new treatment options for patients with advanced solid tumors [1]

Core Viewpoint - Changchun Gaoxin's subsidiary, Changchun Jinsai Pharmaceutical, has received approval from the National Medical Products Administration to conduct clinical trials for the injection of GenSci139 in patients with advanced solid tumors [1] Group 1 - The approval is for the clinical trial of GenSci139, which is a single-agent treatment [1] - The clinical trial will focus on patients suffering from advanced solid tumors [1]