（文章来源：证券日报） 证券日报网讯 11月13日晚间，长春高新发布公告称，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"）收到美国食品药品 监督管理局（以下简称"FDA"）书面通知，金赛药业注射用GenSci143临床试验申请获得批准。 ...

Core Viewpoint - Changchun Gaoxin announced that its subsidiary, Changchun Jinsai Pharmaceutical, received written notification from the U.S. Food and Drug Administration (FDA) approving the clinical trial application for GenSci143, a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, indicating significant progress in its oncology drug development [1] Group 1: Company Developments - Changchun Jinsai Pharmaceutical has developed GenSci143, which is a dual-specific antibody-drug conjugate (BsADC) targeting B7-H3 and PSMA [1] - GenSci143 is classified as a Class 1 biological product intended for the treatment of advanced solid tumors, including prostate cancer and lung cancer [1] Group 2: Industry Implications - The approval of GenSci143 for clinical trials highlights the growing focus on targeted therapies in oncology, particularly those that combine chemotherapy and immunotherapy [1]

Core Viewpoint - Changchun High New Technology Industry Group Co., Ltd. (000661.SZ) announced that its subsidiary, Changchun JinSai Pharmaceutical Co., Ltd. (referred to as "JinSai Pharmaceutical"), received written notification from the U.S. Food and Drug Administration (FDA) that the clinical trial application for GenSci143 has been approved, marking a significant milestone for the company in the biopharmaceutical sector [1]. Group 1 - JinSai Pharmaceutical's GenSci143 is a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, which has potential therapeutic effects in both targeted chemotherapy and tumor immunotherapy [1]. - GenSci143 is classified as a Class 1 therapeutic biological product and is intended for the treatment of advanced solid tumors, including prostate cancer and lung cancer [1].

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received written notification from the U.S. Food and Drug Administration (FDA) approving the clinical trial application for GenSci143, a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, indicating significant progress in its oncology pipeline [1]. Group 1 - Jinsai Pharmaceutical's GenSci143 is a self-developed drug with dual potential therapeutic effects, targeting both chemotherapy and tumor immunotherapy [1]. - GenSci143 is classified as a Class 1 biological product intended for the treatment of advanced solid tumors, including prostate cancer and lung cancer [1].

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), received written notification from the U.S. Food and Drug Administration (FDA) approving the clinical trial application for its injectable GenSci143, a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, which has potential dual therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] Group 1 - Jinsai Pharmaceutical's GenSci143 is a self-developed drug aimed at treating various advanced solid tumors, including prostate cancer and lung cancer [1] - The drug is classified as a Class 1 biological product for therapeutic use [1] - The approval from the FDA marks a significant milestone for the company in the oncology drug development space [1]

人民财讯11月13日电，长春高新（000661）11月13日公告，公司子公司长春金赛药业收到美国食品药品 监督管理局（简称"FDA"）书面通知，金赛药业注射用GenSci143临床试验申请获得批准。GenSci143是 一款治疗用生物制品1类药物，拟用于前列腺癌、肺癌等多种晚期实体肿瘤治疗。 ...

Core Viewpoint - Changchun High-tech announced that its subsidiary, Jinsai Pharmaceutical, has received approval for the clinical trial application of GenSci143 in the United States, which is a bispecific antibody-drug conjugate developed for the treatment of advanced solid tumors such as prostate cancer and lung cancer [1] Group 1 - GenSci143 is independently developed by Jinsai Pharmaceutical [1] - The drug has already been approved for clinical trials in China for advanced solid tumors [1]

证券代码：000661 证券简称：长春高新 公告编号：2025-145 长春高新技术产业（集团）股份有限公司 关于子公司注射用 GenSci143 境外生产药品注册临床试验申请 获得批准的公告 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"）收到美国食品药品 监督管理局（以下简称"FDA"）书面通知，金赛药业注射用 GenSci143 临床试 验申请获得批准，现将相关情况公告如下： 一、药品的基本情况 二、药品的其它情况 GenSci143 是金赛药业自主研发的一款靶向 B7-H3 与 PSMA 的双特异性抗 体偶联药物（BsADC），具有靶向化疗和肿瘤免疫双重潜在治疗作用。是一款 治疗用生物制品 1 类药物，拟用于前列腺癌、肺癌等多种晚期实体肿瘤治疗。 GenSci143 通过结合 B7-H3 或 PSMA，内化至溶酶体，释放 TOPO-I 抑制剂 毒素，实现对 B7-H3 阳性、PSMA 阳性及双阳性肿瘤细胞的杀伤。B7-H3 和 PS ...

Core Insights - The Shenzhen Leading Index (399653) closed at 3104.35 points, up 1.73%, with a trading volume of 105.65 billion yuan and a turnover rate of 0.96% [1] - Among the index constituents, 36 stocks rose while 12 fell, with Ruida Futures leading the gainers at an increase of 8.07%, and Binjiang Group leading the decliners with a drop of 3.33% [1] Index Constituents Summary - The top ten constituents of the Shenzhen Leading Index include: - Ningde Times (20.44% weight) at 415.60 yuan, up 7.56%, with a market cap of 1896.42 billion yuan [1] - Zhongji Xuchuang (8.35% weight) at 481.00 yuan, down 2.19%, with a market cap of 534.45 billion yuan [1] - Midea Group (7.67% weight) at 79.60 yuan, up 0.14%, with a market cap of 611.73 billion yuan [1] - Luxshare Precision (6.06% weight) at 57.38 yuan, down 0.68%, with a market cap of 417.85 billion yuan [1] - Sungrow Power (5.67% weight) at 190.51 yuan, up 1.53%, with a market cap of 394.97 billion yuan [1] - BYD (5.25% weight) at 99.83 yuan, up 2.11%, with a market cap of 910.17 billion yuan [1] - Wugong Liquor (4.41% weight) at 121.20 yuan, up 0.68%, with a market cap of 470.45 billion yuan [1] - Gree Electric (3.53% weight) at 41.00 yuan, down 0.36%, with a market cap of 229.66 billion yuan [1] - ZTE Corporation (2.83% weight) at 40.35 yuan, up 1.56%, with a market cap of 193.02 billion yuan [1] - Yuanlefang A (2.75% weight) at 4.04 yuan, unchanged, with a market cap of 151.15 billion yuan [1] Capital Flow Analysis - The net inflow of main funds into the Shenzhen Leading Index constituents totaled 3.862 billion yuan, while retail investors experienced a net outflow of 684 million yuan [1] - Notable capital flows include: - Ningde Times saw a net inflow of 2.655 billion yuan from main funds, while retail investors had a net outflow of 448 million yuan [2] - BYD had a net inflow of 607 million yuan from main funds, with retail investors experiencing a net outflow of 208 million yuan [2] - Zhongji Xuchuang had a net inflow of 409 million yuan from main funds, while retail investors had a negligible outflow [2]

Core Insights - The biopharmaceutical sector experienced a rise of 1.06% on November 13, with BoHui Innovation leading the gains [1] - The Shanghai Composite Index closed at 4029.5, up 0.73%, while the Shenzhen Component Index closed at 13476.52, up 1.78% [1] Stock Performance - BoHui Innovation (300318) closed at 8.17, with a significant increase of 13.47% and a trading volume of 1.4092 million shares [1] - Other notable performers included: - Sanofi (688336) at 73.00, up 6.57% with a trading volume of 137,200 shares [1] - Jinke (688670) at 23.36, up 5.23% with a trading volume of 124,300 shares [1] - Rongchang Bio (688331) at 89.00, up 3.37% with a trading volume of 68,500 shares [1] Capital Flow - The biopharmaceutical sector saw a net outflow of 211 million yuan from institutional investors, while retail investors contributed a net inflow of 86.65 million yuan [2] - The capital flow for specific stocks included: - Sanofi (688336) with a net inflow of 35.23 million yuan from institutional investors [3] - Junshi Biosciences (688180) with a net inflow of 29.67 million yuan from institutional investors [3] - Long Spring High-tech (000661) experienced a net outflow of 59.78 million yuan from institutional investors [3]