Core Viewpoint - Changchun High-tech (000661) announced that its subsidiary, Jinsai Pharmaceutical, received written notification from the FDA approving the clinical trial application for GenSci143, allowing trials to be conducted in the United States [1] Group 1: Product Development - GenSci143 is a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, indicated for advanced solid tumors, with potential dual therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The drug has already been approved for clinical trials in advanced solid tumors in China, and the FDA approval will help the company expand its business structure and optimize its product portfolio [1] Group 2: Strategic Implications - The approval from the FDA enriches the product line layout in strategic areas for the company, indicating a positive step towards enhancing its market presence and competitiveness [1]

Policy Developments - The National Medical Insurance Administration announced that as of November 12, 2025, 24 provinces and regions in China have completed the deployment of the medical imaging cloud software, with 140 million indexed data uploaded to the national center [2] Drug and Device Approvals - Changchun High-tech's subsidiary received FDA approval for the clinical trial of GenSci143, a dual-specific antibody drug targeting B7-H3 and PSMA for treating advanced solid tumors [4] - Zai Lab announced that its ZG006 injection, in combination with etoposide and cisplatin, received clinical trial approval for advanced neuroendocrine carcinoma [5] - Heng Rui Medicine received approval for the clinical trial of Rivegromab tablets for prostate cancer [6] - Haisco announced that its HSK39297 tablets for age-related macular degeneration received clinical trial approval, showing promising preclinical results [7] Capital Market Activities - Kintor Pharmaceutical reported the repurchase of approximately 3.31 million shares since October 2025, with plans to repurchase up to 25.46 million shares over the next 50 trading days [9] - Changlian Co. signed an agreement to establish a joint venture with Shanghai Waigaoqiao Biopharmaceutical, contributing 30 million yuan for a 60% stake [10] Financial Reports - In the third quarter report, Nocera Biopharma reported a net loss of 64.41 million yuan for the first three quarters of 2025, despite a revenue increase of 59.85% to 1.115 billion yuan, driven by sales of its core product [12] Industry Events - The first China-Africa Joint Medical Center was established in Guinea, aiming to enhance healthcare collaboration and address cardiovascular diseases in West Africa [14] Shareholder Actions - Renhe Pharmaceutical's controlling shareholder plans to reduce its stake by up to 0.21% through public trading or block transactions [16]

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received FDA approval for the clinical trial application of GenSci143, a dual-target antibody-drug conjugate for treating advanced solid tumors [1][2]. Group 1: Drug Information - Product Name: GenSci143 - Application: Clinical trial in the United States - Acceptance Number: 177763 - Applicant: Changchun Jinsai Pharmaceutical Co., Ltd. - Approval Conclusion: Clinical trial permitted in the U.S. - Indication: Advanced solid tumors [1]. Group 2: Drug Mechanism and Innovation - GenSci143 targets B7-H3 and PSMA, internalizing into lysosomes to release TOPO-I inhibitor toxins, effectively killing B7-H3 positive, PSMA positive, and dual-positive tumor cells [2]. - The dual-target mechanism helps overcome tumor heterogeneity and resistance due to reduced expression of single targets, potentially benefiting a broader patient population [2]. Group 3: Company Impact - Successful progress in clinical trials could enhance the company's business structure, optimize product offerings, and strengthen its core competitiveness [3]. - The company is committed to advancing the research project and will fulfill its information disclosure obligations regarding subsequent developments [4].

（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]