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].

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]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for clinical trials of GenSci143 in patients with advanced solid tumors [1] Group 1: Product Development - GenSci143 is an innovative biopharmaceutical developed by Jinsai Pharmaceutical, intended for the treatment of various advanced solid tumors, including prostate cancer and lung cancer [1] - GenSci143 is a bispecific antibody-drug conjugate (BsADC) targeting B7-H3 and PSMA, which offers dual potential therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The drug aims to overcome tumor heterogeneity and resistance caused by reduced expression of single targets, thereby covering a broader patient population and producing more durable anti-tumor efficacy [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for clinical trials of GenSci143 in patients with advanced solid tumors [1] Group 1: Product Development - GenSci143 is an innovative biopharmaceutical developed by Jinsai Pharmaceutical, intended for the treatment of various advanced solid tumors, including prostate cancer and lung cancer [1] - GenSci143 is a bispecific antibody-drug conjugate (BsADC) targeting B7-H3 and PSMA, which offers dual potential therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The drug aims to overcome tumor heterogeneity and resistance caused by reduced expression of single targets, thereby covering a broader patient population and providing more durable anti-tumor efficacy [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 its product, GenSci143, in patients with advanced solid tumors [1] Group 1: Product Development - GenSci143 is a first-class therapeutic biological product independently developed by Jinsai Pharmaceutical, intended for the treatment of various advanced solid tumors, including prostate cancer and lung cancer [1] - GenSci143 is a bispecific antibody-drug conjugate (BsADC) targeting B7-H3 and PSMA, which has the potential for both targeted chemotherapy and tumor immunotherapy [1] Group 2: Market Potential - The drug aims to overcome tumor heterogeneity and resistance caused by reduced expression of single targets, thereby covering a broader patient population and producing more durable anti-tumor efficacy [1]

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 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]