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]

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun JinSai Pharmaceutical Co., Ltd., received written notification from the FDA regarding the acceptance of the clinical trial application for the injectable GenSci143, a dual-target antibody-drug conjugate aimed at treating advanced solid tumors [1][2]. Group 1: Drug Information - Product Name: Injectable GenSci143 [1] - Indication: Advanced solid tumors [2] - Application Details: The clinical trial application has been accepted by the FDA with acceptance number 177763 [1]. Group 2: Mechanism and Technology - GenSci143 targets B7-H3 and PSMA, which are highly expressed in various malignancies, including non-small cell lung cancer, pancreatic cancer, and prostate cancer [2]. - The drug utilizes a proprietary linker technology that enhances the potency and stability of the toxin, aiming to provide a new treatment avenue for tumors expressing B7-H3 and/or PSMA [3]. Group 3: Development Timeline - The clinical trial application for GenSci143 is also set to be accepted in China by the National Medical Products Administration by August 2025 [3]. Group 4: Company Commitment - The company will actively advance the research and development of GenSci143 and will fulfill its information disclosure obligations regarding the project's progress [5].

Core Viewpoint - Changchun High-tech's subsidiary, Changchun Jinsai Pharmaceutical, has received written notification from the FDA regarding the acceptance of the clinical trial application for GenSci143, a dual-target antibody-drug conjugate aimed at treating tumors expressing B7-H3 and PSMA [1][2] Group 1: Product Development - GenSci143 is a self-developed drug that targets B7-H3 and PSMA, combining chemotherapy and tumor immunotherapy potential [1] - The drug utilizes a proprietary linker technology, providing strong cytotoxic activity and high plasma stability, which enhances its safety profile while effectively killing tumor cells [1] - The dual-target design of GenSci143 aims to overcome tumor heterogeneity and resistance, potentially benefiting a broader patient population [1] Group 2: Regulatory Progress - The clinical trial application for GenSci143 has also been accepted by the National Medical Products Administration in China, indicating progress in both U.S. and Chinese markets [2] - The company has received multiple approvals for other clinical trial applications, including GS3-007a and GenSci140, showcasing a robust pipeline of innovative drug candidates [2] Group 3: Strategic Focus - The company has undertaken strategic adjustments and increased investment in innovation, establishing core technology platforms with independent intellectual property rights and international competitiveness [3] - There is a focus on high-demand therapeutic areas, particularly in endocrine metabolism and pediatric fields, aligning with the company's sustainable development and internationalization goals [3]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received a written notification from the U.S. Food and Drug Administration (FDA) regarding the acceptance of the clinical trial application for GenSci143, a dual-target antibody-drug conjugate [1] Group 1: Product Details - GenSci143 is a self-developed dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, which has potential dual therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The mechanism of GenSci143 involves internalization into lysosomes upon binding to B7-H3 or PSMA, releasing TOPO-I inhibitor toxins to kill B7-H3 positive, PSMA positive, and dual-positive tumor cells [1] - The dual-target approach of B7-H3 and PSMA can overcome tumor heterogeneity and resistance caused by reduced expression of a single target, thereby covering more patients and producing more durable anti-tumor efficacy [1] Group 2: Technical Advantages - GenSci143 utilizes self-developed linker technology, which features strong toxin activity and high plasma stability of the linker, resulting in enhanced tumor-killing effects and improved safety [1] - The innovative dual-target design, stable linker technology, efficient cell-killing mechanism, and broad anti-tumor spectrum of GenSci143 may provide new treatment directions for various solid tumors expressing B7-H3 and/or PSMA [1]