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]

Group 1 - The core announcement is that Changchun High-tech Industry (Group) Co., Ltd.'s subsidiary, Changchun JinSai Pharmaceutical Co., Ltd., has received acceptance for the clinical trial application of the injectable GenSci140 from the National Medical Products Administration [1][2] - GenSci140 is a novel dual-target antibody-drug conjugate specifically designed to target the folate receptor alpha (FRα), which is expressed in various tumors, including ovarian cancer [2][3] - The drug utilizes a unique linker technology and is expected to enhance tumor cell killing while maintaining a favorable safety profile, making it a potential best treatment option for FRα-positive cancer patients, particularly those with low to medium expression levels [3] Group 2 - If the clinical trial progresses smoothly, it will help the company expand its business scope, optimize its product structure, and enhance its core competitiveness [4] - The pharmaceutical product development process is characterized by high technology, high risk, and long timelines, which may be influenced by various uncertainties [4][5] - The company will actively promote the research and development of this project and fulfill its information disclosure obligations regarding subsequent progress [5]

Core Viewpoint - Changchun High-tech (000661) announced that its subsidiary, Jinsai Pharmaceutical, has received the acceptance notice from the National Medical Products Administration for the clinical trial application of GenSci140, a new targeted antibody-drug conjugate developed independently by the company [1] Group 1 - Jinsai Pharmaceutical's GenSci140 is a novel targeted antibody-drug conjugate that specifically targets the folate receptor alpha subtype [1] - The acceptance of the clinical trial application marks a significant step in the development of GenSci140, indicating progress in the company's research and development efforts [1]

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received the acceptance notice for the clinical trial application of GenSci140 from the National Medical Products Administration, indicating progress in the development of a new targeted therapy for cancer [1][2]. Group 1 - GenSci140 is a novel dual-target antibody-drug conjugate that targets the folate receptor alpha (FRα), designed to enhance binding and internalization in tumor cells [1]. - The drug combines Fab fragments targeting different epitopes of FRα with a single-domain heavy chain antibody (VHH), utilizing a cleavable linker and a topoisomerase I (TOPOI) inhibitor payload [1]. - GenSci140 has shown significant anti-tumor effects in various models, including ovarian cancer, regardless of FRα expression levels [2]. Group 2 - Preclinical studies indicate that GenSci140 possesses strong tumor cell binding and internalization activity, along with high plasma stability of the linker technology developed in-house [2]. - The innovative dual-epitope design and effective cytotoxic mechanism suggest that GenSci140 could become a potential best treatment option for FRα-positive cancer patients, particularly those with low to medium FRα expression [2].

长春高新(000661.SZ)公告，公司子公司长春金赛药业有限责任公司(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》，金赛药业注射用GenSci140注册临床试验申请获得受理。GenSci140 是金赛药业自主研发的一款新型靶向叶酸受体α亚型双表位抗体药物偶联物，由结合FRα不同表位的Fab 和单域重链抗体(VHH)构成双表位抗体，采用可裂解的连接子并搭载拓扑异构酶I(TOPOI)抑制剂载荷。 GenSci140可同时结合肿瘤细胞上表达的FRα抗原的两个不同表位，增加抗体的结合和内化，促进 TOPOI抑制剂细胞毒性载荷进入细胞，从而直接杀伤肿瘤细胞，同时可通过旁观者杀伤效应进一步增强 抑瘤效果。 ...

综上，GenSci140凭借其创新的双表位设计、稳定的链接子技术和高效的细胞杀伤机制，有望成为FRα 阳性的肿瘤患者的潜在最佳治疗选择，尤其在FRα中低表达人群。 格隆汇9月5日丨长春高新(000661.SZ)公布，近日，长春高新技术产业(集团)股份有限公司子公司——长 春金赛药业有限责任公司(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 药业注射用GenSci140注册临床试验申请获得受理。 临床前体外和体内研究表明，GenSci140具有良好的肿瘤细胞结合和内化活性，在卵巢癌等多种CDX(细 胞系来源的异体移植肿瘤)和PDX(患者来源肿瘤异种移植)模型中，无论FRα表达水平，均展现了显著的 抗肿瘤效果。另外，GenSci140采用自主研发的接头技术，具备有效载荷活性强和连接子血浆稳定性高 等特性，在产生更强肿瘤杀伤作用的同时，还具备更优的潜在安全性。 GenSci140是金赛药业自主研发的一款新型靶向叶酸受体α亚型(Folate Receptor Alpha,FR α/FOLR1)双表 位抗体药物偶联物，由结合FRα不同表位的Fab和单域重链抗体(VHH)构成双表位抗体，采用可裂 ...

长春高新9月5日公告，公司子公司长春金赛药业有限责任公司注射用GenSci140注册上市许可申请获得 国家药品监督管理局出具的《受理通知书》。注射用GenSci140是金赛药业自主研发的一款新型靶向叶 酸受体α亚型（Folate Receptor Alpha, FRα/FOLR1）双表位抗体药物偶联物，由结合FRα不同表位的Fab 和单域重链抗体（VHH）构成双表位抗体，采用可裂解的连接子并搭载拓扑异构酶I（TOPO I）抑制剂 载荷。GenSci140可同时结合肿瘤细胞上表达的FRα抗原的两个不同表位，增加抗体的结合和内化，促 进TOPO I抑制剂细胞毒性载荷进入细胞，从而直接杀伤肿瘤细胞，同时可通过旁观者杀伤效应进一步 增强抑瘤效果。适应症：晚期实体瘤。 ...

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received the acceptance notice from the National Medical Products Administration for the clinical trial application of GenSci140, a novel targeted dual-epitope antibody-drug conjugate [1] Group 1: Product Development - GenSci140 is independently developed by Jinsai Pharmaceutical and is designed as a dual-epitope antibody-drug conjugate targeting the folate receptor alpha (FRα) [1] - The drug consists of Fab fragments that bind to different epitopes of FRα and a single-domain heavy chain antibody (VHH), utilizing a cleavable linker and carrying a topoisomerase I (TOPOI) inhibitor payload [1] - GenSci140 can bind to two different epitopes expressed on tumor cells, enhancing antibody binding and internalization, which promotes the delivery of the TOPOI inhibitor cytotoxic payload into the cells [1] Group 2: Mechanism of Action - The mechanism of GenSci140 involves direct cytotoxicity against tumor cells and an enhanced anti-tumor effect through a bystander killing effect [1]

Core Viewpoint - The approval of the clinical trial application for GenSci140 by the National Medical Products Administration is a significant milestone for the company, enhancing its business scope and product structure [1] Company Summary - The subsidiary, Jinsai Pharmaceutical, has received the acceptance notice for the clinical trial application of GenSci140, a novel targeted antibody-drug conjugate for the treatment of advanced solid tumors [1] - GenSci140 is independently developed by Jinsai Pharmaceutical and targets the folate receptor alpha subtype [1] - The successful acceptance of this application is expected to enrich and improve the strategic product line layout, thereby enhancing the company's core competitiveness [1] Industry Summary - The development and commercialization of new drugs involve lengthy and complex processes, which are subject to various uncertainties [1] - The clinical trial process for GenSci140 may face uncertainties that could impact its timeline and outcomes [1]