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 GenSci143 from the National Medical Products Administration, indicating progress in the development of a novel dual-target antibody-drug conjugate for cancer treatment [1] Group 1 - GenSci143 is a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, designed to provide both targeted chemotherapy and tumor immunotherapy [1] - The mechanism of GenSci143 involves internalization into lysosomes upon binding to B7-H3 or PSMA, releasing a TOPO-I inhibitor toxin to kill B7-H3 positive, PSMA positive, and dual-positive tumor cells [1] - The dual-target approach of B7-H3 and PSMA aims to overcome tumor heterogeneity and resistance caused by reduced expression of single targets, potentially benefiting a larger patient population with more durable anti-tumor efficacy [1] Group 2 - GenSci143 utilizes proprietary linker technology, which enhances the potency of the toxin and the stability of the linker in plasma, contributing to stronger tumor-killing effects and improved safety profiles [1] - The innovative dual-target design, stable linker technology, and efficient cell-killing mechanism of GenSci143 may offer new treatment options for various solid tumors expressing B7-H3 and/or PSMA [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Jinsai Pharmaceutical, has received acceptance for the clinical trial application of GenSci143 by the National Medical Products Administration, indicating progress in the development of a new targeted therapy for certain tumors [2] Company Summary - Jinsai Pharmaceutical, a subsidiary of Changchun High-tech, is developing GenSci143, a bispecific antibody-drug conjugate targeting B7-H3 and PSMA, which may offer dual therapeutic potential in targeted chemotherapy and tumor immunotherapy [2] - The drug is expected to provide new treatment options for various solid tumors expressing B7-H3 and/or PSMA [2]

Core Viewpoint - Changchun Gaoxin's subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the clinical trial application of GenSci143, a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, indicating potential dual therapeutic effects in chemotherapy and tumor immunotherapy [1] Company Summary - Changchun Gaoxin's subsidiary, Changchun Jinsai Pharmaceutical, is advancing its drug development with the acceptance of the clinical trial application for GenSci143 [1] - GenSci143 is a self-developed drug by Changchun Jinsai Pharmaceutical, showcasing the company's commitment to innovative cancer therapies [1] Industry Summary - The acceptance of GenSci143's clinical trial application highlights the growing focus on dual-targeting therapies in the oncology sector, particularly those that combine chemotherapy and immunotherapy [1]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the clinical trial application of GenSci143, a bispecific antibody-drug conjugate targeting B7-H3 and PSMA [1] Group 1 - GenSci143 is designed to have dual therapeutic potential through targeted chemotherapy and tumor immunotherapy [1] - The drug works by binding to B7-H3 or PSMA, internalizing into lysosomes, and releasing TOPO-I inhibitor toxins to kill B7-H3 positive, PSMA positive, and double positive tumor cells [1] - GenSci143 utilizes independently developed linker technology, which features strong toxin activity and high plasma stability of the linker, aiming for enhanced tumor-killing effects and improved potential safety [1]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a significant stock price increase, rising over 7% and currently trading at 9.59 HKD, with a trading volume of 32.19 million HKD. The company is set to hold a board meeting on August 28 to approve its mid-term performance, with expectations of a profit of no less than 20 million RMB for the first half of the year, compared to a loss of approximately 44.90 million RMB in the same period last year. The turnaround is attributed to milestone revenues from three authorized collaborations and sales from commercialized products. Additionally, the company has received acceptance for its clinical trial application for the dual-specific antibody-drug conjugate JSKN022, aimed at treating advanced malignant solid tumors, marking a significant development in the market as no similar targeted ADCs are currently available globally [1][1][1]. Financial Performance - The company anticipates a profit of at least 20 million RMB for the first half of the year, a notable recovery from a loss of around 44.90 million RMB in the previous year [1][1][1]. - The financial turnaround is primarily driven by milestone revenues from three authorized collaborations and sales from commercialized products [1][1][1]. Product Development - Corning Jereh Pharmaceutical has announced that its self-developed dual-specific antibody-drug conjugate JSKN022 has had its clinical trial application formally accepted by the National Medical Products Administration of China [1][1][1]. - The planned clinical study for JSKN022 will focus on treating advanced malignant solid tumors, with no existing targeted ADCs for integrin αvβ6 or PD-L1 currently available on the market [1][1][1].

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has announced that its self-developed PD-L1/Integrin αvβ6 bispecific antibody ADC, JSKN022, has received formal acceptance for clinical trial (IND) application by the National Medical Products Administration (NMPA) in China [1] Group 1: Product Development - The company plans to initiate the first human clinical study of JSKN022 for the treatment of advanced malignant solid tumors [1] - Currently, there are no ADCs targeting Integrin αvβ6 or PD-L1 available on the market globally, and related investigational drugs are still in clinical research stages [1] Group 2: Clinical Data - Preclinical data indicates that JSKN022 exhibits anti-tumor activity against tumor cells expressing Integrin αvβ6 and/or PD-L1 in both in vitro and in vivo models [1] - The drug is expected to provide new treatment options for patients with tumors that are resistant to or ineffective against PD-1/PD-L1 inhibitors, such as non-small cell lung cancer, head and neck squamous cell carcinoma, and colorectal cancer [1]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has received formal acceptance from the National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for JSKN022, a dual-specific antibody-drug conjugate (ADC) targeting programmed cell death ligand 1 (PD-L1) and integrin αvβ6, aimed at treating advanced malignant solid tumors [1] Group 1 - The company plans to initiate the first human clinical study of JSKN022 for the treatment of advanced malignant solid tumors [1] - Currently, there are no ADCs targeting integrin αvβ6 or PD-L1 available on the global market, with all related investigational drugs still in clinical research stages [1] - Preclinical data indicates that JSKN022 exhibits anti-tumor activity against tumor cells expressing integrin αvβ6 and/or PD-L1 in both in vitro and in vivo models [1] Group 2 - JSKN022 is expected to provide new treatment options for patients with tumors that are resistant to or ineffective against PD-1/PD-L1 inhibitors, such as non-small cell lung cancer, head and neck squamous cell carcinoma, and colorectal cancer [1]

Core Viewpoint - The company has received formal acceptance from the National Medical Products Administration (NMPA) of China for its Investigational New Drug (IND) application for JSKN022, a dual-specific antibody-drug conjugate targeting PD-L1 and integrin αvβ6, aimed at treating advanced malignant solid tumors [1] Group 1 - The company is developing JSKN022, which is a dual-specific antibody-drug conjugate [1] - The IND application for JSKN022 has been officially accepted by the NMPA's Center for Drug Evaluation (CDE) [1] - The first human clinical study for JSKN022 is planned to be conducted for the treatment of advanced malignant solid tumors [1]