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康宁杰瑞制药-B:JSKN022 IND申请获CDE正式受理
Zhi Tong Cai Jing· 2025-08-03 10:09
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]
康宁杰瑞制药-B(09966):JSKN022 IND申请获CDE正式受理
智通财经网· 2025-08-03 10:09
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]
康宁杰瑞制药:JSKN022 IND申请获CDE正式受理
news flash· 2025-08-03 10:03
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]