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Alphamab Oncology Announces IND Application for Innovative PD-L1/ VEGFR2 Bispecific ADC JSKN027 was Officially Accepted by CDE
Alphamab Oncology (stock code: 9966.HK) announced that the Investigational New Drug (IND) application for JSKN027, an independently developed innovative bispecific antibody-drug conjugate (ADC) targeting PD-L1 and VEGFR2, has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The Company plans to initiate a clinical study of JSKN027 for the treatment of advanced malignant solid tumors.
About this update from Alphamab Oncology
[{"type":"text","content":"SUZHOU, China, Dec. 18, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that the Investigational New Drug (IND) application for JSKN027, an independently developed innovative bispecific antibody-drug conjugate (ADC) targeting PD-L1 and VEGFR2, has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The Company plans to initiate a clinical study of JSKN027 for the treatment of advanced malignant solid tumors.","length":503,"tagName":"p"},{"type":"text","content":"JSKN027 is a first-in-class bispecific ADC designed to co-engage PD-L1 and VEGFR2. By leveraging glycan-specific conjugation technology, it precisely links its cleavable linker and topoisomerase I inhibitor payload to the antibody's Fc region – maintaining a strong safety profile while unlocking potent anti-tumor activity. JSKN027's efficacy stems from a unique three-fold synergistic mechanism. Beyond the standard ADC effects of targeted cell killing and bystander activity, it also inhibits tumor angiogenesis by blocking VEGF/VEGFR2 signaling and reverses immune suppression by disrupting the PD-1/PD-L1 checkpoint. This integrated attack enhances overall anti-tumor power and is anticipated to help overcome therapeutic resistance.","length":746,"tagName":"p"},{"type":"text","content":"Preclinical data has demonstrated that JSKN027 exhibits potent anti-tumor activity in both in vitro and in vivo models. IND enabling tox study demonstrated good tolerability at highest dose. With combination of targeted chemo, anti-angiogenesis and IO, JSKN027 represents a promising treatment strategy across solid tumors.","length":323,"tagName":"p"},{"type":"text","content":"This Phase I clinical study will evaluate the safety, tolerability, pharmacokinetics (PK)/pharmacodynamics (PD), and antitumor activity of JSKN027 in patients with advanced malignant solid tumors, and determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D).","length":284,"tagName":"p"},{"type":"text","content":"About JSKN027JSKN027 is a first-in-class bispecific ADC designed to co-engage PD-L1 and VEGFR2. By leveraging glycan-specific conjugation technology, it precisely links its cleavable linker and topoisomerase I inhibitor payload to the antibody's Fc region – maintaining a strong safety ...