Alphamab Oncology Announces IND Application for Innovative PD-L1/ VEGFR2 Bispecific ADC JSKN027 was Officially Accepted by CDE

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.

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.

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.

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).

About JSKN027
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. As a result, JSKN027 is poised to offer a novel and robust treatment avenue for patients across multiple solid tumor types. The IND application for the phase I clinical study of JSKN027 for the treatment of advanced malignant solid tumors has been accepted by CDE.

About Alphamab Oncology
Alphamab Oncology (Stock Code: 9966.HK) is an innovative biopharmaceutical company focused on oncology. Leveraging proprietary platforms including single-domain antibodies, bispecific antibodies, glycan-specific conjugation, linker-payloads, dual-payload ADCs, and high-concentration subcutaneous formulations, the Company has built a differentiated and globally competitive pipeline, covering cutting-edge candidates in ADCs, bispecific antibodies, and single-domain antibodies.

One product has received market approval: Envafolimab (KN035, brand name: 恩维达^®), the world's first subcutaneously injected PD-(L)1 inhibitor, offering greater convenience and accessibility in cancer treatment. The NMPA has accepted the new drug application for KN026 (Anbenitamab Injection), a HER2 bispecific antibody, for second-line or later HER2-positive gastric cancer. Four bispecific ADC candidates have entered clinical stages, and next-generation ADC pipelines—such as dual-payload ADCs—are advancing rapidly. The Company has established strategic partnerships with organizations including CSPC, ArriVent, and Glenmark, covering both product development and technology platforms.

Our overarching mission is to make cancer manageable and curable by addressing unmet clinical needs in oncology. Alphamab Oncology is continuously dedicated to the development of effective, safe, and globally competitive anti-tumor drugs, delivering China-innovated cancer therapies to benefit patients worldwide.

SOURCE Alphamab Oncology