Suzhou, China, August 4, 2025 - Alphamab Oncology (stock code: 9966.HK) announced that the Investigational New Drug (IND) application for JSKN022, an independently developed innovative bispecific antibody-drug conjugate (ADC) targeting PD-L1 and integrin αvβ6, has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The Company plans to initiate a first-in-human (FIH) clinical study of JSKN022 for the treatment of advanced malignant solid tumors.
JSKN022 is an innovative bispecific ADC developed in-house with Alphamab’s proprietary glycan-specific conjugation platform. The molecule simultaneously targets and binds to both PD-L1 and integrin αvβ6 on the surface of tumor cells. After binding to either target, JSKN022 enters the lysosome through target-mediated endocytosis. The cleavable linker is specifically hydrolyzed by proteolytic enzymes such as cathepsin B, releasing cytotoxic topoisomerase I inhibitor (T01), which then induces apoptosis of PD-L1 and/or integrin αvβ6 positive tumor cells. In addition, the inhibitor can penetrate the cell membrane and enter the antigen-negative tumor cells to exert bystander effects. These combined effects can effectively inhibit the growth of tumor cells.
At present, no ADC targeting integrin αvβ6 or PD-L1 has been approved for marketing worldwide, with all related investigational candidates remaining in clinical development stages. Preclinical data demonstrate that JSKN022 exhibits potent antitumor activity in both in vitro and in vivo models against tumor cells expressing integrin αvβ6 and/or PD-L1. JSKN022 will potentially bring in novelty in the therapeutic approach for cancers that are refractory or resistant to PD-1/PD-L1 inhibitors, including non-small cell lung cancer, head and neck squamous cell carcinoma, and colorectal cancer.
This Phase I clinical study will evaluate the safety, tolerability, pharmacokinetics (PK)/pharmacodynamics (PD), and antitumor activity of JSKN022 in patients with advanced malignant solid tumors who have failed standard therapies, and determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D).
About JSKN022
JSKN022 is a first-in-class ADC targeting both PD-L1 and integrin αvβ6. Based on independently developed Envafolimab, Alphamab integrates immuno-oncology (IO) mechanisms with ADC approaches. This novel drug molecule utilizes glycan-specific conjugation technology to enhance both stability and homogeneity. The topoisomerase I inhibitor T01 is site-specifically conjugated to antibodies via a cleavable linker, enhancing therapeutic efficacy. JSKN022 is expected to provide a novel therapeutic option for cancers that are refractory or resistant to PD-1/PD-L1 inhibitors. The IND application for the first-in-human clinical study of JSKN022 for the treatment of advanced malignant solid tumors has been accepted by CDE.
About Alphamab Oncology
Alphamab Oncology is an innovative biopharmaceutical company focusing on oncology therapeutics. On December 12, 2019, the Company was successfully listed on the Main Board of the Hong Kong Stock Exchange, trading under the stock code 9966.
By leveraging its proprietary core technology platforms including single-domain antibodies, bispecific antibodies, glycan-specific conjugation, linker-payload, dual-payload antibody conjugation, and subcutaneous high concentration formulation for biologics, the Company has established a product portfolio with differentiated innovation and global competitiveness, covering cutting-edge areas such as antibody-drug conjugates (ADCs), bispecific antibodies, and single-domain antibodies.
The Company has one product approved for marketing (Envafolimab, the world's first subcutaneously injectable PD-(L)1 inhibitor), which has made a significant breakthrough in the convenience and accessibility of cancer treatment. Additionally, the Company has multiple bispecific antibodies and bispecific ADCs in clinical stage, while rapidly advancing the preclinical pipeline prioritizing bispecific ADCs and dual-payload ADCs. Multiple strategic collaborations based on innovative products or technology platforms have been established with partners such as CSPC, ArriVent, and Glenmark.
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.
Alphamab Oncology Forward-Looking Statements
This press release contains statements related to our future business，financial performance and future events involving Alphamab Oncology that may constitute forward-looking statements. These statements include projections and estimates and relevant assumptions, statements regarding plans and expectations and statements regarding future activities, operations and performance. These statements may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," or words of similar meaning. Such statements are based on the certain assumptions of Alphamab Oncology’s management and business operations, which are subject to various risks and uncertainties, including but not limited to political, economic, legal and business environment. The actual results, performance or achievements of Alphamab Oncology may (negatively or positively) vary materially from those described explicitly or implicitly in the relevant forward-looking statements. Unless otherwise required by applicable laws, Alphamab Oncology does not undertake obligation to publicly update any forward-looking statement nor liability for the failure to materialize such forward-looking statements, whether because of new information, future events or otherwise.
Pharmaceutical Information Statements
Alphamab Oncology does not recommend the clinical use of any already approved or under-development drugs/indications. Any information contained in this press release should not be regarded as any drug application, promotion or advertisement.
