Suzhou, China, April 30, 2026 - Alphamab Oncology (stock code: 9966.HK) today announced that the Investigational New Drug (IND) application for JSKN016 subcutaneous formulation (JSKN016SC), the TROP2/HER3 bispecific antibody-drug conjugate (ADC) developed inhouse, for the treatment of advanced malignant solid tumors (study code: JSKN016SC-102), has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This application is being reviewed under the "30‑day review channel" for innovative drug clinical trials.
JSKN016SC is a key innovative product in Alphamab Oncology’s ADC pipeline and the first-in-class subcutaneous injection of bispecific ADC targeting TROP2 and HER3, with JSKN016 as its primary active ingredient. As oncology treatment has entered the era of whole‑process management, improving treatment convenience and patients’ quality of life has become a major clinical priority. Compared with traditional intravenous infusion ADCs, the subcutaneous injection reduces administration time from hours to seconds, significantly enhancing patients’ convenience and compliance, optimizing healthcare resource utilization, and laying the foundation for future community‑based treatment and long‑term chronic disease management. In addition, by alternate the DMPK of ADC drugs, the subcutaneous injection may further improve the safety and tolerability of ADC therapies. The clinical feasibility of subcutaneous ADC formulations has already been successfully validated by the Company’s proprietary JSKN033 (subcutaneous co-formulation consisting of HER2 bispecific ADC and PD-L1 inhibitor), providing robust technical support for the clinical development of JSKN016SC.
JSKN016 has demonstrated superior efficacy and a favorable safety profile across multiple solid tumor types in Phase I/II clinical studies in China. Results from the study in patients with HER2‑negative locally advanced or metastatic breast cancer will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting. A Phase III study of JSKN016 in triple‑negative breast cancer (TNBC) is currently ongoing.
JSKN016SC‑102 is an open‑label, multicenter Phase Ib clinical trial consisting of dose‑escalation and dose‑expansion phases. The study is designed to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and anti-tumor activity of JSKN016SC monotherapy in Chinese patients with advanced malignant solid tumors, and to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D).
About JSKN016
JSKN016 is a TROP2/HER3 targeting bispecific ADC developed using the proprietary single-domain antibody and bispecific antibody platforms. It is conjugated via site-specific glycosylation to generate a homogeneous and stable ADC with a drug-to-antibody ratio (DAR) of 4. JSKN016 binds to TROP2 and/or HER3 on tumor cells, blocks the corresponding signaling pathways and releases topoisomerase I inhibitors through cellular endocytosis, exerting anti-tumor effects. JSKN016SC is a high-concentration subcutaneous formulation containing the same active ingredient as JSKN016 injection.
JSKN016 has demonstrated superior efficacy and a favorable safety profile across multiple solid tumors. Multiple clinical studies of JSKN016 as monotherapy and in combination therapies for lung cancer, breast cancer, and other indications have been initiated. The Phase III clinical study evaluating JSKN016 for the treatment of triple-negative breast cancer (TNBC) is currently ongoing.
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, and currently under review. Five 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, enabling patients to achieve long-term, high-quality survival and delivering China-innovated cancer therapies to benefit patients worldwide.
Alphamab Oncology Forward-Looking Statements
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