Suzhou, China, May 12, 2026 - Alphamab Oncology (stock code: 9966.HK) today announced that the first patient has been dosed in Australia in a Phase I clinical study of JSKN016 high-concentration subcutaneous formulation, the TROP2/HER3 bispecific antibody-drug conjugate (ADC) developed inhouse.
JSKN016 is designed to address unmet clinical needs, reshaping the ADC treatment experience through formulation innovation. Unlike traditional intravenous infusion, subcutaneous injection can significantly shorten the administration time from several hours to tens of seconds, and reduce on‑target toxicity caused by peak drug concentrations by altering the DMPK of ADC drugs, thereby markedly improving patient convenience, compliance, and tolerability. 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 JSKN016 subcutaneous formulation. Currently, the investigational new drug (IND) application for a Phase Ib study in China of the subcutaneous formulation of JSKN016 has been accepted by the CDE.
The study in Australia is an open‑label, multicenter Phase I clinical study designed to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and anti‑tumor activity of JSKN016 subcutaneous formulation in 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. The investigational new drug (IND) application for a Phase Ib study in China of the subcutaneous formulation of JSKN016 has been accepted by the CDE, and the Phase I clinical study in Australia is 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. 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.
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