Suzhou, China, May 13, 2026 - Alphamab Oncology (stock code: 9966.HK) today announced that the first patient has been dosed in a Phase II clinical study (study code: JSKN033-202) of JSKN033 (a proprietary high-concentration subcutaneous co-formulation consisting of HER2 bispecific antibody-drug conjugate (ADC) and PD-L1 immune checkpoint inhibitor) in combination with platinum‑based chemotherapy (with or without bevacizumab) as first‑line treatment of advanced cervical cancer.
Cervical cancer is the most common gynecological malignancy and the fourth leading cause of cancer‑related deaths among women. Patients with early-stage disease often experience recurrence or metastasis after treatment, while those with advanced disease have a five-year survival rate of less than 20%. Although immunotherapy combined with platinum-based (cisplatin or carboplatin) chemotherapy (with or without bevacizumab) represents the guideline-recommended first-line standard of care, tumor heterogeneity in cervical cancer still leads to suboptimal response to immuno‑combination therapies in some patients, highlighting a clear unmet clinical need.
JSKN033 is the world’s first subcutaneous fixed‑dose combination of ADC (JSKN003) and immune checkpoint inhibitor (Envafolimab). Envafolimab (KN035) is a Fc fusion protein consisting of humanized anti-PD-L1 single domain antibody and human IgG1 Fc fragment and the world’s first subcutaneously injected PD‑L1 inhibitor, which can be administered in just 30 seconds. JSKN003 is a HER2 bispecific ADC that uses glycan‑specific conjugation to link a topoisomerase I inhibitor to the N‑glycosylation site of the antibody Anbenitamab (KN026), resulting in a homogeneous drug-to-antibody ratio (DAR) of 4 and significantly lower hematologic toxicity compared to other ADCs. JSKN033 thus offers several distinctive advantages: subcutaneous injection greatly improves dosing convenience and compliance; its low hematologic toxicity makes it one of the few ADCs that can be safely combined with carboplatin, providing individualized, safer and more flexible treatment options tailored to patients with varying renal function and different physical tolerance levels. When combination with platinum drugs and bevacizumab, multiple synergistic antitumor effects are expected—targeted tumor killing, immune activation, anti‑angiogenesis, and chemotherapy—prolonging disease control and improving patient survival. In early-stage clinical studies, JSKN033 monotherapy has demonstrated promising efficacy and a manageable safety profile in patients with cervical cancer who have failed standard therapies, laying a solid foundation for its further promotion to first-line combination therapy scenarios.
JSKN033-202 is an open‑label, multicenter Phase II clinical study designed to evaluate the safety, efficacy, and pharmacokinetics (PK)/pharmacodynamics (PD) of JSKN033 in combination with platinum‑based chemotherapy (with or without bevacizumab) as first‑line treatment for patients with advanced cervical cancer. All patients receive JSKN033 in combination with either cisplatin or carboplatin (with or without bevacizumab), with the choice of platinum agent and the use of bevacizumab determined by the investigator based on individual patient circumstances. The initiation of this study is expected to bring an efficient, safe, and convenient first‑line treatment option to patients with advanced cervical cancer.
About JSKN033
JSKN033 is the global first high-concentration subcutaneous formulation, combining the ADC (JSKN003) with PD-L1(Envafolimab), which is independently developed by the Company. JSKN003 is developed by site-specific conjugation to the Fc glycans of Anbenitamab (KN026), resulting in a homogeneous and stable ADC with a drug-to-antibody ratio (DAR) of 4. JSKN003 binds to two HER2 epitopes on tumor cells and release topoisomerase I inhibitors through cellular endocytosis, exerting anti-tumor effects. Envafolimab is a Fc fusion protein consisting of humanized anti-PD-L1 single domain antibody and human IgG1 Fc fragment, which has been approved by Chinese authorities as the global-first subcutaneous injection PD-(L)1 inhibitor in November 2021.
JSKN033 combines the benefits of immunotherapy and ADCs while enhancing safety and convenience through subcutaneous administration.
Currently, the Phase II clinical study of JSKN033 in combination with platinum‑based chemotherapy as first-line treatment for advanced cervical cancer is advancing smoothly. In addition, multiple monotherapy Phase II clinical studies are also ongoing, with indications including second‑line or above cervical cancer, second‑line or above endometrial cancer, and HER2‑mutant/expressing non‑small cell lung cancer.
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.
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