Alphamab Oncology Announces IND Application for a Phase II Clinical Study of HER2 Bispecific ADC Subcutaneous Co-formulation JSKN033 as First-line Treatment of Advanced Cervical Cancer was Officially Accepted by CDE

SUZHOU, China, Dec. 29, 2025 /PRNewswire/ -- Alphamab Oncology (Stock Code: 9966.HK) announced that the IND application for a Phase II clinical study 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 (Study Number: JSKN033-202), has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).

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 within two years after treatment, while those with advanced disease have a poor prognosis, with a five-year survival rate of less than 20%. Currently, platinum-based (cisplatin or carboplatin) chemotherapy combined with bevacizumab represents the guideline-recommended first-line standard of care. Although immune checkpoint inhibitors have also achieved breakthrough progress, tumor heterogeneity in cervical cancer still leads to suboptimal responses in some patients, highlighting a clear unmet clinical need.

In recent years, multiple clinical studies have confirmed the synergistic potential of combining ADCs with immunotherapy and anti-angiogenic agents. As a first-in-class co-formulation of ADC and immune checkpoint inhibitor, JSKN033 leverages a dual mechanism of action, combining targeted tumor killing with immune activation. 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.

JSKN033-202 is an open-label, multicenter phase II clinical trial designed to evaluate the safety, efficiency 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 will receive treatment with JSKN033 plus 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 provide an innovative and convenient treatment option for 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, Phase I/II clinical trials of JSKN033 for the treatment of solid tumors is being conducted in China and Australia. The IND application for the Phase II clinical study of JSKN033 in combination with chemotherapy as first-line treatment for advanced cervical cancer has been accepted by the 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