Alphamab-B (Alphamab Oncology) disclosed that China’s Center for Drug Evaluation under the National Medical Products Administration has approved the launch of a Phase III study (JSKN033-301) evaluating JSKN033 as a monotherapy for patients with recurrent or metastatic cervical cancer who have progressed after platinum-based chemotherapy and PD-1/PD-L1 inhibitor treatment.

JSKN033 is described as the world’s first high-concentration subcutaneous co-formulation that combines JSKN003—Alphamab’s biparatopic HER2-targeting antibody-drug conjugate—with envafolimab, the first subcutaneously administered PD-L1 inhibitor cleared by the NMPA in November 2021. By linking a topoisomerase I inhibitor to the anti-HER2 bispecific antibody via glycosite-specific technology and pairing it with an immune checkpoint blockade, the candidate is designed to merge the cytotoxic precision of ADCs with the immune activation of PD-L1 inhibition while allowing more convenient subcutaneous dosing.

The multicentre, randomized, controlled and open-label Phase III trial will compare JSKN033 against physicians’ choice of chemotherapy in a population that currently has no highly effective post-platinum, post-PD-1/PD-L1 therapeutic options. The clinical need is acute: cervical cancer remains the most common gynaecological malignancy worldwide and the fourth-leading cause of cancer mortality among women, with five-year survival below 20% for advanced disease.

Alphamab Oncology operates an integrated platform spanning ADCs, bispecific antibodies and multi-functional protein engineering. Its pipeline includes two NMPA-approved products and several late-stage assets. While the CDE approval marks a significant development milestone, the company cautions that successful development and commercialisation of JSKN033 are not guaranteed.