ALPHAMAB-B(09966.HK): CDE Grants Approval for Phase III Clinical Trial of JSKN033 in Cervical Cancer
NewTimeSpace News: Alphamab Oncology (09966.HK) announced that JSKN033, a high-concentration subcutaneous fixed-dose combination consisting of HER2 bispecific ADC and PD-L1 immune checkpoint inhibitor, has obtained approval from CDE of NMPA to initiate a Phase III clinical study (Trial No. JSKN033-301) as monotherapy for recurrent or metastatic cervical cancer refractory to platinum-based chemotherapy and PD-1/PD-L1 inhibitors. JSKN033 is the world’s first such high-concentration subcutaneous injectable combination product.
NewTimeSpace News: Alphamab Oncology (09966.HK) issued a voluntary announcement on 3 August 2026. JSKN033, a high-concentration subcutaneous injectable fixed-dose combination composed of HER2 bispecific antibody ADC and PD-L1 immune checkpoint inhibitor, has obtained approval from CDE to carry out a Phase III clinical study (JSKN033-301). The trial evaluates JSKN033 monotherapy for patients with recurrent or metastatic cervical cancer who failed platinum-based chemotherapy and PD-1/PD-L1 inhibitor treatment.
JSKN033 is the world’s first high-concentration subcutaneous combination product comprising HER2 bispecific ADC (JSKN003) and PD-L1 domain antibody (Envafolimab). Globally, cervical cancer ranks as the most prevalent gynaecological malignancy. The 5-year survival rate of advanced patients is less than 20%, and highly effective therapeutic options remain limited after failure of first-line standard regimens. This Phase III trial adopts a randomised, controlled, open-label, multi-centre design to assess the efficacy and safety of JSKN033 versus investigator’s choice of chemotherapy. The Company cautions that there is no guarantee of successful final development and marketing approval.
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