ALPHAMAB-B (09966.HK) JSKN033 doses first patient in Phase III cervical cancer study

NewTimeSpace News: On 28 October, Alphamab Oncology Limited (ALPHAMAB-B, 09966.HK) announced that JSKN033, a high-concentration subcutaneous injectable combination formulated with a human epidermal growth factor receptor 2 (HER2) bispecific antibody-drug conjugate (ADC) and a programmed death ligand 1 (PD-L1) immune checkpoint inhibitor, has successfully dosed its first patient in the Phase III clinical study of JSKN033 as monotherapy in recurrent or metastatic cervical cancer that has failed platinum-based chemotherapy and PD-1/PD-L1 inhibitor treatment (regardless of HER2 and PD-L1 expression levels).

JSKN033-301 is a randomised, controlled, open-label, multicentre Phase III clinical study designed to evaluate the efficacy and safety of JSKN033 versus investigator's choice chemotherapy in that patient population. The primary endpoints are progression-free survival and overall survival assessed by blinded independent central review (BICR) according to RECIST v1.1, and secondary endpoints include other efficacy endpoints assessed by BICR and investigators under RECIST v1.1, safety and pharmacokinetic characteristics. As the only subcutaneous ADC combination currently in registrational clinical trials globally, JSKN033 enables "second-level" dosing.

The company said JSKN033 monotherapy has already demonstrated favourable efficacy and controllable safety in cervical cancer patients who have failed standard treatment, with detailed data presented in a rapid oral presentation at the ESMO Congress held in October 2026, as further described in the company's announcement dated 26 October 2026. JSKN033 is the world's first high-concentration subcutaneous injectable combination developed by the group from the HER2 bispecific ADC JSKN003 and the PD-L1 single-domain antibody envafolimab; envafolimab, as the world's first subcutaneous PD-L1 inhibitor, was approved for marketing by the National Medical Products Administration in November 2021. The company gave the warning statement required under Rule 18A.05 of the Listing Rules, stating that it cannot assure that JSKN033 will be successfully developed and/or ultimately successfully launched.