ALPHAMAB-B (09966) has announced that Ennituo® (Anituo Monoclonal Antibody Injection), a HER2 bispecific antibody (R&D code: KN026), co-developed with Shanghai Jinmante Biotech Co., Ltd., a subsidiary of CSPC Pharmaceutical Group Limited (Stock Code: 1093), has received marketing approval from the National Medical Products Administration (NMPA) of China. The drug is approved in combination with chemotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive (HER2+) gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) who have previously received at least one trastuzumab-containing treatment regimen.

This approval is based on a pivotal Phase II/III clinical study (KC-WISE) involving HER2+ GC/GEJ patients who had failed at least one prior line of therapy. The study results demonstrated that, compared to standard chemotherapy, Anituo Monoclonal Antibody combined with chemotherapy significantly extended median progression-free survival (mPFS) (7.1 months vs. 2.7 months; hazard ratio [HR] 0.25, representing a 75% reduction in the risk of disease progression or death) and median overall survival (mOS) (19.6 months vs. 11.5 months; HR 0.29, representing a 71% reduction in the risk of death). Consistent benefit trends were observed across all subgroup populations, as well as in objective response rate (ORR) and duration of response (DOR).

Adverse reactions were primarily hematological toxicities dominated by chemotherapy, which are clinically manageable and controllable. Compared to similar competing products, Ennituo® demonstrated a lower incidence of cardiac toxicity, diarrhea, and infusion reactions, indicating a significant safety advantage.