JMT-Bio/Alphamab Oncology：Anbenitamab was approved

Annitumab Injection, co-developed by Shanghai Jinmante Biotechnology Co., Ltd. and Jiangsu Kangning Jierui Biopharmaceutical Co., Ltd., has been approved for marketing. It is a recombinant humanized anti-HER2 biparatopic antibody. The approved indication is in combination with chemotherapy for the treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma in patients who have previously failed at least one trastuzumab-containing regimen.

Treatment options for HER2-positive gastric cancer in later-line settings are limited, and trastuzumab resistance is a clinical challenge. Annitumab, developed on the CRIB charge-repulsion bispecific antibody platform, simultaneously binds two non-overlapping epitopes of HER2, inducing receptor clustering and potently blocking tumor signaling. Preclinical studies have shown that its anti-tumor activity is superior to trastuzumab and pertuzumab, and it remains effective against resistant strains.

This approval is based on the pivotal Phase II/III study KN026-001. Results showed that compared with standard therapy, the drug significantly extended progression-free survival (PFS) and overall survival (OS), with low cardiotoxicity and weak immunogenicity. According to data from Mopheus Pharma, the drug was granted priority review in August 2025, its first marketing application was submitted in September 2025, and it received approval in May 2026.

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