Alphamab Oncology (Alphamab) announced that China’s National Medical Products Administration has approved Anbenitamab injection (R&D code: KN026) in combination with chemotherapy for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer who have received at least one trastuzumab-containing regimen. The product was co-developed with Shanghai JMT-Bio Technology, a subsidiary of CSPC Pharmaceutical Group.
\n\nKey efficacy data originate from the pivotal Phase II/III KC-WISE study, which enrolled patients who had failed at least one prior treatment line. Compared with standard chemotherapy, the Anbenitamab regimen extended median progression-free survival from 2.70 months to 7.10 months (hazard ratio [HR] 0.25) and median overall survival from 11.50 months to 19.60 months (HR 0.29). Objective response rate and duration of response also trended favorably across all patient subgroups.
\n\nSafety signals were mainly chemotherapy-related hematological toxicities that were deemed clinically manageable. Incidences of cardiotoxicity, diarrhea and infusion-related reactions were lower than those reported for comparable therapies, highlighting a potential safety advantage.
\n\nChina records approximately 0.36 million new gastric cancer cases and 0.26 million related deaths each year, with 30 %–40 % of patients diagnosed at an advanced stage. The five-year survival rate after systemic treatment remains below 15 %. HER2 over-expression is associated with poorer prognosis, and therapeutic options beyond first-line trastuzumab have been limited for more than a decade. As the first HER2 bispecific antibody approved for gastric cancer in China, Anbenitamab is positioned to redefine second-line treatment standards.
\n\nUnder an August 2021 licensing agreement, JMT-Bio holds exclusive development and commercialization rights for Anbenitamab in breast and gastric cancer indications within Mainland China. Beyond the newly approved indication, Alphamab is conducting multiple registrational trials, including first-line and perioperative studies in HER2-positive breast cancer and first-line gastric cancer. The molecule has also received FDA Orphan Drug Designation for HER2-positive or HER2-low gastric cancer and NMPA Breakthrough Therapy Designation for second-line or later HER2-positive gastric cancer.
\n\nAlphamab operates an integrated platform focused on antibody-drug conjugates, bispecific antibodies and multifunctional protein engineering. Its pipeline now features two marketed products and several late-stage candidates addressing oncology indications.
\n\nRegulatory notice: In accordance with Hong Kong Listing Rule 18A.05, Alphamab cautions that future development and commercialization of KN026 in indications beyond the newly approved use remain subject to uncertainties. Shareholders and potential investors are advised to exercise due care when dealing in the company’s securities.