China’s National Medical Products Administration (NMPA) has recently accepted the New Drug Application (NDA) of Alphamab Oncology’s KN026 (Anbenitamab). If approved, KN026 is expected to become the first bispecific monoclonal antibody (mAb) targeting HER2-positive gastric or gastroesophageal (GEJ) carcinoma and evolve as a potential treatment option in the gastric cancer landscape in China, says GlobalData.

KN026’s bispecific receptor blockade mechanism enables simultaneous binding to two HER2 epitopes, effectively blocking the HER2 signals. The NDA submission is supported by results from the Phase-II/III KN026-001 trial. KN026, combined with chemotherapy for adult patients with HER2-positive locally advanced, recurrent, or metastatic gastric or GEJ adenocarcinoma who have failed at least one prior systemic therapy containing Trastuzumab, demonstrated an improved Progression-Free Survival (PFS) and Overall Survival (OS) compared to standard-of-care with no new safety concerns in the trail.

According to Globaldata’s Pharmaceutical Intelligence Center, the diagnosed prevalent cases of gastric/GEJ carcinoma in China are expected to increase from one million cases in 2024 to 1.13 million cases in 2029, making it the highest  across the five major markets in the Asia-Pacific (APAC) region, with an annual growth rate of 2.54 percent.

Alphamab Oncology developed KN026 in-house and, in August 2021, licensed it to JMT-Bio Technology, a subsidiary of CSPC Pharmaceutical Group, for development and commercialisation in mainland China. The drug has also received Breakthrough Therapy Designation in November 2024 and Priority Review in August 2025. Moreover, KN026 is being evaluated in Phase-III for breast cancer in China.

Chilamula Srija, Pharma Analyst, GlobalData, commented, “KN026 could capture substantial market share in China’s rapidly expanding HER2 oncology market, particularly in the post-Trastuzumab treatment setting as a second-line treatment, where unmet needs remain high.”

Currently, only two HER2 antagonists are available for gastric cancer in China: Enhertu (Trastuzumab Deruxtecan) from AstraZeneca/Daiichi Sankyo (first line of treatment, combined with chemotherapy) and RemGen’s Edici (Disitamab Vedotin, third line of treatment), both being Antibody-Drug Conjugates (ADCs).

With six other HER2 receptor targeting molecules in Phase-III, and none with a bispecific targeting mechanism, KN026 is anticipated to generate global sales of USD 86 million by 2030, as per Globaldata’s Pharma Intelligence Center.

Chilamula concluded, “Despite advances in HER2-targeted treatments, disease progression and resistance remain major clinical challenges, highlighting the need for novel options like KN026. With its unique bispecific profile and lack of direct bispecific competition, KN026 will reinforce Alphamab Oncology’s leadership in bispecific antibody innovation.”