By Fineline Cube 
CSPC Pharmaceutical Group (HKG: 1093) announced today that Anbenitamab Antibody Injection (KN026), co‑developed with Alphamab Oncology (HKG: 9966), has been filed with the National Medical Products Administration (NMPA) for marketing approval. The submission targets patients with HER2‑positive locally advanced, recurrent, or metastatic gastric/gastroesophageal junction adenocarcinoma who have progressed after at least one line of systemic therapy that included trastuzumab plus chemotherapy.
Clinical Evidence
- Pivotal Trial – The approval application is grounded in the KC‑WISE Phase II/III study.
- Interim Results – Compared with standard of care, Anbenitamab plus chemotherapy produced:
- Significant improvement in clinical efficacy
- Prolonged progression‑free survival (PFS)
- Extended overall survival (OS)
- Safety Profile – No new safety signals; low incidence of cardiotoxicity and immunogenicity.
Drug Profile
- Mechanism – An anti‑HER2 bispecific antibody that binds two non‑overlapping HER2 epitopes, effectively shutting down HER2 signaling.
- First‑in‑class – First anti‑HER2 bispecific antibody to achieve positive results for the second‑line gastric cancer indication in China.
Regulatory Milestone
| Milestone | Date |
|---|---|
| Breakthrough Therapy Designation | Nov 4 , 2023 |
| Priority Review & Approval Status | Aug 28 , 2025 |
| NMPA Marketing Application Submitted | Today |
Strategic Implications
- Market Gap – No approved anti‑HER2 therapies exist for second‑line treatment of HER2‑positive gastric cancer in China; Anbenitamab could become the first of its kind.
- Pipeline Expansion – The approval would broaden CSPC’s oncology portfolio and reinforce its partnership with Alphamab Oncology.
- Competitive Advantage – The bispecific design offers enhanced tumor localization and potentially reduced systemic toxicity compared with existing HER2 agents.-Fineline Info & Tech