Hualan Biological Engineering, Inc. (SZSE: 002007) has announced that its associated company, Hualan Ankang Biological Co., Ltd., received the Acceptance Notice from the National Medical Products Administration on September 22, 2026, for its marketing authorization application for trastuzumab for injection. The regulatory submission has been formally accepted for review.

Trastuzumab for injection is a monoclonal antibody targeting HER2, and its original branded product is Herceptin. It serves as a core first-line treatment for HER2-positive breast cancer and gastric cancer, with broad clinical applications and substantial market demand.