Beta Pharma's Pertuzumab Biosimilar Beze汀® Approved by NMPA for Breast Cancer Treatment

China Interview Network Data  Betta PharmaceuticalsBetta Pharmaceuticals announced today that the Pertuzumab Injection (brand name: Beizeting®), developed in collaboration with Zhejiang Borui Biopharmaceutical Co., Ltd., has received the Drug Registration Certificate (Approval No. S20260009) issued by the National Medical Products Administration, officially approving its market launch. This drug is classified as a therapeutic biological product 3.3 and is a biosimilar of Pertuzumab (original brand name: Perjeta®), used for the treatment of patients with early and metastatic breast cancer. The Phase III clinical trial of Beizeting® met the predefined primary endpoint, demonstrating similarity to the reference drug in terms of efficacy, safety, immunogenicity, and pharmacokinetics. Previously, Betta Pharmaceuticals acquired all rights to Beizeting® in China and the exclusive distribution rights for Trastuzumab Injection (Anruize®) in May 2025, and launched the commercial sales of Anruize® in July 2025. Following the approval of Beizeting®, the company will advance its commercialization efforts. Currently, three Pertuzumab drugs are available on the Chinese market: Roche's Perjeta®, CHIATAI TIANQING's Paretran®, and Qilu Pharmaceutical's Ansaizhu®. The company noted that the specific sales performance of this product may be influenced by market conditions, sales channels, and other factors, and remains uncertain.