{"id":56657,"date":"2026-02-09T20:20:54","date_gmt":"2026-02-09T12:20:54","guid":{"rendered":"https:\/\/flcube.com\/?p=56657"},"modified":"2026-02-09T20:20:55","modified_gmt":"2026-02-09T12:20:55","slug":"betta-pharma-secures-nmpa-approval-for-beizeting-first-domestic-pertuzumab-biosimilar-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=56657","title":{"rendered":"Betta Pharma Secures NMPA Approval for Beizeting, First Domestic Pertuzumab Biosimilar in China"},"content":{"rendered":"\n

Betta Pharmaceuticals Co., Ltd.<\/strong> (SHE: 300558<\/a><\/strong>) announced that the National Medical Products Administration (NMPA)<\/strong> has granted marketing approval<\/strong> for Beizeting<\/strong>, a biosimilar version of Roche’s Perjeta (pertuzumab)<\/strong>, for the treatment of early-stage and metastatic HER2-positive breast cancer<\/strong>. The approval marks a significant milestone in China’s biosimilar oncology market<\/strong>, introducing the first domestically developed alternative to the Swiss originator.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Company<\/strong><\/td>Betta Pharmaceuticals (300558.SZ)<\/td><\/tr>
Agency<\/strong><\/td>NMPA (China)<\/td><\/tr>
Asset<\/strong><\/td>Beizeting (pertuzumab biosimilar)<\/td><\/tr>
Reference Product<\/strong><\/td>Roche Perjeta (pertuzumab)<\/td><\/tr>
Target<\/strong><\/td>Human epidermal growth factor receptor 2 (HER2)<\/td><\/tr>
Indication<\/strong><\/td>Early-stage and metastatic breast cancer<\/td><\/tr>
Biosimilar Status<\/strong><\/td>First domestic pertuzumab biosimilar approved in China<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence & Biosimilarity<\/h2>\n\n\n\n
Parameter<\/th>Beizeting Performance<\/th>Regulatory Standard<\/th><\/tr><\/thead>
Efficacy<\/strong><\/td>Equivalent to Perjeta<\/td>Phase III non-inferiority met<\/td><\/tr>
Safety Profile<\/strong><\/td>Comparable to originator<\/td>No significant differences observed<\/td><\/tr>
Immunogenicity<\/strong><\/td>Similar immunogenic potential<\/td>Anti-drug antibody rates aligned<\/td><\/tr>
Pharmacokinetics<\/strong><\/td>Bioequivalent PK parameters<\/td>Cmax, AUC within acceptance criteria<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Study Design:<\/em> Phase III randomized trial demonstrating biosimilarity to Roche’s Perjeta in HER2-positive breast cancer patients<\/p>\n\n\n\n

Strategic Commercial Arrangement<\/h2>\n\n\n\n
Element<\/th>Detail<\/th>Strategic Value<\/th><\/tr><\/thead>
Betta Pharma Role<\/strong><\/td>Marketing authorization holder and commercialization lead<\/td>Direct revenue control and brand building<\/td><\/tr>
BioRay Partnership<\/strong><\/td>Comprehensive collaboration executed May 2025<\/strong><\/td>Access to complementary biosimilar portfolio<\/td><\/tr>
Anruize Rights<\/strong><\/td>Exclusive China distribution for trastuzumab biosimilar (Anruize)<\/td>HER2 franchise synergy with Beizeting<\/td><\/tr>
Beizeting Rights<\/strong><\/td>Full China rights including registration, commercialization, post-marketing development<\/td>Complete lifecycle management control<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market Context & Competitive Positioning<\/h2>\n\n\n\n