Betta Pharmaceuticals Co., Ltd. (SHE: 300558) announced that the National Medical Products Administration (NMPA) has granted marketing approval for Beizeting, a biosimilar version of Roche’s Perjeta (pertuzumab), for the treatment of early-stage and metastatic HER2-positive breast cancer. The approval marks a significant milestone in China’s biosimilar oncology market, introducing the first domestically developed alternative to the Swiss originator.
Regulatory Milestone
Item
Detail
Company
Betta Pharmaceuticals (300558.SZ)
Agency
NMPA (China)
Asset
Beizeting (pertuzumab biosimilar)
Reference Product
Roche Perjeta (pertuzumab)
Target
Human epidermal growth factor receptor 2 (HER2)
Indication
Early-stage and metastatic breast cancer
Biosimilar Status
First domestic pertuzumab biosimilar approved in China
Clinical Evidence & Biosimilarity
Parameter
Beizeting Performance
Regulatory Standard
Efficacy
Equivalent to Perjeta
Phase III non-inferiority met
Safety Profile
Comparable to originator
No significant differences observed
Immunogenicity
Similar immunogenic potential
Anti-drug antibody rates aligned
Pharmacokinetics
Bioequivalent PK parameters
Cmax, AUC within acceptance criteria
Study Design: Phase III randomized trial demonstrating biosimilarity to Roche’s Perjeta in HER2-positive breast cancer patients
Strategic Commercial Arrangement
Element
Detail
Strategic Value
Betta Pharma Role
Marketing authorization holder and commercialization lead
Direct revenue control and brand building
BioRay Partnership
Comprehensive collaboration executed May 2025
Access to complementary biosimilar portfolio
Anruize Rights
Exclusive China distribution for trastuzumab biosimilar (Anruize)
HER2 franchise synergy with Beizeting
Beizeting Rights
Full China rights including registration, commercialization, post-marketing development
Complete lifecycle management control
Market Context & Competitive Positioning
HER2 Biosimilar Landscape: Beizeting enters a rapidly expanding market following the 2024 NMPA approval of multiple trastuzumab biosimilars; pertuzumab biosimilar availability addresses the dual HER2 blockade standard of care (trastuzumab + pertuzumab) at reduced cost.
Originator Market Size: Roche’s Perjeta generated global sales exceeding CHF 4 billion annually, with China representing a high-growth priority market; biosimilar entry pressures originator pricing and expands patient access.
Betta-BioRay Synergy: The May 2025 collaboration creates a consolidated HER2 biosimilar franchise, enabling bundled commercialization of trastuzumab (Anruize) + pertuzumab (Beizeting) combinations to hospital oncology departments.
National Reimbursement Pathway: Biosimilar status positions Beizeting for NRDL inclusion at significant discount to Perjeta, potentially achieving volume-based procurement (VBP) eligibility and rapid market penetration.
Commercial Outlook
Driver
Impact
First-mover domestic pertuzumab advantage
Market share capture before additional biosimilar entrants
Dual HER2 blockade bundle
Anruize + Beizeting combination sales leverage
NRDL/VBP eligibility
Accelerated hospital formulary adoption and pricing competitiveness
Post-marketing development rights
Potential label expansion to neoadjuvant settings and combination trials
Forward‑Looking Statements This brief contains forward‑looking statements regarding Beizeting commercial launch timelines, NRDL negotiation outcomes, and market share capture in China’s HER2-positive breast cancer segment. Actual results may differ due to competitive responses from Roche, pricing pressures from national procurement programs, and execution risks in the Betta-BioRay commercial partnership.-Fineline Info & Tech
By Fineline Cube 