By Fineline Cube Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has approved the market filing for HLX11 (US trade name: Poherdy), its biosimilar version of Perjeta (pertuzumab), for the treatment of HER2-positive breast cancer. The approval encompasses both adjuvant therapy for early-stage disease and first-line treatment for metastatic or unresectable locally recurrent breast cancer, completing Henlius’ global regulatory success following approvals in the United States (November 2025) and European Union (April 2026), with ongoing marketing review in Canada.
Regulatory Approval Details
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Company | Shanghai Henlius Biotech Inc. (HKG: 2696) |
| Product | HLX11 (Poherdy) – pertuzumab biosimilar |
| Reference Product | Roche’s Perjeta (pertuzumab) |
| Approval Date | 01 Jun 2026 |
| Global Status | Approved in US (Nov 2025), EU (Apr 2026), under review in Canada |
| Market Significance | First pertuzumab biosimilar approved in China |
Indications & Clinical Applications
Adjuvant Setting
- Patient Population: HER2-positive early breast cancer patients with high risk of recurrence
- Regimen: HLX11 + trastuzumab + chemotherapy
- Treatment Goal: Reduce risk of disease recurrence following curative-intent surgery
Metastatic/Unresectable Setting
- Patient Population: HER2-positive, metastatic or unresectable locally recurrent breast cancer patients
- Treatment Criteria: No prior anti-HER2 treatment or chemotherapy for metastatic disease
- Regimen: HLX11 + trastuzumab + docetaxel
- Treatment Goal: First-line systemic therapy for advanced disease
Strategic Market Implications
The NMPA approval positions Henlius to capture significant share in China’s HER2-positive breast cancer market, which represents approximately 20–25% of all breast cancer cases:
- Addressable Population: Estimated 80,000–100,000 new HER2-positive breast cancer patients annually in China
- Pricing Advantage: Biosimilar expected to offer 30–50% cost reduction compared to originator Perjeta
- Franchise Synergy: Complements Henlius’ existing trastuzumab biosimilar (HLX02/Hercebriq), enabling complete dual HER2 blockade regimens
- Market Access: Immediate eligibility for inclusion in provincial reimbursement lists and hospital formularies
“This NMPA approval marks a pivotal milestone in our mission to make high-quality biologics accessible to Chinese patients,” said Dr. Scott Liu, Chief Executive Officer of Henlius Biotech. “With HLX11 now approved across all major global markets, we can provide comprehensive dual HER2 blockade therapy at significantly lower costs, potentially improving outcomes for thousands of breast cancer patients in China.”
Competitive Landscape & Commercial Outlook
Henlius’ first-mover advantage in China’s pertuzumab biosimilar market provides significant strategic benefits:
- Supply Security: Domestic manufacturing ensures consistent availability versus imported originator product
- Healthcare System Integration: Aligns with China’s national policy promoting biosimilar adoption to control healthcare costs
- Revenue Potential: Analysts estimate peak annual sales of ¥1.5–2.5 billion ($210–350 million) in the Chinese market alone
- Global Platform: Successful regulatory pathway across US, EU, and China validates Henlius’ international development capabilities
The company expects immediate commercial launch across major hospitals and cancer centers, with pricing negotiations underway with provincial health authorities for reimbursement inclusion.
Forward‑Looking Statements
This brief contains forward-looking statements regarding regulatory approvals, commercial launches, and market opportunities for HLX11. Actual results may differ due to market adoption patterns, pricing negotiations, and competitive developments.-Fineline Info & Tech