By Fineline Cube 
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that its pertuzumab biosimilar POHERDY (clinical name HLX11) has been granted U.S. Food and Drug Administration (FDA) approval covering every approved indication of Roche’s Perjeta.
FDA‑Approved Indications
| Indication | Patient Population | Treatment Regimen |
|---|---|---|
| Metastatic Breast Cancer (MBC) | HER2‑positive adults with no prior anti‑HER2 therapy or chemotherapy for metastatic disease | POHERDY + trastuzumab + docetaxel |
| Neoadjuvant Therapy | HER2‑positive, locally advanced, inflammatory or early‑stage breast cancer (≥ 2 cm or node‑positive) | POHERDY + trastuzumab + chemotherapy (part of a complete early‑breast‑cancer regimen) |
| Adjuvant Therapy | HER2‑positive early breast cancer at high risk of recurrence | POHERDY + trastuzumab + chemotherapy |
Why the Approval Matters
- Regulatory Confidence – The FDA’s decision was based on a comprehensive comparative data package demonstrating that HLX11 matches Perjeta in quality, safety, and efficacy.
- Market Expansion – POHERDY now joins a limited pool of U.S.‑approved pertuzumab biosimilars, offering oncologists a lower‑cost alternative without compromising clinical outcomes.
- Global Footprint – In addition to the FDA clearance, the NDA for HLX11 has been accepted by the China NMPA, European Medicines Agency (EMA), and Health Canada, positioning Henlius for multi‑regional launch.
Commercial Strategy & Partnerships
- Organon License – In June 2022, Henlius granted Organon an exclusive, worldwide license to commercialize HLX11 outside of mainland China, Hong Kong, Macau, and Taiwan.
- China‑Only Rights – Henlius retains full commercial rights for the Chinese market, where it plans to leverage its existing sales network and oncology partnerships.
- Revenue Outlook – Analysts estimate that, with an average U.S. price parity to Perjeta, POHERDY could generate US$300‑400 million in annual U.S. sales within three years, assuming a 10‑15 % market share of the pertuzumab segment.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory approvals, market potential, and commercial expectations for POHERDY. Actual results may differ due to clinical trial outcomes, regulatory actions, competitive dynamics, and other risk factors.-Fineline Info & Tech