By Fineline Cube 
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has granted two additional indication approvals for Hanlikang, its biosimilar version of rituximab (reference: Roche’s MabThera/Rituxan). The approvals authorize Hanlikang for use in diffuse large B‑cell lymphoma (DLBCL) combination regimens, expanding its addressable patient population in China’s oncology market.
New Indication Approvals
| Indication | Regimen | Patient Population | Setting |
|---|---|---|---|
| 1L DLBCL | Hanlikang + polatuzumab vedotin + cyclophosphamide + doxorubicin + prednisone (pola‑R‑CHP) | Adult patients with previously untreated DLBCL | First‑line |
| R/R DLBCL | Hanlikang + bendamustine + polatuzumab vedotin (pola‑BR) | Adult patients with relapsed/refractory DLBCL ineligible for stem cell transplant | Second‑line |
Approved Indication Portfolio (China)
| Indication | Approval Date | Therapeutic Area |
|---|---|---|
| Non‑Hodgkin’s lymphoma | Feb 2019 | Oncology |
| Chronic lymphocytic leukemia (CLL) | Post‑Feb 2019 | Oncology |
| Rheumatoid arthritis (RA) | Post‑Feb 2019 | Immunology |
| 1L DLBCL (new) | Apr 2026 | Oncology |
| R/R DLBCL (new) | Apr 2026 | Oncology |
Strategic Significance
- Biosimilar Leadership: Hanlikang is China’s first approved rituximab biosimilar (since 2019), establishing Henlius as pioneer in CD20 biosimilar space
- Combination Strategy: New approvals position Hanlikang as backbone therapy for polatuzumab vedotin‑based regimens, aligning with global standard‑of‑care evolution (POLARIX and POLAR trials)
- Market Expansion: DLBCL represents 30‑35% of all non‑Hodgkin’s lymphomas in China; ~20,000‑25,000 new cases annually eligible for these combination therapies
Market Context & Outlook
- China Rituximab Market: US$400‑500 million annually; biosimilars capturing >60% volume share through national reimbursement and tendering advantages
- Polatuzumab Vedotin Access: Roche’s ADC recently gained NMPA approval; Hanlikang combination approvals enable local biosimilar + innovator ADC cost‑effective pairing
- Revenue Impact: New DLBCL indications expected to contribute RMB 150‑200 million incremental annual sales by 2028, assuming 20‑25% penetration in eligible pola‑R‑CHP/pola‑BR regimens
- Pipeline Synergy: Henlius leveraging Hanlikang platform for next‑gen CD20‑targeted therapies and subcutaneous formulation development
Forward‑Looking Statements
This brief contains forward‑looking statements regarding market penetration, revenue projections, and competitive positioning for Hanlikang. Actual results may differ due to risks including pricing pressure, competitive biosimilar entry, combination therapy adoption rates, and reimbursement negotiations.-Fineline Info & Tech