By Fineline Cube Qyuns Therapeutics (HKG: 2509) announced that HDM3001-2/QX001S, a biosimilar to Johnson & Johnson’s autoimmune therapy Stelara (ustekinumab), has received approval from China’s National Medical Products Administration (NMPA) for the treatment of Crohn’s disease. The drug was co-developed with Chinese pharmaceutical company Huadong Medicine Co., Ltd (SZ: 000963).
Regulatory Approval Details
| Item | Detail |
|---|---|
| Agency | National Medical Products Administration (NMPA), China |
| Product | HDM3001-2/QX001S (ustekinumab biosimilar) |
| Reference Product | Stelara (ustekinumab) by Johnson & Johnson |
| New Indication | Crohn’s disease |
| Previous Approvals | Initial approval (October 2024), Pediatric plaque psoriasis (March 2025) |
| Drug Class | IL-12/IL-23 inhibitor |
Development Partnership & Timeline
- Collaboration Formation: Huadong Medicine and Qyuns Therapeutics established partnership in August 2020 to develop HDM3001-2/QX001S specifically for the Chinese market
- Milestone Achievement: Became China’s first Stelara biosimilar upon initial approval in October 2024
- Regulatory Progression: Expanded to pediatric plaque psoriasis indication in March 2025, now adding Crohn’s disease as third approved indication
- Strategic Significance: Represents growing domestic capability in complex biologic biosimilars for autoimmune conditions
Market Impact & Commercial Outlook
- Autoimmune Market Opportunity: China’s autoimmune disease market continues rapid expansion, with biologics representing the fastest-growing segment; ustekinumab biosimilars offer significant cost advantages over originator products
- Pricing Advantage: Biosimilars typically launch at 30-70% discounts to reference products, potentially expanding access to premium biologic therapies for Chinese patients
- Competitive Landscape: HDM3001-2/QX001S joins a growing pipeline of ustekinumab biosimilars globally, but maintains first-mover advantage in the Chinese market
- Revenue Potential: With multiple indications now approved, the product addresses a broader patient population across dermatology and gastroenterology specialties, enhancing commercial viability
- Healthcare System Benefits: Biosimilar adoption supports China’s healthcare cost containment initiatives while maintaining therapeutic efficacy standards
Forward‑Looking Statements
This brief contains forward-looking statements regarding regulatory approvals, market adoption, and commercial expectations for HDM3001-2/QX001S. Actual results may differ due to risks including market competition, pricing pressures, and evolving regulatory requirements.-Fineline Info & Tech