By Fineline Cube Beijing Huasu Pharmaceutical Co., Ltd., a subsidiary of Beijing Centergate Technologies (SHE: 000931), has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its methylphenidate hydrochloride extended-release chewable tablets. The drug will be assessed as a treatment for attention deficit hyperactivity disorder (ADHD) in patients aged 6 years and older.
Regulatory Milestone
| Agency | Approval Type | Product | Indication | Date | Next Steps |
|---|---|---|---|---|---|
| NMPA (China) | Clinical Trial Approval | Methylphenidate hydrochloride extended-release chewable tablets | ADHD in patients aged 6 years and older | 02 Sep 2026 | Clinical trials to establish safety and efficacy of the generic formulation in China |
Drug Profile & Competitive Landscape
- Molecule: Methylphenidate hydrochloride extended-release chewable tablets, a central nervous system (CNS) stimulant indicated for the treatment of ADHD
- Originator: Quillichew ER, developed by US-based Tris Pharma
- China commercialization: Introduced to the Chinese market by Pediatrix Therapeutics, where it has already received marketing approval
- Market structure: The originator currently remains the only approved product for this formulation in China
- First-mover status: Beijing Huasu becomes the first domestic pharmaceutical company to receive clinical trial authorization for a generic version of this chewable sustained-release tablet
Market Impact & Outlook
- First domestic entrant: The clinical trial approval gives Beijing Huasu a potential head start in China’s generic race for methylphenidate extended-release chewable tablets
- Growing demand: Pediatric ADHD diagnosis and treatment rates in China continue to rise, supporting demand for patient-friendly formulations such as chewable tablets
- Import substitution: A successful domestic generic could challenge the current monopoly of originator Quillichew ER, with implications for pricing and market access
- Strategic fit: The approval strengthens the CNS portfolio of Beijing Centergate Technologies and its subsidiary Beijing Huasu
- Sector signal: The milestone reflects increasing domestic capability among Chinese generics developers in complex formulations like extended-release chewable CNS products
Forward‑Looking Statements – This brief contains forward-looking statements regarding the clinical development and potential commercialization of methylphenidate hydrochloride extended-release chewable tablets. Actual results may differ materially due to clinical, regulatory, and market risks. This content is for informational purposes only and does not constitute investment advice.-Fineline Info & Tech