By Fineline Cube 
Humanwell Healthcare (Group) Co., Ltd. (SHA: 600079) announced that the National Medical Products Administration (NMPA) has accepted its marketing application for lisdexamfetamine, a Class 3 generic for treating ADHD in adults and pediatric patients aged 6 years and older, positioning Humanwell as the potential first‑to‑market generic in China.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | Lisdexamfetamine (Class 3 generic) |
| Company | Humanwell Healthcare (Group) Co., Ltd. (600079.SH) |
| Agency | NMPA (China) |
| Application Type | Marketing authorization (generic) |
| Indication | ADHD in adults and pediatric patients aged ≥6 years |
| Market Status | No generic or imported lisdexamfetamine approved in China currently |
| Next Step | Technical review; approval expected Q3 2026 |
Drug Profile
- Originator: Takeda (first approved in U.S. 2007; brand: Vyvanse)
- Mechanism: Prodrug of dextroamphetamine; CNS stimulant for ADHD
- Additional Indication: Also approved for moderate‑to‑severe Binge Eating Disorder (BED) in adults in the U.S. (not included in China application yet)
- Innovation: Class 3 generic pathway offers 12‑month regulatory review vs. 24‑month for Class 4/5
Market Context & Outlook
| Metric | Value |
|---|---|
| China ADHD Diagnosed Patients | ~10 million children + 5 million adults (2024) |
| Treatment Rate | <20% of pediatric, <5% of adult patients currently treated |
| CNS Stimulant Market | ¥8.5 billion (US$1.2 billion) in 2024; growing at 15% CAGR |
| Lisdexamfetamine Potential | ¥1.5‑2.0 billion peak sales by 2030 (assuming 10% share of stimulant market) |
| Pricing | Expected 30‑40% discount to originator pricing when launched in China |
| Competition | First generic applicant; potential 12‑month exclusivity if approved before other generics |
- Regulatory Advantage: NMPA’s acceptance signals bioequivalence data adequacy; no clinical efficacy trials required for Class 3
- Commercial Strategy: Humanwell can leverage existing CNS distribution network and hospital relationships from its other psychiatry products
- Patient Access: Generic entry expected to improve affordability and drive market penetration in tier‑2/3 cities
Forward‑Looking Statements
This brief contains forward‑looking statements regarding lisdexamfetamine’s approval timeline, market potential, and competitive position. Actual results may differ materially due to risks including NMPA review outcomes, competitive dynamics, and market adoption rates.-Fineline Info & Tech