National Medical Products Administration (NMPA)
Is Elamipretide (SS-31) legal in China?
Not approvedNot approved in China; Stealth BioTherapeutics filed an import clinical-trial application in 2026.
Not approved as a medicine here.
CDE's public register shows an import clinical-trial application for elamipretide injection by Stealth BioTherapeutics, accepted on 2026-06-05. We found no marketing application and no entry on the NMPA innovative-drug approvals list, so it cannot lawfully be sold as a medicine in China (Drug Administration Law, Articles 24 and 98). NMPA's own database could not be searched, so an approval under a different Chinese name cannot be fully excluded.
Last verified 2026-09-29 · how we verify
Elamipretide (SS-31) elsewhere
Sources (3)
- 01CDE public register of accepted drug applications (受理品种目录浏览)Center for Drug Evaluation (CDE), NMPA · 2026-09-29 · accessed 2026-09-29
- 02NMPA innovative drug approvals list (创新药品名录)National Medical Products Administration (NMPA) · 2026-09 · accessed 2026-09-29
- 03Drug Administration Law of the PRC (中华人民共和国药品管理法)National Medical Products Administration (NMPA) · 2019-08-26 · accessed 2026-09-29