Beijing, Aug 26, 2026 — China’s Center for Drug Evaluation (CDE) proposed adding Peiyuan Mingmu Pills, developed by the China Academy of Chinese Medical Sciences Eye Hospital, to the “Care Program – Extension” pilot for rare disease innovative drug development, targeting retinitis pigmentosa with a public comment deadline of Sept 4, 2026.
Program Snapshot
| Attribute | Detail |
|---|---|
| Program | Care Program – Extension (Rare Disease Innovative Drug Development Incentive Pilot) |
| Product | Peiyuan Mingmu Pills |
| Applicant | China Academy of Chinese Medical Sciences Eye Hospital |
| Indication | Retinitis pigmentosa |
| Comment deadline | Sept 4, 2026 |
| Contact | zhaona@cde.org.cn |
Clinical Context
Retinitis pigmentosa is a rare, inherited degenerative eye disorder that progressively damages the retina and can lead to vision loss. No curative therapy is currently approved in China, leaving a significant unmet medical need in a patient population estimated in the tens of thousands.
Market Impact Analysis
The inclusion of a traditional Chinese medicine (TCM) formulation in a rare disease innovation pilot marks a notable convergence of Beijing’s dual policy priorities: advancing rare disease drug development and elevating TCM within modern clinical frameworks. The China Academy of Chinese Medical Sciences Eye Hospital’s sponsorship signals institutional confidence in the pill’s potential neuroprotective or retinal function benefits, though robust clinical validation will be required under the pilot’s accelerated development track.
For the TCM sector, Peiyuan Mingmu Pills’ entry into the Care Program – Extension could establish a regulatory precedent for heritage formulas addressing genetic ophthalmic conditions, potentially opening a new R&D pathway for TCM developers targeting rare diseases with limited Western pharmaceutical options. The short comment window—just over one week—suggests CDE aims to fast-track pilot enrollment, minimizing procedural delays for an asset addressing a high-urgency, low-prevalence indication.
Forward-Looking Statement
Industry analysts expect the Care Program – Extension to provide Peiyuan Mingmu Pills with expedited clinical trial consultation, priority review status, and potential conditional approval pathways if early-phase data demonstrates retinal function stabilization or delayed disease progression. The pilot’s rare disease focus aligns with China’s broader strategy to expand its orphan drug catalog and incentivize domestic innovation in underserved therapeutic areas. If successful, the program could validate TCM-based approaches to retinitis pigmentosa, encouraging similar submissions for other degenerative ocular conditions and reinforcing TCM’s role in precision rare disease care. Final pilot inclusion is anticipated following the comment period, barring substantive objections.-China Health Reform Pulse
Policy Source: https://www.cde.org.cn/main/news/viewInfoCommon/8c4cd228434871f711710953c16af228