By Fineline Cube China’s Shanghai RAAS (SHE: 002252) announced that its candidate SR604 has been included by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) into the Encouragement Pilot Program for Innovative Rare Disease Drug R&D (“Caring Program – Extension“). The designation recognizes SR604 Injection, a novel humanized monoclonal antibody intended for the prophylactic treatment of bleeding in patients with hemophilia and congenital factor VII deficiency, as a priority innovation in China’s rare disease landscape.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) |
| Designation | Encouragement Pilot Program for Innovative Rare Disease Drug R&D (“Caring Program – Extension”) |
| Product | SR604 Injection (humanized monoclonal antibody) |
| Indication | Prophylactic treatment of bleeding in hemophilia and congenital factor VII deficiency |
| Sponsor | Shanghai RAAS (SHE: 002252) |
| Date | 28 Aug 2026 |
Drug Profile & Mechanism of Action
- Molecule: SR604 Injection, a humanized monoclonal antibody independently developed by Shanghai RAAS
- Mechanism: High-affinity binding to human activated protein C (aPC), specifically inhibiting the anticoagulant function of aPC — a novel rebalancing approach that shifts the hemostatic balance toward clot stability in bleeding disorders
- Indications: Prophylactic treatment of bleeding in patients with hemophilia (including populations with and without inhibitors, per the aPC-inhibition concept) and congenital factor VII deficiency
- Differentiation: The aPC-targeting mechanism offers a mechanism distinct from factor replacement and other rebalancing agents, with potential for broad applicability across hemophilia types
- Rare Disease Priority: Inclusion in the “Caring Program – Extension” signals regulatory encouragement and potential pathway acceleration for innovative rare disease drugs in China
Market Impact & Outlook
- Regulatory Tailwind: Entry into the NMPA CDE encouragement pilot program typically brings early regulatory communication and potential development acceleration, de-risking the clinical pathway for SR604
- Rare Disease Focus: Hemophilia and congenital factor VII deficiency represent high-unmet-need bleeding disorders in China, where access to prophylactic therapy remains limited relative to developed markets
- Plasma Leader Diversifying: For Shanghai RAAS — a major player in blood products — SR604 represents strategic expansion from plasma-derived therapies into innovative biologic development
- Novel Mechanism Positioning: The aPC-inhibition approach places SR604 within the global frontier of rebalancing hemophilia therapies, a space attracting significant industry and investor attention
- Catalyst Watch: Clinical development milestones under the pilot program framework will be the key value drivers for Shanghai RAAS (SHE: 002252) as SR604 advances
Forward‑Looking Statements — This brief contains forward-looking statements regarding regulatory designation, clinical development, and market potential that involve risks and uncertainties. Regulatory inclusion does not guarantee approval. Nothing herein constitutes investment advice.-Fineline Info & Tech