Beijing, Aug 28, 2026 — China’s Center for Drug Evaluation (CDE) proposed adding SR604 injection, developed by Shanghai RAAS Blood Products Co., Ltd., to the “Care Program – Extension” pilot for rare disease innovative drug development, targeting prophylactic treatment for congenital Factor VII deficiency 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 | SR604 Injection |
| Applicant | Shanghai RAAS Blood Products Co., Ltd. |
| Indication | Prophylactic treatment of congenital Factor VII deficiency |
| Comment deadline | Sept 4, 2026 |
| Contact | zhaona@cde.org.cn |
Clinical Context
Congenital Factor VII deficiency is a rare inherited bleeding disorder caused by deficient or dysfunctional coagulation Factor VII, leading to prolonged bleeding after injury or surgery and spontaneous hemorrhages in severe cases. Prophylactic therapy aims to prevent bleeding episodes, particularly in patients with severe phenotypes, significantly improving quality of life and reducing hospitalization burden.
Market Impact Analysis
The inclusion of SR604 in the Care Program – Extension marks a strategic advance for Shanghai RAAS, one of China’s largest blood products manufacturers, into the rare disease biologics segment. By targeting congenital Factor VII deficiency—an ultra-rare hematologic condition with limited therapeutic options—the company is diversifying beyond plasma-derived products into recombinant or specialized coagulation factor therapies with higher margins and stronger patent protection.
For the rare disease landscape, the pilot entry signals CDE’s willingness to support prophylactic regimens for bleeding disorders under the accelerated development framework, potentially shortening clinical development timelines and easing registration hurdles. Shanghai RAAS’s established distribution infrastructure in hematology and hospital channels could facilitate rapid commercialization if SR604 achieves conditional approval, leveraging existing relationships with hematology departments nationwide.
The one-week comment window suggests regulators view the application as aligned with the pilot’s eligibility criteria, expecting smooth inclusion by mid-September 2026.
Forward-Looking Statement
Industry analysts expect SR604 to advance into clinical trials under the pilot’s enhanced regulatory support, with Phase I/II studies potentially initiating by early 2027. Success in congenital Factor VII deficiency could establish Shanghai RAAS as a domestic leader in rare coagulation disorder therapies, opening pathways for expanded indications in other factor deficiencies or acquired bleeding conditions. The pilot’s backing also reinforces China’s strategic push to develop domestic alternatives to imported recombinant Factor VIIa products, which currently dominate the market at high cost. Final pilot inclusion is anticipated following the Sept 4 comment deadline, barring substantive objections.-China Health Reform Pulse
Policy Source: https://www.cde.org.cn/main/news/viewInfoCommon/a8646368a44742771b628586e61eb6c1