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

Beijing, Aug 28, 2026 — China’s Center for Drug Evaluation (CDE) proposed adding GLB-005 tablets, developed by Hangzhou Gebo Biopharmaceutical Co., Ltd., to the “Care Program – Extension” pilot for rare disease innovative drug development, targeting transfusion-dependent beta-thalassemia 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	GLB-005 Tablets
Applicant	Hangzhou Gebo Biopharmaceutical Co., Ltd.
Indication	Transfusion-dependent beta-thalassemia
Comment deadline	Sept 4, 2026
Contact	zhaona@cde.org.cn

Clinical Context

Transfusion-dependent beta-thalassemia is a rare inherited blood disorder characterized by defective hemoglobin production, requiring lifelong regular blood transfusions and iron chelation therapy. The disease imposes substantial clinical and economic burdens on patients, with limited curative options beyond allogeneic hematopoietic stem cell transplantation, which is constrained by donor availability and transplant risks.

Market Impact Analysis

The inclusion of GLB-005 in the Care Program – Extension signals CDE’s commitment to expanding China’s rare disease pipeline beyond oncology and genetic ophthalmic disorders into hematologic conditions with severe unmet need. Hangzhou Gebo’s focus on transfusion-dependent beta-thalassemia—a disease predominantly prevalent in southern China—positions the asset to address a geographically concentrated patient pool with high clinical urgency.

For the domestic biotech sector, GLB-005’s pilot entry reinforces the viability of the Care Program – Extension as a regulatory fast lane for novel mechanisms in underserved therapeutic areas. The program’s incentive structure—likely encompassing expedited clinical trial consultations, rolling data submissions, and conditional approval pathways—could compress development timelines by 12 to 18 months compared with standard review tracks, provided early-phase data demonstrates meaningful reductions in transfusion burden or improved hemoglobin levels.

The short one-week comment window suggests regulators view the application as non-controversial and aligned with the pilot’s eligibility criteria, potentially clearing the way for formal inclusion by mid-September 2026.

Forward-Looking Statement

Industry analysts expect GLB-005 to advance rapidly into clinical trials under the pilot’s enhanced regulatory support framework, with Phase I/II initiation possible by early 2027 if pharmacology and toxicology packages are complete. Success in beta-thalassemia could open broader indications within the hemoglobinopathies spectrum, including sickle cell disease variants prevalent in China’s southern provinces. The pilot’s backing of GLB-005 also underscores Beijing’s strategic emphasis on reducing reliance on imported orphan drugs for blood disorders, creating a favorable policy environment for domestic developers with gene therapy, small-molecule, or protein-based approaches to thalassemia. 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/67a5e0012e1365506db4e423b6c9ba52

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