Beijing, Aug 28, 2026 — China’s Center for Drug Evaluation (CDE) proposed adding a human bone marrow mesenchymal stem cell injection, developed by Jiuzhitang Meike (Beijing) Cell Technology Co., Ltd., to the “Care Program – Extension” pilot for rare disease innovative drug development, targeting autoimmune pulmonary alveolar proteinosis with a public comment deadline of Sept 4, 2026.

Program Snapshot

Clinical Context

Autoimmune pulmonary alveolar proteinosis (aPAP) is a rare autoimmune disorder characterized by the accumulation of surfactant-like material in the alveoli due to autoantibodies against granulocyte-macrophage colony-stimulating factor. The disease leads to progressive respiratory failure with limited treatment options beyond whole-lung lavage and, in severe cases, lung transplantation.

Market Impact Analysis

The inclusion of a mesenchymal stem cell (MSC) therapy in the Care Program – Extension marks a significant expansion of China’s rare disease pilot into advanced cell therapy modalities. Jiuzhitang Meike, a subsidiary of the traditional Chinese medicine giant Jiuzhitang, is leveraging its cell technology platform to address autoimmune pulmonary alveolar proteinosis—an ultra-rare interstitial lung disease with no approved pharmacologic cure in China.

For the regenerative medicine sector, the pilot entry signals CDE’s openness to cell-based immunomodulatory approaches for rare autoimmune conditions, potentially establishing a regulatory precedent for MSC therapies in pulmonary indications. The choice of aPAP as the target indication is clinically compelling: the disease affects an estimated few thousand patients in China, creating a clear orphan drug pathway, while the autoimmune etiology aligns with MSCs’ established anti-inflammatory and immunomodulatory mechanisms.

Jiuzhitang Meike’s involvement highlights the convergence of traditional Chinese medicine conglomerates with modern biotech, as established pharmaceutical players diversify into cell therapy through dedicated subsidiaries. The short one-week comment window suggests regulators view the application as aligned with the pilot’s eligibility criteria, with formal inclusion expected by mid-September 2026.

Forward-Looking Statement

Industry analysts expect the stem cell injection to advance into clinical trials under the pilot’s enhanced regulatory support framework, with Phase I/II studies potentially initiating by early 2027. Success in autoimmune pulmonary alveolar proteinosis could validate MSC therapy as a disease-modifying approach for rare interstitial lung diseases, opening pathways for indications such as idiopathic pulmonary fibrosis or other autoimmune-driven respiratory conditions. The pilot’s backing also reinforces China’s strategic commitment to building domestic cell therapy capabilities, reducing reliance on imported biologics for ultra-rare diseases. 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/c5e79f73a0617dc4c2f449ee7d580c00

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

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