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
| Attribute | Detail |
|---|---|
| Program | Care Program – Extension (Rare Disease Innovative Drug Development Incentive Pilot) |
| Product | Human Bone Marrow Mesenchymal Stem Cell Injection |
| Applicant | Jiuzhitang Meike (Beijing) Cell Technology Co., Ltd. |
| Indication | Autoimmune pulmonary alveolar proteinosis |
| Comment deadline | Sept 4, 2026 |
| Contact | zhaona@cde.org.cn |
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