, all test results were合格 (qualified), and also The Investigational New Drug (IND) application for "Human Bone Marrow Mesenchymal Stem Cell Injection" has received implicit approval from the National Medical Products Administration (Acceptance No.: CXSL2300202). ， Indication: autoimmune pulmonary alveolar proteinosis (aPAP) This marks the first-ever clinical trial application in China to use stem cells for treating autoimmune alveolar proteinosis (aPAP), offering new hope for patients suffering from this condition.

Basic Information on the Medication

Drug Name: Human Bone Marrow Mesenchymal Stem Cell Injection

Indication: Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

Registration Category: Biologic Products for Therapeutic Use, Class 1

Application Item: Clinical Trial for Registration of Pharmaceuticals Manufactured Domestically

Applicant: Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd.

Application Number: CXSL2300202

Human bone marrow mesenchymal stem cell injection is Jiuzhitang Maker's independently developed cryopreserved stem cell preparation , derived from the bone marrow of healthy young adult donors, and conducted entirely under conditions that mimic the real physiological environment of the human body— Hypoxic conditions To be developed further, it is clinically intended for the treatment of autoimmune alveolar proteinosis (aPAP).

Autoimmune alveolar proteinosis (aPAP)

Pulmonary alveolar proteinosis (PAP) is a diffuse lung disease characterized primarily by breathing difficulties, resulting from the abnormal accumulation of pulmonary surfactant within alveolar macrophages and alveolar spaces. It is broadly categorized into autoimmune, hereditary or congenital, and secondary forms, among which Autoimmune alveolar proteinosis (aPAP) is the most common form, accounting for 90% of PAP patients. Clinical manifestations are diverse, ranging from no obvious clinical symptoms to life-threatening severe respiratory failure.

Currently, the standard treatment for Pulmonary Alveolar Proteinosis (PAP) is whole-lung lavage—a procedure that mechanically flushes and removes the lipid-rich material accumulated in the alveolar spaces, thereby restoring lung function. However, while this technique offers therapeutic benefits, it does not provide a cure, is highly invasive, and carries the risk of unforeseen complications. Currently, there are no approved medications available for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). Developing safe and effective therapeutic drugs is currently an unmet clinical need.

Project Advantages

Jiuzhitang Maker, as a company A national high-tech enterprise specializing in stem cell drug research and development Initiated and established through investment by the Yonghe Qihang Fund, launched by the century-old pharmaceutical company Jiuzhitang Co., Ltd. (stock code: SZ000989), the fund has now completed construction at the Beijing Daxing Biomedical Base in "China Pharmaceutical Valley," adhering to international standards. China, the United States, and EU GMP Standards A large-scale stem cell R&D and production base, with an office and production area of approximately 4,800 m², features a dedicated production platform. 4 independent B+A cleanrooms , capable of producing products that meet Chinese and U.S. pharmaceutical regulatory requirements Clinically grade stem cells.

Leveraging its world-class, advanced manufacturing processes and comprehensive quality management system, Jiuzhitang Maker has achieved standardized, large-scale production of clinical-grade stem cells. The company’s stem cells—produced from diverse donors and across multiple batches—are now Undergoing comprehensive quality testing by the China National Institute for Food and Drug Control (referred to as "NIFDC") , all test results were合格 (qualified), and also The China Association of Medical Biotechnology has approved the "Self-Regulatory Standards for Quality Management in Stem Cell Preparation." A certified on-site inspection was conducted, and we were awarded the "Stem Cell Preparation Quality Management Certification," making us a stem cell preparation company accredited by the China Association for Medical Biotechnology.

After years of dedicated cultivation, Jiuzhitang Maker has already Stem Cell Preparation Process and Quality Management System has accumulated extensive hands-on experience in various areas, and the successful completion of the Investigational New Drug (IND) application for "Human Bone Marrow Mesenchymal Stem Cell Injection" further underscores Jiuzhitang Maker remains firmly committed to ramping up R&D and expanding across multiple stem cell pipelines. We have reason to believe that, driven by both "technology" and "quality" in its stem-cell products, Jiuzhitang Maker will not only achieve more clinical research and development milestones in stem cells but also: Shining brightly in the increasingly competitive race to develop stem-cell-based therapies 。