All test results are合格. Different donor sources, different batches The "Inspection Report" for the human bone marrow mesenchymal stem cell product, All test results are合格. 。

All inspection reports for stem cell products from different donors and different batches have passed successfully.

After years of meticulous management and development, Jiuzhitang Maker’s stem cell production process and quality management system have become mature and stable. To verify whether the stem cell products manufactured under Jiuzhitang Maker’s GMP-compliant conditions meet clinical application standards, Jiuzhitang Maker will Four human bone marrow mesenchymal stem cell cell banks sourced from different donors—each including preparations, master solutions, and high-passage products—totaling 16 distinct samples. , sent to the China National Institute for Food and Drug Control for re-examination and verification. The testing includes cell identification assays, sterility tests, mycoplasma detection, immunological reaction assessments, induced differentiation capability tests, cell viability assessments, and tumorigenicity checks, among others. All test results are合格. 。

This indicates that Jiuzhitang Maker's "human bone marrow mesenchymal stem cell" product demonstrates excellence in terms of basic biological properties, microbiological safety, biological safety, and biological efficacy. It has met the national standards for clinical application. 。

Stem Cell Quality Accreditation Review Organization

According to the current policy requirements of the National Health Commission, the stem cell products used in the "dual filing" projects for clinical stem cell research are… A quality testing certificate of conformity issued by a third-party inspection agency accredited by CNAS is required. 。

The China National Institute for Food and Drug Control is the nation's statutory agency responsible for inspecting the quality of pharmaceuticals and biological products, as well as the highest technical arbitration body in this field. , it legally undertakes the approval, registration, and inspection of products across multiple fields—including pharmaceuticals, biological products, and medical devices—as well as import inspections, supervisory testing, safety evaluations, and batch release for biological products. It is also responsible for the research, distribution, and management of national reference standards for pharmaceuticals and medical devices, along with microbial strains used in production and quality control. Additionally, the lab conducts related technical research and holds both laboratory accreditation (CNAS) and certification (CMA) qualifications, making it a nationally recognized testing facility. China's most authoritative stem cell quality review institution.

Becoming a higher-quality stem cell pharmaceutical company

“Quality” is the fundamental guarantee for the high-quality development of the stem cell industry—and also the industry’s most critical challenge. Only high-quality cells can deliver consistently reliable clinical outcomes. Since its establishment until now, Jiuzhitang Maker has always placed stem cell quality at the core of its company's development. 。

To ensure that every step of the production process for each stem cell product is backed by corresponding quality control methods and standards, Jiuzhitang Maker takes a proactive approach from the very source of manufacturing, emphasizing robust quality management and systematically enhancing the overall standardization of quality control practices. Established a comprehensive system encompassing process development, production preparation, and quality control across the entire stem cell industry chain. , and successfully passed the on-site inspection conducted by the China Association of Medical Biotechnology regarding the "Self-Regulatory Standards for Quality Management in Stem Cell Preparation," earning the prestigious "Certificate of Compliance for Quality Management in Stem Cell Preparation." Officially certified as a stem cell preparation company by the China Association of Medical Biotechnology 。

Summary

In the future, Jiuzhitang Maker will Staying true to Jiuzhitang's over-300-year commitment to pharmaceutical quality , continuing to pursue a high-quality stem-cell pharmaceutical enterprise development path, while accelerating clinical research and the translation of scientific and technological advancements into practical applications to address critical unmet clinical needs. Further accelerate the rapid development of regenerative medicine, led by stem cells. , continuously safeguarding the lives and health of the people.