Guangzhou Double Biotech's Class 1 Biological Product 'Human Umbilical Cord Mesenchymal Stem Cell Injection' Receives IND Acceptance from NMPA for Phase I Clinical Trial

Nov 15, 2023 08:32 CST Updated 08:32

Double Bioproduct

Developer of Anti-Tumor Gene Therapy Drugs

NEWS

Guangzhou Dabo Biological Products Co., Ltd. (referred to as "Dabo Biological") recentlyIssued by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA)AboutHuman Umbilical Cord Mesenchymal Stem Cell InjectionThe acceptance notice for the Phase I clinical trial application, with the acceptance number beingCXSL2300769。

Human Umbilical Cord Mesenchymal Stem Cell Injection（E10I）Is byDabo BioThe independently developed cryopreservation-type stem cell preparation is a suspension of human umbilical cord mesenchymal stem cells obtained from the in vitro separation, screening, and large-scale three-dimensional expansion of umbilical cord tissue, which is clinically intended for the treatment of type 2 diabetes.

About E10I

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Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) are a type of mesenchymal stem cell present in Wharton's jelly and the perivascular tissue of the umbilical cord. Mesenchymal stem cells derived from the umbilical cord are considered an ideal source due to their convenient procurement, absence of ethical controversies, high yield of obtainable cells, strong proliferation capacity, significant immunomodulatory effects, and substantial secretion of growth factors. They are also easy to expand and passage, with no issues related to matching or rejection, making them highly suitable for clinical research and applications.

In recent years, continuous research achievements have made umbilical cord mesenchymal stem cells a rising star in the field of clinical research and application of stem cells. Guangzhou Dabo Biological Products Co., Ltd. has rich experience in the separation, purification, amplification, and clinical application of stem cells, and has currently launchedUmbilical Cord Mesenchymal Stem Cells（E10I）Clinical research on the treatment of diabetes and rheumatoid arthritis.

About Dabo Bio

Guangzhou Dabo Biological Products Co., Ltd. is a national high-tech enterprise in China with a rich drug pipeline and independent innovation capabilities in the fields of anti-tumor innovative drugs and regenerative medicine. The company is committed to independent research and development, clinical research, and commercial production. Long-term relentless efforts have enabled Dabo Biological to continuously achieve impressive results in the biopharmaceutical field.

The company always focuses on forward-looking technology research and development, and has established a GMP workshop in compliance with international standards. As the host organization, it has built two provincial enterprise key laboratories (engineering laboratories) for anti-tumor drug research and development and one municipal enterprise key laboratory for gene therapy. Supported by these three laboratory platforms, the company has also established five new drug R&D functional platforms, including a gene therapy drug industrial production and quality control platform, a cell-based biotherapy R&D and application platform, a tumor vaccine and specific immunotherapy product platform, and a platform for constructing lead macromolecule candidate drugs for anti-tumor treatments and evaluating their pharmacodynamics.

After more than 20 years of continuous innovation and development, Guangzhou Dabo Biological Products Co., Ltd. has formed a series of product lines with independent intellectual property rights and obtained multiple clinical trial approvals, with projects currently in Phase I, Phase II, and Phase III clinical trials. Among them, E10A (Recombinant Human Endostatin Adenovirus Injection) is China's first gene therapy drug to enter Phase III clinical trials, and E10H (Autologous NK Cell Injection) is China’s first approved NK cell therapy drug to enter clinical trials.(For more details, see www.gzdoublle.com).

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