In 2023, driven by policies, China's stem cell industry will expand rapidlyThe application of new stem cell drugs also ushered in a historic blowout！According toCenter for Drug Evaluation (CDE) of the State Food and Drug AdministrationAccording to the official website, as of August 2023, there have been nearly 100 cases across the country40 enterprisesMore than 60 stem cell products have been submitted for IND approvalIt is enough to see that the research and development of stem cell products in China is increasing day by day.
Among them, it is worth mentioning that:Huaxia Source Cell GroupObtained stem cell products since July 2023"Elpis Human Umbilical Cord Mesenchymal Stem Cell Injection".Since the acceptance of the fifth indication IND, it has become one of the many enterprises in one fell swoopThe company with the largest number of new stem cell drug IND acceptances leads the country
At present, Huaxiayuan original research stem cell products"Elpis Human Umbilical Cord Mesenchymal Stem Cell Injection".The 5 indications declared cover the more common autoimmune diseasesModerate to severe chronic plaque psoriasis, severe lupus nephritis, moderate to severe active inflammatory bowel diseaseThere are alsoAcute-on-chronic (subacute) liver failurewithModerate to severe intrauterine adhesionsFour of them have received implicit approval to conduct clinical trials of new drugs.
Up to now, Huaxiayuan has five product indications of "ELPIS Human Umbilical Cord Mesenchymal Stem Cell Injection" accepted by CDE, of which four have been approved for clinical trial mode, and the fifth is expected to be approved by IND in October this year.
The success of Huaxiayuan's "ELPIS Human Umbilical Cord Mesenchymal Stem Cell Injection" has also gone through a long and arduous research and development journey, and the product has received major special funding for many times, and has given active support at different stages.
November
Led by Huaxiayuan Cell Group"R&D project of umbilical cord mesenchymal stem cell injection applied to psoriasis and diabetes clinic".Successfully selectedMajor industrial technology research projectsIt was also the only stem cell and regenerative medicine project selected at that time!
April
Huaxiayuan wonZhangjiang National Independent Innovation Special Development** The first batch of supportHuaxiayuan Cell Group became the first batch of enterprises with special development funds in the demonstration zone and received financial subsidies.
June
Huaxiayuan "ELPIS Human Umbilical Cord Stem Cell Injection" was obtainedChina Institute for Food and Drug Control, Inspection Report :(SH202006168).Huaxiayuan's successful acquisition of the inspection report of the Chinese Institute for Inspection and Inspection marks that the Electrops umbilical cord mesenchymal stem cell products have been recognized by the national authority in terms of preparation process and quality control.
July
Zong Ming, Vice Mayor of ShanghaiThe delegation visited Huaxiayuan for research and guidance to understand the progress of Huaxiayuan's first cell product "ELPIS umbilical cord mesenchymal stem cell injection".
July
Huaxiayuan Cell Group's "Elpis Umbilical Cord Mesenchymal Stem Cell R&D Project" was successfully obtainedShanghai Municipal Science and Technology Commission 2021 Shanghai High-tech Achievement Transformation Project Certification
August
Huaxia SourceThe project of "Umbilical Cord Mesenchymal Stem Cells**Lupus Nephritis" was supported by the special project of biomedical science and technology support of Shanghai "Science and Technology Innovation Action Plan".This is Huaxiayuan's second undertaking of the city's leading research projects and topics on the road of independent innovation in stem cell drug research and development.
October 25
Huaxiayuan ushered in the first indication of "ELPIS Human Umbilical Cord Mesenchymal Stem Cell Injection".Moderate to severe chronic plaque psoriasis, officially obtained the drug clinical trial approval notice from the Center for Drug Evaluation (CDE) of the State Food and Drug Administration (Notice No.: 2021LP01737). Huaxiayuan's "Elpis Human Umbilical Cord Mesenchymal Stem Cell Injection" is the first new stem cell drug for psoriasis in China.
June 16
Huaxiayuan's second "ELPIS Human Umbilical Cord Mesenchymal Stem Cell Injection" (acceptance number CXSL2200142) was officially approved for drug clinical trials by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration (Notice No.: 2022LP00973). Huaxiayuan "ELPIS Human Umbilical Cord Mesenchymal Stem Cell Injection" isThe first new stem cell drug approved for clinical trials of lupus nephritis** in China
February 10
Huaxiayuan's third "ELPIS Human Umbilical Cord Mesenchymal Stem Cell Injection" (acceptance number: CXSL2200581) was officially approved by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration (CDE) for drug clinical trial approval (notice number: 2023LP00238), allowing it to carry out phase Ib clinical trials. This is the third application direction of Huaxiayuan stem cell new drug products, and it will also bring a new choice for chronic acute (subacute) liver failure.
April 6
Huaxiayuan's fourth project "ELPIS Human Umbilical Cord Mesenchymal Stem Cell Injection" (acceptance number: CXSL2300030) was officially approved by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration (Notice No.: 2023LP00589). This is the fourth application direction of Huaxiayuan's new stem cell products, and it also represents that the first new stem cell drug for intrauterine adhesions in China is about to enter the clinic.
July 21
The IND application (IND) for the fifth indication of Huaxiayuan's original stem cell product "ELPIS Human Umbilical Cord Mesenchymal Stem Cell Injection" was accepted (acceptance number: CXSL2300501). This is the fifth indication of Huaxiayuan's ELPIS product that has been accepted by CDEModerate to severe active inflammatory bowel diseaseIt is a relatively common type of autoimmune disease, which further indicates that the field of autoimmune diseases is the main application direction of Huaxiayuan Group's stem cell products.