Source: Stem cell base

As of August 31, 2023, 87 clinical trial applications for stem cell drugs from 52 domestic enterprises (excluding subsidiaries) were accepted, of which 3 new applications were added in August. A total of 70 of 43 companies (excluding subsidiaries) have been granted tacit access to clinical trials (implied permission for clinical trials), of which 3 were added in August. Of the 87 accepted stem cell drugs, 8 have been unable to find IND review information or review suspended, and 8 are under review.

New Acceptance 1:

On August 16, 2023, a drug clinical trial application of "Human umbilical cord mesenchymal stem cell (allogenic) injection" of Zhejiang Golden Times Biotechnology Co., Ltd. was accepted (acceptance number: CXSL2300547). This is the first stem cell drug approved by the Zhejiang Golden Age.

New Acceptance 2:

On August 22, 2023, a drug clinical trial application for "Allogeneic Endothelial Progenitor cells (EPCs) injection" of Cheno Regenerative Medicine Technology (Beijing) Co., Ltd. was accepted (acceptance number: CXSL2300561). This is the second indication to be accepted for this EPCs injection, which has previously been implicitly approved for use in large atherosclerotic acute ischemic stroke (acceptance number: CXSL2100023).

New Acceptance 3:

On August 23, 2023, the application for a drug clinical trial of "NCR300 injection" (IPSCS-derived NK cells) of Anhui Zhongsheng Tracer Biotechnology Co., Ltd. was accepted (accepted as CXSL2300562), which is the second indication of this stem cell injection. It has previously been implicitly licensed for use in myelodysplastic syndrome (MDS) (Acceptance number: CXSL2300109).

Added Implied License 1:

Wuhan Ruijian Pharmaceutical Technology Co., LTD. "Human Dopaminergic Precursor cell Injection" (IPSC-derived drug) (acceptance number: CXSL2300346) obtained the implied approval of new drug clinical trial, the indication is: Parkinson's disease. This is the first indication of this stem cell injection, which was previously accepted on April 28, 2022, and the progress information of the task is no longer available without tacit approval (acceptance number: CXSL2200194).

Added Implied License 2:

Guangdong Qianhui Biotechnology Co., LTD. 's "Mesenchymal stem cells for blood Purification" (Bioartificial liver) (Acceptance number: CXSL2300379) obtained the implicit approval of new drug clinical trial, indication: slow plus acute liver failure (early and middle stage). This is the first indication of the stem cell injection.

Added Implied License 3:

Jiangsu Ruiyuan Biotechnology Co., LTD. 's "RY_SW01 cell injection" (allogenic mesenchymal stem cells) (acceptance number: CXSL2300385) obtained the implied approval of new drug clinical trial, indication: systemic sclerosis. This is the second indication for this stem cell injection, which has previously been implicitly approved for clinical trials in active lupus nephritis (acceptance number: CXSL2200303).