The Nation’s First Stem Cell Drug Production License Issued Cell Therapy Track to Meet the Development Opportunities

September 2, 2024  Source: drugdu 45

"/Beijing Drug Administration held a half-year working meeting, at which the work of issuing the country's first stem cell “drug production license” was particularly recognized. According to the search results of “Administrative License Information” on the website of Beijing Drug Administration, Platinum Bio-Excellence Biotechnology (Beijing) Co., Ltd. is the first company to obtain the national stem cell drug production license. The issuance of the Drug Manufacturing License is of epoch-making significance as it is the first drug manufacturing license specifically for stem cell drugs in China. The issuance of the Drug Manufacturing License signifies that the relevant enterprise has obtained the legal qualification and ability to manufacture stem cell drugs.

In recent years, with the introduction of policies such as the “14th Five-Year Plan” for the development of bio-economy, China has clearly put forward the development of new technologies such as stem cell therapy, strengthening the synergy between industry, academia, research and utilization, and accelerating the transformation of related technologies and products and their clinical applications. The State Drug Administration (CDE) has also issued a number of guidelines, such as the “Technical Guidelines for Clinical Trials of Human-Derived Stem Cells and Derived Cellular Therapeutic Products (for Trial Implementation)”, to provide technical guidance for the research and development, registration and clinical trials of stem cell products. The issuance of the Drug Manufacturing License for stem cells means that China's stem cell drugs already have the basic conditions to advance into the market, signaling that the door to a new era of cell therapy is slowly opening.

According to Caixin's theme library, among the relevant listed companies:

Huabang Health said on the interactive platform that the company's shareholding enterprise Hebei Life Origin is the construction and operator of the Hebei Provincial Stem Cell Bank, whose core business is cell storage business such as neonatal stem cells and adult immune cells, and clinical research and application transformation of stem cell products.

Boao International Hospital, a subsidiary of Jimin Health, currently has a stem cell drug development pipeline that mainly includes fat mesenchymal stem cell treatment of retinitis pigmentosa and fat mesenchymal stem cell treatment of type 2 diabetes, all of which are in the preclinical stage.

https://finance.eastmoney.com/a/202408303170644587.html

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