Recently, Chongqing Precision Biotech passed the comprehensive review by the Chongqing Food and Drug Administration and was approved for the Drug Production License of CAR-T cell therapy products, becoming the first in the western region and one of the few in the country to have this license from the same industry.

A milestone of Chongqing Precision Biotech

The approval of the Drug Production License is a milestone event of Chongqing Precision Biotech, which is of great significance to company , social livelihood and economic development. It marks a further step for of Precision Biotech in the industrialization of immunotherapy and the benefit of tumor patients, and it will also play a role in demonstrating and leading the formation of gene and cell industry clusters in Chongqing in the future. We will take this as a new starting point to accelerate the incubation of cell therapy drugs, so that more Chinese people can afford CAR-T cell drugs.

Upgrading in the development stage: Since its establishment in 2016, after seven years of intensive research and development, Precision Biotech has begun to upgrade to the stage of biopharmaceuticals, and has achieved a qualitative leap in the industrialization of cell drugs such as CAR-T.

Expansion of the base construction: The issuance of the production license boosted confidence in the project construction of the "Chongqing Regional Cell Preparation Center" (jointly approved by the Chongqing Economic and Information Commission, the Health Commission and the Food and Drug Administration). The project is located in the core area of the Western (Chongqing) Science City, covering an area of more than 150 mu. After the overall completion, it can realize the entire industrial chain and batch production of plasmids, vectors and cell-based drugs.

Preparation for business expansion: This production license can provide support for the application of Class I biological new drugs, and accumulates management and operation capabilities for market expansion.

With the advancement of modern medicine, gene and cell medicine has become a trend in the treatment of malignant tumors. The CAR-T products independently developed and transformed by Precision Biotech can help tens of thousands of cancer patients receive effective treatment every year, break the monopoly of some foreign CAR-T drugs, reduce drug prices, and benefit domestic cancer patients.

Research and development progress: the company has independently developed more than 10 pipelines for solid tumor and hematological tumor CAR-T product , and has obtained 6 indications of 3 CAR-T Class I new drugs. Its CAR-T treatment of solid tumors such as kidney cancer and colorectal cancer is the first in China and the first breakthrough in the world. Precision Biotech’s pCAR-19B candidate is progressing rapidly in ALL (acute lymphoblastic leukemia) indications, especially in refractory and relapsed ALL indications in children. It is the earliest CAR-T product in China to enter clinical phase II and has achieved excellent results curative effect. After the product is launched, it is expected to become the first CAR-T product for this indication in China.

The breakthrough in the research and development of cell-based drugs by Precision Biotech has achieved industrialization, which will stimulate the development needs of medical equipment, reagent consumables, medical cosmetology, and general health, and form an industrial agglomeration effect that will continue to grow and become an industrial cluster of the biomedical industry. In addition, the latest data from the International Agency for Research on Cancer of the World Health Organization shows that the domestic tumor cell immunotherapy market will reach a scale of 100 billion in the future, and Precision Biotech will bring considerable economic benefits to the local and attract a large number of biomedical scientific research talents.