Recently, good news came from cell Valley enterprises in Tianjin high tech Zone. On March 27, Tianjin Pharmaceutical Research Institute Co., Ltd. announced that its self-developed class 1 new drug, tapgrel clinical trial application (ind), was approved by the U.S. Food and Drug Administration (FDA). This is the first innovative drug approved by FDA for clinical trial.
Tepgrel is a P2Y12 receptor antagonist intended for the prevention and treatment of thrombosis in patients with cardiovascular disease. Based on the R & D experience of innovative drugs in the whole chain, Tianjin Pharmaceutical Research Institute has established a systematic in vivo and in vitro screening and evaluation system. Preclinical research work provides full support for the clinical research of the drug. In 2021, tepgrel ind applied for permission from the National Drug Evaluation Center (CDE), and is currently carrying out phase I clinical research in China.
In addition to Tianjin Pharmaceutical Research Institute, recently, many high-tech enterprises have made breakthroughs and certification in cell therapy technology.
On March 25, Heyuan biology, a new generation biomedical enterprise, announced that the car-t therapy candidate product hy027 independently developed by the company targeting B cell maturation antigen (BCMA) had completed its first subject administration in the clinical trial initiated by the researcher. After the reinfusion administration, the patient was in good condition, and the researchers are evaluating its safety and efficacy according to the clinical research protocol.
Hy027 is a BCMA targeted car-t product independently developed by Heyuan biology. By using highly specific humanized anti BCMA scFv sequence, it can effectively avoid the production of anti drug antibodies. Combined with the international leading production technology and quality control system, it is expected to bring rapid, in-depth and lasting treatment effects to patients such as recurrent / refractory multiple myeloma.
In addition, in early March, kuangbo biology, a high-tech enterprise mainly engaged in the development and production of biological reagent products for scientific research and clinical diagnosis, independently developed five flow detection reagents and obtained the EU CE certification. These five products can form a commonly used six or four-color lymphocyte subgroup detection scheme, which is of great significance in the auxiliary diagnosis, medication guidance and prognosis evaluation of many diseases such as autoimmune diseases, immune deficiency diseases, allergic diseases, blood diseases, malignant tumors and so on.
\u3000\u3000 "The cell valley of the high tech Zone has gathered more than 40 cell related enterprises, including many types of enterprises such as cell storage, cytology testing, cell therapy, cell culture and cell sequencing. From the beginning of construction, we have been vigorously attracting more biomedical enterprises to develop in the cell valley. We have issued a series of cell industry innovation policies to vigorously support the biomedical industry and build a high-quality cell industry cluster. At present, a series of policies have been formed Cover cell extraction and preparation, cell storage, quality control inspection, R & D and production, application transformation, cold chain logistics and other relatively complete industrial chains. " Zheng Chunlin, deputy director of Biomedical Industry Investment Promotion Bureau of Tianjin Binhai high tech Zone, introduced that in addition to enterprises, cell Valley has also built many innovation platforms. Like the vascular network that gives vitality to the human body, the platform carrier closely connects independent enterprises to stimulate vitality and rejuvenate.
In mid February this year, Tianjiu regenerative medicine (Tianjin) Technology Co., Ltd., the head enterprise of cell industry in the high tech Zone, was approved by Tianjin Development and Reform Commission to build "Tianjin cell and exosome Engineering Research Center". This is another municipal key innovation platform achieved in the construction of "cell Valley" in the high tech Zone.
The newly approved "Tianjin cell and exosome Engineering Research Center" will focus on the research and development of exosome related technical products, focus on the application of exosomes in major refractory diseases, focus on the research and development of exosome related ultra early in vitro detection Innovation Medical Management Co.Ltd(002173) instruments, strive to break through the "neck" technical bottleneck in the field of exosomes, and form a center focusing on the research and development of exosome products, Build a diversified health industry service platform covering the fields of cell therapy, organoids, gene testing and gene therapy, characteristic medical services and biopharmaceutical.
The cell valley of high tech Zone is a breakthrough measure for Tianjin to build an important source of independent innovation and the main source of original innovation. It is an important mission of building an "upgraded" national independent innovation demonstration zone. After the center is approved, Tianjin high tech Zone will continue to comprehensively promote the construction of "cell Valley" and strive to build an innovation system of "one laboratory, two bases and four centers", namely cell ecological Haihe laboratory; Cell industry transformation base of Chinese Academy of Medical Sciences and linkage innovation demonstration base of China (Tianjin) pilot free trade zone; Tianjin cell technology innovation center, cell engineering innovation center, cell drug regulatory science research center, cell and exosome Engineering Research Center.
Zheng Chunlin said that in the future, the high tech Zone will also do a good job in the construction of the innovation system and supporting services of the biomedical industry in terms of industrial development planning, the construction of science and innovation platforms, the construction of professional carriers, policy and system innovation, government service approval, and the recruitment of key projects.
