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Shenzhen Pregene Obtained the Clinical Implied License for the Anti-BCMA CAR-T Drug from NMPA with t
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time:2020.03.17

Shenzhen Pregene Obtained the Clinical Implied License for the Anti-BCMA CAR-T Drug from NMPA with the Support from Lewwin


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Shenzhen Pregene obtained the clinical implied license for the anti-BCMA CAR-T drug treating RRMM from NMPA with the support from Lewwin (Approval No. CXSL1900147; approval date: 17 March 2020).


The product is the only CAR-T cell drug in South China that has been implicitly licensed by NMPA for clinical use so far. Non-registered clinical trials have shown that its efficacy has reached the international leading level and has significant economic and social value. Pregene and Lewwin jointly built Guangdong Provincial Center for Innovative Drug Engineering Technology Research on Cell and Gene Therapy, which is committed to conquering the global technical difficulties in the development and non-clinical evaluation of cell and gene therapy drugs and completing a number of breakthroughs in common key technologies. 


Guangdong Lewwin Pharmaceutical Research Institute Co., Ltd. (Center for Drug Non-clinical Evaluation and Research of Guangdong Institute of Applied Biological Resources, hereafter referred to as "Institute") is the first institute(currently the only one) in South China to own nine full GLP certification qualifications of NMPA, and has been fully certified by AAALAC in a variety of animals(more than 7 species). Lewwin is the non-clinical evaluation research technology platform that have attained AAALAC International full accreditation in multi-business areas, and it is the only Drug GLP certified institute that has won the "Outstanding Enterprise" award of China Innovation & Entrepreneurship Competition since the start of the competition; Lewwin owns  Guangdong Provincial Key Laboratory of Drug Non-clinical Evaluation and Research, Non-clinical Evaluation Sub-center of Traditional Chinese Drug of Research National Engineering Research Center for Modernization of Traditional Chinese Drug, Guangdong new R&D institution, Guangdong Engineering Research Center for Innovative Drug Evaluation and Research, Guangdong Engineering Research Center for Ophthalmic Drug Creation and Evaluation(Ophthalmic Drug Integrated Creation Platform of South China), Guangdong Engineering Laboratory for Traditional Chinese Medicine Broken Wall Pieces, "Technology Platform for Drug Development and Evaluation Based on Molecular Imaging Technology" co-founded with University of Virginia, "Research and Evaluation Center of Guangdong-Hong Kong-Macao Greater Bay Area for Anti-Tumor Drugs" co-founded with HKUST, etc. lewwin can provide new drug research and development, new drug screening, pharmacological efficacy, drug safety evaluation, pre-clinical toxicokinetics research, animal model preparation and research for human diseases, toxicology calculation and other professional technical services for biomedical research and development.



As the most qualified GLP leading agency in South China, the Institute will rely on its leading technology platform, strong research strength and first-class non-clinical evaluation of drug research capabilities in promoting the GLP development in South China, and in the mean time, the Institute will play its own advantages on innovative drug development, Cutting-edge technology research and scientific payoff transformation, in order to provide critical support and technical services for enterprises and research institutes, and to help the healthy and rapid development of Chinese medicine economy in Guangdong province and even in South China.


In particular, the Institute has strong technical development ability and advantages in cell and gene drug detection platform. It has advanced detection platforms such as high-sensitivity multi-factor electrochemiluminescence detection platform, flow detection platform, molecular imaging technology platform, enzyme-linked immunosorbent assay platform and nucleic acid fluorescence quantitative detection technology. In addition to more than 600 pieces/set of standard supporting instruments and equipment, it also has high-sensitivity multi-factor electrochemiluminescence analyzer MSD S600, Beckman flow cytometry FLEX, real-time PCR Light Cycler 480, fluorescence luminescence full-wavelength multi-functional microplate reader Synergy LX, small animal in vivo imaging system IVIS Lumina LT, gene amplification instrument Life-Eco, gel imaging system CytoGel Doc XR +, vertical electrophoresis tank, nucleic acid electrophoresis tank, digital pressure-stable current electrophoresis instrument, transfer membrane instrument, inverted fluorescence microscope 400, high-speed frozen table-top centrifuge, Optima MAX-XP table-top ultracentrifuge and other molecular biology research equipment. And a series of Waters ultra-high performance liquid chromatography mass spectrometer LC/MS XEVO TQD, XEVO TQS, H-Class Plus/XEVO TQD, Vion IMS QTof ion mobility analysis mass spectrometer and other 


About Pregene

Shenzhen Pregene Biopharma Co., Ltd has renowned institutional investors as its shareholder, including National Small and Medium-sized Enterprise Development Fund, Guokegahe Fund under the Chinese Academy of Sciences, Shenzhen Capital Group, Haier Biomedical and Huapont Life Sciences. The core team of the company comes from well-known institutions and companies such as the Academy of Military Medical Sciences of the Chinese People's Liberation Army, the University of Toronto, and the US FDA. Pregene has a professional and experienced team for the R&D and industrialization, and has built a lab-scale and pilot-scale amplification system for new biopharmaceuticals such as gene editing platform, virus and cell large-scale preparation platform, and nanobody screening platform in the facility in Shenzhen. The company focuses on the R&D and promotion of cell and gene therapy drugs and participated in drafting the national drug standard "Key Points to Consider in the Quality Control Testing and Non-clinical Evaluation of CAR-T Cells" issued by the National Institutes for Food and Drug Control in June 2018


The company has obtained IND applications of multiple CAR-T cell drugs, and has now built a whole-process and quality control system for the preparation of plasmids, viruses and CAR-T cells that comprehensively meet the IND application criteria, so that the development cycle of new products is controllable. The company will always be committed to making original new biopharmaceuticals in China and composing a new chapter in life. At the 12th China Bio-industry Conference, which opened on June 10, 2019, under the witness of many experts and scholars, Shenzhen Pregene, Guangdong Lewwin, Cancer Research Center of Hong Kong University of Science and Technology and Macao Institute of Drugs and Health signed a joint construction of the "One-stop Public Service Platform for the R & D and Evaluation of Cell and Gene Therapy Drugs in Dawan District, Guangdong, Hong Kong and Macao University of Science and Technology". They gathered and met here to make the greatest effort and contribution to the cell and gene therapy industry in the Gulf.