Domestic CD19 car-t cell therapy! Casi / synbiotic cnct19 cell injection was approved by nmpa to carry out new drug clinical trials in China!

December 6, 2019 / BIOON / -- CASI pharmaceuticals, Inc is a NASDAQ listed Biomedical Company in the United States It has drug development, product acceleration and innovative therapy exploration platforms in China, the United States and other regions of the world Recently, the company announced that China National Drug Administration (nmpa) drug evaluation center (CDE) has officially approved two new drug clinical trial applications of cnct19 cell injection (anti-CD19 chimeric anti protoreceptor T cell injection) submitted by its partner, Heyuan Biotechnology (Tianjin) Co., Ltd (hereinafter referred to as Heyuan Biology), which are respectively: treatment recurrence or difficulty The clinical trial (acceptance No.: CXSL1800106) for the treatment of ALL and the clinical trial (acceptance No.: CXSL1800107) for the treatment of relapsed or refractory invasive B cell non Hodgkin lymphoma (B-NHL) Heyuan biological cnct19 cell injection is a car-t cell treatment product with independent intellectual property right for CD19 target, which originates from the long-term technological innovation accumulation of the hematology Hospital of the Chinese Academy of Medical Sciences (Hematology Research Institute of the Chinese Academy of Medical Sciences) Cnct19 cell injection is the first immunocytotherapy product approved by clinical trials of new drugs since the establishment of synbiotics In June this year, CASI company and Heyuan biology officially signed a license agreement to obtain the global exclusive commercial rights and interests of cnct19 project Cnct19 is an autogenous anti-CD19 T cell therapy product developed by synbiotics Since then, Heyuan biology will continue to carry out the research and development of cnct19 project, and CASI will join the project steering committee In the future, according to the agreement, CASI will pay relevant expenses to Heyuan biology after the project R & D progresses to the major milestone stage; after entering the commercialization stage, CASI will pay sales dividends to Heyuan biology according to the agreement Kaixin Yuanda Pharmaceutical (Wuxi) Co., Ltd associated with this agreement is a CASI 80% joint venture company that will invest 80 million yuan (about 11.6 million US dollars) as advance payment to Heyuan biology through a wholly-owned subsidiary of its company The CD19 target of cnct19 is one of the important membrane antigens widely expressed in B cell activation and proliferation It is a common surface marker of all B cells, and also an effective target of B lymphocyte system malignant hematopathy The chimeric antigen receptor (car) with CD19 as the target from different research institutions has shown continuous and effective antitumor effect in children and adults with B-ALL, CLL and B-NHL CD19 is the most commonly used biomarker in the clinical trials of car-t in the treatment of leukemia, lymphoma and other hematological malignancies "This is a very exciting milestone for CASI," said Dr Zhang Wei, President of CASI China Car-t therapy was first approved in the United States in 2017 and has not yet been listed in China Cnct19 will be produced in China at a much lower cost than imported therapies, which will eventually allow us to offer it more widely to Chinese patients We expect to start recruiting patients in early 2020 " Heyuan biology, founded in 2018, is a biomedical enterprise focusing on the research and development of innovative immunotherapy drugs Heyuan biology adheres to the guidance of meeting clinical needs, builds innovative R & D pipeline, with efficient R & D and transformation platform, and through strict production and quality system of cell therapy products, to create safe, efficient and accessible immune cell therapy products for patients At present, the company has 1300 square meters of R & D center in Beijing, 1400 square meters of GMP immune cell drug R & D, transformation and production facilities in Tianjin, and 7000 square meters of GMP immune cell drug production base under construction Original source: CASI pharmaceuticals announcements China nmpa approval of cnct19 (CD19 car-t) clinical trial applications