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Hrain News

Hrain News

Hrain Receives Another Clinical Trial Approval in Multiple Myeloma, Leading Chin

On December 7, 2018, Hrain Biotechnology Co., Ltd. announced that the anti-human BCMA T cell injection for treating BCMA positive recurrent/refractory multiple myeloma was granted implied license for clinical trials by the National Medical Products Administration (NMPA), the second CTA for BCMA CAR T cells in China. The research and development of this BCMA CAR T cell now enjoys a leading status around the globe, and it is equivalent to its foreign counterparts in terms of safety and effectiveness. China has approved 7 clinical trials of CAR T, including 3 from Hrain, which cover main hematologic tumors, including lymphoma, leukemia and multiple myeloma.



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History of IND declaration of Hrain’s anti-human BCMA T cell injection:


In May 2018, IND application was accepted;


In October 2018, data was released;


On December 6, 2018, implied license (Approval No. CXSL1800063) was issued for clinical trials.


Hrain has been approved for clinical trials of 3 CAR T products targeting lymphoma, leukemia and multiple myeloma, making it the domestic enterprise with the most clinical trials of CART-T drug registration. This demonstrates that the company has completed all the technological reserve required for the research on the drug industrialization of CAR-T and has received recognition from NMPA.


The clinical trial for the drug registration of Hrain’s first approved anti-human CD19 T cell injection has been launched at Zhongshan Hospital affiliated to Fudan University, and the enrollment of first patient and blood sampling have been completed. The clinical trial for the registration of drug targeting leukemia will soon be launched at the Department of Hematology of Shanghai General Hospital, and the clinical trial for the registration of multiple myeloma drugs will be started at the Department of Hematology of Shanghai Changzheng Hospital.


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R&D Director of Hrain Delivers Report at ASH Conference


The research level and product quality of Hrain in the field of CAR T has won high recognition from international counterparts. On December 4, 2018, Dr. Liu Yarong, R&D Director of Hrain, delivered an academic report titled “Durable Remission Achieved from BCMA-Directed CAR-T Therapy Against Recurrent or Refractory Multiple Myeloma” at the 60th Annual Meeting of the American Society of Hematology (ASH) in San Diego, CA, USA, releasing the research content of the company project of using anti-human BCMA T cell injection to treat recurrent or refractory multiple myeloma and the results of safety and effectiveness research. According to the report, the overall objective remission rate among 20 enrolled subjects has reached 85%. International counterparts spoke highly of Hrain’s research outcomes, saying that the enrollment conditions for this research are comparable to those for clinical trials by major US companies and that its overall safety and effectiveness is on par with US counterparts.


At present, relevant departments and hospitals in US, Israel, Czech and Hungary are having consultations with Hrain on cooperation in the clinical trial research of CAR T drugs. The Health Ministry of Israel has approved the clinical trial research of Hrain’s CAR-T products in Israeli hospitals.


About Hrain


Hrain Biotechnology Co., Ltd., established in July 2015 by renown international experts from University of Southern California, Duke University and University of California, Los Angeles, and domestic scientists, is an international R&D driven pharmaceutical enterprise, which is devoted to the research and product application of innovative tumor immunotherapy CAR-T cell technology.


The company has won supports from authoritative scientific advisory committees, and successively conducted cooperations with top international universities and such famous domestic research institutions as the Cellular Gene Therapy Center of the Academy of Military Medical Sciences and the Cancer Institute of PLA.


So far, Hrain has established clinical trial centers in Beijing, Chongqing, Jiangsu, Zhejiang, Henan and Jiangxi, and so on places. It engages cooperation on clinical trial with hospitals and medical institutions in the US, Europe and Middle East, and continues to expand its international presence.


Multiple myeloma (MM) is a kind of malignant disease arising from the abnormal proliferation of clonal plasma cells, and the No.2 common malignant tumor of the hematological system. Its common clinical manifestations include bone pains, anaemia, renal insufficiency, infection and hypercalcemia, etc. In China, MM is one of several major hematological system tumors, and its morbidity is about 1/100,000. In recent years, China has seen major progress in treatment choices for MM. Many types of drugs for MM treatment have been approved for sales, including CD38 single antibody. The Guidelines for the Diagnosis and Treatment of Multiple Myeloma in China (2017 version) has identified Bortezomib, Thalidomide and Revlimid as key drugs in the treatment of recurrent or refractory MM. The clinical trial of CAR-T, as a new tumor immunotherapy against MM, is mainly used for final-line treatment after standard therapy, namely recurrent or refractory patients who have developed resistance to protease inhibitor and immunomodulator therapy or experienced failure of regular therapy above 3rd line, offering hope for patients with advanced MM.