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The adaptive disorder is relapsed or incurable acute lymphoblastic leukemia.
December 23, the Hospital of Hematology of the Chinese Academy of Medical Sciences (Institute of Hematology of the Chinese Academy of Medical Sciences) announced that Heyuan Biotech (Tianjin) Co., Ltd. (hereinafter referred to as Heyuan Bio) CNCT19 cell injection (anti-CD19 inlay antigen-infused antigen-controlled T-cell injection) was approved by the Drug Review Center (CDE) of the State Drug Administration to be formally incorporated into the "breakthrough treatment drug", adaptive to recurring or difficult acute lymphoblastic leukemia.
, there is no CAR-T product approved worldwide for adult recurrence or resoicable acute lymphoblastic leukemia, and clinical needs are urgent. Pre-
clinical research data show that CNCT19 cell injection in the treatment of adult recurrence or recurring acute lymphoblastic leukemia showed excellent efficacy and safety, the total remission rate of more than 90%, the current maximum survival has been more than 3 years, is expected to become an adult recurrence or recurring acute lymphoblastic leukemia, one of the most promising clinical treatment drugs.
In car-T products developed entirely by China and with independent intellectual property rights, CNCT19 cell injection clinical research progress is in the forefront, this time into the CDE breakthrough drug procedure, is expected to become China's first listed car-T new drug with independent intellectual property rights.
from the end of November 2019 to obtain a new drug clinical trial license, to January 2020 into the registration of Phase I clinical trials, and then in December was included in the "breakthrough therapeutic drugs" list, out of China's cell therapy new drug research and development industrialization of the "new speed of production and research."
Professor Wang Jianxiang, Director and Vice President of the National Center for Clinical Medicine of Blood System Diseases, said: "The prognostics of adult patients with relapsed or incurable acute lymphoblastic leukemia in China are extremely poor, the existing treatment model has little effect, the total survival rate of 5 years is less than 10%, and clinical needs are urgent."
CNCT19 cell injections offer breakthrough treatment options and healing hopes for this patient group.
The National Drug Administration's Drug Review Center's inclusion of CNCT19 cell injections in breakthrough therapeutic drugs fully reflects the urgency of its clinical needs, and we will accelerate the clinical research process so that patients can benefit from this breakthrough therapy as early as possible.
"