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CNBG Sumgen Announces Clinical Trial Approval of SG404

date:2020-11-09      source:

On Nov. 9, 2020, CNBG Sumgen Biopharmaceutical (Hangzhou) Co., Ltd. (hereinafter “CNBG Sumgen”) announced that the IND application for its anti-CD47 product SG404 was approved by the Center for Drug Evaluation (CDE) of NMPA. This is the first clinical trial approval received by CNBG Sumgen since its founding in Mar. 2020.

In the past decade, the CD47-SIRPα signaling pathway has become a potential target for tumor immunotherapy. At the ASH meeting held in Dec. last year, Forty Seven demonstrated that the combined use of its anti-CD47 antibody Magrolimab and Azacitidine resulted in an overall response rate (ORR) of up to 92% in previously untreated high-risk myelodysplastic syndrome (MDS) patients and up to 64% in untreated AML patients. These promising data brought great encouragement to other companies engaged in the development of anti-CD47 therapies. In Mar. 2020, pharmaceutical giant Gilead Sciences acquired Forty Seven for $4.9 billion USD.

According to the NextPharma database, there are currently over 50 anti-CD47 therapies under development worldwide, including nearly 20 candidate drugs in the clinical stage. Although there are many candidate drugs in the clinical trial, erythrotoxicity remains a topic of controversy in the developability of CD47. Therefore, further research is needed for the design of safer and more effective CD47-targeted drugs.


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