CNBG Sumgen Announces Clinical Trial Approval of SG404

On November 9, 2020, Sumgen Biotech reported that the IND application for its anti-CD47 product SG404 was approved by the Center for Drug Evaluation (CDE) of NMPA (Press release, Sumgen Biotech, NOV 9, 2020, View Source;a=nav&id=241 [SID1234625260]). This is the first clinical trial approval received by CNBG Sumgen since its founding in Mar. 2020.

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In the past decade, the CD47-SIRPα signaling pathway has become a potential target for tumor immunotherapy. At the ASH (Free ASH Whitepaper) 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.