Hangzhou Sumgen Biotech Co., Ltd. (hereinafter "Sumgen”) has recently announced that their proprietary recombinant anti-PD-1 fully human monoclonal antibody injection (SG001), a national Class I new drug, was approved for clinical trial by NMPA. SG001 is the first product of Sumgen that has been approved for clinical trial and serves as a major progress milestone for the company’s tumor immunotherapy pipeline.
Dr. Lv, the founder and chairman of Sumgen, stated that, “Sumgen continues to align with international standards and global technology, and places great emphasis in innovative R&D. It only took two months for this project from submission to clinical trial approval, which not only reflects the government’s support for innovative drug R&D, but more importantly highlights the government’s recognition of Sumgen’s R&D and clinical registration capabilities. As an innovative biopharmaceutical enterprise in China, we will seize the opportunity of national reform in biomedicine industry to develop novel and effective drugs that can fulfill the domestic clinical demands in cancer treatment, and provide high-quality treatment regimens for more cancer patients.”
About SG001
SG001 is a proprietary recombinant fully human anti-PD-1 monoclonal antibody developed by Sumgen. SG001 can specifically recognize PD-1, block the interactions between PD-1 and PD-L1/PD-L2, reverse PD-1 signaling pathway-mediated immunosuppression, and activate antitumor immune responses. This type of antibodies is expected to become the basic medication for the clinical treatment of tumors. Pre-clinical results showed that SG001 has stable production process, defined pharmacodynamics, and satisfactory safety. The clinical registration was formally filed NMPA on Jul. 24, 2018 and approved on Sep. 29, 2018.
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