The board of directors (the "Board") of 3D Medicines Inc. announced that on December 30, 2022, the U.S. Food and Drug Administration (the "FDA") has formally notified the Company that an investigational new drug application ("IND") for the Phase II study for the Company's core product envafolimab for the treatment of mismatch repair deficiency ("dMMR") advanced solid tumors may proceed with its proposed clinical study protocol. This IND is a phase II, multiregional, multicenter, single arm study to evaluate the efficacy and safety of envafolimab monotherapy in subjects with dMMR advanced solid tumors. Envafolimab is the core product in the Company's drug pipeline, and will be administrated to the patients subcutaneously every three weeks in this IND study. The Company's core product envafolimab is a subcutaneously-injectable PD-L1 antibody and has been approved by the China National Medical Products Administration (the "NMPA") for the treatment of previously treated MSI-H/dMMR advanced solid tumors on November 24, 2021. For the year ended December 31, 2021 and for the five months ended May 31,
2022, all of the Group's revenue was generated from the sales of envafolimab, which amounted to RMB 60.3 million and RMB 161.1 million, respectively. In November 2016, company received the IND approval for envafolimab from FDA for solid tumors. In February 2017, company launched (i.e. the first patient was enrolled) a first-in-human Phase I clinical trial of envafolimab in subjects with advanced solid tumors in the U.S. On January 16, 2020, the FDA granted envafolimab with orphan drug designation for the treatment of advanced biliary tract cancer. On June 28, 2021, the FDA granted envafolimab with orphan drug designation for the treatment of soft tissue sarcoma, and this clinical trial was sponsored by the partner TRACON. In October 2021, company completed the Phase I clinical trial of envafolimab in subjects with advanced solid tumors in the U.S.