Shanghai, China July 14, 2021- 3D Medicines Inc., a China-based late clinical stage biopharmaceutical company, announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application submitted by 3D Medicines to participate in Aravive’s international AVB-500 (3D-229) Phase 3 platinum resistant ovarian cancer (PROC) clinical trial. (ClinicalTrials.gov Identifier: NCT04729608) This is expected to be a registrational Phase III multi-regional clinical trial (MRCT), in China, of AVB-500 (3D-229) IV infusion, a GAS6/AXL inhibitor, in patients with PROC. This is the first international Phase III clinical trial approved for GAS6/AXL inhibitor in China.
Shanghai, March 31, 2021 - 3D Medicines Inc.(3DMed), a biopharmaceutical company focused on treating cancer as a chronic disease, and ImmuneOncia Therapeutics, Inc., a clinical-stage, immuno-oncology company in South Korea, today announced the execution of an exclusive license agreement for the development, manufacture and commercialization of IMC-002, ImmuneOncia’s monoclonal antibody against CD47, for oncology indication in the Territory of Greater China (Mainland China, Hong Kong, Macau, and Taiwan). ImmuneOncia will retain rights to IMC-002 in the rest of the world including the United States, European Union, and Japan.
March 2, 2021 – 3D Medicines Inc. announced the appointment of Shen Xiao, M.D., Ph.D., as Chief Strategy Officer. He would be responsible for tasks including strategic innovation, competitive positioning and business model establishment for the company, he would provide support for the Chief Executive Officer on strategy planning and execution, and be in charge of the Regulatory Affairs Department. Shen Xiao, M.D., Ph.D., would report to John Gong, M.D., Ph.D., Chairman and Chief Executive Officer of 3D Medicines.
February 26, 2021 – the construction of 3D Medicines’ R&D and Manufacturing Center was officially started, which was announced at the Xuzhou venue of the Joint Groundbreaking Ceremony of Jiangsu Province, as one of the 2021 Key Projects in Jiangsu.
January 29, 2021 – 3D Medicines Inc. announced that the National Medical Products Administration (NMPA) has granted the IND approval for 3D011, a Class 1 innovative drug self-developed by 3D Medicines for the treatment of advanced solid tumors.
January 19, 2021 – 3D Medicines Inc. announced that the NDA of Envafolimab (KN035), the recombinant humanized PD-L1 single-domain antibody on which 3D Medicines has established a strategic collaboration with Alphamab Oncology (9966.HK) and Simcere Pharmaceutical Group Limited (2096.HK), was granted Priority Review by the Center for Drug Evaluation (CDE) under National Medical Products Administration (NMPA).