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).
Shanghai (China), Daejeon (South Korea),January 5th 2021 - 3D Medicines Inc., a clinical stage biopharmaceutical company focusing on the development and commercialization of differentiated immuno-oncology drugs, and Y-Biologics, the South Korean biotech company, have entered into a license agreement, and 3D Medicines will obtain exclusive rights to develop, manufacture, and commercialize YBL-013, a T cell bi-specific engager based on ALiCE platform technology, in the Territory of Greater China (mainland China, Hong Kong, Macau and Taiwan) and will co-developed it across the globe. For 3D Medicines, acquiring this candidate drug will further improve its product layout in the field of immune-oncology, and build a highly competitive and complementary pipeline.
December 22, 2020 - 3D Medicines Inc. announced the New Drug Application (NDA) of Envafolimab (KN035), a recombinant humanized PD-L1 single-domain antibody has been accepted by the National Medical Products Administration (NMPA) on December 17, with the registration number CXSS2000060 for the indications of previously treated microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) advanced colorectal cancer, gastric cancer and other advanced solid tumors. 3D Medicines, Alphamab Biopharmaceuticals Co., Ltd. (9966.HK) and Simcere Pharmaceutical Group Ltd. (2096.HK) reached the strategic collaboration on Envafolimab (KN035), the PD-L1 inhibitor formulated for subcutaneous injection, which can fill the unmet clinical needs after the marketing approval.
SHANGHAI and NEW YORK, December 8, 2020 -- 3D Medicines, Inc., a clinical stage biopharmaceutical company focusing on the development and commercialization of differentiated immuno-oncology drugs, and SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS”), a late-stage clinical biopharmaceutical company focusing on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced that they have entered into an Exclusive License Agreement granting rights to 3D Medicines to develop and commercialize SELLAS’ lead clinical candidate, galinpepimut-S (GPS) and candidate GPS+ at preclinical stage, across all therapeutic and diagnosis uses in the Greater China territory (mainland China, Hong Kong, Macau and Taiwan).
November 16, 2020, 3D Medicines Inc. announced the New Drug Application (NDA) of Envafolimab (KN035), a recombinant humanized PD-L1 single-domain antibody, which has reached the strategic collaboration with Alphamab Biopharmaceuticals Co., Ltd. (9966.HK) and Simcere Pharmaceutical Group Ltd. (2096.HK). The application has been officially submitted to the National Medical Products Administration (NMPA), and the indications are for the treatment of microsatellite instability (MSI-H) in advanced colorectal cancer, gastric cancer, and other mismatch repair defective (dMMR) advanced solid cancers that have failed previous standard treatment.