Beijing, China April 18, 2022 - 3D Medicines Inc. (3D Medicines) announces that the multi-center, open-label phase Ib/II clinical trial of Batiraxcept (3D229) in combination with envafolimab or lenvatinib in patients with advanced solid tumor was approved by China’s National Medical Products Administration (NMPA).
Beijing，April 6，2022 - 3D Medicines Inc. (the “Company”), today announced that an IND application to initiate the first clinical trial in China for 3D189, also known as SELLAS’s galinpepimut-s (“GPS”), has been approved by China’s National Medical Products Administration (“NMPA”) to evaluate safety and immunogenicity of 3D189 in Chinese patients with hematological malignancies.
Beijing China, March 15, 2022 - 3D Medicines, a commercial-stage, oncology-focused Bio-pharmaceutical company, and Merck, a global leading science and technology company, today announced a partnership on clinical research. Under the collaboration, a clinical trial is designed to evaluate the combination of envafolimab, the world’s first subcutaneously injected PD-L1 antibody drug, and Erbitux® (cetuximab), an epidermal growth factor receptor (EGFR) inhibitor in the treatment of patients with RAS/BRAF wild-type, non-MSI-H/pMMR metastatic colorectal cancer (mCRC) who previously failed the treatment with fluorouracil, oxaliplatin, irinotecan and bevacizumab
Beijing, January 27, 2022 – 3D Medicines Inc. (the Company), today announced that an IND application to initiate the first clinical trial in China for 3D189, also known as SELLAS’ galinpepimut-S (GPS), has been accepted by China’s National Medical Products Administration (“NMPA”). The company expects to initiate the trial by mid-2022 and will be responsible for all expenses related to executing the trial in China.
Beijing, January 7, 2022, 3D Medicines Inc, announced that China‘s National Medical Products Administration（NMPA）has approved 3D Medicines’ IND to initiate this first Phase 1 trial with 3D197 in China. 3D Medicines also plans to subsequently conduct a Phase 1b/2 study to evaluate the combination of 3D197 with envafolimab, azacitidine, rituximab, and other standard agents in solid tumors and hematological malignancies.
On 26 November 2021, 3D Medicines (Beijing) Co., Ltd. (3DMed) , Alphamab Oncology (stock code: 9966.HK)，and Simcere Pharmaceutical Group Limited (Simcere) jointly announced that Envafolimab (Enweida®), the world's first single-domain PD-L1 antibody formulated for subcutaneous injection (SC) co-developed by the three companies, has received approval from the Chinese National Medical Products Administration (NMPA) to be commercialized in China. The approved indication for Enweida® is for adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors, including those patients with advanced colorectal cancer who have experienced disease progression following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as well as patients with other advanced solid tumors who have experienced disease progression following prior treatment and have no satisfactory alternative treatment options. This represents the first tissue-agonistic indication granted to an immune checkpoint inhibitor by NMPA.