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 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 tissue-agonistic indication granted to an immune checkpoint inhibitor by NMPA. 

HOUSTON, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative, targeted therapeutics to treat life-threatening cancers, today announced that positive new data from the Phase 1b portion of its open-label Phase 1b/2 trial evaluating batiraxcept (AVB-500) in combination with cabozantinib in patients with clear cell renal cell carcinoma (ccRCC) will be presented at the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting on November 13, 2021. 

On November 4th, 2021 - 3D Medicines Inc. announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) had accepted the Investigational New Drug (IND) application of 3D197 (also known as IMC-002), which is their 8th drug candidate under clinical-stage. 3D197 is a of fully human immunoglobulin G4 (IgG4) monoclonal antibody (mAb) targeting a cluster of differentiation 47 (CD47). It is an innovative biological drug and has not been marketed globally.

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.