3D Medicines Announces that China NMPA Has Accepted the Investigational New Drug Application of the Global Innovative Drug 3D197

2021-11-04 00:00:00 Source:思路迪 Author:思路迪医药 Views:1201

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.


This IND application contains the first phase I study of 3D197 in China, which is designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) profiles, immunogenicity, and preliminary efficacy of 3D197 in subjects with locally advanced or metastatic solid tumors and relapsed or refractory hematological tumors. The study is divided into two parts, including dose-escalation and dose-expansion.


About 3D197 (IMC-002)

3D197 (also known as IMC-002) is a fully human IgG4 monoclonal antibody designed to block the CD47–SIRPα interaction in order to promote the phagocytosis of cancer cells by macrophages. According to its non-clinical results, it binds to human CD47 with an optimal affinity that maximizes efficacy without binding to RBCs or causing anemia which is often seen in other CD47 blocking agents under development. For more information about the Phase 1 clinical trial currently conducted by ImmuneOncia in the US and Korea, visit, identifier number NCT04306224.


About 3D Medicines Inc.

3D Medicines Inc. is a leading innovative biopharmaceutical company and committed to the development and commercialization of immuno-oncology (I/O) therapies with differentiated clinical benefit in response to the trend of treating cancer as a chronic disease. The mission is to help prolong the survival of cancer patients and improve their quality of life. The visionary management team has led us to build industry-leading, fully-integrated capabilities in end-to-end drug R&D from pre-clinical discovery to clinical development and commercialization. The core product envafolimab is a global first and only BLA-stage, subcutaneously-injectable PD-L1 antibody that has the potential to address a global unmet medical need for the treatment of cancer as a chronic disease. With a robust I/O monotherapy and combo-therapy portfolio of more than 10 drug candidates with envafolimab as the backbone, we strive to become a leader in the chronic cancer treatment market.

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About ImmuneOncia Therapeutics, Inc.
ImmuneOncia is an immuno-oncology-centric biopharmaceutical company. Established in 2016 as a joint venture company between Yuhan Corporation in South Korea and Sorrento Therapeutics, Inc. in the US, ImmuneOncia leverages both companies’ expertise in drug development and antibody engineering. The company’s mission is to bring safe, effective and novel immunotherapies to oncology patients worldwide, and its portfolio includes diverse immune checkpoint antibodies. ImmuneOncia has successfully completed a Phase I study of IMC-001, its leading candidate anti-PDL1 antibody, and has initiated its Phase II study in the second half of 2020. In March 2021, ImmuneOncia and 3D Medicines signed an exclusive license agreement to develop, manufacture and commercialize IMC-002 in Greater China. Meanwhile, ImmuneOncia continues to retain the rights of IMC-002 in the rest of the world including the United States, European Union and Japan. A Phase I study of IMC-002 by the company is ongoing in the US and Korea.

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