Janssen's BCMA/CD3 Bispecific Antibody Teclistamab Granted Clinical Approval in China for Multiple Myeloma
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
Janssen Pharmaceuticals
Pharmaceutical R&D Developer
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
The Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA) announced that teclistamab injection, a Class 1 innovative biologic developed by Janssen, a subsidiary of Johnson & Johnson, has been approved for clinical trials for the treatment of multiple myeloma (MM). It is a bispecific antibody targeting B-cell maturation antigen (BCMA) and the CD3 receptor on the surface of T lymphocytes. Previously, it received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for the treatment of multiple myeloma.
According to the latest abstract data presented at the 2021 ASCO Annual Meeting, as of February 4, 2021, 156 patients had received teclistamab treatment, of whom 84 received intravenous (IV) administration and 72 received subcutaneous (SC) administration.
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