People's Daily health client reporter Wang Zhuo
On April 13, the NmEDA approved marketing applications, new indications and clinical procedures for several drugs, including three anti-cancer drugs.
Bayer's "unlimited cancer" therapy TRK inhibitors were approved
A marketing application submitted by Bayer for ralotinib sulfate capsules has been approved for the treatment of adult and pediatric patients with solid tumors carrying the fusion gene of the neurotrophic factor receptor tyrosine kinase (NTRK).
People's Daily health client query public information shows that this is an "unlimited cancer" therapy, it is the world's first oral TRK inhibitor designed for NTRK gene fusion cancer patients. Bayer now has exclusive rights to the global development and commercialization of the drug.
It is understood that it is a new anti-cancer drug that has targeted specific gene mutations since the early development period, rather than specific cancer species. In the United States, it has been granted breakthrough therapy accreditation, orphan drug status, and rare pediatric disease accreditation by the FDA.
BeiGene anti-PD-1 tirelizumab was approved for the 8th indication
An application for marketing of a new indication for BeiGene's anti-PD-1 antibody, Terelizumab (Bizean), has been approved. This is also the eighth indication approved for tirelizumab in China for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) that has progressed or become intolerable after previous first-line standard chemotherapy.
Previously, terelizumab has been approved in China for fully approved combination chemotherapy for the treatment of patients with first-line advanced squamous non-small cell lung cancer (NSCLC); first-line advanced non-squamous NSCLC patients; treatment of patients with second- or third-line locally advanced or metastatic NSCLC who have previously received platinum-containing chemotherapy; and 4 conditionally approved indications for a total of 7.
Roche tocilizumab injection was approved for new indications
Roche's application for the listing of new indications for tocilizumab injection (subcutaneous injection) was also approved today. Public information shows that tocilizumab is an anti-IL-6R recombinant humanized monoclonal antibody, which has been approved in China for a variety of indications.
According to Roche's official website, tocilizumab has been approved for a number of indications worldwide, including rheumatoid arthritis, childhood idiopathic arthritis, systemic jiastiac arthritis, giant cell arteritis and CAR-T cell-induced cytokine release syndrome.
Beida Pharmaceuticals ensartinib for new indications was approved for clinical practice
Beida Pharmaceuticals announced that the new indication of ensartinib has been approved for clinical use in the postoperative adjuvant therapy of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer. This is currently the only domestic ALK inhibitor approved for listing, and has entered the new version of the medical insurance directory through medical insurance negotiations.
Ensartinib was approved for marketing in November 2020 for patients with locally advanced or metastatic non-small cell lung cancer who have previously progressed after treatment with crizotinib or who are intolerant to clozotinib or who are intolerant of an anaplastic lymphoma kinase (ALK).