Recently, Immatics announced that its T cell receptor T cell (TCR-T) therapy IMA203 under research has been granted the Regenerative Medicine Advanced Therapy (RMAT) designation by the Center for Biologics Evaluation and Research (CBER) of the U.S. FDA.
On Oct 24, 2023, China's CDE announced that Purunao Biotechnology, a subsidiary of Anshi Biotechnology, applied to list a new indication for the Class 1 new drug Vebreltinib on their official website.
On Oct 25, 2023, Huadong Medicine's subsidiary, Hangzhou Zhongmeihuadong Pharmaceutical, was granted a "Notice of Acceptance" by the NMPA for their marketing application for Mirvetuximab Soravtansine Injection (IMGN853, HDM2002), co-developed with ImmunoGen.
On Oct 25, 2023, Celltrion reported US FDA approval of Zymfentra (infliximab) for continued treatment of adult ulcerative colitis (UC) and Crohn's disease (CD) after intravenous infliximab treatment.
Yasheng Pharmaceutical presented updated clinical data for APG-1252 and Osimertinib to treat EGFR mutation lung cancer patients at the 2023 ESMO meeting on October 23, 2023.
On October 24, 2023, BioNova Pharmaceuticals announced that the U.S. FDA has granted Fast Track Designation to its product BN104 for the treatment of relapsed/refractory acute leukemia.
The Drug Evaluation Center of the NMPA in China announced on Oct 24, 2023, on its official site, that Innovent Biologics' Category 1 new drug, GFH925 (IBI351), is slated for priority review.
Arvinas Inc. recently reported positive results for its AR-targeting protein degraders, bavdegalutamide (ARV-110) and ARV-766, in Phase 1/2 trials for mCRPC treatment at ESMO.
Immutep recently introduced its novel LAG-3 immunotherapy, Eftilagimod Alpha (Efti), for cancer and autoimmune disease treatment at the 2023 ESMO meeting. It presented positive data from two trials for Efti with pembrolizumab ± double chemotherapy as first-line NSCLC treatments.
Inxmed Co. announced that the significant clinical research results of its independently developed core product, Ifebemtinib (IN10018), the world's first small molecule FAK inhibitor.
Dizal Pharmaceutical'S EGFR inhibitor named Sunvozertinib for first-line treatment of EGFR exon20ins mutation type advanced NSCLC, debuted at the 2023 European Society for Medical Oncology (ESMO) meeting.
On Oct 22, 2023, Amgen published results from their CodeBreaK 300 study on Lumakras and Vectibix's efficacy in treating chemo-resistant mCRC with KRAS G12C mutation.