PharmaVibe, capture the dynamics of the pharmaceutical industry

The online platform for CPHI & PMEC China is fully live now! The online event will be live for 54 days to help you connect for an extended period of time. Looking back on this week's pharma news, BeiGene's new indication for Zanubrutinib was approved in the EU while TopAlliance submitted a marketing application for the anti-PD-1 monoclonal antibody Toripalimab in the EU. The most noteworthy in the R&D section is Hengrui's JAK inhibitor Phase III clinical success, making it be expected to become the first product made in China in the field of autoimmune system diseases.

This week, the first highly selective PI3Kδ inhibitor in China, linperlisib of YL-Pharma, was approved for marketing. Multiple positive results have been released from several clinical trials, but GSK announced that the Phase III superiority trial of its BCMA ADC combined with pomalidomide in the treatment of relapsed or refractory multiple myeloma, did not meet its primary endpoint of progression-free survival (PFS). Jumpcan Pharmaceutical entered into a cooperation agreement with Newsoara and obtained the development rights of two innovative drugs.

This week, Toludesvenlafaxine Hydrochloride Extended-Release Tablets, a kind of first-in-class anti-depressant drug developed by the Chinese company Luye Pharma, was approved for marketing. In terms of R&D, the phase III clinical research of PCSK9 Monoclonal Antibody developed by Akeso met the endpoints and was planned to apply for marketing. In terms of business, SonnetBio and Janssen, a subsidiary of Johnson & Johnson, reached a cooperation agreement on three candidate products.

The marketing application of HAISCO's first-in-class HSK16149 Capsule was submitted, presumably for the treatment of diabetic peripheral neuralgia. While in the global markets, Simcere Pharmaceutical's SIM0237 had been approved for clinical use in the United States for the treatment of locally advanced unresectable or metastatic solid tumors. In terms of R&D, several clinical trials achieved positive results, while Alpine Immune terminated two clinical trials of davoceticept due to the death of patients.

The two most noteworthy news were the approval of the two-drug HIV therapy developed by GSK for marketing in China and the submission of the marketing application for Zevorcabtagene Autoleucel injection of CARsgen, which is the second BCMA CAR-T product to be declared for marketing in China. The results of the Phase I study of Innovent’s GLP-1R/GCGR dual agonist were published, with a weight loss of over 11.5% at 12 weeks of dosing.