Shenzhen Chipscreen Biosciences Co. Ltd.’s Bilessglu (chiglitazar), a peroxisome proliferator-activated receptor (PPAR) pan-agonist globally for the treatment of type 2 diabetes mellitus, has received marketing approval from the NMPA in China.
The race for a Japan-made COVID-19 vaccine is heating up as players make progress with their trials. Daiichi Sankyo Co. Ltd. recently shared the results from its phase I/II trial for DS-5670, its mRNA vaccine. The mRNA vaccine candidate initiated studies in March 2021. The findings showed that in terms of immunogenicity, both neutralizing activity and IgG titer increased after the vaccination.
Innovent Biologics Co. Ltd.’s phase III Orient-31 trial for sintilimab in EGFR-mutated nonsquamous non-small-cell lung cancer (nsqNSCLC) met its primary endpoint. In combination with anti-VEGF antibody Byvasda (bevacizumab biosimilar injection) and chemotherapy, the treatment improved progression-free survival vs. chemotherapy alone. “The detailed results of Orient-31 will be released in 2021, and Innovent will file for the new drug application for that indication around early 2022,” Ronnie Ede, chief financial officer and executive director at Innovent, told BioWorld.
Biopharmas in Asia-Pacific raising money in public or private financings: Anticancer Bioscience, Appili, Axial, Cellorigin, Sciwind, Topelia Australia.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Adocia, Advaccine, Asieris, Beigene, Brii, Curevac, Escugen, H. Lundbeck, Hoth, Inovio, Kintor, Merck, Nrx, Otsuka, Regeneron, Ridgeback, Roche, Sorrento, Tonghua Dongbao.
D&D Pharmatech Inc., a Korean-American firm commercializing innovation from Johns Hopkins University raised $51 million in a pre-IPO series C round, which sets the stage for an IPO in Seoul early next year.
RSS
