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. Read More
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. Read More
China’s Center for Drug Evaluation (CDE) released a draft guide on clinical trials of drugs for rare disease as part of an ongoing push to encourage new drug development and nudge developers to focus on biomarkers, pharmacometrics and patient-reported outcomes. Both are needed to continue moving China’s R&D capabilities up the value chain and closer to being on par with the capabilities of other countries that are at the forefront of new drug development. Read More
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. Read More
Cerecin Inc. has raised $40 million in an oversubscribed round of financing, paving the way for a potential listing in South Korea. Proceeds of the financing will fund the expansion of the company’s current studies and support the planning and initiation of a global phase III study of its lead candidate, tricaprilin, in Alzheimer’s disease. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Algernon, Antengene, Aslan, Astrazeneca, Atreca, Bill & Melinda Gates Foundation, Calithera, Canbridge, China Resources Double-Crane, Daiichi Sankyo, Enanta, Galecto, Histoindex, I-Mab, Immunome, Incyte, Inflarx, Inovio, Legochem, Ligand, Marinomed, Merck, Novavax, Oncodesign, Scriptr Global, Shandong Luoxin Pharmaceutical Group Stock, Shionogi, Specialized Therapeutics Asia, Takeda, Tiumbio, United, Wave Life Sciences. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Alphamab Oncology, Beigene, Biontech, Canbridge, Cstone, I-Mab, Innocare, Johnson & Johnson, Kintor, Moderna, Moleculin, Nanolek, Neuren, Pfizer, Shenzhen Chipscreen. Read More
