Shanghai Junshi Biosciences Co. Ltd. could receive an aggregate $1.1 billion from Coherus Biosciences Inc. for the rights to develop and commercialize Junshi’s anti-PD-1 antibody toripalimab in the U.S. and Canada. The deal is powered by Coherus’ core biosimilar business and is designed to steer the company into the business of immuno-oncology. Read More
Citing “troubling reports” about Beijing Genomics Institute’s (BGI) efforts to “exploit the pandemic to expand their reach within the United States,” Sens. Marco Rubio (R-Fla.) and Chuck Grassley (R-Iowa) are calling on the U.S. Health and Human Services (HHS) Office of Inspector General (OIG) to expand the scope of an ongoing audit aimed at better protecting Americans’ genomic data. Read More
HONG KONG – Osaka, Japan-based Shionogi & Co. Ltd. has inked a license agreement with Bioage Labs Inc. that sets the stage for the Richmond, Calif.-based startup to test asapiprant for the treatment of COVID-19 and age-related declines in immune function. Read More
KRAS is the most frequently mutated oncogene in solid tumors in general, and in lung tumors in particular. There are more patients whose lung tumors are driven by KRAS mutations than by ALK, Ros, Ret and TRK alterations. Combined. Read More
HONG KONG – Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted approval for Biocryst Pharmaceuticals Inc.’s Orladeyo (berotralstat), the first and only drug for prophylactic treatment of hereditary angioedema (HAE) approved in the country. Biocryst’ partner, Torii Pharmaceutical Co. Ltd., will launch the drug after completing pricing negotiations with the Japanese National Health Insurance System (NHI). Tokyo-based Orphanpacific Inc., Biocryst’s representative in Japan, holds the marketing authorization. Read More
While the FDA’s Center for Drug Evaluation and Research met all action dates for the 53 new molecular entities approved in 2020, despite the COVID-19 pandemic, developers of at least 8 drugs continue to wait for a decision beyond their expected timelines. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: Ampio, Appili, Astrazeneca, Beigene, Daiichi Sankyo, Dimerix, Dr. Reddy’s, Dynavax, Eli Lilly, Eucure Beijing, Glaxosmithkline, Humanigen, I-Mab, Immutep, Innovation, Johnson & Johnson, Lead Discovery Center, Morphosys, Novavax, Oncosec Medical, Qurient, Redhill, Regeneron, Sichuan Clover, Sorrento, Takeda, Valneva, VBL, Vicore, Vir. Read More
