Clinical trials in China are growing up in much the same way the R&D enterprise in China has grown up. They are evolving and becoming more sophisticated, reflecting the maturation of the R&D environment around them.
Baili Biopharmaceutical Co. Ltd. has raised ¥990.47 million (US$146 million) on the Shanghai STAR Market. Its shares opened Jan. 6 at ¥28.75 apiece, surging over 30% its first trading day, and closing at ¥38.40 on Jan.9.
As expected, the U.S. FDA gave its go-ahead to lecanemab, an amyloid-beta binder for mild cognitive impairment caused by Alzheimer’s disease (AD) and mild AD from Biogen Inc. and Eisai Co. Ltd, which have assigned to the compound the brand name Leqembi.
China’s NMPA has approved Merck & Co. Inc.’s COVID-19 treatment molnupiravir for emergency use to combat the increasing number of cases in the country.
After receiving approval in Japan for its orally administered COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622) in late November, Shionogi & Co. Ltd. is gearing up for approvals in South Korea and China.
Raynovent Biotech Co. Ltd. has raised ¥370 million (US$54 million) in a series C round to further develop candidates in the field of respiratory and metabolic diseases.
Wuxi Biologics (Cayman) Inc. is providing an exclusive license to GSK plc for a preclinical bispecific T-cell engaging antibody along with the option of three additional bi- and multispecific TCE antibodies developed by Wuxi. In exchange, Wuxi will receive an up-front payment of $40 million and up to $1.46 billion in additional payments for research, development, regulatory and commercial milestones across the four TCE antibodies. Wuxi Biologics, of Shanghai, is also eligible to receive tiered royalties on net sales.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: American Cryostem, Cleave, Daiichi Sankyo, Innovent Biologics, Legend, Revive, Transcenta.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Aribio, Curevac, Hutchmed, Immutep, JS Innopharm, Medincell, Onquality, Redhill, Takeda, Valneva, Visen.
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