China is the latest country mixing things up when it comes to COVID-19 boosters. Since boosters were implemented in China in October, adults have been given a third dose of their primary vaccine regimen, which has consisted of one of three inactivated vaccines produced by Sinopharm Group Co. Ltd. and Sinovac Biotech Ltd. Read More
Livzon Pharmaceutical Group Inc.’s key interim data from the phase III trials of its recombinant SARS-CoV-2 fusion protein vaccine, V-01, has shown efficacy against the omicron variant. The phase III trial aims to evaluate the efficacy, safety and immunogenicity of V-01 as a booster in adults older than 18 after they have received two doses of inactivated vaccines. Read More
India’s health care industry stakeholders have been left scratching their head as authorities, who have championed self-reliance and increased supplies, provided mixed signals in recent notices. Read More
Over the past few years, China has been quick to make promises to improve its regulatory and patent schemes for biopharmaceuticals and medical devices in keeping with its World Trade Organization (WTO) commitments, but it’s been slow to fulfill those promises – at least in the eyes of the Office of the U.S. Trade Representative (USTR). Read More
In the wake of recent U.S. FDA pushback on an NDA filing by Innovent Biologics Inc. and Eli Lilly and Co. built around ex-U.S. trial data, few companies are likely to attempt such a feat again soon – at least when the source of the data is China alone. Read More
Researchers at Inserm have developed a method to direct pre-existing antibodies toward new targets. Their bimodular fusion proteins could be a broadly useful method for expanding access to antibody therapy. In a study that appeared in the Feb. 11, 2022, issue of Science Advances, the teams showed that antibodies to Epstein-Barr virus (EBV), which are present in 95% of the global population, could be redirected to a target cell of their choosing by fusing an EBV antigen to a cellular targeting ligand. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Bionet Asia, Edesa, Enanta, Gracell, JCR, Laurent, Nrx, Pharmajet, Regencell, Resverlogix, Technovalia. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Aridis, Biontech, Biovaxys Technology, Davita Clinical Research, Fosun, Global Medical Solutions Australia, Insilico Medicine, Johnson & Johnson, Novelty Nobility, Pfizer, Recbio, Shionogi, Telix, Trestle, Valenzabio. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Affamed, Arch Biopartners, Ascletis, Beigene, Biontech, Cstone, Jixing, Lupin, Moderna, Zai Lab. Read More
