BEIJING – Androgen receptor (AR)-related disease specialist Kintor Pharmaceutical Ltd., of Suzhou, China, is looking to raise up to HK$1.861 billion (US$240 million) in a Hong Kong IPO to advance its small-molecule AR antagonists, proxalutamide and pyrilutamide, both of which have first- and best-in-class potential. Read More
HONG KONG – Singapore-based Proteona Pte. Ltd. has started a partnership to characterize the clinical response to a new COVID-19 vaccine, with clinical trials soon to start at Flinders Medical Centre testing the candidate developed in collaboration with Adelaide, Australia-based Vaxine Pty Ltd. Read More
HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19. Read More
LONDON – Support is growing for human challenge trials in COVID-19 to be approved in order to speed up development of effective vaccines against the pandemic infection. The World Health Organization (WHO) has just released guidelines for assessing the ethical acceptability, saying such trials would allow for more rapid and standardized testing, accelerating development and enabling candidates to be prioritized. Read More
HONG KONG – The Japanese government is tightening its grip on its listed companies, including those working on promising COVID-19 treatments. On May 8, the Japanese Ministry of Finance released a list of 518 companies that would be subject to stricter restrictions on receiving foreign investments. Read More
HONG KONG – South Korea’s Hanmi Pharmaceutical Co. Ltd. has filed a new drug approval application for Rolontis (eflapegrastim) with the country’s Ministry of Food and Drug Safety (MDFS). Read More
BEIJING – Canbridge Pharmaceuticals Inc. is to add another source of income after Chinese regulators approved Nerlynx (neratinib) to be marketed for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer. Read More
HONG KONG – South Korea’s Bridge Biotherapeutics Inc. wrapped up the week by announcing its awaited IND clearance for its epidermal growth factor receptor tyrosine kinase inhibitor, BBT-176, for non-small-cell lung cancer. Read More
PERTH, Australia – CSL Behring Australia, a subsidiary of CSL Ltd., will begin developing an anti-SARS-CoV-2 plasma product to treat people with serious complications of COVID-19. Read More
HONG KONG – After inking a recent deal with China’s Jiangsu Hengrui Medicine Co. Ltd., South Korea’s Crystalgenomics Inc. is celebrating its 20th anniversary by seeking more partners to further develop its anti-PD-1 inhibitor pipeline. Read More
The challenges to deploy diagnostic and surveillance testing for the COVID-19 pandemic will persist at least until a vaccine is ready if not well beyond that milestone. In our series “Diagnosing the state of COVID-19 testing,” BioWorld MedTechexplores the complexities of developing accurate, properly regulated tests to help bring the world back online with confidence.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief, including: Adma Biologics, AI Vivo, Altum, Amgen, Antengene, Arcturus, ARTMS Products, Aum Biotech, Aum Lifetech, Beroni Group, Betterlife, Bio Science, Biopharma Plasma, Burning Rock, Certara, Cipla, Cocrystal, Cohbar, Dongwha, Fortebio Analytics, GC Pharma, Gilead Sciences, Idbiologics, Illumina, Innovation, Karyopharm, Lineage Cell, Molecular Partners, Montreal Heart Institute, Noveome, Ose Immunotherapeutics, Predictive Oncology, Proteogenix, Sanquin, Sinovac, Soluble, Sorrento, Sosei Heptares, Telix, Tetra Bio-Pharma, Themis, Tianjin University, Tonix, Vanderbilt University Medical Center, Vaxil Bio, Wuhan University, Zyus Life Sciences. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Biomedical Advanced Research and Development Authority, CHMP, EMA, FDA, Gilead Sciences, National Institute for Health and Care Excellence, Nichi-Iko Pharmaceutical, Office of Special Counsel, Sagent Pharmaceuticals, SEC, Shriram Institute for Industrial Research, Therapeutic Goods Administration, U.S. Senate. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: Athersys, Biontech, Calcimedica, Cytodyn, Daewoong, Eli Lilly, Enlivex, Hightide, Humanigen, Innovent Biologics, Kiniksa, Mesoblast, Noxopharm, Pfizer, Rising. Read More
