BEIJING – One more company is joining the global efforts in developing a vaccine for COVID-19. Beijing-based Yisheng Biopharma Co. Ltd. unveiled YS-SC2-010, which was developed through recombinant protein technology and its proprietary PIKA (polyinosinic-polycytidylic acid-based adjuvant) technology. Read More
HONG KONG – Japan’s Seikagaku Corp. is contemplating the next move for its ONO-5704/SI-613 (diclofenac etalhyaluronate), a treatment for arthritis that it is co-developing with fellow Japanese company Ono Pharmaceutical Co. Ltd. Read More
BEIJING – Nasdaq-listed Chinese vaccine developer Sinovac Biotech Ltd., of Beijing, said the preliminary results of the phase I/II trials of its COVID-19 inactivated vaccine candidate, Coronavac, demonstrated favorable immunogenicity and safety profiles. Read More
All the primary and secondary efficacy endpoints were met in Boulder, Colo.-based Brickell Biotech Inc.’s pivotal phase III study of the anticholinergic sofpironium bromide in treating primary axillary hyperhidrosis, which involves excessive sweating in the armpits that interferes with daily life and work. Read More
BEIJING – CAR T therapy developer JW Therapeutics (Shanghai) Co. Ltd. raised another $100 million this week after securing $90 million in series A round in 2018. The funds will continue to go toward its lead program, JWCAR-029, a CAR T-cell product targeting CD19 that is now in a phase II study. Read More
HONG KONG – Korea’s Celltrion Inc. aims to wrap up its first major M&A deal with Japan’s Takeda Pharmaceutical Inc. by the end of 2020, pending approvals. Read More
HONG KONG – Singapore-based Tychan Pte. Ltd. is starting a phase I trial for a novel monoclonal antibody (MAb) that specifically targets SARS-CoV-2, the coronavirus that causes COVID-19. The trial is expected to take only around six weeks to complete. Read More
HONG KONG – Takeda Pharmaceutical Co. Ltd. is preparing to take Takhzyro (lanadelumab) to the world stage after announcing its interim results for a phase III hereditary angioedema long-term prophylaxis (HELP) study. Read More
PERTH, Australia – Melbourne, Australia-based Opthea Ltd. announced positive top-line results of its phase IIa trial evaluating safety and efficacy of OPT-302 administered with Eylea (aflibercept, Regeneron Pharmaceuticals Inc.) in treatment-refractory patients with persistent diabetic macula edema (DME). Read More
BEIJING – Rare disease specialist Canbridge Pharmaceuticals Inc., of Beijing, said it is collaborating with the Horae Gene Therapy Center at the University of Massachusetts (UMass) Medical School to conduct gene therapy research with a focus on neuromuscular conditions. Read More
HONG KONG – India’s Ministry of Health and Family Welfare (MOHFW) has drafted rules for the manufacturing, import and the compassionate use of unapproved drugs in the treatment of patients. Read More
HONG KONG – Astellas Pharma Inc. reported positive results from phase III of its DOLOMITES study comparing the efficacy and safety of roxadustat to that of darbepoetin alfa in treating anemia in nondialysis-dependent, stage 3 to 5 chronic kidney disease (CKD) patients. Read More
Biopharmas in Asia-Pacific raising money in public or private financings, including: Albireo, Appili, JW Therapeutics (Shanghai) Co., Immvira, Shattuck Labs, Takeda. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Department of Defense, FDA, Minister of Health, National Center for Advancing Translational Sciences, NIH. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: Atyr, Can-Fite, Eli Lilly, Humanigen, Immunic, Kyowa Kirin, Moderna, Neurorx, Oncoimmune, Opko Health, Opthea, Orpheris, Otsuka, Pluristem, Regeneron, Relief, Sinovac, Solasia, Tychan. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Biophytis, Diffusion, Fulcrum, Genequantum, Immune, Immunic, Immuron, Redhill, Revive. Read More
