Innovent Biologics Inc., of Suzhou, has out-licensed ex-China rights for its PD-1 drug Tyvyt (sintilimab) to Eli Lilly and Co. in an expanded license deal. The Chinese firm will receive $200 million upfront in the deal, the value of which could approach up to $1.03 billion. Innovent’s CEO Michael Yu called this “the first solid step in getting Innovent's innovative portfolio into the global market.” With the ex-China rights of Tyvyt, Lilly plans to seek approval for the PD-1 drug in the U.S. and other markets. Read More
HONG KONG – Stempeutics Research Pvt Ltd. received the green light from the Drug Controller General of India (DCGI) to launch its Stempeucel therapy to treat critical limb ischemia (CLI) due to Buerger’s disease and atherosclerotic peripheral arterial disease. Read More
HONG KONG – Hua Medicine Ltd. has signed a commercialization and partnership deal with Bayer AG for a new diabetes treatment in China. Hua’s dorzagliatin, a first-in-class dual-acting glucokinase activator, is designed to control the progressive degenerative nature of diabetes by restoring glucose homeostasis in patients with type 2 diabetes (T2D). Read More
PERTH, Australia – As Victoria suffers through a second COVID-19 wave, bringing the death toll to 430 for Australia, Prime Minister Scott Morrison said that Australians could be among the first in the world to receive a COVID-19 vaccine through an agreement with Astrazeneca plc. Under the deal, every Australian would be able to receive AZD-1222, which is being developed with the University of Oxford. Read More
Shanghai-based nanobody specialist Novamab Biopharmaceuticals Co. Ltd. is developing a new neutralizing nanobody, Nb11-59, as a potential inhaled therapy for COVID-19 – a convenient treatment if developed successfully. Similar research is being conducted worldwide. Read More
HONG KONG – Researchers from the Massachusetts Institute of Technology’s (MIT) research enterprise in Singapore have found a way to not just reverse antibiotic resistance but also increase sensitivity in some bacteria, using hydrogen sulfide. Read More
A first half of the year progress report from the international advocacy group Alliance for Regenerative Medicine finds that the regenerative medicine and advanced therapy sector is in very good shape and has performed well in terms of both clinical development and fundraising. Read More
HONG KONG – Last week was a busy one for Harbour Biomed Therapeutics Ltd., seeing the company sign a COVID-19 research collaboration with several Dutch institutions as well as lodge an application to list on the Hong Kong Stock Exchange. Read More
Privately held Alzheon Inc. picked up a $47 million grant from the NIH’s National Institute on Aging that will last over five years to support a phase III clinical trial of its oral brain-penetrant small molecule ALZ-801 to treat Alzheimer’s disease. Read More
Biopharmas in Asia-Pacific raising money in public or private financings, including: Bone Therapeutics, Connect Biopharmaceuticals, Opthea, Rnaimmune, Sirnaomics. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: Acepodia, Ascletis, Aslan, Biontech, Cynata, Novavax, Organicell Regenerative Medicine, Pfizer, Reithera, Revive, Sab, Telix Pharmaceuticals Japan, Trevena, Vanda. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Aligos, Astrazeneca, Carsgen, Kazia, Kimera Labs, Lidds, Merck, Opthea, Samsung Bioepis, Sorrento. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Department of Health and Human Services, Drug Enforcement Administration, FDA, Health Canada, National Center for Advancing Translational Sciences, SK Biopharma. Read More