HONG KONG – China is steadily greenlighting more COVID-19 vaccines and drugs to go deeper into the clinic, giving the country a growing arsenal against the disease. To date, China’s National Medical Products Administration (NMPA) has approved a handful of drugs and 16 domestically developed COVID-19 vaccine candidates for trials, up from 11 in September 2020. Read More
Chengdu-based Sichuan Clover Biopharmaceuticals Inc., known for its Trimer-Tag technology, raised $230 million in a series C financing round. The proceeds will, most notably, help it advance its COVID-19 vaccine candidate, S-Trimer (SCB-2019), to a global phase II/III trial by June. Following its $43 million series B round in December 2019, Clover said on Tuesday, Feb. 23, that it raised more than $400 million in the last 12 months. The company uses its Trimer-Tag technology platform to produce covalently-trimerized fusion proteins to develop protein-based vaccines and biologic cancer therapies. Read More
CAJICA, Colombia – A cooler box with 70 vials allegedly filled with counterfeit COVID-19 vaccines seized from a Chinese couple in Colombia’s El Dorado International Airport on Feb. 17 underscored the growing challenges facing pharmaceutical companies, law enforcement authorities and health care regulators around the world. Patient safety, company liability, and the security of distribution channels have all been areas of growing concern. Read More
PERTH, Australia – The fight against diffuse intrinsic pontine glioma may finally see some progress, after experiments using 3D models of the tumor in animal studies showed that a combination therapy of the polyamine inhibitor AMXT-1501 (Aminex Therapeutics Inc.) and the ornithine decarboxylase 1 inhibitor difluoromethylornithine could eradicate cancer cells. Read More
HONG KONG – Beijing-based Beigene Ltd. struck its second deal outside China this year, signing an option and license agreement with Boston Immune Technologies & Therapeutics Inc. (BITT) for the latter’s tumor necrosis factor receptor 2 (TNFR2) antagonist antibodies. Read More
HONG KONG – Hansoh Pharmaceutical Group Co. Ltd. picked up the greater China rights to Scynexis Inc.’s lead candidate, ibrexafungerp. Hansoh will take charge of the development, regulatory approval and commercialization of the antifungal in exchange for a $10 million up-front payment and as much as $112 million in milestones. Read More
HONG KONG – Ferring Pharmaceuticals’ microbiome-focused subsidiary Rebiotix Inc. and Mybiotics Pharma Ltd. have agreed to a multiyear strategic collaboration to develop live microbiota-based biotherapeutics to address bacterial vaginosis. Read More
PERTH, Australia – With the first COVID-19 vaccine ready to be launched in Australia, the Therapeutic Goods Administration has released guidance on its pharmacovigilance plan to track real-world safety data and adverse events following immunization. Read More
Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C). Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology Genitourinary Cancers Symposium, including Astellas, Eisai, Merck, Seagen. Read More
Biopharmas in Asia-Pacific raising money in public or private financings, including: Molecular Templates, Regor, Sciwind, Takeda, Theravectys. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: Adagio, Algernon, Astellas, Bionomics, Biontech, Biophytis, Clene, Diffusion, Evgen, Gannex, Glaxosmithkline, Immunic, India Globalization Capital, Kintor, Kyowa Kirin, Mesoblast, Neuren, Novavax, Pfizer, PTC, Realta Life Sciences, Recce, Redhill, Sagent, Sanofi, Vtv. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Adamis, AIM Immunotech, Altimmune, Astellas, Astrazeneca, Beigene, Biontech, Celltrion, Curocell, Cytocom, Daiichi Sankyo, Dr. Reddy’s, Janssen-Cilag, JCR, Johnson & Johnson, Junshi, Pfizer, Pharmamar, RDIF, Seagen. Read More
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Indoco Remedies, Takeda, Therapeutic Goods Administration, Torrent, U.S. Court of Appeals for the Federal Circuit. Read More