Cansino Biologics Inc. launched its second pre-revenue share offering on Aug. 13, reaping ¥5.2 billion ($749 million) from Shanghai’s STAR market. Trading under the ticker 688185, its shares surged 87.5% to close at ¥393 on the first trading day. The company, currently developing 16 vaccine candidates for 13 infectious diseases, has grabbed headlines this year for its COVID-19 vaccine candidate, Ad5-nCoV, which is due to enter phase III trials in Saudi Arabia shortly. Read More
The FDA granted accelerated approval to Viltepso (viltolarsen) to treat Duchenne muscular dystrophy patients (DMD) who have a confirmed mutation of the DMD gene amenable to exon 53 skipping, pitting it against Sarepta Therapeutics Inc.’s Vyondys (golodirsen), which was given accelerated approval last year in a controversial decision by the FDA following an agency complete response letter (CRL) highlighting safety concerns. Read More
HONG KONG – Huya Bioscience International LLC, which has a special interest in China-developed assets, has obtained an exclusive global license, bar China, for the SHP2 inhibitor HBI-2376 from Suzhou-based Genhouse Pharmaceutical Co. Ltd. Financial terms were not disclosed. Read More
HONG KONG – China’s Lianyungang-based Jiangsu Hengrui Medicine Co. Ltd. has obtained approval from Korea’s Ministry of Food and Drug Safety (MFDS) to begin a phase III trial for a combination therapy of its PD-1 inhibitor candidate camrelizumab and VEGFR-2 inhibitor rivoceranib. Read More
Chinese state-backed vaccine developer China National Biotec Group (CNBG), of Beijing, published an interim analysis of randomized phase I/II trials of its inactivated SARS-CoV-2 vaccine candidate in the Journal of the American Medical Association last week. With the added detail, the data encouraged the company in its plans to produce 220 million doses per year. Read More
HONG KONG – China’s Arctic Vision Biotechnology Co. Ltd. has entered into an exclusive deal with New York-based Eyenovia Inc. to develop and commercialize ophthalmic formulations that are delivered using the latter’s first-in-class microdosing spray technology. Read More
PERTH, Australia – Aussie regenerative medicine company Regeneus Ltd. has out-licensed its lead mesenchymal stem cell (MSC) and secretome therapy, Progenza, to Japan’s Kyocera Corp. for osteoarthritis of the knee for the Japan market. Read More
HONG KONG – Singapore-based Tessa Therapeutics Pte. Ltd. released the results of two investigator-initiated phase I/II trials that found its autologous CD30 CAR T-cell therapy TT-11 showed a high rate of durable complete responses and a favorable safety profile in patients with relapsed/refractory Hodgkin lymphoma. Read More
Newly founded Lianbio, with offices in Shanghai and San Francisco, aims to quickly establish a presence in China and Asia with late-stage assets in-licensed from Bridgebio Pharma Inc. and Myokardia Inc. in two deals amounting to $531.5 million and $187.5 million, respectively. Read More
A bid by top shareholders and managers of the U.S.-China cell therapy developer Cellular Biomedicine Group Inc. to take the company private pushed shares (NASDAQ:CBMG) 35% higher Wednesday to $19.27, just shy of the offering price. Read More
A Sino-U.S. collaborative study has demonstrated that acupuncture regulates inflammation by activating pro- or anti-inflammatory signaling pathways, while mitigating cytokine storms in mice with systemic inflammation, the study authors reported in the Aug. 12, 2020, edition of Neuron. Read More
Biopharmas in Asia-Pacific raising money in public or private financings, including: Atriva, Genome and Co., Scioto, Organicell Regenerative Medicine. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Medicines and Healthcare Products Regulatory Agency, Moderna, Office of the U.S. Trade Representative, Pan American Health Organization, SEC, Therapeutic Goods Administration, World Health Organization. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: Algernon, Ansun, Arcturus, Ascletis, Blade, Botanix, GNI Group, I-Mab, Merck, Novavax, Romark Laboratories, SAB, Syndax. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Adamis, Antengene, Arca, Atyr, Eli Lilly, Enzychem Lifesciences, Equillium, Henlius, Hoth, Innovent, Kyorin, Mesoblast, Pliant, Redhill, Seattle Genetics, TLC, Verona. Read More
