Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Direct Biologics, Dr. Reddy’s Laboratories, Edesa, Eisai, Enlivex, Gilead Sciences, Immunitybio, Moderna, Prestige, Recce, Sorrento, Tevogen.
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has approved an additional indication for CT-P59, Incheon-based Celltrion Inc.’s anti-COVID-19 monoclonal antibody.
HONG KONG – Belgium-based Bone Therapeutics SA has inked development and commercialization deals for its bone cell therapy platform in Chinese and Southeast Asian markets.
HONG KONG – Galmed Pharmaceuticals Ltd. has struck an agreement with Ascletis Pharma Inc.’s Gannex arm to develop a combination therapy comprising Ascletis’ ASC-41 and Galmed’s Aramchol (arachidyl amido cholanoic acid) for nonalcoholic steatohepatitis (NASH).
PERTH, Australia – Astrazeneca plc is leasing 175 Sozo devices from Impedimed Ltd. and plans to put them in 20 countries to run phase II trials for a combination drug that looks at fluid imbalance in the human body in patients with heart failure (HF) and chronic kidney disease.
The appetite for biopharma IPOs this year has been voracious with no signs of a slowdown anytime soon. Year-to-date, a total of $14.63 billion was raised from 66 new global issues, a total that is already well ahead of the $10.7 billion in 2018, from 80 transactions, that represented the previous record for IPOs. In terms of volume, BioWorld has recorded that the highest number of IPOs in a single year was 84 in 2014, followed by 83 in 2000.
BEIJING – Biologics developer Genor Biopharma Co. Ltd. raised HK$2.69 billion (US$347 million) via a pre-revenue IPO on the Hong Kong Stock Exchange on Oct. 7, with shares (HKEX:6998) trading 16.25% higher to close at HK$27.95.
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