Several South Korean biotech and biopharmaceutical companies completed IND submissions or won nods to start clinical trials in either the U.S. or South Korea, including SK Bioscience Co. Ltd., Genosco Inc., Pimedbio Inc., Sillajen Inc. and Ami Pharm Co. Ltd.
Countries in the Asia Pacific (APAC) region have an opportunity, or a time-limited “gap,” to become leaders on the global biotechnology stage, panelists at the Bio Asia 2025 conference said in Singapore Sept. 9.
Telix Pharmaceuticals Ltd. received an FDA complete response letter (CRL) a day after the Aug. 27 PDUFA date for its BLA for radiopharmaceutical renal cancer imaging agent, Zircaix (TLX250-CDx, 89Zr-DFO-girentuximab).
The recombinant fusion protein drug telitacicept from Remegen Co. Ltd. and Vor Bio Inc. has notched a phase III win in treating adults with IgA nephropathy. The clinical trial of the fusion protein hit the primary endpoint, reducing proteinuria, too much protein in patients’ urine, in stage A of the study in China.
South Korea’s Ministry of Food and Drug Safety approved Moderna Inc.’s Spikevax LP.8.1 vaccine as an updated shot for COVID-19 targeting the LP.8.1 variant, according to Moderna Korea’s announcement Sept. 1. The regulatory clearance comes days after the U.S. FDA accepted, on Aug. 27, Moderna’s supplemental BLAs for two of its COVID-19 vaccines, Spikevax and Mnexspike.
South Korea’s Ministry of Food and Drug Safety (MFDS) launched a new industry-academia-research consortium to support the nation’s organoid industry, expected to grow in light of the U.S. FDA’s shift away from animal testing in the development of novel drugs.
Beone Medicines Ltd. (formerly Beigene Ltd.) is selling its worldwide royalty rights on Imdelltra (tarlatamab) sales, excluding China, to Royalty Pharma for up to $950 million.
The amount of money raised through global biopharma IPOs in the first seven months of 2025 is at the lowest level since 2016, and more than half of the 13 completed through July were done on ex-U.S. exchanges. Only five of the companies have U.S. roots, while the rest are based in Asia: four in China, two in South Korea, one in Taiwan and one in Hong Kong.
Avixgen Co. Ltd., a subsidiary of Dx&Vx Co. Ltd., inked a $360 million license agreement with an unidentified U.S.-based biotechnology company, granting the latter rights to its advanced cell penetrating (ACP) peptide drug delivery platform.
CSL Ltd.’s stock tumbled 16.88% on the news that it plans to cut 3,000 jobs and to hive off its Seqirus vaccine unit in a cost-cutting measure to save more than $500 million per year over the next three years.
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