Building D&D Pharmatech Inc. has been a rollercoaster ride, according to CEO Seulki Lee. The U.S. and Korea-based biotech is on another ascent, having scored U.S. FDA fast track designation for its metabolic dysfunction-associated steatohepatitis (MASH) drug, ahead of its third attempt at a public listing.
China’s Visen Pharmaceuticals (Shanghai) Co. Ltd. is targeting an IPO on the Hong Kong stock exchange with three rare endocrine disease therapies licensed-in from Denmark’s Ascendis Pharma A/S, including U.S. FDA-approved Skytrofa (lonapegsomatropin).
In a potential watershed moment for South Korea’s Hanmi Group, a hair-splitting vote at the 51st shareholder meeting favored the two sons of the late founder and Chairman Lim Sung-ki, effectively halting a merger between Hanmi and OCI Holdings Co. Ltd.
Announcing two licensing deals with Swiss pharma giant Novartis AG, Shanghai-based Argo Biopharmaceutical Co. Ltd. said on Jan. 7 that it stands to gain up to $4.165 billion for two of its cardiovascular assets combined. Marking the “first significant overseas out-licensing transaction in the RNAi field from a Chinese biotech company,” the deal includes an up-front payment of $185 million from Novartis to Argo.
Genexine Co. Ltd.’s recombinant human growth hormone eftansomatropin alfa (GX-H9/TJ-101) met the primary endpoint in a phase III pediatric study conducted in China in children with growth hormone deficiency, and the company plans to file a BLA in 2024 in China on the data.
China’s National Medical Products Administration has approved Innovent Biologics Inc.’s proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitor, Sintbilo (tafolecimab), making it the first first locally developed PCSK9 monoclonal antibody to be approved in China.
Junshi Biosciences Co. Ltd.’s ongericimab, a recombinant humanized anti-PCSK9 monoclonal antibody, met the primary endpoints of reducing the levels of low-density lipoprotein cholesterol in two phase III trials in primary hypercholesterolemia and mixed hyperlipidemia.
Denali Therapeutics Inc.’s extensive update on clinical programs in central nervous system diseases at the start of this year included plans for lead asset DNL-310 in mucopolysaccharidosis II (MPS II), also known as Hunter syndrome – a space where other notable players include such names as Regenxbio Inc. and Takeda Pharmaceutical Co. Ltd.
The U.S. FDA has lifted the clinical hold on Astellas Pharma Inc.’s Fortis phase I/II trial evaluating AAV gene replacement therapy AT-845 in adults with late-onset Pompe disease.
Sosei Heptares and Eli Lilly and Co. have signed a potential $731 million deal to discover, develop and commercialize small molecules that modulate G protein-coupled receptor (GPCR) targets associated with diabetes and metabolic diseases.
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