South Korea’s Eubiologics Co. Ltd. said it gained the World Health Organization’s (WHO) prequalification designation on April 16 for its simplified oral cholera vaccine, approved as Euvichol-S.
Samsung Bioepis Co. Ltd., of Incheon, South Korea, is the latest to announce a win in the biosimilar space, gaining MFDS approval of Epyztek (SB-17) as the country’s first biosimilar to Stelara (ustekinumab, Janssen Pharmaceutical Inc.) on April 11.
Samsung Bioepis Co. Ltd., of Incheon, South Korea, is the latest to announce a win in the biosimilar space, gaining MFDS approval of Epyztek (SB-17) as the country’s first biosimilar to Stelara (ustekinumab, Janssen Pharmaceutical Inc.) on April 11.
Follow-on biologic makers in China have been working to capitalize on looming patent cliffs of blockbuster biologics. Advancing biosimilars of denosumab (Prolia/Xgeva; Amgen Inc.) and semaglutide are the latest examples.
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.
Biosimilar competition to Amgen Inc.’s denosumab (Prolia/Xgeva) is rising globally, with Mabwell (Shanghai) Bioscience Co. Ltd. gaining the latest China NMPA approval of Maiweijian (TK-006) on April 8. Mabwell’s wholly owned subsidiary, Jiangsu T-mab Biopharma Co. Ltd., gained NMPA clearance of Maiweijian (120 mg) as the first denosumab biosimilar for the indications of U.S.-licensed Xgeva for bone-related diseases.
“A biotech company cannot survive on ‘drug efficacy’ alone,” former Korea Drug Development Fund (KDDF) CEO Hyunsong Muk said recently, “because novel drug development is not just a scientific problem.” Financial toxicity is, in fact, a major obstacle for biotech companies trying to advance preclinical candidates to early stage clinical trials, Muk said at Novo Nordisk A/S’ Partnering Day and Symposium on April 4 in Seoul, South Korea.
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).
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).
“A biotech company cannot survive on ‘drug efficacy’ alone,” former Korea Drug Development Fund (KDDF) CEO Hyunsong Muk said recently, “because novel drug development is not just a scientific problem.” Financial toxicity is, in fact, a major obstacle for biotech companies trying to advance preclinical candidates to early stage clinical trials, Muk said at Novo Nordisk A/S’ Partnering Day and Symposium on April 4 in Seoul, South Korea.
