South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.
Innovent Biologics Inc.’s picankibart (IBI-112) met all primary endpoints and key secondary endpoints in the phase III registrational Clear-1 trial in Chinese subjects with moderate to severe plaque psoriasis.
South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.
Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
Denver-based Arcscan Inc. gained Chinese approval of its computer-controlled, ultra-high frequency ultrasound diagnostic imaging solution for myopia called Insight 100, expanding its reach beyond the U.S. and Europe.
CSPC Pharmaceutical Group Ltd.’s anti-βKlotho monoclonal antibody drug JMT-202 has received clearance from China’s National Medical Products Administration (NMPA) to enter clinical trials to lower triglyceride levels in patients with hypertriglyceridemia.
CSPC Pharmaceutical Group Ltd.’s anti-βKlotho monoclonal antibody drug JMT-202 has received clearance from China’s National Medical Products Administration (NMPA) to enter clinical trials to lower triglyceride levels in patients with hypertriglyceridemia.
Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
Innovent Biologics Inc.’s glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor dual agonist, mazdutide, met the primary endpoint of superiority in a head-to-head phase III trial in Chinese patients with type 2 diabetes compared to Eli Lilly and Co.’s GLP-1, dulaglutide, for glycemic control.
Innovent Biologics Inc.’s glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor dual agonist, mazdutide, met the primary endpoint of superiority in a head-to-head phase III trial in Chinese patients with type 2 diabetes compared to Eli Lilly and Co.’s GLP-1, dulaglutide, for glycemic control.
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