SK Bioscience Co. Ltd. of Seongnam-si, South Korea, gained the World Health Organization’s (WHO) prequalification certification for typhoid conjugate vaccine, Skytyphoid (NBP-618), on Feb. 23. Skytyphoid conjugates a polysaccharide of typhoid bacteria, which serves as an antigen, to a diphtheria toxin protein called diphtheria toxoid that acts as a carrier.
Korean neurodegenerative disease-focused Aribio Co. Ltd. gained the U.K.’s regulatory clearance to start the phase III Polaris-AD trial on AR-1001 (mirodenafil), an investigative therapy for early Alzheimer’s disease (AD). The U.K.’s Medicines and Healthcare products Regulatory Agency gave notice of acceptance to Seoul, South Korea- and San Diego-based Aribio for the clinical study on Feb. 21 after “confirming a favorable ethical opinion,” Aribio said. AR-1001 is an oral phosphodiesterase-5 inhibitor under development to treat early AD.
In a surprise reveal that propelled stocks by 25%, Alteogen Inc., of Daejeon, South Korea, named MSD International Business GmbH as its counterpart in a near-$4 billion technology transfer agreement inked in 2020, while upping terms of the deal.
South Korea’s MFDS gave regulatory clearance to SK Inc. C&C’s artificial intelligence (AI) solution to diagnose cerebral infarction called Medical Insight+ Brain Infarct on Feb. 22, as a class III device.
Amid intensifying competition in the PD-1/PD-L1 checkpoint space, Samsung Bioepis Co. Ltd. kicked off a phase I study of SB-27, a biosimilar of Merck & Co Inc.’s blockbuster immunotherapy, Keytruda (pembrolizumab), for lung cancer. Posted on clinicaltrials.gov on Feb. 20, the randomized, double-blind, three-arm, parallel group and multicenter phase I study will examine the pharmacokinetics, efficacy and safety of SB-27 against an EU-sourced and U.S.-sourced Keytruda in 135 patients with non-small-cell lung cancer.
Hun-taek Kim founded Tiumbio Co. Ltd. in 2016 after spending more than two decades at a major chemical and life science firm, SK Chemicals Co. Ltd. “The prospects for our three major assets are very bright, and the probability of failure is low,” CEO Kim told BioWorld. “We’re looking for a breakthrough in rare diseases – to develop new treatments for [niche] markets with large unmet demand.”
San Francisco-based Xyphos Biosciences Inc. is pooling technology platforms with Boston’s Kelonia Therapeutics Inc. in a novel immuno-oncology (I-O) drug discovery deal that could fetch more than $800 million. Xyphos and Kelonia will collaborate to develop a maximum of two in vivo CAR T-cell therapy programs, utilizing both Kelonia’s in vivo gene placement system called iGPS and Xyphos’ Accel technology platform.
South Korean biopharmaceutical firm GNT Pharma Co. Ltd. on Feb. 13 reported positive findings from a domestic phase III trial of its neuroprotectant therapy, nelonemdaz (NEU-2000), for patients with acute ischemic stroke.
Palo Alto, Calif.-based Bridgebio Pharma Inc. will hand over development and sales of its rare bone growth disorder therapy, infigratinib, in Japan to Kyowa Kirin Co. Ltd. under its latest exclusive licensing deal.
Hong Kong’s Hutchmed (China) Ltd. reported mixed phase III results of fruquintinib as a second-line combination therapy for advanced gastric cancer on Feb. 6, with the oral vascular endothelial growth factor receptor inhibitor hitting just one co-primary endpoint.
