HLB announced on the 14th that the last hurdle for U.S. Food and Drug Administration (FDA) approval of its liver cancer new drug, the manufacturing and quality control (CMC) audit, has been completed. This CMC audit was conducted at the production facility of its partner, China's Hengrui Medicine, specifically for the immuno-oncology drug "Camrelizumab" earlier this month. The audit for HLB's anticancer drug, Rivosertib, has already been completed. The CMC audit is a procedure in which FDA inspectors visit the production facility of the drug to directly verify the entire production facility and process. The company stated that it has re-examined all facilities and processes from the beginning, including the corrections pointed out during the first approval review. HLB noted that "Hengrui Medicine has informed us that they are preparing supplementary documents" and "we plan to submit them to the FDA within 15 business days in accordance with FDA regulations." The FDA is expected to make a decision on the new drug approval by March 20, the new drug approval decision date (PDUFA date), reflecting the improvements.
Medical artificial intelligence (AI) corporation AirsMedical announced that it has signed a supply contract for the AI-based MRI acceleration image restoration solution "SwiftMR®" with Seoul National University Hospital. SwiftMR is software that shortens magnetic resonance imaging (MRI) shooting time by up to 50%, while simultaneously restoring low-quality images into high-quality images with less noise using deep learning algorithms. It supports equipment of all MRI manufacturers, all body parts, and pulse sequences, making it highly versatile.
Seoul National University Hospital announced on the 14th that a team led by Professor Ahn Yong-min in the Department of Psychiatry has recently developed standard clinical guidelines for suicide prevention, which have been certified by the Ministry of Health and Welfare's suicide prevention program. Based on overseas guidelines, 26 experts participated in creating these guidelines, which were developed to allow for the identification and application of the most objective and effective suicide prevention treatment methods for patients.
CURACLE announced on the 14th that it is officially starting to develop an Alzheimer’s treatment based on the next-generation vascular endothelial dysfunction blocker CU71. CU71 is an oral treatment candidate that improves blood-brain barrier (BBB) dysfunction and neuroinflammation. After applying for a material patent for CU71 in July last year, CURACLE additionally applied for a utility patent on the 10th. The company indicated that preclinical results show CU71 statistically significantly improved cognitive function compared to the existing treatment (donepezil) and restored long-term memory ability to normal levels. CURACLE aims to swiftly complete efficacy and toxicity tests, develop clinical plans, and enter Phase 1 clinical trials as quickly as possible.
Il-Yang Pharmaceutical reported on the 14th that it received a certificate of appreciation and a plaque from the Ministry of National Defense in recognition of its efforts to promote the social advancement of service members scheduled to be discharged. The company has continuously participated in job fairs organized by the Ministry of National Defense, providing recruitment consultations and mentoring services for service members wishing to be hired. It also conducted standalone recruitment briefing sessions for service members. The company has supported the employment of discharged service members and has been operating customized training programs.
SillaJen announced on the 14th that three research results on its developing anticancer drug candidate "BAL0891" have been accepted for poster presentation at the Annual Meeting of the American Association for Cancer Research (AACR), which will be held from April 25-30 (local time) in Chicago, Illinois, USA. BAL0891 is currently undergoing Phase 1 clinical trials for solid tumor patients in the U.S. and Korea. Recently, it was revealed that it has received tislelizumab (Tevimbra) from the global pharmaceutical company BeiGene to conduct combination clinical trials. The company explained that the three accepted research findings demonstrate the anticancer mechanism of BAL0891 and the synergy effects with immune checkpoint inhibitors.