On the 20th, the Ministry of Food and Drug Safety granted approval for the depression probability indication software medical device (product name ACRYL-D01), it announced on the 23rd. Developed by the artificial intelligence (AI) specialized company Acryl, this product quantifies the probability of depression by analyzing patient interview records through AI, assisting psychiatric clinicians in diagnosing depression. It has been approved as the first software in the country to assess depression probability. The Ministry noted, "We will continue to work actively to ensure that new software medical devices based on artificial intelligence can be supplied, expanding treatment opportunities for diseases that have been difficult to diagnose and predict."
On the 23rd, Samchundang Pharm announced that it has signed a contract to exclusively supply and sell its self-developed SCD411 with Fresenius Kabi, a subsidiary of Fresenius, in six countries in the Americas and Latin America. The contract amount and milestones were not disclosed. Samchundang Pharm will be responsible for development, manufacturing, and supply, while Fresenius Kabi will commercialize the product after obtaining approvals from the health authorities in each country. Aflibercept recorded global sales of approximately 12 trillion won last year and is a blockbuster drug. Fresenius Kabi is a corporation that supplies pharmaceuticals and injections for the treatment of serious and chronic diseases in the global market, with sales of about 12 trillion won last year.
Suzentech, a corporation specializing in in vitro diagnostics, announced on the 23rd that it has invested about 2 billion won in redeemable convertible preferred stock (RCPS) in the biotech venture company Promedigen. Through this investment, the two companies plan to strengthen collaboration in various fields, including new drug research, securing future growth momentum. Promedigen is a biotech venture company founded in 2019 by Professor Park Hee-sung of KAIST's Department of Chemistry and holds the world’s only customized protein phosphorylation technology.
On the 23rd, Daewoong Pharmaceutical announced that it has terminated the 859 million won supply contract for Fexuclu (ingredient name fexuprazan) with Brazil's EMS S/A. According to the announcement, Daewoong Pharmaceutical had signed a contract with EMS S/A for the sale of Fexuclu in Brazil in 2020. Daewoong Pharmaceutical stated that "EMS S/A has the obligation to proceed with the approval process for product commercialization as the local licensing authority" and added, "The supply contract was terminated on the 20th due to the failure to fulfill the related contractual obligations." Fexuclu is a treatment for gastroesophageal reflux disease in the potassium competitive acid secretion inhibitor (P-CAB) category, launched as the 34th domestic new drug in July 2022.
On the 23rd, Onconic Therapeutics announced that its Chinese partner, Livzon Pharmaceutical, has received approval for the clinical phase 3 trial plan for the gastroesophageal reflux disease treatment new drug "Zacubotamab" (ingredient name zastaprazan) and is set to receive milestone payments. Zastaprazan is a new drug in the potassium competitive acid secretion inhibitor (P-CAB) category developed by Onconic Therapeutics, a subsidiary of Jeil Pharmaceutical. Last March, rights for development, licensing, production, and commercialization in the Greater China region were transferred to Livzon Pharmaceutical for a maximum of 160 billion won. This clinical phase 3 trial received approval from the National Medical Products Administration (NMPA) of China on the 22nd of last month, with the first patient administered on the 5th. The company stated that while the milestone amount is not publicly disclosed, it exceeds 10% of the company's previous year sales of 21 billion won.
On the 23rd, GC Biopharma announced that it donated 200 million won for neighbor assistance at the year-end. Of this donation, 100 million won will be used for the neighbors in need and patients with rare diseases through social welfare institutions nationwide, while the other 100 million won will be allocated through the Korean Red Cross for disaster relief and various welfare projects for seniors, the disabled, and children and youth.
On the 23rd, Humanc Group’s healthcare subsidiary Humanc announced the completion of its production plant in Vietnam. The newly completed plant covers about 15,000 square meters and has an annual production capacity of 60 million vials and 80 million cartridges. The company explained that this is about 70% of the production capacity at its domestic plant for the two items. Humanc invested approximately 7 billion won, starting construction at the beginning of this year and completing it in eight months. The plant will begin operating its production line in the first quarter of next year, and the company plans to expand its business based on this.
On the 23rd, Engine Bio announced that it will supply the acute myeloid leukemia (AML) next-generation sequencing (NGS) based super-sensitive gene diagnosis product "MRD AccuPanel" and high-performance analytical solutions, developed in collaboration with the Advanced Precision Medicine Support Center at Chonnam National University Hospital, to the hospital. The MRD AccuPanel utilizes technology that simultaneously amplifies and detects ITD and TKD mutations of the FLT3 gene.
On the 23rd, Paxel Bio announced that it has signed a joint development agreement for the "CAR-NK" treatment for autoimmune diseases with the viral vector design company BioDesign Lab. Paxel Bio will provide third-generation natural killer (NK) cells and oversee the drug development process, while BioDesign Lab will independently design and provide the lentivirus vector for delivering therapeutic genes.