■SK bioscience said on the 15th that it will enter clinical trials for a universal vaccine responding to various viruses, including the novel coronavirus infection (COVID-19) and severe acute respiratory syndrome (SARS). It submitted a plan for a global phase 1/2 trial of the universal vaccine candidate GBP511 to Australian authorities. In Australia, it will conduct the trial through 2028 with 500 healthy adults aged 18 or older. The company received 90 billion won in initial research and development funding from the Coalition for Epidemic Preparedness Innovations (CEPI) in 2021.
■CHA Vaccine, an affiliate of CHA Biotech, said on the 15th that it applied to the Ministry of Food and Drug Safety for a phase 2 clinical trial plan for the shingles vaccine candidate "CVI-VZV-001." It will conduct the trial at seven domestic medical institutions with 135 healthy adults aged 50 or older. The phase 2 trial will determine the optimal dose and evaluate the immune response in the elderly aged 65 or older. CVI-VZV-001 is a recombinant shingles vaccine based on the immune adjuvant Lipopharm, which CHA Vaccine is independently developing. Lipopharm induces a cellular immune response to suppress viral activity.
■Celltrion said on the 15th that it formed a venture investment association worth 1.5 billion won with TVG Partners, SINSIN PHARM, and the Incheon Techno Park. It will nurture bio-healthcare startups less than three years old in Korea. It will jointly operate the association with JNP Medi Partners.
■Daewon Pharmaceutical said on the 15th that it received approval from the Ministry of Food and Drug Safety for a phase 3 clinical trial plan for the new drug candidate DW4421. DW4421 suppresses gastric acid secretion and treats gastroesophageal reflux disease. It will evaluate safety and efficacy in 327 domestic patients with gastroesophageal reflux disease.
■Yuhan Corporation said on the 15th that it received approval from the Ministry of Food and Drug Safety for a phase 2 clinical trial plan for the allergy new drug candidate resigercept. It will administer resigercept and a placebo to 150 patients with chronic spontaneous urticaria for 12 weeks to evaluate safety and efficacy. The trial will be conducted in Korea, Europe, and Asia.
■HK inno.N said on the 15th that K-CAB, a treatment for gastroesophageal reflux disease, has a Helicobacter pylori eradication effect. Helicobacter is a bacterium that infects half of humanity and is known to cause gastritis, gastric ulcers, and gastric cancer. It conducted a clinical trial administering K-CAB for 14 days to 382 patients with Helicobacter to eradicate the bacterium. As a result, the eradication rate was 80% or higher at all doses, including 50 mg and 100 mg of K-CAB.
■Vivozon said on the 15th that it will produce the high-concentration injectable formulation of Ahnapra as an investigational medicinal product. Ahnapra is a non-narcotic analgesic candidate. It plans to conduct a phase 3 clinical trial in the United States starting in the third quarter of next year with patients undergoing hallux valgus surgery. The high-concentration injectable formulation can reduce the container size to one-tenth or less of the existing one.
■Daewoong Pharmaceutical said on the 15th that it introduced "Impactime A+ stick jelly" for test-takers. It contains plant-derived natural caffeine, L-theanine, taurine, vitamins, and lemon concentrate. It blends choline and inositol, known to regulate the balance of neurotransmitters. The company said it alleviates tension associated with caffeine intake.
■Lunit said on the 15th that it signed a business agreement with Rebellions for innovation in medical artificial intelligence (AI). Rebellions develops AI semiconductors optimized for inference and computation. The two companies plan to improve the accessibility and quality of medical AI and participate in various government projects.
■SillaJen said on the 15th that it will present two studies related to the anticancer drug BAL0891 under development at the American Society for Immunotherapy of Cancer annual meeting in Nov. The company plans to explain the effects of combining BAL0891 with an immune checkpoint inhibitor. An immune checkpoint inhibitor prevents cancer cells from binding to immune checkpoints so they are again attacked by immune cells.
■Keeps Biopharma said on the 15th that its U.S. subsidiary AlgokBio has started dosing patients in a phase 1b/2a combination clinical trial of the ovarian cancer treatment candidate idetrexed. It plans to evaluate the safety and efficacy of idetrexed in combination with the anticancer agent Lynparza. The trial is led by The Institute of Cancer Research in the United Kingdom.
■Shaperon said on the 15th that it registered a patent for the core technology of an immuno-oncology drug, the "CD47 single-domain antibody." It blocks the protein signal expressed by cancer cells to evade attacks from immune cells. The company said it can prevent the phenomenon in which cancer cells suppress immune cell function.
■ELECSEL said on the 15th that its wound treatment patch won product of the year at a Boston medical device exhibition in the United States. As exudate comes from a wound and moisture evaporates, it promotes cell regeneration with microcurrents. It reduces reactive oxygen species to alleviate inflammation. It has no separate charging device.
■Chong Kun Dang disclosed on the 15th that it issued 6.1 billion won in private exchangeable bonds (EB). The exchangeable bonds were decided through a board resolution on Sept. 30, and the payment date was Oct. 14, the previous day. There is no planned number of shares to be issued, and the actual issuance amount was tallied at 6,110.42 million won.