■ GC Cell said on the 31st that its CAR-NK therapy AB-201 (GCC2003) simultaneously received approval for an advanced regenerative medicine clinical research plan from the Ministry of Health and Welfare and the Ministry of Food and Drug Safety, and regulatory sandbox approval from the Ministry of Trade, Industry and Energy. This approval is the first advanced regenerative medicine clinical research in Korea targeting HER2-positive solid tumors using allogeneic CAR-NK cells. Yonsei Cancer Center is set to conduct a study in a patient group with advanced HER2-positive gastric cancer and gastroesophageal junction cancer, and Konyang University Hospital will conduct a study in a patient group with advanced HER2 overexpressing breast cancer. GC Cell will be responsible for manufacturing, storage, transport and management of AB-201 for the clinical research.
■ Celltrion said on the 31st that it signed a joint R&D agreement for a new immuno-oncology drug with MustBio, a domestic multi-antibody development company. Through this agreement, Celltrion secured joint development and global sales rights for a triple fusion protein drug candidate targeting "PD-1 x VEGF x IL-2v." Under the terms, Celltrion will pay MustBio up to 71.25 billion won, including a 3 billion won upfront payment, up to 39.5 billion won in development milestones, and up to 670 billion won in commercialization milestones (upon achieving 10 trillion won in net sales). If commercialization succeeds, a separate 5% sales royalty based on net sales will be paid.
■ Hanmi Science said on the 31st that it joined the MedicalAIAlliance (MAA), a coalition formed by domestic innovative medical artificial intelligence (AI) corporations. MAA is the largest domestic medical AI alliance, launched by medical, AI and bio corporations to drive innovation in medical data and build a next-generation healthcare ecosystem. Currently, a range of corporations and medical institutions, including SELVAS AI, SELVAS Healthcare, Mediana, HLB Global, JLK, Polaris Pharmaceutical, Hancomwith and Siloam Eye Hospital, are participating as initial members.
■ Shaperon said on the 31st it will attend Europe's largest bio partnering event, "BIO-Europe Fall 2025" (hereinafter, Bio Europe), to be held in Vienna, Austria, from Nov. 3 to 5. At the event, Shaperon plans to expand partnerships with global pharmaceutical companies and move into full-fledged technology transfer talks to attract strategic investment.
■ ABL Bio, a bispecific antibody specialist corporation, will also attend BioEurope2025. The company said it will meet with various corporations to discuss collaboration related to its blood-brain barrier (BBB) shuttle platform "Grabody-B," as well as 4-1BB bispecific antibody immuno-oncology therapies and next-generation ADC (antibody-drug conjugate) technologies.
■ Dongkook Pharmaceutical said on the 31st that it launched the oral hemorrhoid drug "Chisen Tab," a high-strength diosmin (600 mg) formulation for people with moderate to severe hemorrhoid symptoms. Compared with the existing Chisen capsules (diosmin 300 mg), it doubles the amount of the active ingredient, diosmin, to improve dosing convenience for users.
■ Samil Pharmaceutical said it released a limited-edition collaboration of the antipyretic "Brufen Children's Syrup" to commemorate the 50th anniversary of Sanrio's flagship character My Melody. The product will be available at pharmacies and convenience stores nationwide starting in November.
■ The Ministry of Food and Drug Safety said on the 31st that it attended the "2025 International Coalition of Medicines Regulatory Authorities (ICMRA) annual summit and general assembly," hosted by the European Medicines Agency (EMA), to promote Korea's regulatory capabilities, including its status on the WHO Listed Authorities (WLA), and to strengthen cooperation with major regulatory bodies.