The Ministry of Food and Drug Safety announced on the 11th that it has proposed revisions to the 'Standards for Medical Device Manufacturing and Quality Management' aimed at facilitating rapid reviews for medical device manufacturing and quality management compliance certification until the 31st. It plans to establish a 'combined review' system that allows simultaneous reviews for domestic GMP compliance certification and the Medical Device Single Audit Program (MDSAP) recognized by export countries. With this revision, when medical device exporters apply for domestic GMP compliance certification and MDSAP through combined review with quality management review organizations, they will be able to undergo both types of reviews at the same time. Furthermore, to support expedited reviews, GMP reviews for Class 3 medical devices manufactured and imported will be conducted exclusively by private quality management review organizations with expertise.
MedPacto announced on the 11th that it presented the clinical trial plan and potential of its TGF-beta (β) inhibitor anticancer drug 'Bactosertip' for osteosarcoma at the 'Kleinman Symposium' held at the University of Texas MD Anderson Cancer Center on the 7th. Professor Alex Huang from Case Western Reserve University led the presentation, emphasizing that patients with high levels of TGF-beta have low survival rates and explaining the therapeutic effect of 'Bactosertip' and the importance of the tumor microenvironment. The preclinical trials confirmed the tumor size reduction and inhibitory effects on lung metastasis, and based on this, Phase 2 clinical trials will be conducted at 12 hospitals in the North American POETIC consortium. MedPacto plans to promote joint research with MD Anderson through this conference.
DEEPNOID announced on the 11th that it has signed a memorandum of understanding (MOU) with the Gwangju Institute of Science and Technology (GIST) to operate an AI-based medical image analysis platform. Through this agreement, DEEPNOID and GIST plan to work closely on the efficient operation of the AI-based medical image analysis and Picture Archiving and Communication System (PACS) platform, planning and discovering new medical services linked to local hospitals, establishing strategies for platform advancement according to AI technological changes, expanding remote reading services and large language model (LLM)-based platform services, utilizing platform education and infrastructure for GIST medical scientists, and jointly utilizing facilities and equipment of the GIST AI data center.
Enzychem Lifesciences announced on the 11th that it has organized a team for the full-scale development of new drugs utilizing AI, embarking on innovative 'anti-aging drug development' aimed at effectively eliminating aging cells starting from the end of 2024. Enzychem Lifesciences has already discovered numerous anti-aging small molecules through AI-based structural analysis, and plans to optimize lead compounds by early 2026, secure intellectual property, and promote licensing out, while also developing an AI drug development platform for the mechanism of aging cell elimination.
The 54th anniversary of the passing of Dr. Yoo Il-han, the founder of Yuhan Corporation, has arrived. Dr. Yoo passed away at the age of 76 on March 11, 1971. Yuhan Corporation, the Yuhan Foundation, and Yuhan Academy held a memorial service for Dr. Yoo Il-han at the auditorium of Yuhan University located in Bucheon, Gyeonggi Province, on the morning of March 11. The memorial service was solemnly held, attended by around 300 people, including family members and Yuhan Corporation President Cho Uk-je, employees of Yuhan Corporation, officials from the Yuhan Foundation and Yuhan Academy, employees from the Yuhan family business, and students from Yuhan Technical High School and University. Prior to the memorial service, employees of Yuhan Corporation paid their respects with a moment of silence and floral tributes at Dr. Yoo's gravesite in Yuhan Mountain.
Dong-A Pharmaceutical announced on the 11th that its premium collagen brand Ailo has launched a new product 'Mucin Collagen Jelly.' This new product is a newly introduced collagen item following Ailo's representative product 'Type 1 Collagen Ampoule,' developed in a jelly stick form for convenient consumption in busy daily life. It is designed to contain four key ingredients in one packet, including plant-derived mucin extracted from domestic raw materials, low molecular weight type 1 collagen at 300 daltons, hyaluronic acid, and aloe vera gel. Type 1 collagen is a major component that accounts for 90% of the dermal layer of the skin among the 28 types of collagen in the body, designed with a low molecular structure of 300 daltons. Another feature is that it allows for a refreshing and sweet taste made from concentrated flat peach juice.
Hanmi Pharmaceutical announced on the 11th that Professor Park Soo-hyun from the Pediatric Emergency Center at Bundang CHA Hospital won the grand award with his work 'Heavy Currency' at the '24th Hanmi Essay Literary Award' ceremony. In addition, 14 other award recipients were honored with plaques and cash prizes. The total prize money distributed to the awardees this year is 55 million won, with 10 million won for the grand award, 5 million won each for excellent awards (3 people), and 3 million won each for encouragement awards (10 people). The grand award winner will be given the opportunity to officially debut as an essayist through the literary magazine 'Korean Prose.' Since its inception in 2001, the Hanmi Essay Literary Award has contributed to enhancing trust and mutual understanding between patients and physicians by soliciting and awarding essays recording the diverse experiences and feelings of doctors in the medical field.
YBrain announced on the 11th that CEO Lee Gi-won attended the 'BCI International Standardization Commission (ISO/IEC JTC1 SC43)' meeting as the representative speaker from Korea from the 3rd to the 6th. This BCI (brain-computer interface) meeting, held for the first time in Korea, was attended by over 70 technical standard experts from nine countries, including the United States, China, and India. The company explained that CEO Lee drew attention for proposing guidelines on context-based adaptive interfacing technology for a multipurpose BCI system. Context-based adaptive interfacing is a technology that analyzes the user's state and surrounding environment in real-time, automatically adjusting the optimal operation method and interface. This has improved upon existing medical BCI systems that operated in only one way, causing inconvenience to users.
Yonsei University Yongin Severance Hospital announced on the 11th that, in collaboration with SK Telecom, KT, LG Uplus, and NICE Information Communication, it has introduced the country's first mobile identification service using the PASS app. The service will officially start operating on March 11. The hospital expects that the introduction of this service will simplify the patient identification process and create a convenient and safe environment for both patients and hospital staff. Patients can easily verify their identities by generating a personal identification QR code through the app and scanning it at the hospital kiosk. In this process, essential information such as name, resident registration number, and mobile phone number will be safely transmitted to the hospital. Hospital staff will no longer need to check identification cards one by one, reducing manual entry errors and enhancing overall operational efficiency.
The Ministry of Food and Drug Safety announced on the 11th that it has approved a total of 111 medical products last month, a decrease of 8.2% compared to February of last year (121 products). The Ministry granted approval for a new drug, 'Petroza 1 gram (cepidolol tosylate sulfate monohydrate)' by Jeil Pharmaceutical, used for complicated urinary tract infections and hospital-acquired pneumonia. An artificial intelligence (AI)-based bladder cancer image detection and diagnosis assistance software called 'Robin-B' was also approved. This software, produced by INFINIQ, analyzes bladder endoscopic images of patients and marks suspected locations for bladder cancer to assist doctors in diagnosis.