■Eancell announced on the 26th that it has signed a contract for contract manufacturing organization (CMO) with a global pharmaceutical company. The company has previously provided CMO services to Novartis, Janssen, and others. The new customer secured through this contract will not be disclosed due to a confidentiality agreement. Eancell offers differentiated contract development and manufacturing organization (CDMO) solutions to clients with its one-stop service and a pharmaceutical manufacturing and quality control (GMP) facility that is unique in being able to produce cells and viruses simultaneously.
■Celltrion announced on the 26th that its biosimilar of the breast and stomach cancer treatment Herceptin, "Herzuma," recorded a market share of 74% in Japan, a key pharmaceutical market in Asia, as of November this year. Herzuma first surpassed the original product in market share in the second quarter of 2021 and has maintained its lead for three consecutive years, currently recording a market share of over 70%. The company has demonstrated product competitiveness by obtaining approval for a three-week regimen that accounts for over 90% of the Japanese breast cancer market in August 2019, citing a favorable regulatory environment for biosimilars and tailored sales strategies that closely analyze the local pharmaceutical market as factors behind its success.
■Lunit announced on the 26th that a study published in the European Journal of Radiology found that the use of "Lunit Insight CXR" in actual emergency situations at medical institutions reduced the time to classify emergency patients by 77%. Dr. Srinath Sridharan and his team at Singapore's Changi General Hospital classified a total of 20,944 chest X-ray images taken in the hospital's emergency room from August to December 2023 into three categories: normal, non-emergency, and emergency, using Lunit's AI solution. The evaluation by 43 radiologists showed that the AI sensitivity for normal cases was 89% and specificity was 93%, indicating reliable results. For non-emergency cases, the AI recorded a sensitivity of 93% and specificity of 91%, demonstrating its performance in identifying non-urgent cases. In emergency cases, the AI showed a sensitivity of 82% and specificity of 99%, proving the necessity of AI solutions in emergency situations.
■Medytox announced on the 26th that its affiliate NewMeCo has obtained product approval for the botulinum toxin product "NEWLUX" in Thailand. With this approval in Thailand, NewMeCo has successfully achieved its second overseas approval following Peru, and it explained that the product can be produced at Medytox's Osong Plant 3, which has a mass production system, to smoothly meet high demand in overseas markets. Medytox and NewMeCo plan to diversify their toxin portfolio based on the approval of NEWLUX.
■The National Institute of Food and Drug Safety Evaluation, part of the Ministry of Food and Drug Safety, announced on the 26th that it will initiate collaborative research with the United Nations Office on Drugs and Crime (UNODC) to establish scientific evidence necessary for the designation and management of new psychoactive substances as narcotics. The Ministry of Food and Drug Safety, along with UNODC and the Korea Institute of Science and Technology (KIST), plans to prepare a total of four international guidelines by 2028 based on the existing guidelines on dependency evaluation published by the Ministry. The UNODC is a United Nations agency that oversees global drug prevention, crime response, and rehabilitation. The Ministry and UNODC signed a memorandum of understanding (MOU) in September last year that included sharing mutual experiences and capabilities for effective responses to domestic and international drug issues. This collaborative research is a follow-up measure to that agreement.