Korean Biopharma Legal

Earlier this year, The 'Korea Pharmaceutical and Bio-Pharma Manufacturers Association(KPBMA)' officially launched the 'Convergence AI Institute for Drug Discovery(CAIID)' and held the grand opening ceremony on January 31st. The South Korean CAIID aims to serve as a hub for jointly planning and executing digital convergence research and aims to establish safe utilization platform for diverse data, which may enhance the performance of AI.  The CAIID's head Hwajong Kim stated, "Currently, pharmaceutical companies are collaborating individually with AI companies. However, there is no perfect match between the data held by pharmaceutical companies and the advantages of each solution provider." He continued, "Since each pharmaceutical company possesses different data, the approach to AI should also vary. However, at this point, we cannot predict this in advance, which limits us." He emphasized, "It is not a stage to debate whether this business wi

South Korean  GNT Pharma Co. Ltd announced on the 13th of this month, that administering their stroke treatment drug 'Nelonemdaz' to patients within one hour of arrival at the emergency room showed nearly a five-fold improvement in disability compared to a placebo treatment. T he chief investigator of the Phase 3 trial at Seoul Asan Hospital's Neurology Department, presented the key findings at ISC 2024 held at the Phoenix Convention Center in Arizona, USA. It has been reported that  the Phase 3 trial of Nelonemdaz targeted severe stroke patients receiving intravenous thrombolysis within 12 hours of onset. The 496 patients in this trial received medication within 7 hours of onset upon arrival at the emergency room and underwent thrombolysis simultaneously, analyzing disability improvement and safety 12 weeks later.  The efficacy of Nelonemdaz was found to be related to the time of medication administration and thrombolysis. Particularly, among 47 patients who promptly recei

On the first day of this month, the Ministry of Food and Drug Safety and the biotech industry welcomed the acceptance of the bill adding 'Regenerative Medical Institutions' as human cell management by the National Assembly, amending the 'Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products'.  Human Cell Management businesses are operators who collect, import, inspect, process, and supply human cells, which have been mostly in-house product manufacturers or the blood banks. Now that this amendment has been approved, advanced regenerative medical institutions equipped with facilities, equipment, and personnel similar to the standards for human cell management, shall also be recognized as subjects for permits for the management of human cells. This means that advanced regenerative medical institutions can supply raw materials by performing minimal procedures such as simple isolation, washing, freezing, and thawing of cells ob

The global competition for Antibody-Drug Conjugate (ADC) technology, a cutting-edge method in anti-cancer drug development, is intensifying. Major global pharmaceutical companies, including Pfizer, AbbVie, and Johnson & Johnson, invested significantly to secure ADC technology. This trend is also evident in South Korea, with companies like Samsung Biologics and Celltrion leading the race to obtain ADC capabilities. ADC involves attaching drugs that can attack cancer cells to antibodies, offering targeted drug delivery for anti-cancer agents. The technology is gaining attention globally, and the ADC market is expected to reach $19.8 billion by 2028. The interest in ADC further increased with the approval of 'Enhertu,' an ADC drug for breast cancer jointly developed by AstraZeneca and   Daiichi Sankyo. Major global pharmaceutical companies are actively involved in ADC technology, with Pfizer's Seagen acquisition being the largest M&A deal in the sector. Korean companie

The South Korean Government is currently proposing several measures to address regional medical disparities and improve healthcare accessibility, particularly during nighttime and holidays. Here's a summary of the key points; 1. Amendments to Medical Laws  There are proposed amendments to allow the delivery of pharmaceuticals from public late-night pharmacies for non-face-to-face consultations during evenings and holidays. 2. Establishment of Regional Medical Schools  Plans include promoting the establishment of regional medical schools to address the demand and conditions of medically underserved areas. Additionally, there is an intention to enact a 'Special Law for Resolving Regional Medical Disparities' ( 지역 의료 격차 해소 특별법)  to support this effort. 3. Improving Regional Medical Infrastructure  Efforts are underway to enhance regional hub public hospitals with advanced systems and establish a cooperative network between regional national hospitals and public hospitals to st

As the research and development (R&D) capabilities of Korean pharmaceutical companies significantly improve and new drug development continues, the number of cases of marketing and sales collaboration, such as 'co-promotion' agreements executed for joint sales of drugs has been reported to be increasing. It was reported on the 14th of this month, that a total of 14 cases of marketing and sales collaboration between Korean pharmaceutical companies occurred this year, through co-promotion agreements for joint sales of medicines. List of Korean 'co-promotion' Agreements executed in the year of 2023 Co-promotion has the advantage of allowing developers with weak sales capabilities to leverage the capabilities of other pharmaceutical companies with strong sales capabilities in the field. One example is the joint sales of ‘Zemiglo’ by LG Chem and Daewoong Pharmaceutical, where at the time of approval, LG Chem signed a joint sales agreement with the global pharmaceutical c