(Health Korea News / Chang-yong Lee) It was found that the drug that underwent the most clinical trials in Korea last year was an anticancer drug. This is a point where we can see that the field that pharmaceutical companies are putting the most effort into is conquering cancer.
The Korea Biotechnology Association recently published ‘Pharmaceutical Market and Clinical Trial Trends in the First Half of 2024’ containing this content. Looking at this trend, the total number of clinical trials conducted in Korea in 2023 was 783, of which 294, or 37.5% of the total, were anticancer drug-related clinical trials.
This exceeds the number of clinical trials combined from 2nd to 5th places. 2nd place was the endocrine system (82 cases), 3rd place was the cardiovascular system (81 cases), 4th place was the central nervous system (61 cases), and 5th place was the digestive system (56 cases).
Anticancer drug clinical trials are consistently conducted at a rate of 200 to 300 each year. Looking at the number of anticancer drug clinical trials over the past five years, there were 207 in 2019, 309 in 2020, 321 in 2021, and 259 in 2022. 2023 increased by 13.5% from 2022. It is lower than the number that increased during the COVID-19 pandemic in 2020, but excluding that period, it shows a continuous increase since 2019.
Among these, domestic clinical trials for immunotherapy drugs increased by 33.9% from 62 in 2022 to 83 in 2023. This is different from the increase in clinical trials of targeted anticancer drugs such as ACD around the world.
The central nervous system is the field in which the fourth largest number of clinical trials have been conducted, following the endocrine system and cardiovascular system. The increase rate in the number of clinical cases was also the highest. In 2023, 61 clinical trials in the central nervous system field were conducted in Korea. Compared to 38 cases in 2022, it increased by just 60.5%. By field, there were 14 cases related to Alzheimer’s disease, 10 cases related to painkillers, and 5 cases each related to Parkinson’s disease and depression.
The rapid increase in central nervous system clinical trials is noteworthy. According to a report published by Fierce Biotech, central nervous system clinical trials are difficult diseases that are always included in major clinical trial failures. Central nervous system drugs must undergo drug (clinical) re-evaluation in accordance with the Pharmaceutical Affairs Act even after marketing approval, as they often fail to prove effectiveness.
Clinical trials on the digestive system have also increased. It recorded 46 cases, an increase of 24.3% compared to 2022. There were 12 cases of colitis, 11 cases of gastroesophageal reflux disease, 7 cases related to Helicobacter infection, and 6 cases of Crohn’s disease. Among these, clinical trials related to gastroesophageal reflux disease and Helicobacter infection, which occur frequently in Koreans, were conducted 100% domestically.
Musculoskeletal clinical trials were conducted in 32 cases, 11 more than in 2022. Compared to 2022, respiratory system cases increased by 10 to 36, immunosuppressants increased by 8 to 23, skin diseases increased by 7 to 34, and urinary systems increased by 2 to 18.
There are also areas that have decreased. The number of clinical trials in the fields of antibiotics, endocrine system, blood, and cardiovascular system decreased by 15, 10, 3, and 1 respectively compared to 2022, reaching 26, 82, 11, and 81.
Additionally, it is worth noting that the number of phase 3 clinical trials has increased. In 2023, there were 237 phase 3 clinical trials led by domestic pharmaceutical companies. This is a 26.7% increase from 187 cases in 2022.
Phase 3 clinical trials are conducted after the effectiveness of a new drug has been established to some extent, and are the final clinical trials to obtain marketing approval. The success rate is high compared to other clinical trial stages.
Another characteristic is the increase in multinational clinical trials. Last year, the number of clinical trials conducted in Korea alone increased by 6.1% to 381 cases compared to the previous year, while the number of multinational clinical trials conducted in two or more countries, including Korea, increased by 14.2% to 402 cases.
In multinational clinical trials, there were 196 phase 3 trials, an increase of 33.3% compared to 2022.
There were also 17 multinational phase 1 clinical trials conducted in Korea, a three-fold increase compared to 2022 (6 cases).
When dividing domestic clinical trials by sponsor, AstraZeneca Korea accounted for the largest proportion among pharmaceutical companies with 23 cases. Among domestic pharmaceutical companies, Boryung requested 20 cases, tied for second place with Roche Korea (20 cases). This was followed by Janssen Korea (19 cases), Chong Kun Dang (19 cases), GSK (13 cases), AbbVie Korea (12 cases), Daewoong Pharmaceutical (12 cases), Novartis Korea (12 cases), and BMS Pharmaceuticals Korea (11 cases).
Researchers from Seoul National University Hospital, Asan Medical Center, and Samsung Seoul Hospital requested a total of 15 cases. Severance Hospital and National Cancer Center also requested 12 and 8 cases, respectively.
The report said, “Continuing from 2023, clinical trials for anti-cancer drugs, central nervous system disease treatments, and endocrine disease treatments are continuing to be strong this year, and the clinical trial pipeline for Alzheimer’s and obesity-related treatments is also rapidly increasing,” adding, “Domestic clinical trial competitiveness.” “In order to strengthen, we need to quickly respond to global trends and secure global clinical trials, and we also need to improve regulations to promote multi-country clinical trials,” he suggested.
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