Will Steady R&D Shine... Korea's Most Clinical Approvals by Chong Kun Dang and Daewoong

Chongkundang Tops Clinical Approvals for 5 Consecutive Years
Three Phase 3 Trials for Chronic Disease Combination Drugs

Daewoong Ranks 2nd for 4 Consecutive Years
Active Development of Diabetes Drug 'Enblo'

Jongkundang Building Exterior (Photo by Jongkundang)

[Asia Economy Reporter Lee Chun-hee] As COVID-19 transitions into an endemic phase, domestic pharmaceutical companies in South Korea are continuously taking on new clinical trials. In particular, Chong Kun Dang Pharmaceutical and Daewoong Pharmaceutical are standing out by persistently conducting various clinical trials.

According to the Ministry of Food and Drug Safety on the 5th, a total of 1,011 domestic clinical trials were approved last year. Excluding general hospitals, clinical research organizations, and foreign companies, Chong Kun Dang led domestic companies with 21 approved trials. Notably, Chong Kun Dang has recorded the highest number of domestic clinical trial approvals for five consecutive years since 2018. After ranking first with 29 trials in 2018, the numbers have steadily continued with 26 → 34 → 31 → 21 trials.

Among the clinical trials approved this year, three are Phase 3 trials, all related to combination drugs for chronic diseases. 'CKD-371' for type 2 diabetes is a clinical trial involving the addition of empagliflozin to a metformin and sitagliptin combination therapy for patients whose blood sugar is not controlled. 'CKD-828' for essential hypertension is a trial combining telmisartan and amlodipine, seemingly aimed at developing a combination drug based on this. 'CKD-391' targets dyslipidemia and is developed as a combination drug of atorvastatin and ezetimibe.

Chong Kun Dang has recently achieved results such as obtaining product approval for 'Lucenvis,' a biosimilar of the age-related macular degeneration treatment 'Lucentis,' while continuing these clinical trials.

Daewoong Pharmaceutical's diabetes treatment 'Envlo (active ingredient: Inavogliflozin)' logo (Photo by Daewoong Pharmaceutical)

Daewoong Pharmaceutical is also a representative company continuously engaging in clinical trials. It received approval for 19 clinical trials last year, following Chong Kun Dang. Since 2019, Daewoong Pharmaceutical has consistently pursued various clinical trials with 19 → 19 → 22 → 19 approvals, maintaining the second-highest number of domestic clinical trials among local companies each year during this period.

Among Daewoong Pharmaceutical's clinical trials approved last year, notable are those for the additional development of 'Enblo Tablets (DWP16001),' a type 2 diabetes treatment approved as the 36th domestic new drug in November. Daewoong Pharmaceutical received approval for three clinical trials using Enblo Tablets within just two months, November and December.

Regarding indications, in November, a Phase 3 clinical trial was approved for Enblo Tablets as an add-on therapy to insulin, with or without other antihyperglycemic agents, in patients with type 2 diabetes. In December, a Phase 1 clinical trial was approved to evaluate the safety, tolerability, and pharmacokinetic properties of Enblo Tablets in patients with liver impairment and those with normal liver function.

Attempts to develop combination drugs based on Enblo Tablets are also ongoing. After completing a Phase 1 clinical trial for 'DWJ1525,' a combination with metformin approved in January last year, a Phase 1 clinical trial for 'DWJ1563,' a two-drug combination with LG Chem's 'Gemiglo' (active ingredient gemigliptin), was approved last month. Since Daewoong Pharmaceutical is responsible for the sales of Gemiglo, this is seen as a plan to generate significant synergy. Additionally, a Phase 3 clinical trial combining Enblo Tablets, metformin, and Gemiglo has also been successful, with further clinical trials underway.

Following these, Huons and Daewon Pharmaceutical received approval for 16 clinical trials. Among major trials, Huons was approved for a Phase 3 clinical trial of 'HU007,' a combination eye drop for dry eye syndrome, and Daewon Pharmaceutical is recruiting patients for clinical trials of 'DW1026,' a type 2 diabetes treatment, and 'DW1125,' a dyslipidemia treatment.

However, the number of domestic clinical trial approvals, which had been increasing annually, decreased last year. The number of approvals was 655 in 2017, surpassed 1,000 for the first time in 2020 with 1,120, and rose to 1,349 in 2021, but fell back to 1,011 last year.

An industry insider said, "As COVID-19, which was a turning point for new drug development in the pharmaceutical and bio industries, becomes endemic, the explosive growth in new drug development seems to have weakened. With the expected investment downturn this year due to high interest rates and other factors, some companies are likely to streamline their pipelines, so the number of clinical trial approvals may decrease further."