Last year’s clinic 3 top increased 20%… New drug development to speed up
Kim Ji Seob | cloud50@ | 2018-01-04 09:55:50
The domestic pharmaceutical industry has been actively conducting clinical trials for new drug development last year. In particular, Phase 3 clinical trials, which are the final stage for license approval, have increased significantly.
According to the Korea Food and Drug Administration (KFDA) on January 3, the total number of clinical approvals last year was 658, up 4.8 percent from the previous year. In particular, the number of clinical trials for acquiring data on efficacy data for a large number of patients was 211, up 20.6%. Meanwhile, the number of clinical trials to confirm the side effects and drug stability of new drug candidates decreased by 3.3% to 174 cases, and to the optimal dose to determine the effectiveness of clinical trials, the number of clinical trials decreased by 7.3% to 89 cases. Last year, clinical approval was concentrated on the final stage of development.
Kolon Bioscience has been approved in November for clinical trials to extend the treatment of the gene therapy drug Invosa to mild patients with moderate knee osteoarthritis. Huynos entered clinical phase 3 of the nanocomposite eye drop `HU007` for dry eye patients last October. The company plans to release the drug in Korea next year with a new drug approval. Huynos Global, a holding company of Huions, received clinical trials for botulinum toxin `Toxox` for improving wrinkles in October last October, and started full-fledged clinics from last month. Hottox has already been approved for export in October, but it is seeking additional data on the improvement of wrinkles in the US.
Hanmi Pharmaceutical was approved for Phase 3 clinical trials of the Flephegrass team (HM10460A) in the treatment of neutropenia using `Lapscoverage` technology, which will increase the duration of the drug`s efficacy in July. The PLA Pegasus team is a technology export of Hanmi Pharm to the US market. The world market for neutropenic drugs is estimated at 6 trillion won. Earlier, Hanmi Pharm was approved in April for the global clinical trials of the lung cancer drug Olta (HM61713). Olita is marketed under a conditional approval based on the results of Phase 2 clinical trials since May of last year, but in order to secure a wide range of data through the large-scale Phase III trials.
Biosimilar development is also taking place. Samsung BioEpis has been approved for the global clinical trials of comparing Lucentis` biosimilars` SB11 `for macular degeneration treatment with original products last September. Lucentis of the original Swiss Novartis is the world`s 4 trillion won sales. In addition, CJ Healthcare received approval for Phase 3 clinical trials to compare its biosimilars `CJ-40001`, an anemia treatment drug `Nepes`, with its original products.
The development of a combination of new drugs and other ingredients that have already been launched is also active. CJ Healthcare received approval for clinical trials of CJ-30061, which is being developed as a treatment for hypertension in June, and Chong Kun Dang`s efficacy and efficacy in the treatment of diabetes mellitus, DUBIE, Additional clinical trials to verify safety have been approved. Boryung Pharmaceutical was approved in June for a three-phase combination study that combines hypertension treatment with Lipitor, an anti-hyperlipidemia drug. In March, Novartis acquired Canvas, Novacek, a hypertension treatment, and Crestor, And the third phase of development.
According to an expert from the pharmaceutical industry, "The increase in the number of clinical trials has increased the likelihood of commercialization of items that have confirmed their potential in the earlier phase of clinical trials as the R & D investment is activated," he stated.
By Kim Ji Seob cloud50@
[ copyright ⓒ The Digitaltimes ]
According to the Korea Food and Drug Administration (KFDA) on January 3, the total number of clinical approvals last year was 658, up 4.8 percent from the previous year. In particular, the number of clinical trials for acquiring data on efficacy data for a large number of patients was 211, up 20.6%. Meanwhile, the number of clinical trials to confirm the side effects and drug stability of new drug candidates decreased by 3.3% to 174 cases, and to the optimal dose to determine the effectiveness of clinical trials, the number of clinical trials decreased by 7.3% to 89 cases. Last year, clinical approval was concentrated on the final stage of development.
Kolon Bioscience has been approved in November for clinical trials to extend the treatment of the gene therapy drug Invosa to mild patients with moderate knee osteoarthritis. Huynos entered clinical phase 3 of the nanocomposite eye drop `HU007` for dry eye patients last October. The company plans to release the drug in Korea next year with a new drug approval. Huynos Global, a holding company of Huions, received clinical trials for botulinum toxin `Toxox` for improving wrinkles in October last October, and started full-fledged clinics from last month. Hottox has already been approved for export in October, but it is seeking additional data on the improvement of wrinkles in the US.
Hanmi Pharmaceutical was approved for Phase 3 clinical trials of the Flephegrass team (HM10460A) in the treatment of neutropenia using `Lapscoverage` technology, which will increase the duration of the drug`s efficacy in July. The PLA Pegasus team is a technology export of Hanmi Pharm to the US market. The world market for neutropenic drugs is estimated at 6 trillion won. Earlier, Hanmi Pharm was approved in April for the global clinical trials of the lung cancer drug Olta (HM61713). Olita is marketed under a conditional approval based on the results of Phase 2 clinical trials since May of last year, but in order to secure a wide range of data through the large-scale Phase III trials.
Biosimilar development is also taking place. Samsung BioEpis has been approved for the global clinical trials of comparing Lucentis` biosimilars` SB11 `for macular degeneration treatment with original products last September. Lucentis of the original Swiss Novartis is the world`s 4 trillion won sales. In addition, CJ Healthcare received approval for Phase 3 clinical trials to compare its biosimilars `CJ-40001`, an anemia treatment drug `Nepes`, with its original products.
The development of a combination of new drugs and other ingredients that have already been launched is also active. CJ Healthcare received approval for clinical trials of CJ-30061, which is being developed as a treatment for hypertension in June, and Chong Kun Dang`s efficacy and efficacy in the treatment of diabetes mellitus, DUBIE, Additional clinical trials to verify safety have been approved. Boryung Pharmaceutical was approved in June for a three-phase combination study that combines hypertension treatment with Lipitor, an anti-hyperlipidemia drug. In March, Novartis acquired Canvas, Novacek, a hypertension treatment, and Crestor, And the third phase of development.
According to an expert from the pharmaceutical industry, "The increase in the number of clinical trials has increased the likelihood of commercialization of items that have confirmed their potential in the earlier phase of clinical trials as the R & D investment is activated," he stated.
By Kim Ji Seob cloud50@