Currently, 22 products of COVID-19 vaccine and treatment are in clinical trials in Korea
(Seoul = Yonhap News) Reinek. 2021.02.26. [GC녹십자웰빙 제공. 재판매 및 DB 금지]
(Seoul = Yonhap News) Reporter Jandi Kim = The Ministry of Food and Drug Safety has approved a phase 2 clinical trial plan to confirm the effectiveness of the treatment of a novel coronavirus infection (Corona 19) of Rineekju (a placental injection). It was revealed on the 26th.
GC Green Cross Wellbeing’s Rineekju is a specialty medicine injection used for the treatment of improving liver function in patients with alcoholic and non-alcoholic steatohepatitis. It is a human placenta hydrolyzate made from a substance extracted from the human placenta.
This clinical trial was designed to evaluate the efficacy and safety of Rineek in corona19 patients. Rineek is currently a drug that is administered subcutaneously or intramuscularly, but in this clinical trial, it was decided to change to intravenous administration.
In a non-clinical trial, Rineek showed the effect of reducing the amount of virus and cell lesions caused by viral infection. GC Green Cross Wellbeing said in an animal experiment in May last year that it confirmed the effect of Reinek in relieving the symptoms of Corona 19.
With the approval on that day, the number of drugs that were approved for clinical trials related to Corona 19 in Korea and are in development were 22 products, including 8 vaccines and 14 treatments (12 components). Among them, Celltrion’s Rekironaju (ingredient name Regdanvimab) was approved on the 5th as a treatment developed in Korea.
[표] Current status of approval of clinical trials for COVID-19 treatment and vaccine in Korea
| Serial number | Requester | product name (Ingredient name) |
Clinical trial contents (summary) | step | Approval date |
| One | Bukwang Pharmaceutical Co., Ltd. | Levovir Capsule 30mg (Clevudine) |
Evaluation of the safety and effectiveness of commercially available drugs (hepatitis B drugs) for patients with moderate corona19 | 2 phase | 2020-04-14 |
| Safety and efficacy evaluation of commercially available drugs (hepatitis B drugs) for mild and moderate corona19 patients | 2 phase | 2021-01-07 | |||
| 2 | Shinpoong Pharmaceutical Co., Ltd. | Piramax tablet (Pyrrolidine, altesunate) |
Safety, efficacy and safety comparative evaluation of commercially available drugs (antimalarial drugs) for mild or moderate Corona19 patients | 2 phase | 2020-05-13 |
| 3 | Chong Kun Dang Co., Ltd. | CKD-314 (Napamostat) |
Evaluation of the safety and effectiveness of commercially available drugs (anticoagulants) for hospitalized patients with COVID-19 pneumonia | 2 phase | 2020-06-17 |
| 4 | crystal Genomics Co., Ltd. |
CG-CAM20 (Duck start) |
Evaluation of the safety and effectiveness of commercially available drugs (pancreatitis drugs) for patients with COVID-19 | 2 phase | 2020-07-01 |
| 5 | Daewoong Pharmaceutical Co., Ltd. | DWJ1248 tablets (Duck start) |
Evaluation of the safety and effectiveness of commercially available drugs (pancreatitis drugs) for mild and moderate corona19 patients | 2/3 phase | 2020-07-06 |
| Safety and efficacy evaluation of DWJ1248 and Remdesivir combination therapy for severe corona19 patients | 3-phase | 2020-12-31 | |||
| DWJ1248 safety and effectiveness evaluation for prevention after exposure to the corona 19 virus, such as those in contact with corona 19 confirmed patients | 3-phase | 2021-01-22 | |||
| Evaluation of safety and pharmacokinetic characteristics according to dose after administration of DWJ1248 in healthy adults | 1 phase | 2021-02-23 | |||
| 6 | Genexine | GX-I7 | Exploring the safety and preliminary effects of clinical trial drugs (anticancer drugs) for patients with COVID-19 | 1b phase | 2020-08-07 |
| 7 | Celltrion | CT-P59 | Safety, tolerability and virology evaluation for patients with mild corona19 | 1 phase | 2020-08-25 |
| Safety and efficacy evaluation in parallel with standard treatment for mild and moderate corona19 patients | 2/3 phase | 2020-09-17 | |||
| Preventive efficacy, virology, and safety evaluation for contact with COVID-19 | 3-phase | 2020-10-08 | |||
| 8 | Lily Korea | LY 3009104 (Varicitinib) |
Therapeutic confirmation test of commercially available drugs (arthritis drugs) for patients with COVID-19 | 3-phase | 2020-09-07 |
| 9 | Daewoong Pharmaceutical Co., Ltd. | DWRX2003 (Niclosamide) |
Evaluation of safety, tolerability, and pharmacokinetic characteristics of commercially available drugs (parasite repellents) for healthy adults | 1 phase | 2020-10-08 |
| 10 | MSD Korea | MK-4482 | Evaluation of the safety, efficacy, and pharmacokinetics of clinical trial drugs (influenza drugs) for adult hospitalized patients with COVID-19 | 2/3 phase | 2020-10-29 |
| 11 | New Gen Therapeutics |
New Genna Pharmost Tablet (Napamostat) |
Evaluation of the safety, tolerability, and pharmacokinetic characteristics of commercially available drugs (anticoagulants) for healthy adult males | 1 phase | 2020-11-03 |
| 12 | Dong Wha Pharm. | DW2008S | Comparative evaluation of the safety and effectiveness of clinical trial drugs (asthma drugs) for moderately corona 19 patients | 2 phase | 2020-11-23 |
| 13 | Immunmed Co., Ltd. | hzVSF-v13 | The safety, efficacy, and safety of the standard therapy of clinical trial drug (influenza drug) for patients with moderate and severe corona19 (influenza drug) and the combined administration of hzVSF-v13 for each dose were compared with the standard therapy group alone. | 2 phase | 2020-12-07 |
| 14 | Green Cross Wellness Co., Ltd. | Rineneck (Hydrolysis product) |
Evaluation of the safety and effectiveness of commercially available drugs (liver function improvement drugs) for patients with moderate corona19 | 2a phase | 2021-02-26 |
※ Provided by the Ministry of Food and Drug Safety
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2021/02/26 14:52 sent