It was found that five companies, including the International Vaccine Research Institute, SK Bioscience, Celid, Jinwon Life Science, and Genexine, are conducting initial clinical trials for the domestic Corona 19 vaccine. As for the COVID-19 treatment, 15 companies, including Daewoong Pharmaceutical and Celltrion’s Phase 2/3 clinical trial, are conducting clinical trials, and Celltrion plans to apply for approval for use with the results of phase 2 of the antibody treatment’CT-P59′ within this month. Table below)
The Ministry of Food and Drug Safety announced on the 27th through the domestic and overseas Corona 19 vaccine and treatment development status.
In the case of the global COVID-19 vaccine clinical trial, a number of companies such as AstraZeneca, Pfizer, Modena, and Janssen (Johnson & Johnson) are conducting phase 3 clinical trials. As of the 25th, the Pfizer vaccine has been approved for emergency use in eight countries, including the United States, United Kingdom, Bahrain, Canada, Saudi Arabia, Mexico, Kuwait and Singapore, and conditionally licensed in the European Union and Switzerland. The Modena vaccine has been approved for emergency use in the United States.
In Korea, five vaccine products are currently undergoing clinical trials, and most of them are undergoing initial clinical trials (Phase 1, Phase 1/2). In addition, a preliminary review by the Ministry of Food and Drug Safety is currently underway for three vaccine items developed by overseas pharmaceutical companies.
In the case of COVID-19 treatment, Lily and Regeneron are conducting phase 3 clinical trials for antibody treatments, and they have been approved for emergency use in the United States. In addition, clinical trials are in progress to add the efficacy and effect of COVID-19 treatment to existing drugs such as Lily’Varicitinib’ (arthritis treatment).
In Korea, it was found that a total of 15 products (13 ingredients), including antibody treatments being developed as a new Corona 19 treatment, are undergoing clinical trials. In particular, the Ministry of Food and Drug Safety said, “We plan to apply for approval for use this month,” referring to Celltrion’s antibody treatment.
The Ministry of Food and Drug Safety has organized and is operating a dedicated evaluation team for the approval of the Corona 19 vaccine and treatment, and the final approval of the data submitted by the company by combining the review results of experts in each field and the opinions of external experts such as the Central Pharmacy Review Committee if necessary. “We aim to shorten the existing processing period by more than 180 days and process it within 40 days through the preliminary review for each item and the rapid permission review by the exclusive approval team.”
Corona 19 vaccine clinical trial status. Source = Ministry of Food and Drug Safety
| Serial number | Requester | product name | Clinical trial contents (summary) | step | Approval date |
| One | International Vaccine Research Institute | INO-4800 | Evaluation of the safety, tolerability, and immunogenicity of the COVID-19 vaccine using electroporation (EP) after intradermal vaccination in healthy adults | 1/2a phase | 2020-06-02 |
| 2 | SK Bio Science Co., Ltd. |
NBP2001 | Evaluation of the safety, tolerability, and immunogenicity of the COVID-19 vaccine in healthy adults aged 19 to 55 | 1 phase | 2020-11-23 |
| 3 | Sellide Co., Ltd. | AdCLD-CoV19 | Confirmation of the safety and immunogenicity of the COVID-19 vaccine for healthy adult volunteers | 1/2a phase | 2020-12-04 |
| 4 | Jinwon Life Science Co., Ltd. | GLS-5310 | Evaluation of the safety, tolerability and immunogenicity of COVID-19 vaccine administered intradermally to healthy adults | 1/2a phase | 2020-12-04 |
| 5 | Genexine | GX-19N | Exploring the safety, tolerability, and immunogenicity of the COVID-19 vaccine in healthy adults | 1/2a phase | 2020-12-11 |
Current status of clinical trials for COVID-19 treatment
| 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 |
| 2 | NG Chem biology |
EC-18 | Evaluation of the safety and effectiveness of clinical trial drugs (neutropenia drugs) for patients with COVID-19 pneumonia | 2 phase | 2020-05-12 |
| 3 | 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 |
| 4 | 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 |
| 5 | 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 |
| 6 | Daewoong Pharmaceutical Co., Ltd. | DW1248 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 |
| 7 | 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 |
| 8 | Green Cross Co., Ltd. | GC5131 | Establishment of the dose of H-Ig (high immunoglobulin) for COVID-19 patients and evaluation of efficacy and safety | 2 phase | 2020-08-20 |
| 9 | 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 patients | 3-phase | 2020-10-08 | |||
| 10 | Lily Korea | LY3009104 (Varicitinib) |
Therapeutic confirmation test of commercially available drugs (arthritis drugs) for patients with COVID-19 | 3-phase | 2020-09-07 |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 |
| 14 | 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 |
| 15 | 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 |