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Expectations for’the 1st domestic treatment’ in January
According to the related industry on the 31st, expectations for the development of a COVID-19 treatment and vaccine are expected to increase. It is noteworthy whether the first domestic treatment will be released sooner or later. On the 28th, after completing the global clinical phase 2 of the corona19 antibody treatment’CT-P59 (ingredient name regdanbimab)’, it submitted an application for conditional approval to the Ministry of Food and Drug Safety. As the Ministry of Food and Drug Safety is planning to conduct the review through a high-speed program, it is expected that the approval will be issued in January next year as early as possible. If safety and efficacy are sufficiently verified in phase 2 clinical trials, it is expected that domestic supply can start in late January or early February. Celltrion has already finished producing antibody treatments for 100,000 people, and plans to supply 1.5 to 2 million antibodies for COVID-19 next year.
In the beginning of next year, other domestic pharmaceutical and bio companies are also planning to apply for permission to treat Corona 19. Chong Kun Dang developed Napabeltan, a acute pancreatitis drug, and Daewoong Pharmaceutical, developed a chronic pancreatitis drug Hoy Star, as a treatment for COVID-19, and plans to apply for permission in January next year. GC Green Cross plans to start phase 2 clinical trials in September and apply for conditional approval in the first quarter as soon as the medication for 60 patients is completed.
Corona 19 vaccine companies are also speeding up their development. Although global pharmaceutical companies have released vaccines, it is because it is judged that a domestic vaccine is absolutely necessary as it is difficult to end Corona 19 in a short period of time.
Is conducting a domestic clinical trial phase 1/2a to confirm the safety of the DNA vaccine GX-19N. It has improved immune function than GX-19, which was previously developed. In phase 2a, based on the results of the interim analysis, we plan to apply for emergency use approval after conducting large-scale clinical trials at the same time in Korea and abroad.
For GLS-5310, Celide for AdCLD-CoV19 is currently undergoing approval for a Phase 1/2 clinical trial protocol. SK Bioscience’s NBP2001 has been approved for phase 1 clinical trials. An official in the domestic vaccine industry said, “We can expect to develop a vaccine around the next year because our country is a little late. It is important.”
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Started global vaccine production… Consignment company beneficiary
As global pharmaceutical companies have successfully developed vaccines, manufacturing capabilities to meet the overflowing demand for vaccines in each country are expected to become important next year. This is why pharmaceutical and bio companies with facilities that can produce corona 19 vaccines in Korea are attracting attention.
SK Bioscience is a company that officially received an order for vaccine production from a global pharmaceutical company. In July, after signing a letter of intent for cooperation with AstraZeneca for domestic and global supply of Corona 19 vaccine, it has already started production. A contract for consignment development and production (CDMO) was also signed with NovaVax, which is developing a synthetic antigen vaccine, and the quantity was decided to wait. GC Green Cross has agreed to participate in the production of Corona 19 vaccine developed by overseas pharmaceutical companies with the International Private Organization for Infectious Diseases Innovation (CEPI). It is set to produce more than 500 million doses from next March to May 2022.
Green Cross, Hanmi Pharm, and ST Pharm are emerging as possible consignment production companies according to the possibility of domestic consignment production (CMO) by Modena in the United States. Hanmi Pharmaceutical has facilities that can produce gene vaccines such as mRNA and DNA. It is known that vaccine production of up to 1 billion doses per year is possible here. ST Pharm is considered to be a company that can produce the mRNA raw material developed by Modena. In October, it completed a domestic patent application for the RNA synthesis method’Five Prime Capping’, a key technology for stabilizing molecules required for mRNA synthesis. Currently, it has a raw material production facility capable of producing about 20,000 doses of mRNA corona vaccine.
The outlook is strong that diagnostic kit makers will also benefit. Although the vaccine was developed, it will take some time to lead to global vaccination, and there will be demand for corona19 diagnosis before and after vaccination. Diagnosis kit makers such as Seegene, Bioneer, and Suzentech are responding to global demand while preparing for’Post Corona’ through business diversification. An official in the diagnostic industry said, “Just because a vaccine has been developed, will not eliminate the need for a diagnostic kit right away,” and explained, “We are developing diagnostic products tailored to various diseases while diversifying our business portfolio.”