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Celltrion Vice President Ki Woo-sung explains COVID-19 antibody treatment at the ‘2020 Korea Bioinvestment Conference (KBIC)’ held by the Korean Economic Journal in Dragon City, Seoul on the 28th. Celltrion plans request conditional approval from the Ministry of Food and Drug Safety on the 29th. Reporter Shin Kyung-hoon [email protected]
On the 29th, Celltrion requests the conditional approval of a treatment for the new coronavirus infection (Corona 19). It is expected to start selling in Korea in the middle of next month.
Celltrion Vice President Ki Woo-sung said at the ‘2020 Korea Bioinvestment Conference (KBIC)’ held for two days in Dragon City, Hangang-ro, hosted by the Korean Economic Daily. “I’ll apply for parole sooner or later,” he said.
In this regard, Nak-yeon Lee, executive director of the Democratic Party, said at the party’s Supreme Council meeting held in the National Assembly that day, “Celltrion will request permission from the Ministry of Food and Drug Safety on the 29th, and it will be decided in January of next year. ” Conditional approval is a system that grants permission to market under the condition of a subsequent phase 3 clinical trial if there is no treatment.
Vice President Ki said: “K’s quarantine will be completed with the development of the Celltrion treatment” and said: “If vaccines and treatments are combined, daily life can be restored in the second half of next year.” The company has already produced 100,000 doses of treatment. To date, it is double the accumulated number of confirmed national cases (57,780).
He was also confident in the efficacy of the treatment. When asked by an online participant about the comparison to the COVID-19 antibody treatment from Regeneron and Eli Lilly from the US, he said: “This is undisclosed information, so I cannot say in detail, but I will be able to find out the effectiveness in a few days (through disclosure). Said. Experts hope to publish new data that has outperformed its competitors or has not been tested. He added: “We are ahead of the two companies that do not have their own production facilities in terms of supply capacity.”
92 national biology and health companies participated in this conference. After 46 on this day, 46 companies will hold a corporate briefing (IR) on the 29th. In addition to Vice President Ki, SCM Executive Director of Life Sciences Lee Byung-gun and CEO of Utilex , Choi Soo-young, was attended by domestic and foreign biological industry officials.
Celltrion “Ahead of therapeutic production capacity … Apply for approval in the US and Europe early next month”
Development of a new drug that takes more than 10 years to complete in 10 months
“Korea will be the second country in the world to ensure both a new vaccine against coronavirus infection (Corona 19) and a new drug from February next year.”
Celltrion Vice Chairman Kee Woo-sung was the first presenter of the ‘2020 Korea Bioinvestment Conference (KBIC)’ hosted by the Korean Economic Journal on the 28th, saying: “If Corona 19 is diagnosed and treated in time, the number of seriously ill patients will be greatly reduced. ” Celltrion’s COVID-19 treatment ‘CT-P59’, which is being developed by Celltrion, applies for a conditional permit from the Ministry of Food and Drug Safety on the 29th. Vice President Ki said: “The development of a new drug, which it usually takes more than 10 years, it took 10 months to complete. ” “The accomplishments of employees working 24 hours a day would have made it impossible without Celltrion.”
“Dominate the European market for Corona treatment”
According to the government, Celltrion’s COVID-19 treatment is expected to be commercially available from the middle of next month. This treatment is the only new drug for COVID-19 that can be applied outside of the United States. The only companies that have developed a new drug to treat COVID-19, without changing the use of existing drugs, are the US pharmaceutical companies Regeneron and Eli Lilly.
However, they cannot produce sufficient quantities of drugs because the production facilities for antibody treatments are not large. It is difficult to meet demand in the United States, where there are many confirmed cases, so it is difficult to introduce it in other countries. Gilead Science’s remdesivir, originally developed as a treatment for the Ebola virus, can be mass-produced, but there is much disagreement about the efficacy of the treatment.
Celltrion is expected to quickly dominate the Corona 19 treatment market in Europe and elsewhere. In a conference on the day, Vice President Ki emphasized: “If two companies that do not have their own production facilities carry out consignment production (CMO), mass production will be possible only one or two years later.”
Celltrion plans to use its own factory in Songdo, Incheon (100,000 liters) as a treatment production base. It has already produced 100,000 antibody drugs. Vice President Ki believes that the efficacy of treatment will be better in Korea, where the early diagnosis system is developed. CT-P59 traps the virus that is active 3 to 5 days after infection and prevents lung damage. The Regeneron and Eli Lilly treatments are also intended for mild patients.
Vice President Ki has repeatedly expressed his intention to supply therapeutic products to the Korean people at the cost level. “It was developed from the beginning to save people from money,” he stressed. Remdesivir is supplied in Korea for $ 390 (about 430,000 won) a bottle. The Celltrion treatment is expected to launch at a lower price.
“Takeda Acquisition, Thrill as a Korean”
Vice President Ki said he will apply for emergency use approval (US) in the United States and Europe early next month after Korea. In foreign markets, you get your price. Regeneron and Eli Lilly receive millions of won per shot in the United States.
Celltrion also announced plans to expand its manufacturing facility. Vice President Ki said, “We plan to build the fourth plant in Songdo and the overseas plants in Incheon,” and said, “We plan to have a production capacity of about 600,000 liters by 2030.” This is close to Samsung Biologics’ total production (crop quantity) of 620,000 liters due to the expansion of the Songdo 4 plant.
It is also preparing to take a leap forward as a comprehensive pharmaceutical company. Celltrion acquired the commercial rights in the Asia-Pacific region of Takeda Pharmaceutical, a multinational pharmaceutical company in Japan, for 330 billion won in June. Vice President Ki said, “As a Korean, I thought it was exciting to take over the business division of the best pharmaceutical company in Japan.” He said: “We will learn technology to develop new drugs (such as Dalbi Lee, a treatment for hypertension) and we will continue to produce new improved drugs.” Vice President Ki said: “We will launch at least one biopharmaceutical every year by 2030. We will try to become Samsung Electronics in the biological field.”
News on Corona Treatment Development Continues
In addition to Celltrion, there were several companies that announced plans to develop COVID-19 treatments. Utilex first announced that it will begin clinical trials for COVID-19 treatment in October next year. Utilex CEO Choi Soo-young said: “We have found a combination of peptides that prevents crown 19 bumps (spikes) from entering the body.” Jaewon Lee, director of AbClone, which is developing a corona19 antibody treatment with Yuhan Corporation, said: “We are planning to apply for a clinical trial plan (IND) for phase 1 clinical trials early next year.” .
Reporter Kim Woo-seop / Lee Woo-sang [email protected]
