Celltrion Vice Chairman Ki Woo-sung is explaining the COVID-19 antibody treatment at the ‘2020 Korea Bio Investment Conference (KBIC)’ held by the Korea Economic Daily in Dragon City, Seoul on the 28th. Celltrion plans to apply for conditional approval to the Ministry of Food and Drug Safety on the 29th. Reporter Shin Kyung-hoon [email protected]
On the 29th, Celltrion is applying for conditional approval of a treatment for the novel coronavirus infection (Corona 19). It is expected to start selling in Korea in the middle of next month.
Celltrion Vice Chairman Ki Woo-sung said at the ‘2020 Korea Bio-Investment Conference (KBIC)’ held for two days at Dragon City, Hangang-ro, hosted by the Korea Economic Daily. “I will apply for a conditional permit sooner or later,” he said.
In this regard, Nak-yeon Lee, CEO of the Democratic Party, said at the party’s Supreme Council meeting held at the National Assembly that day, “Celltrion will apply for permission to the Ministry of Food and Drug Safety on the 29th, and it will be decided in January next year.” Conditional approval is a system that grants marketing permission under the condition of a later phase 3 clinical trial if there is no treatment.
Vice-Chairman Ki said, “K quarantine will be completed with the development of Celltrion’s treatment,” and said, “If vaccines and treatments are together, it is possible to return to daily life in the second half of next year.” The company has already produced 100,000 doses of treatment. As of this day, it is twice that of the cumulative domestic confirmed cases (57,780).
I was also confident in the efficacy of the treatment. When asked by an online participant for comparison with the US Regeneron and Eli Lilly’s COVID-19 antibody treatment, he said, “It is undisclosed information, so I cannot tell you in detail, but I will be able to find out the efficacy within a few days (through disclosure).” I said. Experts expect to release new data that have either outperformed their competitors or have not proven them. He added, “We are ahead of the two companies that do not have their own production facilities in terms of supply capacity.”
92 domestic bio and healthcare companies participated in this conference. Following 46 on this day, 46 companies will be holding a corporate briefing session (IR) on the 29th. In addition to Vice Chairman Ki, SCM Life Science CEO Lee Byung-gun, and Utilex CEO Choi Soo-young, domestic and foreign bio industry officials attended.
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 finish in 10 months
“Korea will be the second country in the world to secure both a novel coronavirus infection (Corona 19) vaccine and a new drug from February next year.”
Celltrion Vice Chairman Kee Woo-sung was the first presenter of the ‘2020 Korea Bio-Investment Conference (KBIC)’ hosted by the Korea Economic Daily on the 28th, and said, “If Corona 19 is diagnosed early and treated, the number of severely ill patients will be greatly reduced. Celltrion’s COVID-19 treatment’CT-P59′, which is being developed by Celltrion, is applying for conditional permission from the Ministry of Food and Drug Safety on the 29th. Vice-Chairman Ki said, “The development of a new drug, which usually takes more than 10 years, was completed in 10 months.” “The achievements achieved by employees working in shifts around the clock would have made it impossible without Celltrion.”
“Dominate the European Corona Treatment Market”
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 the United States. The only companies that have developed a new drug for treating COVID-19, not changing the use of the existing drug, are the US pharmaceutical companies Regeneron and Eli Lilly.
However, they are not able to produce sufficient amounts of drugs because the production facilities for antibody treatments are not large. It is difficult to meet the 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 are many disagreements about the efficacy of the treatment.
Celltrion is expected to quickly dominate the Corona 19 treatment market in Europe and other places. In a lecture on the day, Vice Chairman Ki emphasized, “If two companies lacking their own production facilities to consign a treatment (CMO), mass production will be possible only one to 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-Chairman Ki believes that the effect of the treatment will be better in Korea, where the early diagnosis system is developed. CT-P59 catches the virus that is actively active 3 to 5 days after infection and prevents lung damage. Regeneron and Eli Lilly’s treatments are also intended for mild patients.
Vice-Chairman Ki has repeatedly expressed his intention to supply therapeutics to the Korean people at the cost level. “It was developed from the beginning to save people away from money,” he stressed. Remdesivir is supplied in Korea for 390 dollars (about 430,000 won) per bottle. Celltrion treatment is expected to be released at a lower price.
“Acquisition of Takeda, excitement as a Korean”
Vice-Chairman Ki said he will apply for emergency use approval (EUA) in the US and Europe early next month following Korea. In overseas markets, it gets its 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 Chairman Ki said, “We plan to build the 4th plant in Songdo and 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 (culture amount) of 620,000 liters due to the expansion of the Songdo 4 plant.
It is also preparing for a leap forward as a comprehensive pharmaceutical company. Celltrion acquired business rights in Asia-Pacific region of Japan’s Takeda Pharmaceutical, a multinational pharmaceutical company, for 330 billion won in June. Vice Chairman Ki said, “As a Korean, I thought it was exciting to take over the business division of Japan’s best pharmaceutical company.” He said, “We will learn technology to develop new drugs (such as Dalbi Lee, a treatment for hypertension) and continue to produce improved new drugs.” Vice Chairman Ki said, “We will release at least one biopharmaceutical every year by 2030. We will try to become Samsung Electronics in the bio field.”
News of Corona treatment development continued
At the event, in addition to Celltrion, there were several companies that announced plans to develop COVID-19 treatment. Utilex announced for the first time that it will begin clinical trials for COVID-19 treatment in October next year. Utilex CEO Choi Soo-young said, “We have found a peptide combination that prevents corona 19 protrusions (spikes) from entering the body. We will develop clinical candidates from February to March next year and enter clinical trials in October next year.” Jaewon Lee, director of AbClone, who 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]