[팍스넷뉴스 김새미 기자] Celltrion is a leading company among domestic bio ventures. It succeeded in developing a biosimilar for the first time in the world and pioneered a new market that did not exist in the world. This year, as the new coronavirus infection (Corona 19) spreads, we are developing an antibody treatment for Corona 19 at an unprecedented speed based on our experience in developing antibody drugs. In the bio industry, it is said that without Celltrion, there would have been no Samsung Biologics and Epis. Currently, Celltrion and Samsung Biologics are two-top K-bio companies based in Songdo, Incheon.
◆ Focus on the bio business even in the early stages of business failure
The forerunner of Celltrion Group is Nexol. Celltrion Group Chairman Seo Jeong-jin caught the eyes of Daewoo Group Chairman Kim Woo-jung after passing through Samsung Electro-Mechanics and Korea Productivity Center and was scouted as a Daewoo Group executive. Chairman Seo, who was working in the planning and coordination office of Daewoo Motors, left the company when Daewoo Group was disbanded in 1998 due to the financial crisis, and established Nexol (currently Celltrion Healthcare) and Nexol Biotech (currently Celltrion Skin Cure) in 2000.
Nexol was followed by Chairman Seo and Vice Chairman of Celltrion, Woosung Ki, Vice Chairman of Celltrion Healthcare, Hyungki Kim, Vice Chairman of Celltrion Healthcare, Heonyoung Yoo, Vice Chairman of Celltrion Holdings, Kwangyoung Moon, former President of Celltrion Skincure, and Geunyoung Lee, former Celltrion Healthcare Advisor. . Nexol tried various businesses such as the food import business, but failed once. Then, considering that the biotechnology business was promising, he jumped into the bio business.
Celltrion was founded in February 2002 as a joint venture between American biotechnology company Baxgen and Nexol Biotech. At the time of establishment, BaxGen had 46.9%, Nexol Biotech 18.7%, and Korea Tobacco Ginseng Corporation 17.2%. BaxGen is a subsidiary of Genetec, an American biotechnology company, founded in 1995 to develop AIDS vaccines.
At the time, Celltrion was a company set up for the consignment production of biopharmaceuticals (CMO) of Baxgen’s AIDS vaccine’AIDSVax’. However, in February 2003, a result was found that AIDSVax did not reach the target level in phase 3 clinical trials. In fact, BaxGen, which failed clinical trials, was expelled from the NASDAQ market in August 2004. At the time, Celltrion was building a 50,000-liter factory with an investment of 240 billion won. Celltrion faced a crisis as CMO volumes evaporated ahead of the completion time.
◆ Laying the foundation for growth through CMO business
Fortunately, Celltrion revived its driver in 2005 by signing a CMO contract with BMS for the treatment of rheumatoid arthritis’Orencia’. At that time, the contract amount reached 2 billion dollars (about 2 trillion won) over a 10-year period. At that time, it attracted attention both at home and abroad, as it succeeded in winning a large-scale contract, beating Lonza, the industry’s number one company.
The CMO of Celltrion became possible only when the completion ceremony of Celltrion Plant 1 was held in July 2005 and obtained cGMP from the US Food and Drug Administration (FDA) in December 2007. Since then, Celltrion held a completion ceremony for the second plant with a capacity of 90,000 liters, the world’s largest single plant at the time, in October 2011 to stably supply medicines to overseas markets.
Celltrion went on track in 2007 with sales of 63 billion won and operating profit of 15.5 billion won, making the first surplus in five years since its foundation. Celltrion, who has climbed to Tantan-daero through the CMO business, suddenly made an appearance in the biosimilar business in 2008.
◆ Biosimilar business challenge
In simple terms, a biosimilar is a generic drug for biopharmaceuticals. Unlike synthetic drugs, biological drugs such as antibodies cannot produce generic drugs that are structurally identical, so instead of generic drugs, the expression “similar” was used. Chairman Seo held the’Biosimilar Development Declaration Ceremony’ in Sogong-dong, Seoul on September 9, 2008, and declared “We will launch 7 types of antibody drugs worldwide from 2011.”
Chairman Seo’s idea for the biosimilar business has been in the works for a long time. After the founding of Nexol, Chairman Suh recklessly visited San Francisco, the center of the world’s bio industry, to search for bio business items. He meets scholars who have won the Nobel Prize in Medicine and learns that the blockbuster biopharmaceutical patent is about to expire. Chairman Seo was convinced that biosimilars will emerge as food for the future. However, Chairman Seo, who decided that it would be difficult to research and develop biopharmaceuticals on its own right now started with the CMO business.
Celltrion, which started developing biosimilars in earnest, succeeded in obtaining approval from the Ministry of Food and Drug Safety (MFDS) for the world’s first remicade biosimilar’Remima’ in 2012. In August 2013, it obtained a marketing license for Remsima from the European Medicines Agency (EMA). Remsima, the world’s first antibody biosimilar, marked the opening of the global biosimilar market.
After that, Celltrion introduced breast cancer treatment’Herceptin’ and blood cancer treatment’Truxima’ to the market one after another. Celltrion has also developed Remsima SC, which improves the convenience of administration by developing Remsima as a subcutaneous injection (SC) formulation. Celltrion obtained approval from the European Medicines Agency in November of last year (Remsima SC as an indication for rheumatoid arthritis from EMAP, and obtained final marketing authorization for all adult indications in July. Starting with Germany, it started sales in Europe.
When Celltrion developed the world’s first biosimilar, not only domestic companies such as Samsung but also global pharmaceutical companies entered the biosimilar market. In March 2015, Novartis’ subsidiary Sandos received the approval of the New Forgen biosimilar’Jaxio’, and Amgen entered the biosimilar market in September 2016 and Pfizer in December 2017.
Celltrion pioneered a new global market called biosimilars. The biosimilar market is expected to reach 100 trillion won in 2030 as a number of global biopharmaceutical patents, which have risen to the top in sales for the next 10 years, expire.
◆ Leap forward as a global bio-pharmaceutical company by developing new drugs
Celltrion’s dream is moving to a new bio drug through CMO and biosimilar. New drugs have the disadvantage that the development success rate is significantly lower than that of biosimilars, but they have the advantage of high added value.
Celltrion is developing antibody treatments based on its experience in developing antibody drug biosimilars. Celltrion started developing a comprehensive influenza antibody treatment,’CT-P27′, and has ended phase 2b (late phase 2 clinical trial) in 2018. Another antibody treatment,’CT-P59′, is not only fast in development, but also attracts great attention as a domestic treatment to respond to Corona 19.
Celltrion submitted an application for conditional permission for CT-P59 to the Ministry of Food and Drug Safety on the 29th. Conditional authorization permits the urgent sale of new drugs only with the results of phase 2 clinical trials when it is impossible to treat life-threatening diseases with conventional methods. The Ministry of Food and Drug Safety must decide whether to approve or not within 40 days of receiving the application. Therefore, CT-P59 is expected to be released in Korea after mid-January next year. Celltrion plans to apply for emergency use approval to the US Food and Drug Administration (FDA) and European EMA based on the results of CT-P59 global phase 2 clinical trials.
Lee Seung-gyu, vice chairman of the Korea Bio Association, diagnosed, “If Celltrion succeeds in developing an antibody treatment for Corona 19, it could become a new blockbuster drug sold not only in Korea but also overseas,” he said.
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