Lee Woo-suk, CEO of Kolon Tissuechin, said: "Invoices,

[Seoul-NewYes] Kolong Tissue Jean's young reporter will enter the third phase of clinical trials to seek US Food and Drug Administration (FDA) approval in 2021 for the first gene therapy product for osteoarthritic cells , Invo. Lee Woo-suk, CEO of Kolon Tissue, held a press conference at the Magog Kolon One & Only Tower in Gangseo-gu, Seoul, Oct. 10, and said: "We plan to apply for the third phase from the US FDA. "

" Our goal is to change the game in the global market for osteoarthritis drugs, "said Lee." Through this clinical trial, (DMOAD), including the 39, improvement, "he said.

To this end, Kolon Tissue Jean began clinical trials of 1,020 patients in 60 major hospitals in the United States since September. (BLA) after completion Clinical data badysis in 2021. In addition, Kolon Tissue Jean is an American company with worldwide rights to "Invosa" except in Asia.

Clinical trials "Invosa" for 159 patients in the clinical phase 3 of Korea, with significant pain relief and function

Kolon Tissue Jean vi to demonstrate a wide range of effects, including structural improvement, by doubling the patient population and the validation period in phase III clinical trials in the United States. Clinical patients should be easier to confirm the structural improvement by extending them to benign patients, as opposed to domestic patients who are moderate patients who are in the preoperative stage of an artificial replacement surgery.

"This will lead to a differentiated preventive effect on the market as an innovative global drug, first clbad." The US FDA is redefining the guidelines of DMOAD, the concept of treating osteoarthritis fundamentally, "We are confident that we will acquire DMOAD by increasing the number of mild case patients for mild patients and extend the period of verification. from one year to two years. "

The industry expects the osteoarthritis market to develop further in the 2030s, with a population of 1.4 billion people worldwide. A recent report from L.E.K., a US market research agency, estimates that the global market for osteoarthritis drugs will reach between $ 40 billion and $ 50 billion.

Representative Lee said, "In the case of" Invo ", sales are expected to exceed $ 10 billion ( about 11 trillion won) on the basis of the highest sales rate. " "If you get DMOAD, you can get additional sales of $ 2.2 billion (about 2.4 billion won), resulting in annual sales of $ 5.5 billion (about 6 trillion won). "He said. The US market currently accounts for 50% of the global pharmaceutical market, with 25% in Europe, 10% in Japan and 15% in other regions. Global sales are generally estimated to double the US market.

In response to the first year of approval of domestic products by the company Invo, the company's representative has become a nationally successful drug in Korea, exceeding 1,000 in May, I have badessed the performance. In July, there are 79 general hospitals out of 101 general hospitals, including the Seoul National University Hospital, Severance Hospital and Samsung Seoul Hospital, and the gene therapy institutions that can administer "It was about 80, but now there are 695.

In order to extend the scope of Korea's "bills" to mild and moderate patients, Kolon Life Science plans to conduct clinical trials in 146 hospitals in 16 hospitals. by 2020, have already received medication. By the end of the clinical trial, more than 1.8 million patients out of 2.7 million patients with osteoarthritis should benefit from invasive surgery.

In addition, he becomes active in the Asian market beyond the domestic market. The company signed an export contract with Saudi Arabia and the UAE in July for an export contract of about 17 billion won in Hong Kong and Macau, and to the US. about 10 billion won in Mongolia in July.

Kolon Life Science plans to build a plant with a production capacity of 10,000 doses in 2014, and plans to increase production to 100,000 doses by 2021.

Representative Lee said: "The Domestic Gene Therapy Product," The launch of Phase III clinical trials in the United States opened the possibility of Invivo as a global blockbuster: "We will focus more on the development of significant biotech products at the global level. beyond the company. "

.com