'Inbosakakeiju', which was sold as a medicine remedy for gine for skeleton view / image = Kolon Science Science
The Criminal Food and Drug Administration has asked Kolon Life Science to stop the creation and sale of "Invo Sake", a result of gast osteoarthritis medicine.
According to Kolon Life Science on 31 March, sales and sales were stopped because it was shown that one of the main parts of Invo was different from that at the time of granting.
"We research that the company (Kolon Life Science) says the cells have changed," he said. "I don't think there will be good safety concerns so far."
However, he added, "We will carry out a detailed safety and efficiency audit," he said. "We expect to extend the survey of long-term follow-up for all patients, and if the illegal act is found through the process of product approval, we will provide a administrative solution."
Invo is a medicine that uses middle (medium) osteoarthritis. C.
Kolon Tissue Jean, a subsidiary of Kolon Life Sciences, has been approved for Korea's first gig production in July 2017 from the Food and Drugs Bureau in Korea. In the main decision one solution (homologous chondrocytes) and two solutions (chondrocytes were obtained from poems submitted by TGF-β1).
The problem was found in Feb 22, when Kolon Life Science received approval from the USA for the Invivo clinical trial (stage 3) of the Invivo clinical trials. Kolon Life Sciences published it to KFDA and the final results were confirmed on 29.
The number of acute pain in the third and fourth patients is known to have been reduced to up to two years when the knee joints are altered to replace the operation.
Although the price of a vaccine for around one million is earned, it has been sold up by registering over 3,000 cumulative methods.
However, there was controversy about an agreed invoice such as pain relief rather than the recovery of osteoarthritis.
As there are no reports of hazardous safety reactions over the last 11 years from the first clinical trial, safety is not of any safety aspect.
The pharmacy office provides information to the sick assessment, assessment and assessment office, which is not available for the doctor to administer the medicine. If the bad weather is bad, tell the medical director, Korea Pharmacopoeia, or the hospital immediately.
The next question is with the hospital.
– A gene gene for gene.
It is a medicinal material that is used to treat disease through modification such as genetic insertion.
– The method of genetic cure.
Don Following the investigation and development of non-clinical work, such as animal testing, Clinical Contract 1, 2, 3 approval has been completed and the result has been finally licensed for marketing.
– Status of genetic drugs licenses.
Vo Invo is the only treatment for breeding in Korea now.
An Invoice that is approved for treatment of a patient with middle knee osteoarthritis, which is still paining, despite a cure for physical medicine, is a result of a genetic remedy.
– What is the biggest in Invo?
▲ The main part is made of 1 and 2. 1 is a homologous chondrocyte, and 2 as a homologous chondrocyte with a factor (TGF-β1 gene) cause rapid cell propagation.
– How and when did you know when the cells changed?
The company told our office on 22 March and the final result on 29 March after the company had passed the Level 3 clinical trials in the US Labor Department. T
However, the results used in clinical trials in the United States differ from that used in the products domestically marketed. As a result, the cells that are used in Korea are now proven. The results will be released on 15 April. Based on the results, we plan to explore the cause and follow them.
– What cell did you change?
To date, a line of cells has been estimated from the black jaws arising from TGF-β1 (GP2-293 cells), which are not permitted in the chondrocyte transmissible horizon, included in the main component. of the drug. These cells are the cells that are used in the two-leaf making process.
– What caused the cells to change?
The company claims that the TGF-β1 gene (a factor that increases the cell size) of its cells in cartilage cells made in two liquids is used using renal cells (GP2) which are used in the manufacture of cells. -293). The TGF-β1 gene will be separated and flushed from black cells (a voluntary TGF-β1 gene) that were sent into chondrocytes. In this process, it is estimated that the projected cartilage cells were replaced with black cells as part of the kidney cells that did not have enough separation tables. In this regard, we will thoroughly investigate the cause of the cell and will investigate the cause in hospital.
– What is the proof of the 'destination' of the company's claim?
The company is researching what it says it has changed cells. In the United States, the same materials are released from the house and will be sent to them on 15 April. If necessary, it will make a separate domestic inspection.
– There are no problems with the Invo safety and effectiveness.
To date, 102 adverse reactions have been reported, but no reports of adverse reactions have been caused by safety concerns. During the licensing period, the poisonous tests submitted did not show results. During the manufacturing process the cells were surrounded by radiation to provide safety so that they did not stay in the body.
Considering this, it is unlikely that there are important safety concerns. According to the company, from an early stage of development, a line of cells from pages with TGF-β1 gene, which the cartilage cell is not used, is permitted during the permitted test. Therefore the company reports that there are no safety and efficiency issues, but we intend to prove it fully.
– What is the plan for permission to change the main features of the invoice?
Air Based on actual results, if illegal cases are detected, management will be dealt with in accordance with the Health Matters Law.
– Are the drugs used for clinical trials in the United States and the domestic licensing drugs the same?
Igeach Clinical testing results in the USA (BioRelance) and domestic products (WUXI) are differently made. As a result, we are also confirming household results and the results will be released on 15 April.
To Jung-hoon Han recital Kyung-duk [email protected]