The Ministry of Food and Drug Safety announced on the 18th that it had approved Yuhan Corporation’s non-small cell lung cancer treatment’Recrajajeong’ (ingredient name Razertinib) as the 31st new drug developed in Korea.
It is the second Yuhan Corporation’s new drug that was born in 16 years following the anti-ulcer drug’Revanex’ (ingredient name Levaprazan), which was approved in September 2005. ‘(Ingredient name Tegoprazan) is a Korean new drug in about 3 years since it was licensed as No. 30.
‘Rekrazyme’ is used in patients with advanced lung cancer with mutations in specific genes who have previously been treated for lung cancer. It can be used to treat patients with T790M mutation-positive locally advanced or metastatic non-small cell lung cancer who are resistant to the first and second generation EGFR target treatments. In particular, as it can pass through the cerebral vascular barrier (BBB), it has excellent efficacy and excellent tolerability even for lung cancer patients with brain metastases.
In addition, this product is a target anticancer agent that inhibits the proliferation and growth of lung cancer cells by interfering with the signal transmission involved in lung cancer cell growth, and has the advantage of being less toxic to normal cells.
Based on the results of a phase 2 clinical trial (therapeutic exploratory clinical trial) conducted in Korea, Yuhan applied for permission to conduct a phase 3 clinical trial (therapeutic confirmation clinical trial) after marketing.
The Ministry of Food and Drug Safety reviewed and evaluated the quality, safety and effectiveness, and post-marketing safety management plan for the applied drug in accordance with the pharmacist law review criteria. The Central Pharmacist Review Committee, which includes experts treating lung cancer in the medical field, gave the final approval after consulting on the completion of the permit and conformity to the system.
The Ministry of Food and Drug Safety said, “Through this new drug approval, it is expected that the range of drug options for the treatment of patients with recurrent non-small cell lung cancer will be expanded.”
Lee Jung-hee, CEO of Yuhan Corporation, said, “Recraja is an innovative new drug created with Yuhan’s new drug development capabilities and the dedication of domestic researchers. It is a new domestic drug that has received hot interest and positive medical evaluation from the development stage.” “We are pleased to be able to provide new treatment options to patients with EGFR-positive NSCLC in Korea.”
Reporter Jeong Hyun-jung [email protected]