According to the Ministry of Food and Drug Safety, Hanmi submitted a plan to end the development of Olita 200 mg and 400 mg. The ministry has given a green light for sales of Olita in 2016, on condition that phase 3 clinical trials data are submitted.
Olita, until recently, was expected to become the Korean drugmaker’s first original treatment.
|Hanmi Pharmaceutical’s smart plant in Paltan-myeon, Hwaseong, Gyeonggi Province (Hanmi Pharmaceutical)|
However, with the launch of Swedish rival AstraZeneca’s Tagrisso, another lung cancer treatment with the same efficacy, Hanmi faced difficulties in patient recruitment for trials of the drug. Tagrisso is currently released in 40 countries around the world after completing phase 3 clinical tests in 2016.
“Although Hanmi was a step ahead in developing Olita in the early stages, the company struggled in the face of a competition against a foreign pharmaceutical giant’s R&D investment and speed in development,” said a Hanmi official.
“(Development) was also delayed after an exclusive sales licensing deal with Boehringer Ingelheim was canceled in 2016.”
Last month, China’s pharmaceutical company Zai Lab also returned China rights for sales of Olita to Hanmi.
According to market data, AstraZeneca currently invests at least 5.9 trillion won ($5.5 billion) in R&D a year. Hanmi, on the other hand, has injected 170 billion won into R&D in 2017, 18.6 percent of its sales last year.
Hanmi said that it will instead concentrate on developing other new drugs. The company said it had 25 other candidate drugs.
According to government, in 2016, actual output of 26 domestically developed new drugs was calculated at 167 billion won, accounting for 0.9 percent of the total medicine’s actual output at 18.8 trillion won.
Meanwhile, the ministry said it will continue to review safety plans handed out by Hanmi, so that some 100 patients who are currently taking Olita can be assured of safety and swiftly switch to other medication without side effects.
By Kim Da-sol (firstname.lastname@example.org)