Withdrawal of Hanmi's Olita permit, cancellation of benefit

Phase 3 development suspended after being pushed by Tagrisso

The benefit of Olita, a new domestic drug, will be canceled following the withdrawal.

 

It has been six years since it was approved as the new domestic drug No.

 

27 in May 2016.

 

Since Hanmi Pharmaceutical already announced the suspension of development in April 2018, the withdrawal of the license and cancellation of the benefit were scheduled, but it withdrew from the market due to global competitive drugs.

 

According to the industry on the 28th, Hanmi Pharmaceutical's non-small cell lung cancer treatment drugs Olita 200mg and Olita 400mg will be removed as of the 1st of next month.

 

It is a procedure following the withdrawal of permission.

 

Olita has maintained permits for existing patients permission was withdrawn on 12 August.

 

Hanmi Pharmaceutical, which received phase 3 from the Ministry of Food and Drug Safety, decided to suspend Olita's development in April 2018.

 

This is because it was expected that it would be difficult to recruit phase 3 clinical patients as a competitive drug called Tagrisso quickly entered the market.The return of Olmutinib rights by Beringer Ingelheim and its Chinese partner Zai Lab affected the suspension of development.

 

Tagrisso of AstraZeneca, a competitive drug, started selling around the world and received benefits in Korea, making it difficult to recruit patients necessary for phase 3 progression.

 

Although Olita's domestic application was November 15, 2017, a month earlier than Tagrisso's (December 15, 2017), Tagrisso's benefit is a problem for Olita's domestic development because it had to proceed with a phase 3 clinical trial, which is a condition of permission.

 

However, while the development was suspended, the permission was maintained for patients taking Olita at the time, but the permission and cancellation were a matter of timing because they did not meet the conditions of the permission, phase 3.