Will Hanmi also target Stivarga's patent?

Possible to build a lineup of primary and secondary liver cancer target treatments

Reviewing re-challenge by confirming passive scope of rights

Hanmi's generic launch of Nexavar (Sorafenib) is imminent.

 

Hanmi is considering internally reviewing a plan to target the patent of 'Stivarga (Legorafenib)', a secondary target treatment for liver cancer.

 

If Hanmi succeeds in overcoming patents to Nexavar and Stivarga, it is expected that a lineup of targeted treatments for liver cancer will be established.

 

According to the pharmaceutical industry on the 14th, Hanmi recently submitted an application of generic for Nexevar to the MFDS.

 

Unless there is a special variable, the approval of an item for “Hanmisorafenib (tentative name)” is expected to be made soon.

 

It is confirmed that Hanmi is already in the process of planning for the next step as the launch of Generic for Nexavar is imminent.

 

Hanmi intends to target the patent of Stivarga, following to Nexava.

 

Stivarga is a targeted anticancer drug that can be used as a secondary treatment for patients who fail to treat Nexavar.

 

Bayer has a patent right.

 

An official from Hanmi said in a call with Dailypharm, "With the imminent approval of generic for Nexavar, we are considering a new way to re-challenge the patent in the next step." In fact, Hanmi had previously tried the patents.

 

However, the results were not good.

 

It ended in defeat or self-dismissal.

 

In April 2015, Hanmi, together with Huons, Yuhan, and Chong Kun Dang, requested invalidated trials for Stivarga's material patent (expired in March 2025), formulation patent (expired in August 2025), and hydrate patent (expired in September 2027).

 

In June 2017, the Patent Tribunal sided with the original company on a trial of “partial dismissal” against the invalidation trial for a formulation patent.

 

Subsequently, in August, domestic companies voluntarily canceled the trial for invalidating a patent.

 

Although domestic companies seemed to have failed to acquire Stivarga's patent, Boryung requested a judgment to confirm the scope of passive rights alone in the hydrate patent.

 

In the end, after two years of fighting, Boryung succeeded in pursuing patents in April 2019, leading to a trial.

 

The decision was confirmed in May of the same year.

 

Hanmi's strategy is no different from Boryung.

 

It intends to re-challenge by raising a judgment on the passive scope of rights to Stivarga's hydrate patent.

 

If Hanmi targets patents following Nexavar and Stivarga, it is expected to generate considerable synergy in that it will have both generics of primary targeted treatments for liver cancer.

 

The original company, Bayer, also has the advantage of being able to perform continuous treatment and has an advantage over Lenvima.

 

According to drug research agency IQVIA, sales of each drug amounted to ₩25.4 billion in Nexavar and 23.6 billion in Stivarga as of last year.