Hanmi Pharmaceutical has received additional approval for the therapeutic use of the anti-cancer drug candidate Belvarafenib, which was technologically transferred to global pharmaceutical company Genentech, a member of the Roche Group (RHO).
According to the Ministry of Food and Drug Safety on Jan. 10, Severance Hospital of Yonsei University received approval for the therapeutic use of Belvarafenib targeting individual patients for the treatment of melanoma a day earlier. This marks the second approval for therapeutic use of Belvarafenib specifically for melanoma patients. Previously, Severance Hospital obtained approval for therapeutic use targeting the same indication in December of last year.
The system for therapeutic use targeting individual patients allows for the use of a drug for indications other than those under research or already approved. Under this system, physicians can apply for the use of a drug based on their judgment, and they can administer the drug to the patient if approved by the regulatory authorities. This system is utilized when a physician deems that the benefits outweigh the risks, especially for patients suffering from severe illnesses.
Belvarafenib is a targeted anti-cancer drug candidate for oral use developed in-house by Hanmi Pharmaceutical. It belongs to the RAF and RAS inhibitor class, and RAF and RAS are mitogen-activated protein kinases that mediate intracellular signal transduction.
Hanmi Pharmaceutical transferred the technology of Belvarafenib to Roche;s subsidiary, Genentech, in September 2016. Under the technology transfer agreement, Hanmi Pharmaceutical received a non-refundable upfront payment of US$80 million. The total contract amount, including development stage milestone payments, could reach up to US$910 million.
The research on Belvarafenib, led by Genentech, commenced on May 13, 2021. The target completion date for the research is Sept. 1, 2024. Belvarafenib is one of the core pipelines for Roche. The company initiated the large-scale clinical study named TAPISTY in January 2021. In May of the same year, Belvarafenib was included in the study.