(Health Korea News / Lee Chung-man) Following Hanmi Pharmaceutical’s launch of the first generic version of the prostate cancer treatment ‘Zytiga’ (ingredient name: abiraterone acetate), this time, it has launched ‘Xtandi,’ Ingredient name: enzalutamide) We are attempting to develop the first generic.
As a result of this newspaper’s coverage, it was confirmed that Hanmi Pharmaceutical began recruiting participants for the bioequivalence test of ‘HGP2407’ on the 15th. The test is to evaluate the bioequivalence of ‘HGP2407’ and ‘RLD2403’ in healthy adult men. The exam will run until May 9th.
‘HGP2407′ is a generic version of Japan’s Astellas’ prostate cancer treatment ‘Xtandi’ (ingredient name: enzalutamide). This is the first time among domestic pharmaceutical companies to develop a generic version of ‘Xtandi’.
‘Xtandi’ is a hormone therapy that selectively acts on the androgen receptor, a male hormone. The U.S. Food and Drug Administration (FDA) and Korea’s Ministry of Food and Drug Safety approved ‘Xtandi’ in August 2012 and June 2013, respectively.
This drug is a blockbuster drug with sales of $5.3 billion (about 7.7 trillion won) in 2023. In Korea, it recorded prescription sales of 43.2 billion won in 2023 (based on IQVIA), ranking first in domestic prostate cancer hormone therapy treatment sales.
The domestic material patent for ‘Xtandi’ is scheduled to expire on June 27, 2026. However, there are not many companies developing generics. In the case of anticancer drugs, there is a high preference for originals and the development conditions are difficult.
‘Zytiga’, a prostate cancer treatment in the same class, is a representative example. The domestic patent for this drug expired in 2018, but so far, news of domestic pharmaceutical companies developing generics has been quiet.
Meanwhile, Hanmi Pharmaceutical set its sights on ‘Zytiga’ and secured the first generic, opening the door to competition in the market. In June 2023, the Ministry of Food and Drug Safety approved ‘Abiterone Tablets’ (ingredient name: Abiraterone), a generic version of Hanmi Pharmaceutical’s ‘Zytiga’.
Hanmi Pharmaceutical did not stop here and began developing the first generic version of ‘Xtandi’. If ‘HGP2407’ is commercialized, it is expected to compete in earnest with ‘Xtandi’.
Meanwhile, according to Shinhan Investment & Securities, the domestic prostate cancer treatment market was worth 692 billion won in 2020. The market for hormone therapy drugs is estimated at approximately 50 billion won.
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