Hanmi Pharmaceutical Gains Approval for Generic Xtandi, Intensifying Prostate Cancer Treatment Competition

Hanmi Pharmaceutical is expanding its presence in the prostate cancer treatment market with the recent approval of its generic version of Xtandi (enzalutamide), named Enzaron Soft Capsule 40mg, by the Ministry of Food and Drug Safety. This approval adds another treatment option for patients and intensifies competition in the prostate cancer landscape.

Fifth Generic Approval for Xtandi

Enzaron marks the fifth generic version of Xtandi to receive approval. Prior approvals were granted to Alvogen Korea, Daewon Pharmaceutical, Hanall Biopharma, and Menarini Korea. Notably, Enzaron is the first domestically manufactured generic Xtandi, distinguishing it from previously approved imported products.

Patent Landscape and Launch Timeline

Hanmi anticipates launching Enzaron as early as June 27, coinciding with the expiration of the material patent for Xtandi. The company successfully navigated a challenge to the formulation patent, which expires on September 11, 2033, with a favorable ruling from the Intellectual Property Trial and Appeal Board on February 26.

Xtandi’s Market Position and Increased Accessibility

Xtandi, alongside Ellida and Zytiga, is a widely prescribed treatment for prostate cancer. Its accessibility has increased since November 2023, when mandatory benefits were applied, reducing the patient out-of-pocket cost from 30% to 5%. According to UBIST data, outpatient prescriptions for Xtandi reached 38 billion won in 2023.

Hanmi’s Expanding Prostate Cancer Portfolio

Hanmi entered the prostate cancer market in October 2023 with the approval of its generic version of Zytiga, Abiterone Tablet 500mg (Abiraterone Acetate). The following year, the company introduced Abiterone Duo Tablet, a combination of abiraterone and prednisolone. Abiterone has been gaining market share, reaching 4.4 billion won in outpatient prescriptions in 2023.

Mechanism of Action: Abiraterone vs. Enzalutamide

Both abiraterone and enzalutamide are next-generation androgen receptor pathway blockers used in the treatment of hormone-responsive and castration-resistant prostate cancer. Abiraterone functions by blocking the production of male hormones (androgens), while enzalutamide directly blocks androgens from binding to receptors.

Future Outlook

With the addition of enzalutamide to its portfolio, Hanmi Pharmaceutical is well-positioned to enhance its competitiveness in the prostate cancer treatment market by offering multiple therapeutic options.