Hansoh Pharma Submits First Domestic ANDA for Enzalutamide Capsules, a $4.3B Blockbuster Prostate Cancer Drug

By Zhang Xiaoyi

According to the CDE website on June 2, Jiangsu Hansoh Pharmaceutical's Enzalutamide Capsules were submitted for marketing approval as a Class 4 generic drug. Upon approval for production, it will be considered to have passed the consistency evaluation and is expected to become the first domestic generic version of this product in China.

The originator of this product is Astellas. On November 26, 2019, Astellas announced that its enzalutamide capsules had been approved by the National Medical Products Administration for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic and have not received chemotherapy after failure of androgen deprivation therapy (ADT).

Enzalutamide, a next-generation androgen receptor inhibitor initially co-developed by Astellas and Medivation, was acquired by Pfizer in August 2016 when it purchased Medivation for $14 billion.

The drug was first approved by the FDA in August 2012 for the treatment of advanced castration-resistant prostate cancer (CRPC), under the brand name Xtandi. In 2019, global sales of enzalutamide reached approximately $4.3 billion, making it an undisputed blockbuster in the current prostate cancer market.

In China, the marketing application for imported enzalutamide soft capsules was accepted by the Center for Drug Evaluation (CDE) on April 16, 2018, with the acceptance number JXHS1800020. On June 13 of the same year, this application was included in the priority review by the CDE on the grounds of being an “innovative drug with significant therapeutic advantages.” The entire process from submission to approval took 19 months.

Insight database shows that, in addition to Hansoh Pharma, Kelun Pharmaceutical’s generic drug is currently undergoing bioequivalence (BE) trials; furthermore, clinical trial approvals have been granted to six other companies.

Merely six months after the original drug was approved for import, the first domestic generic version submitted its marketing application, demonstrating remarkable speed. However, according to the Insight database, the compound patent for enzalutamide in China does not expire until 2026. Even if a company obtains marketing approval before the patent expires, it cannot commercially launch the product during the patent term. Nevertheless, it is understood that Fosun Pharma has successfully challenged the domestic patent.