Qilu Pharmaceutical's Class 4 Generic Abiraterone Acetate Tablets Approved for Launch in China

On April 15, the official website of the National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical’s Class 4 generic drug, Abiraterone Tablets, had received approval, becoming the fourth domestically produced generic version of this product following Hengrui Medicine, Chia Tai Tianqing, and Jiangxi Xiangshan Pharmaceutical.

All Three Generic Drugs in the Centralized Procurement Were Successfully Selected

On July 5, 2019, Jiangsu Hengrui Medicine successfully secured the first generic approval for "Abiraterone Acetate Tablets." Shortly thereafter, on July 17, Chia Tai Tianqing announced the market approval of its "Abiraterone Acetate Tablets." Xiangshan Pharmaceutical also received approval on September 17. All three companies successfully joined the national second batch of centralized volume-based procurement, with their bids accepted at prices of RMB 3,828, RMB 2,800, and RMB 4,296 per box, respectively. The originator product from Johnson & Johnson was unfortunately excluded.

Abiraterone acetate tablets are a novel prostate cancer therapeutic agent with a unique mechanism of action, featuring a well-defined clinical positioning and widespread application. The originator company is Johnson & Johnson. It was first launched in the United States on April 28, 2011, under the brand name Zytiga. Benefiting from a surge in the European market, its global sales reached a peak of $3.5 billion in 2018. In 2019, Zytiga’s global sales amounted to $2.795 billion, representing a significant year-on-year decline of 20%.

In China, the original drug was approved on May 6, 2015, for use in combination with prednisone or prednisolone as first-line treatment for newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC), including patients with mHSPC who have not received prior endocrine therapy or have received endocrine therapy for ≤3 months.

In July 2017, the price of the originator abiraterone was reduced by 52.9% for inclusion in the National Reimbursement Drug List (NRDL), leading to a significant increase in sales volume. Sales in sample hospitals reached RMB 320 million in 2018, representing a nearly six-fold year-on-year growth. In 2019, with the release of the new NRDL, abiraterone was transferred to the regular reimbursement list due to the approval of generic versions. Amid the continuous approval of generics and the orderly implementation of centralized volume-based procurement, the originator abiraterone in China has faced substantial pressure.

Intense R&D Competition as Indian Generics Enter the Market

Prostate cancer is the second most common type of tumor in men worldwide. Approximately 1 in 9 men will be diagnosed with prostate cancer during their lifetime, with about 1.3 million new cases reported globally in 2018. In the United States, an estimated 174,650 men were expected to be diagnosed with prostate cancer in 2019. In China, prostate cancer is the most common genitourinary cancer among men, with an incidence rate of approximately 9.8 per 100,000 population.

It is understood that abiraterone acetate combination therapy has been designated as a first- or second-line treatment option for prostate cancer by clinical guidelines in Europe and the United States. Its favorable clinical efficacy, coupled with strong market performance, has spurred domestic companies to compete in developing generic versions.

According to the Insight database, four domestically produced abiraterone products have been approved in China. Additionally, three companies—Dr. Reddy’s Laboratories (India), Hangzhou Heze Kunyuan Pharmaceutical, and Lianyungang Jierui Pharmaceutical—have submitted marketing applications. Furthermore, two other products are currently in clinical trials.

Original Title: Qilu Pharmaceutical’s “Abiraterone” Approved for Market Launch