Hansoh Pharma's Fulvestrant Injection Nears Approval as Second Domestic Generic

On November 11, the listing application for Hansoh Pharma's generic fulvestrant entered the administrative approval stage and is expected to be approved soon. If approved, this would become the second domestically produced fulvestrant injection in China.

Source: NMPA Official Website

Fulvestrant is an estrogen receptor (ER) downregulator, which can block the binding of estrogen to ER. It is clinically used for the treatment of postmenopausal women with ER+ locally advanced or metastatic breast cancer that has recurred after or during anti-estrogen adjuvant therapy, or progressed during anti-estrogen therapy.

The original developer of Fulvestrant is AstraZeneca. On April 25, 2002, the FDA approved the listing of Fulvestrant Injection for postmenopausal women with breast cancer whose condition continues to worsen after treatment with anti-estrogen drugs (such as Tamoxifen). In 2018, the drug's sales reached a peak of $1.028 billion. Subsequently, due to the impact of generic drugs, its sales have been declining, with sales of $580 million in 2020.

Fulvestrant Original Global Sales (Insight)

From Insight Database (http://db.dxy.cn/v5/home/)

AstraZeneca's original drug entered China in 2010, with the earliest listed price at RMB 5,458.99 per vial, imposing a heavy burden on patients. In 2017, Fulvestrant Injection was included in the Class B National Medical Insurance Catalog after a negotiated price reduction of 43%. The medical insurance payment standard was set at RMB 2,400 (5ml: 0.25g/vial), and that year, sales revenue in sample hospitals exceeded RMB 48.4 million, showing significant growth. In the 2019 renewal negotiations, AstraZeneca failed to reduce the price and missed the opportunity; however, in the updated medical insurance catalog released in 2020, Fulvestrant finally returned to the Class B list, with the latest medical insurance payment price at RMB 2,306 per vial. After medical insurance reimbursement, patients' out-of-pocket expenses do not exceed RMB 1,000.

In October 2019, Fulvestrant Injection was listed as one of the 33 varieties in the "First Batch of Encouraged Generic Drug Directory." The first domestic generic was obtained by Zhengda Tianqing, known as the "King of First Generics," in August 2020. Now, following Tianqing, Hansoh Pharma's Fulvestrant has also entered the administrative approval stage, indicating that the second domestically produced generic is finally on its way. Additionally, according to the Insight database, Dr. Reddy's Laboratories from India and Hangzhou Jiuyuan Gene Engineering have already submitted their marketing applications, and three foreign companies have been approved for clinical trials. Overall, the competition remains relatively moderate.

Fulvestrant Competitive Landscape in China (Insight)

From Insight Database (http://db.dxy.cn/v5/home/)