Techdagar Successfully Secures First-to-File Generic of $1.5B Blockbuster Everolimus

Recently, Everolimus Tablets submitted by CHIATAI TIANQING Pharmaceutical for marketing approval as a Class 4 generic drug have entered the administrative approval stage. Currently, no generic version of this product has been approved in China. In 2020, the combined sales volume in China's public medical institutions and urban retail pharmacy terminals exceeded RMB 100 million. Data from Menet Network shows that since 2018, CHIATAI TIANQING Pharmaceutical has obtained marketing approval for nine antineoplastic and immunomodulatory agents submitted under the new classification system, five of which are first-to-market generics.

Source: Official Website of the National Medical Products Administration

Everolimus is an mTOR inhibitor developed by Novartis. As a rapamycin derivative, it forms a complex with immunophilin to interfere with the synthesis of regulatory proteins controlling cellular metabolism and proliferation, thereby exerting triple anti-tumor effects: inhibition of tumor cell growth and proliferation, suppression of tumor nutrient metabolism, and anti-angiogenic activity.

Global Sales of Everolimus

Source: MENET Multinational Listed Companies Sales Database

Everolimus was first approved for marketing in Sweden in 2003, subsequently launched in Europe, the United States, Japan, and other regions, and secured approvals for multiple indications, with global sales reaching $1.535 billion in 2020.

The originator product was approved for marketing in China in January 2013 and was included in the national medical insurance reimbursement list through negotiation in 2017. In 2020, its total sales across urban public hospitals, county-level public hospitals, urban community health centers, and township health centers in China (hereinafter referred to as Chinese public medical institutions), as well as physical retail pharmacies in Chinese cities, exceeded RMB 100 million.

Sales Performance of Everolimus Tablets in Urban Retail Pharmacies in China (Unit: 10,000 RMB)

Source: MENET Competitive Landscape of China's Urban Retail Pharmacy Market

China's public medical institution terminal remains the "main battlefield" for everolimus, but the physical pharmacy terminal has also maintained a robust expansion trend, achieving a growth rate of 20.13% in 2020, which surpassed the 9.68% growth rate of the public medical institution terminal.

Antineoplastic and Immunomodulatory Agents Approved for Marketing by Chia Tai Tianqing Pharmaceutical Since 2018 (New Registration Classification)

Source: Menet MED2.0 China Drug Review Database

According to Menet data, from 2018 to the present (calculated based on the status start date), nine anti-tumor and immunomodulatory drugs submitted for production under the new classification system by Chia Tai Tianqing Pharmaceutical have been approved for marketing and are deemed to have passed the consistency evaluation. Among them, Lenvatinib Mesylate Capsules (jointly), Fulvestrant Injection, Pomalidomide Capsules, Bendamustine Hydrochloride for Injection, and Azacitidine for Injection (jointly) are first-to-market generics.

Source: MENET Database, Official Website of the National Medical Products Administration

Note: The China Urban Physical Pharmacy Terminal Competitive Landscape Database is an expanded urban physical pharmacy database that covers physical pharmacies in 293 prefecture-level and above cities in China (excluding pharmacies in counties, townships, and villages) and continuously monitors all product categories. The aforementioned sales figures are calculated based on the average retail price of products at the terminal. Data statistics are as of September 2. Should there be any omissions or inaccuracies, corrections are welcome!