Qilu Pharmaceutical's Aprepitant Capsules Granted First Domestic Generic Approval

By Baihuawen

On July 20, Qilu Pharmaceutical’s aprepitant capsules, a Class 4 generic drug, were approved for marketing by the National Medical Products Administration (NMPA), deemed to have passed the consistency evaluation, and marked as the first generic version in China.

Aprepitant is a highly selective neurokinin-1 (NK1) receptor antagonist for substance P. It is clinically indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy.

Merck’s aprepitant, the original research product, was approved by the FDA in March 2003 and entered the Chinese market in May 2013. Currently, the median winning bid price in China is RMB 191.67 per capsule. In 2019, Merck’s aprepitant sales amounted to USD 388 million.

Source: PharmaGo - Bid Winning Database

Merck & Co. also developed fosaprepitant, a prodrug of aprepitant, which was approved in the European Union in January 2008 and in the United States in October 2017. Fosaprepitant is an injectable formulation indicated for patients who are unable to tolerate oral administration due to confusion or disease-related nausea. Currently, the originator product of fosaprepitant has not been approved in China; however, generic versions developed by Hansoh Pharmaceutical and Chia Tai Tianqing have each received approval and been launched on the market. The new drug application for the generic fosaprepitant submitted by Qilu Pharmaceutical is currently under review.

Source: PharmaGo - Listed Drug Database

In China, in addition to Qilu Pharmaceutical, the manufacturers that have submitted marketing applications for aprepitant under the new Class 4 category include Chia Tai Tianqing and Nanjing Chia Tai Tianqing. The manufacturers that have submitted marketing applications under Class 5.2 are Glenmark Pharmaceuticals and Haisco Pharmaceutical.