Qilu Pharmaceutical's Class 4 Generic Aprepitant Capsule Nears Approval as China's First Domestic Version

Author | Dopine

Recently, the marketing application for Qilu Pharmaceutical’s Class 4 generic drug, Aprepitant Capsules (acceptance numbers CYHS1800538 and CYHS1800539), has changed its status to “Under Review” at the NMPA, indicating that the approval of the first domestically produced Aprepitant Capsules is imminent.

Aprepitant, the originator drug developed by Merck & Co., is a neurokinin-1 (NK-1) receptor antagonist that highly selectively binds to and blocks NK-1 receptors, thereby inhibiting chemotherapy-induced nausea and vomiting.

This drug is the first globally approved NK-1 receptor antagonist antiemetic and the first pitant drug marketed in China. It is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy.

In March 2003, the originator aprepitant was approved by the FDA under the brand name Emend, and it is currently approved for marketing in more than 90 countries and regions worldwide. It is reported that global sales of Emend reached $522 million in 2018.

In September 2013, aprepitant capsules were approved in China under the brand name Emend. According to public databases, the sales of Emend at the terminal level of public hospitals in key provinces and municipalities across China amounted to RMB 74.78 million in 2018.

Currently, Qilu Pharmaceutical, Chia Tai Tianqing, and Nanjing Chia Tai Tianqing have successively submitted marketing applications for aprepitant capsules as Class 4 generic drugs in China. In addition, Granmark Corp. has also submitted an import application for aprepitant capsules. Based on the current review progress, Qilu Pharmaceutical is expected to break through first and secure the approval for the first generic version of aprepitant capsules.

In the first half of 2020, Qilu Pharmaceutical was arguably one of the biggest winners in generic drug approvals. According to data from PharmaCube, a total of 10 generic drugs were approved; unfortunately, none of them were first-to-market generics.

Furthermore, it is worth noting that Qilu Pharmaceutical was the major winner in the consistency evaluation during the first half of 2020, with a total of 12 drugs passing the evaluation. Among them, seven varieties—Bivalirudin for Injection, Capecitabine Tablets, Pregabalin Capsules, Leflunomide Tablets, Exemestane Tablets, Oxaliplatin Injection, and Cefprozil Granules—were the first to pass the consistency evaluation.