Qilu Pharmaceutical Submits NDA for Aprepitant-Palonosetron Emulsion Injection to Address High-Emetogenic Chemotherapy-Induced Nausea and Vomiting

On December 15, the CDE website showed that Qilu Pharmaceutical's Class 2.3 new drugAprepitant Palonosetron Emulsion InjectionThe listing application has been accepted. Based on the clinical research progress of the drug, the Insight database speculates that the indication for this application is forPrevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy Regimens。

Screenshot source: CDE official website

Aprepitant, the original drug developed by Merck, is a neurokinin-1（NK-1）Receptor antagonist, mainly used for the prevention and treatment of nausea and vomiting caused by chemotherapy or surgery. In China, in addition to the original drug, there are multiple generic versions of Aprepitant available on the market. Among them, Qilu Pharmaceutical has developedAprepitant InjectionAndAprepitant CapsulesBoth dosage forms have been approved.

Palonosetron is a 5-HT3 receptor antagonist, mainly used for the prevention and treatment of nausea and vomiting caused by chemotherapy or surgery. The original research drug was developed by the Swiss Helsinn Group.（Helsinn）R&D. In October 2021, Fosun Pharmaceutical reached an agreement with Helsinn Group to obtain products including Netupitant and Palonosetron Capsules.(Product name: Ocozen)The exclusive licensing, distribution, and promotion rights for multiple related tumor supportive treatment drugs, including Akynzeo capsules, in mainland China, Hong Kong, and Macao. Among them, Akynzeo capsules were approved for marketing in mainland China in 2019.

In China, in addition to the original Palonosetron drug, there are multiple generic drugs already on the market, including the Palonosetron Hydrochloride Injection developed by Qilu Pharmaceutical.

Qilu Pharmaceutical's submission this time isA Compound Preparation of Two Drugs — Aripiprazole Palonosetron Emulsion for Injection(Research Code QLM2010)。

According to the Insight database, in October this year, Qilu Pharmaceutical has completed a multi-center, randomized, double-blind, positive drug parallel-controlled Phase III clinical study in China.（CTR20242556）, this trial aims to evaluate the efficacy and safety of QLM2010 in preventing nausea and vomiting induced by highly emetogenic chemotherapy regimens.

Screenshot source:Insight Database

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Editor: Xinyao

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