FOSUNPHARMA/Helsinn’s Class 5.1 Imported New Drug AKYNZEO® Concentrated Solution for Injection Approved for Marketing
On May 29, the NMPA official website shows that FOSUNPHARMA/Helsinn’s Class 5.1 imported new drug, AKYNZEO® concentrated solution for injection, obtains marketing approval in China for the prevention of chemotherapy‑induced nausea and vomiting.
AKYNZEO® intravenous injection (NEPA) is a fixed‑dose combination product containing 235 mg of fosnetupitant (equivalent to 260 mg of fosnetupitant chloride hydrochloride) and 0.25 mg of palonosetron (equivalent to 0.28 mg of palonosetron hydrochloride).
Among the two components, fosnetupitant (netupitant) is a neurokinin‑1 (NK1) receptor antagonist, while palonosetron is a 5‑hydroxytryptamine type‑3 (5‑HT3) receptor antagonist. The combination covers the entire phase (acute and delayed) of chemotherapy‑induced vomiting, improves the control rate of refractory vomiting through dual‑pathway blockade, and simplifies the clinical antiemetic regimen.
According to Insight Database, this drug first received marketing approval in the United States in April 2018, in combination with dexamethasone for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy in adults. In December 2021, the drug also obtained approval in the European Union.
As early as October 2021, FOSUNPHARMA signed an exclusive license and distribution agreement with the Helsinn Group for a series of products. Under the agreement, effective from October 1, 2021, Helsinn grants FOSUNPHARMA’s wholly‑owned Swiss subsidiary, Fosun Pharma AG, the exclusive right to distribute, promote and sell Aloxi®, Akynzeo® and Anamorelin in Mainland China, Hong Kong and Macau.
These products include two already approved products, Aloxi® (palonosetron hydrochloride) and Akynzeo® oral (netupitant and palonosetron hydrochloride), the intravenously administered NEPA (fosnetupitant and palonosetron hydrochloride) that receives approval in this announcement, and Anamorelin (a novel selective oral ghrelin receptor agonist) which has not yet been submitted for approval in China.
