Zambon Pharma has received approval from Chinese regulatory authorities and launched Fluimucil (N-acetylcysteine) intravenous (IV) formulation in the country.
The development signifies an advancement in Zambon’s commitment to therapeutic innovation within respiratory care globally.
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Fluimucil IV is now available to patients across China as an essential hospital-based treatment for respiratory conditions associated with excessive mucus secretion.
Zambon chief medical officer and research and development head Paola Castellani stated: “The approval of Fluimucil IV in China is a major recognition of the scientific rigour with which we conducted the clinical trials and the quality of our collaboration with local research centres.
“We would like to sincerely express our gratitude to patients participating in our clinical studies, as well as to investigators for their commitment.”
The drug’s launch into the Chinese market follows clinical trials, including Phase I and Phase III studies, that verified its safety, efficacy and tolerability.
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By GlobalDataThe Phase I study involved healthy volunteers and was conducted at Ruijin Hospital. It showed that single and multiple Fluimucil IV 600mg doses were well-tolerated.
The Phase III trial was carried out in 333 adult patients and also concluded that the drug is well-tolerated.
With initial distribution focused on select hospitals in China, the development marks another strategic move by Zambon to strengthen its presence within this key market.
Zambon CEO Giovanni Magnaghi stated: “We are proud to celebrate the 60th anniversary of Fluimucil by making its intravenous formulation available in China, confirming the long-standing efficacy of this molecule.
“This approval is the result of a joint effort with local scientific communities and reinforces our commitment and sense of responsibility to improving patients’ quality of life.”
