Zambon, a multinational chemical-pharmaceutical company, announces the approval by Chinese regulatory authorities and the launch on the Chinese market of the intravenous (IV) formulation of Fluimucil (N-acetylcysteine). This milestone marks a significant step in the company’s commitment to global therapeutic innovation in respiratory diseases, reflecting its dedicated focus on both clinical research and patient care.

Already available in several international markets, Fluimucil IV represents a new option for Chinese patients, where it can provide an important hospital-based therapeutic option for treating respiratory diseases characterized by excessive mucus secretion.

The approval in China follows a locally conducted clinical development program, a Phase 1 and a Phase 3 clinical trial that confirmed the drug’s safety, tolerability, and efficacy profile.

The Phase 1 pharmacokinetics and tolerability study of Fluimucil IV in healthy volunteers, run at the Ruijin Hospital affiliated with the Shanghai Jiao Tong University School of Medicine and led by Prof. Yaozong Yuan, showed that single and multiple 600 mg doses of Fluimucil IV were well tolerated and free from significant adverse events.

“The approval of Fluimucil IV in China is a major recognition of the scientific rigor with which we conducted the clinical trials and the quality of our collaboration with local research centers,” said Paola Castellani, Chief Medical Officer and Head of R&D at Zambon. “We would like to sincerely express our gratitude to patients participating in our clinical studies, as well as to investigators for their commitment.”

“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,” said Giovanni Magnaghi, CEO of Zambon. “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.”