Zambon Secures Chinese Approval for Intravenous Fluimucil Following Successful Phase 3 Trial
Key Insights
Zambon (search) has received Chinese regulatory approval and launched the intravenous formulation of Fluimucil (N-acetylcysteine) for treating respiratory diseases with excessive mucus secretion.
A pivotal Phase 3 trial involving 333 patients across 28 Chinese hospitals demonstrated that IV Fluimucil was significantly superior to placebo and non-inferior to ambroxol in reducing sputum viscosity.
The approval follows a robust local clinical development program including Phase 1 and Phase 3 studies that confirmed the drug's safety, tolerability, and efficacy profile.
Zambon (search), the Italian multinational pharmaceutical company, has announced the approval by Chinese regulatory authorities and market launch of the intravenous formulation of Fluimucil (N-acetylcysteine) for treating respiratory diseases characterized by excessive mucus secretion. The milestone represents a significant advancement in hospital-based therapeutic options for Chinese patients and strengthens Zambon's presence in the Chinese market.
Clinical Evidence Supporting Approval
The Chinese approval follows a comprehensive local clinical development program consisting of Phase 1 and Phase 3 trials that confirmed the drug's safety, tolerability, and efficacy profile. The Phase 1 pharmacokinetics and tolerability study conducted at Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine (search), led by Prof. Yaozong Yuan, demonstrated that single and multiple 600 mg doses of Fluimucil IV were well tolerated and free from significant adverse events in healthy volunteers.
Pivotal Phase 3 Trial Results
The pivotal Phase 3 clinical trial, conducted from June 2019 to February 2021, enrolled 333 adult patients with respiratory diseases and abnormal mucus secretions across 28 hospital centers in China. Led by Prof. Jieming Qu, the study demonstrated that Fluimucil IV administered at 600 mg twice daily was significantly superior to placebo and non-inferior to intravenous ambroxol hydrochloride in reducing sputum viscosity and improving ease of expectoration after 7 days of treatment. The trial data also confirmed that the drug is well tolerated.
Company Leadership Perspectives
"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 (search). "We would like to sincerely express our gratitude to patients participating in our clinical studies, as well as to investigators for their commitment."
Giovanni Magnaghi, CEO of Zambon (search), emphasized the historical significance of the approval: "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."
Market Access and Distribution Strategy
The intravenous formulation of Fluimucil will initially be distributed in a selection of Chinese hospitals, representing another step forward in Zambon (search)'s expansion strategy in the Chinese market. Already available in several international markets, Fluimucil IV now provides Chinese healthcare providers with an important hospital-based therapeutic option for managing respiratory diseases with excessive mucus secretion.