Zambon Announces Approval and Launch in China of the Intravenous Formulation of Fluimucil® (N-acetylcysteine)

• The approval in China is supported by a robust local clinical development program confirming the drug’s safety, tolerability, and efficacy profile
• The launch strengthens Zambon's presence in China and 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

MILAN--(BUSINESS WIRE)--Zambon, a multinational chemical-pharmaceutical company founded on the history and values of an Italian family and committed to innovate cure and care to make patients’ lives better, 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 study¹ 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 events².

A pivotal Phase 3 clinical trial³ - started in June 2019 and concluded in February 2021 - involving 333 adult patients with respiratory diseases and abnormal mucus secretions across 28 hospital centers in China, and led by Prof. Jieming Qu, demonstrated that Fluimucil® IV (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 data also demonstrate that the drug is well tolerated⁴.

“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 60^th 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.”

The intravenous formulation of Fluimucil® will initially be distributed in a selection of Chinese hospitals and represents another step forward in Zambon's expansion strategy in the Chinese market.

For further information on Zambon please visit www.zambon.com

¹ Study Details | A Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Multiple Intravenous Doses of N-acetylcysteine (NAC) in Chinese Healthy Volunteers | ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT03881163
² Sun J, Zhang X, Wang L, Di Stefano A F D, Zanin V, Magrone P, Yuan Y : Phase I study of the pharmacokinetics and safety of single and multiple doses of intravenous N-acetylcysteine in healthy Chinese subjects: https://www.europeanreview.org/wp/wp-content/uploads/12103-12111-1.pdf
³ Study Details | A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions | ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT03843541
⁴ Tang W, Zhu D, Wu F, Xu J-F, Yang J-P, Deng Z-P, Chen X-B, Papi A, Qu J-M Intravenous N-acetylcysteine in respiratory disease with abnormal mucus secretion: https://www.europeanreview.org/wp/wp-content/uploads/5119-5127.pdf