- FLUIMUCIL® (Acetylcysteine Injection) is the first and only acetylcysteine injection product approved in China for the treatment of respiratory diseases associated with excessive mucous secretion[1].
- In addition to its mucolytic, expectorant, and antitussive effects, FLUIMUCIL® (Acetylcysteine Injection) also offers multi-dimensional lung protection, including anti-inflammatory, antioxidant properties, and inhibition of bacterial and viral adhesion and replication.
- Clinical data shows that FLUIMUCIL® (Acetylcysteine Injection) not only reduces mucous viscosity and alleviates expectoration difficulties but also significantly improves the prognosis of patients with severe respiratory conditions, shortening hospital stays and reducing mortality rates.
- With well-established efficacy and a strong safety profile, FLUIMUCIL® (Acetylcysteine Injection) provides a novel therapeutic option for critically ill patients who are unable to tolerate oral or nebulized therapies.
May 21, 2025 - Hong Kong WinHealth Pharma Group (WinHealth Pharma) announces that the National Medical Products Administration (NMPA) of China has officially approved FLUIMUCIL® (Generic Name: Acetylcysteine Injection) an originator product developed by Zambon SpA, for the treatment of respiratory tract diseases with thick mucous secretions, such as: acute bronchitis, chronic bronchitis and exacerbations, emphysema, mucoviscidosis and bronchiectasis.
Mucolytic therapy plays a crucial role in the management of respiratory diseases. Mucus hypersecretion and increased sputum viscosity are common symptoms in various respiratory conditions, including acute bronchitis, exacerbations of chronic bronchitis, emphysema, and bronchiectasis. Viscous sputum not only obstructs the airways, leading to respiratory distress, but can also result in secondary infections, exacerbating the condition. Mucolytic treatment plays a vital role in alleviating symptoms, restoring lung function, and preventing complications. Mucolytic therapy works by reducing sputum viscosity, promoting its clearance, and assisting patients in regaining normal respiratory function, making it an indispensable part of comprehensive respiratory disease management.
The approval is based on the results of a Phase III clinical trial conducted in China, which demonstrated that FLUIMUCIL® (Acetylcysteine Injection) is both highly effective and well-tolerated in patients with respiratory diseases with excessive mucous secretion. Compared to placebo, FLUIMUCIL® (Acetylcysteine Injection) significantly improved sputum viscosity and eased expectoration difficulties in patients[2].
Jack Wang, Chairman of Hong Kong WinHealth Pharma Group, said: "The approval of FLUIMUCIL® (Acetylcysteine Injection) in China marks a significant advancement in providing patients with a highly effective treatment option, particularly for patients with severe respiratory conditions who are unable to take oral or nebulized therapies. As a company steadfast in its commitment to putting patients first, we leverage our global perspective to introduce innovative therapies and original brands that address patients’ unmet needs. With years of specialized expertise in the respiratory field, this approval represents a major step forward for WinHealth Pharma, reinforcing our dedication to bringing internationally recognized treatments to Chinese patients. Moving forward, we will continue to introduce more cutting-edge therapies to China, expanding access for Chinese patients and contributing to the realization of the 'Healthy China 2030' initiative."
Since its global launch, FLUIMUCIL® (Acetylcysteine Injection) has been widely adopted across multiple countries and regions, owing to its exceptional efficacy and strong safety profile. Due to its antioxidant properties, FLUIMUCIL® (Acetylcysteine Injection) has been included in the Italian COVID-19 treatment guidelines for the management of COVID-19. Additionally, ongoing research into its mucolytic and antioxidant effects continues to be published, further underscoring its broad clinical potential.
About FLUIMUCIL® (Acetylcysteine Injection)
Fluimucil® (Acetylcysteine Injection), a product of Zambon SpA, has been granted exclusive commercialization rights in Mainland China to WinHealth Pharma, following a strategic agreement signed on February 24, 2025. FLUIMUCIL® (Acetylcysteine Injection) is a mucolytic medicine with multiple mechanisms of action. The active substance of this product is acetylcysteine (chemical name: N-acetyl-L-cysteine; abbreviation NAC), a synthetic amino acid derivative that effectively depolymerizes mucoproteins in sputum[3], reducing its viscosity and promoting its clearance. In addition, NAC also exhibits antioxidant and anti-inflammatory properties, which help alleviate respiratory inflammation and protect lung tissue from oxidative damage[4]，[5].
Since its market introduction, FLUIMUCIL® (Acetylcysteine Injection) has been widely used in clinical practice, owing to its excellent mucolytic effects and solid safety profile. The mucolytic action occurs in two key ways: first, by breaking the disulfide bonds and disaggregating the mucoproteins in sputum, reducing its viscosity and facilitating expectoration[3]; second, by enhancing the movement of airway cilia and their ability to clear sputum, facilitating the physiological transport of sputum[6]. Clinical studies have demonstrated that FLUIMUCIL® Solution for Injection effectively improves sputum viscosity and expectoration difficulties, with a favorable tolerance profile[2].
About FLUIMUCIL® (Acetylcysteine Injection) Phase III Clinical Trial
The Phase III clinical trial of FLUIMUCIL® (Acetylcysteine Injection) in China evaluated the efficacy and safety of the product in the Chinese population. The study results demonstrated that FLUIMUCIL® intravenous injection (600mg, twice daily) significantly improved sputum viscosity and expectoration difficulty scores from baseline to day 7 compared to placebo. In addition, FLUIMUCIL® (Acetylcysteine Injection) showed rapid onset of action, proven efficacy, and was well-tolerated and safe in patients with acute and chronic respiratory diseases associated with excessive mucus secretion[2].
About WinHealth Pharma
Founded in 2006, WinHealth Pharma is a Hong Kong-headquartered biopharmaceutical company with a comprehensive, end-to-end value chain. The company focuses on three core areas: proprietary pharmaceutical products, CSO business, and specialty care, with a strong commitment to the development and commercialization of cutting-edge medicines. Guided by a patient-first philosophy, we are dedicated to delivering breakthrough therapies and innovative healthcare solutions to patients with cardio-renal diseases, hematologic cancers, gastrointestinal diseases, respiratory and infectious diseases, rare diseases, and other unmet medical needs. Our commitment is to improve patients’ lives through transformative treatments. With a well-established presence in China, WinHealth Pharma is actively expanding across Asia and other international markets, building a comprehensive healthcare ecosystem, driving innovation, and addressing the evolving treatment needs of patients. For more information, please visit www.winhealth.hk.
References
【1】 As of April 2025, the data source: Ding Xiang Yuan database.
【2】 Tang W, , et al. Intravenous N-acetylcysteine in respiratory disease with abnormal mucus secretion. Eur Rev Med Pharmacol Sci. 2023 Jun;27(11):5119-5127. doi: 10.26355/eurrev_202306_32628.
【3】Davis SS, et al. The effect of sulphydryl compounds and cross linking agents on the viscous and viscoelastic properties of mucus. Biorheology. 1975 Jun;12(3-4):225-32. doi: 10.3233/bir-1975-123-415.
【4】Sadowska AM, et al. The interrelationship between markers of inflammation and oxidative stress in chronic obstructive pulmonary disease: modulation by inhaled steroids and antioxidant. Respir Med. 2005 Feb;99(2):241-9. doi: 10.1016/j.rmed.2004.07.005.
【5】Szkudlarek U, et al. D. Effect of inhaled N-acetylcysteine on hydrogen peroxide exhalation in healthy subjects. Pulm Pharmacol Ther. 2004;17(3):155-62. doi: 10.1016/j.pupt.2004.01.007.
【6】Rogers DF. Mucoactive agents for airway mucus hypersecretory diseases. Respir Care. 2007 Sep;52(9):1176-1193.