{"id":61477,"date":"2025-06-24T10:03:52","date_gmt":"2025-06-24T08:03:52","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/zambon-announces-approval-and-launch-in-china-of-the-intravenous-formulation-of-fluimucil-n-acetylcysteine\/"},"modified":"2025-06-24T10:03:52","modified_gmt":"2025-06-24T08:03:52","slug":"zambon-announces-approval-and-launch-in-china-of-the-intravenous-formulation-of-fluimucil-n-acetylcysteine","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/zambon-announces-approval-and-launch-in-china-of-the-intravenous-formulation-of-fluimucil-n-acetylcysteine\/","title":{"rendered":"Zambon Announces Approval and Launch in China of the Intravenous Formulation of Fluimucil\u00ae (N-acetylcysteine)"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<i>The approval in China is supported by a robust local clinical development program confirming the drug\u2019s safety, tolerability, and efficacy profile<\/i><\/li>\n<li>\n<i>The launch strengthens Zambon&#8217;s presence in China and marks a significant step in the company\u2019s commitment to global therapeutic innovation in respiratory diseases, reflecting its dedicated focus on both clinical research and patient care<\/i><\/li>\n<\/ul>\n<p>MILAN&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/hashtag\/China?src=hash\" target=\"_blank\">#China<\/a>&#8212;<b>Zambon<\/b>, 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\u2019 lives better, <b>announces the approval by Chinese regulatory authorities and the launch on the Chinese market of the intravenous (IV) formulation of Fluimucil\u00ae <\/b>(N-acetylcysteine). This milestone marks a significant step in the company\u2019s commitment to global therapeutic innovation in respiratory diseases, reflecting its dedicated focus on both clinical research and patient care.<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20250618274587\/en\/2501473\/5\/Zambon_LogoPositivoCMYK.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250618274587\/en\/2501473\/22\/Zambon_LogoPositivoCMYK.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20250618274587\/en\/2501473\/5\/Zambon_LogoPositivoCMYK.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250618274587\/en\/2501473\/21\/Zambon_LogoPositivoCMYK.jpg\"><\/a><\/p>\n<p>\nAlready available in several international markets, <b>Fluimucil\u00ae IV represents a new option for Chinese patients<\/b>, where it can provide an important hospital-based therapeutic option for treating <b>respiratory diseases characterized by excessive mucus secretion.<\/b><\/p>\n<p>\nThe approval in China follows a locally conducted clinical development program, a <b>Phase 1<\/b> and a <b>Phase 3 <\/b>clinical trial that confirmed the drug\u2019s <b>safety, tolerability, and efficacy profile.<\/b><\/p>\n<p>\nThe <b>Phase 1 <\/b>pharmacokinetics and tolerability <b>study<\/b><sup>1<\/sup><b> <\/b>of Fluimucil\u00ae IV<b> <\/b>in healthy volunteers, run at the <b>Ruijin Hospital<\/b> affiliated with the <b>Shanghai Jiao Tong University School of Medicine<\/b> and led by <b>Prof. Yaozong Yuan<\/b>, showed that single and multiple 600 mg doses of Fluimucil\u00ae IV were well tolerated and free from significant adverse events<sup>2<\/sup>.<\/p>\n<p>\nA pivotal <b>Phase 3 clinical trial<\/b><sup>3<\/sup> &#8211; started in June 2019 and concluded in February 2021 &#8211; involving <b>333 adult patients<\/b> with respiratory diseases and abnormal mucus secretions across <b>28 hospital centers in China, <\/b>and led by <b>Prof. Jieming Qu<\/b>, demonstrated that <b>Fluimucil\u00ae IV<\/b> (600 mg, twice daily) <b>was significantly superior to placebo and non-inferior to intravenous ambroxol hydrochloride<\/b> in reducing sputum viscosity and improving ease of expectoration after 7 days of treatment. The data also demonstrate that the drug is well tolerated<sup>4<\/sup>.<\/p>\n<p>\n\u201c<i>The approval of Fluimucil\u00ae 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<\/i>,\u201d said <b>Paola Castellani, Chief Medical Officer and Head of R&amp;D at Zambon<\/b>. \u201c<i>We would like to sincerely express our gratitude to patients participating in our clinical studies, as well as to investigators for their commitment.<\/i>\u201d<\/p>\n<p>\n\u201c<i>We are proud to celebrate the 60<sup>th<\/sup> anniversary of Fluimucil\u00ae by making its intravenous formulation available in China, confirming the long-standing efficacy of this molecule,\u201d<\/i> said <b>Giovanni Magnaghi, CEO of Zambon<\/b>. \u201c<i>This approval is the result of a joint effort with local scientific communities and reinforces our commitment and sense of responsibility to improving patients&#8217; quality of life.<\/i>\u201d<\/p>\n<p>\nThe <b>intravenous formulation of Fluimucil\u00ae<\/b> will initially be distributed in a selection of Chinese hospitals and represents another step forward in Zambon&#8217;s expansion strategy in the Chinese market.<\/p>\n<p>\nFor further information on Zambon please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.zambon.com%2F&amp;esheet=54278017&amp;newsitemid=20250618274587&amp;lan=en-US&amp;anchor=www.zambon.com&amp;index=1&amp;md5=c80c426a219a49e5dee42311091c24bb\" rel=\"nofollow\" shape=\"rect\">www.zambon.com<\/a><\/p>\n<p>\n<sup>1<\/sup> <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03881163&amp;esheet=54278017&amp;newsitemid=20250618274587&amp;lan=en-US&amp;anchor=Study+Details+%7C+A+Study+to+Evaluate+Pharmacokinetics%2C+Safety+and+Tolerability+of+Single+and+Multiple+Intravenous+Doses+of+N-acetylcysteine+%28NAC%29+in+Chinese+Healthy+Volunteers+%7C+ClinicalTrials.gov&amp;index=2&amp;md5=5598d150baec1cccfc33e0655857ded0\" rel=\"nofollow\" shape=\"rect\">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<\/a>: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03881163&amp;esheet=54278017&amp;newsitemid=20250618274587&amp;lan=en-US&amp;anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03881163&amp;index=3&amp;md5=6d621d60a7c922ccd7a7fe54afb09b6d\" rel=\"nofollow\" shape=\"rect\">https:\/\/clinicaltrials.gov\/study\/NCT03881163<\/a><br \/><sup>2<\/sup> Sun J, Zhang X, Wang L, Di Stefano A F D, Zanin V, Magrone P, Yuan Y : <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.europeanreview.org%2Fwp%2Fwp-content%2Fuploads%2F12103-12111-1.pdf&amp;esheet=54278017&amp;newsitemid=20250618274587&amp;lan=en-US&amp;anchor=Phase+I+study+of+the+pharmacokinetics+and+safety+of+single+and+multiple+doses+of+intravenous+N-acetylcysteine+in+healthy+Chinese+subjects%3A&amp;index=4&amp;md5=d50315a133c8ddf24406aa72f8907631\" rel=\"nofollow\" shape=\"rect\">Phase I study of the pharmacokinetics and safety of single and multiple doses of intravenous N-acetylcysteine in healthy Chinese subjects:<\/a> <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.europeanreview.org%2Fwp%2Fwp-content%2Fuploads%2F12103-12111-1.pdf&amp;esheet=54278017&amp;newsitemid=20250618274587&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.europeanreview.org%2Fwp%2Fwp-content%2Fuploads%2F12103-12111-1.pdf&amp;index=5&amp;md5=ca4dd62a0da605afaee1101bddcd6f31\" rel=\"nofollow\" shape=\"rect\">https:\/\/www.europeanreview.org\/wp\/wp-content\/uploads\/12103-12111-1.pdf<\/a><br \/><sup>3<\/sup> <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03843541&amp;esheet=54278017&amp;newsitemid=20250618274587&amp;lan=en-US&amp;anchor=Study+Details+%7C+A+Clinical+Trial+to+Compare+the+Efficacy+and+Safety+of+1-week+Treatment+of+Intravenous+N-acetylcysteine+%28NAC%29+600+mg+Twice+Daily%2C+Ambroxol+Hydrochloride+30+mg+Twice+Daily+and+Placebo+as+Expectorant+Therapies+in+Adult+Chinese+Patients+With+Respiratory+Tract+Diseases+and+Abnormal+Mucus+Secretions+%7C+ClinicalTrials.gov&amp;index=6&amp;md5=3b41317161db7f81861a63cdff8c3897\" rel=\"nofollow\" shape=\"rect\">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<\/a>: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03843541&amp;esheet=54278017&amp;newsitemid=20250618274587&amp;lan=en-US&amp;anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03843541&amp;index=7&amp;md5=d2f7a43a7bd912f45dde7bc4aadb3633\" rel=\"nofollow\" shape=\"rect\">https:\/\/clinicaltrials.gov\/study\/NCT03843541<\/a><br \/><sup>4<\/sup> Tang W, Zhu D, Wu F, Xu J-F, Yang J-P, Deng Z-P, Chen X-B, Papi A, Qu J-M <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.europeanreview.org%2Fwp%2Fwp-content%2Fuploads%2F5119-5127.pdf&amp;esheet=54278017&amp;newsitemid=20250618274587&amp;lan=en-US&amp;anchor=Intravenous+N-acetylcysteine+in+respiratory+disease+with+abnormal+mucus+secretion&amp;index=8&amp;md5=6871f7e7f57dad20aefdeec71b519822\" rel=\"nofollow\" shape=\"rect\">Intravenous N-acetylcysteine in respiratory disease with abnormal mucus secretion<\/a>: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.europeanreview.org%2Fwp%2Fwp-content%2Fuploads%2F5119-5127.pdf&amp;esheet=54278017&amp;newsitemid=20250618274587&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.europeanreview.org%2Fwp%2Fwp-content%2Fuploads%2F5119-5127.pdf&amp;index=9&amp;md5=d22654423c92dbbdfd755f4a01c022b0\" rel=\"nofollow\" shape=\"rect\">https:\/\/www.europeanreview.org\/wp\/wp-content\/uploads\/5119-5127.pdf<\/a><\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Media Contacts<\/b><br \/>Marco Allegrini, Corporate Communications<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;&#105;&#x6c;&#116;&#x6f;&#58;&#x6d;&#101;&#x64;&#105;&#x61;&#64;&#x7a;&#97;&#x6d;&#98;&#x6f;&#110;&#x67;&#114;&#x6f;&#117;&#x70;&#46;&#x63;&#111;&#x6d;\" rel=\"nofollow\" shape=\"rect\">&#109;e&#x64;i&#x61;&#64;&#x7a;a&#x6d;&#98;&#x6f;&#110;&#x67;&#114;&#x6f;&#117;p&#46;c&#x6f;m<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The approval in China is supported by a robust local clinical development program confirming the drug\u2019s safety, tolerability, and efficacy profile The launch strengthens Zambon&#8217;s presence in China and marks a significant step in the company\u2019s commitment to global therapeutic innovation in respiratory diseases, reflecting its dedicated focus on both clinical research and patient care &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/zambon-announces-approval-and-launch-in-china-of-the-intravenous-formulation-of-fluimucil-n-acetylcysteine\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-61477","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Zambon Announces Approval and Launch in China of the Intravenous Formulation of Fluimucil\u00ae (N-acetylcysteine) - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/zambon-announces-approval-and-launch-in-china-of-the-intravenous-formulation-of-fluimucil-n-acetylcysteine\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" 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