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康哲藥業:自願性及業務進展公告 亞甲藍腸溶緩釋片萊芙蘭中國新藥上市申請獲批

CMS: Voluntary and Business Update Announcement New Drug Application of Methylthioninium Chloride Enteric-coated Sustained-release Tablets Lumeblue Approved in China

HKEX ·  Jun 18 17:16

Summary by Futu AI

康哲药业(CMS)宣布,其創新藥物萊芙蘭®的新藥上市許可申請已於2024年6月11日獲得中國國家藥品監督管理局(NMPA)批准,並於6月18日收到藥品註冊證書。該產品是一種口服診斷藥物,用於增強結直腸病變的可視化,以幫助篩查和監測結腸鏡檢查的成人患者。萊芙蘭®採用專利的多基質(MMX)技術,能夠將活性物質直接輸送至結腸並局部控制釋放,從而提高非息肉樣結直腸病變的檢出率。中國III期臨床研究結果顯示,該產品能顯著提高病變檢測率。萊芙蘭®已於2020年在歐盟以Lumeblue™的商品名獲批上市,並於同年12月獲得獨家許可權。隨著中國結直腸癌篩查的普及,預計腸鏡檢查台數將有顯著增長。康哲药业將推進產品的商業化工作,以造福患者。公司股東和投資者被建議在交易時謹慎操作。
康哲药业(CMS)宣布,其創新藥物萊芙蘭®的新藥上市許可申請已於2024年6月11日獲得中國國家藥品監督管理局(NMPA)批准,並於6月18日收到藥品註冊證書。該產品是一種口服診斷藥物,用於增強結直腸病變的可視化,以幫助篩查和監測結腸鏡檢查的成人患者。萊芙蘭®採用專利的多基質(MMX)技術,能夠將活性物質直接輸送至結腸並局部控制釋放,從而提高非息肉樣結直腸病變的檢出率。中國III期臨床研究結果顯示,該產品能顯著提高病變檢測率。萊芙蘭®已於2020年在歐盟以Lumeblue™的商品名獲批上市,並於同年12月獲得獨家許可權。隨著中國結直腸癌篩查的普及,預計腸鏡檢查台數將有顯著增長。康哲药业將推進產品的商業化工作,以造福患者。公司股東和投資者被建議在交易時謹慎操作。
CMS Pharmaceuticals announced that its innovative drug, Levoflan®, has obtained the new drug market approval application from the National Medical Products Administration of China (NMPA) on June 11, 2024, and received a drug registration certificate on June 18. The product is an oral diagnostic drug used to enhance the visualization of colonic lesions to assist in screening and monitoring adult patients undergoing colonoscopy. Levoflan® uses patented multi-matrix (MMX) technology to deliver active ingredients directly to the colon and control local release, thereby improving the detection rate of non-polypoid colonic lesions. The results of Phase III clinical trials in China showed that the product significantly improved lesion detection rates. Levoflan® was approved for marketing in the European Union under...Show More
CMS Pharmaceuticals announced that its innovative drug, Levoflan®, has obtained the new drug market approval application from the National Medical Products Administration of China (NMPA) on June 11, 2024, and received a drug registration certificate on June 18. The product is an oral diagnostic drug used to enhance the visualization of colonic lesions to assist in screening and monitoring adult patients undergoing colonoscopy. Levoflan® uses patented multi-matrix (MMX) technology to deliver active ingredients directly to the colon and control local release, thereby improving the detection rate of non-polypoid colonic lesions. The results of Phase III clinical trials in China showed that the product significantly improved lesion detection rates. Levoflan® was approved for marketing in the European Union under the name Lumeblue™ in 2020 and obtained exclusive licensing rights in December of the same year. With the popularization of colorectal cancer screening in China, the number of colonoscopy examinations is expected to increase significantly. CMS Pharmaceuticals will promote the commercialization of the product for the benefit of patients. Shareholders and investors are advised to exercise caution when trading.

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