翰宇藥業(300199.SZ)收到利拉魯肽注射液註冊申請受理通知書
格隆匯10月31日丨翰宇藥業(300199.SZ)公佈,公司近日收到國家藥品監督管理局(“國家藥監局”)下發的《受理通知書》,公司利拉魯肽注射液申報生產的藥品註冊申請已獲正式受理。
利拉魯肽是一種胰高血糖素樣肽-1(GLP-1)類似物,可以激活人GLP-1受體,促進胰腺細胞分泌胰島素。利拉魯肽與傳統口服降糖藥和胰島素的區別是,能根據體內葡萄糖水平高低“按需”調節胰島素分泌,具有模擬人體自身內分泌、保護胰島β細胞功能的作用,因此不僅具有降低心血管風險和心血管死亡風險的特點,在長期需要大劑量胰島素治療的2型糖尿病患者接受利拉魯肽治療6個月後,可見肝臟和皮下脂肪的減少和胰島素分泌的改善,未來發展潛力巨大。
利拉魯肽注射液在國內已被批准用於成人2型糖尿病患者控制血糖;在美國除2型糖尿病治療外,還獲批用於肥胖症的治療。
據國際糖尿病聯盟(International Diabetes Federation,IDF)統計,預計到2045年全球糖尿病患者將達到6.29億,我國是糖尿病患者(20-79歲)人數最多的國家,2017年達到了1.14億,2045年可能達到1.5億以上。隨着城市化、老齡化和超重肥胖患病率的增加,診斷率、就診率的提高,未來5年,中國糖尿病醫療市場還有較大增長。目前全球僅有原研廠家諾和諾德的利拉魯肽注射液上市銷售,根據IQVIA數據顯示,2018年利拉魯肽注射液全球銷售額達59億美元。
2017年9月,公司收到國家食品藥品監督管理總局核准簽發的關於利拉魯肽注射液的《藥物臨牀試驗批件》;2018年11月通過了《人類遺傳資源採集、收集、買賣、出口、出境審批決定》;2019年10月,公司利拉魯肽注射液申報生產的藥品註冊申請獲國家藥監局受理。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!

Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.