以嶺藥業(002603.SZ):連花清咳片獲得藥品註冊批件
格隆匯5月17日丨以嶺藥業(002603.SZ)公佈,近日,公司收到國家藥品監督管理局核准簽發的《藥品註冊批件》。
連花清咳片是公司以中醫絡病理論為指導所研製的用於治療急性氣管-支氣管炎的中藥6.1類新藥,屬於2020年版《藥品註冊管理辦法》中藥註冊分類中"中藥創新藥",公司擁有該藥獨立完整的知識產權。截至目前,公司對連花清咳片項目累計研發投入約2,019.80萬元。
急性氣管-支氣管炎以咳嗽、咳痰為主要症狀,可見於任何年齡、任何性別的患者,是最常見的呼吸系統疾病之一,發病率約為肺炎的10倍,哮喘的20倍,34%的患者在隨後3年的隨訪中被診斷為慢性支氣管炎,從而嚴重影響患者生活質量(數據來源:鍾南山.劉又寧.呼吸病學(第二版)[M].北京:人民衞生出版社,2018,393-394.)。中醫藥在呼吸系統疾病治療方面具有療效確切、毒副作用小、不易產生耐藥性等顯着特色優勢,我國止咳化痰類藥物市場也以中成藥為主,近五年中成藥所佔比重均在78%左右,且比重不斷增加,顯示出止咳化痰類中成藥良好的成長性(數據來源:《中國止咳化痰中成藥市場評估與投資戰略報告(2019版)》)。根據米內數據庫數據顯示,2019年度中國城市公立、城市社區、縣級公立、鄉鎮衞生止咳化痰平喘類內服中成藥銷售總額為136.6億元,相比2018年增長了6.1%,其中口服制劑2019年銷售總額115.10億元,相比2018年增長了9.0%,銷售額佔該類功效品種的84.3%,顯示出口服制劑的市場優勢。
連花清咳片是公司繼連花清瘟之後,以中醫絡病理論為指導,集合傳統經典名方及臨牀實踐研製的呼吸系統又一獨家專利創新中藥,具有宣肺泄熱,化痰止咳功效。藥效研究證實,連花清咳片具有阻斷以氣道炎症反應為核心的級聯反應鏈的獨特藥效作用,廣譜抗病毒、抑菌,鎮咳化痰,解痙平喘,解熱抗炎,並可發揮免疫調節調節作用。臨牀試驗結果顯示,在咳嗽症狀消失率、單項症狀改善等方面,連花清咳片與安慰劑對照組比較的差異具有統計學意義。
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