以嶺藥業(002603.SZ):連花清瘟膠囊獲得新加坡註冊批文
格隆匯5月6日丨以嶺藥業(002603.SZ)公佈,近日,公司收到新加坡衞生科學局(HSA)核准簽發的“中成藥”註冊批文,批准公司藥品連花清瘟膠囊符合新加坡中成藥標準註冊。連花清瘟產品為公司的主導產品、國家基本藥物目錄和國家醫保目錄(甲類)品種,主要用於感冒、流感相關疾病的治療。
連花清瘟產品先後多次被國家衞生健康委、國家中醫藥管理局列入感冒、流感相關疾病診療方案。2020年連花清瘟膠囊/顆粒被列為國家衞生健康委和國家中醫藥管理局聯合發佈的《新型冠狀病毒感染的肺炎診療方案》(試行第四/五/六/七版)推薦用藥。2020年4月12日,國家藥品監督管理局批准連花清瘟膠囊/顆粒在原批准適應症的基礎上,增加“新型冠狀病毒肺炎輕型、普通型”的新適應症。
2019年度,公司連花清瘟產品實現營業收入17.03億元,佔公司總營業收入的29.24%。2020年一季度,連花清瘟產品實現營業收入15.42億元,佔公司總營業收入的66.07%。
公司表示,此次連花清瘟膠囊獲得新加坡中成藥註冊批文,標誌着公司具備了在新加坡市場以藥品身份銷售該產品的資格,對公司拓展海外市場帶來積極影響。
截止目前,連花清瘟膠囊已在中國的香港地區、澳門地區和巴西、印度尼西亞、加拿大、莫桑比克、羅馬尼亞、泰國、厄瓜多爾分別以“中成藥”、“藥品”、“植物藥”、“天然健康產品”、“食品補充劑”、“現代植物藥”、“天然藥物”等身份註冊獲得上市許可。
公司強調,目前海外銷售收入佔公司營業總收入比例較低,暫未實現規模銷售,對公司經營業績不構成重大影響。
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