健友股份(603707.SH):注射用替加環素獲批上市
格隆匯4月18日丨健友股份(603707.SH)公佈,公司於近日收到國家藥監局關於核准簽發注射用替加環素(規格:50mg)藥品註冊證書的通知(藥品批准文號:國藥準字H20223221)。截至目前,該產品項目已投入研發費用約為2437.39萬元人民幣。
注射用替加環素是第一個甘氨酰環素類抗生素,是四環素類抗生素的半合成衍生物。臨牀用於18歲以上患者在下列情況下由特定細菌的敏感菌株所致感染的治療:複雜性腹腔內感染、複雜皮膚及軟組織感染、社區獲得性肺炎。
注射用替加環素由惠氏(Wyeth)研發,於2005年6月首次在美國食品藥品監督管理局(FDA)批准上市,商品名為Tygacil,持有人為PF PRISM CV;於2010年11月,獲准進口在中國上市銷售,持證商為Pfizer Limited,商品名為泰閣。目前為國家醫保目錄乙類品種。公司注射用替加環素(50mg)已於2021年5月13日已獲得FDA的批准。
經查詢,除公司外,還有江蘇奧賽康、江蘇豪森、湖南賽隆藥業、正大天晴、浙江海正、南京海辰、福安藥業集團、成都百裕製藥、揚子江藥業集團等9家公司的注射用替加環素獲批上市;經查詢,注射用替加環素2020年國內銷售額約為1.74億美元。
公司注射用替加環素獲得國家藥監局簽發的藥品註冊證書,標誌着公司具備了在國內市場銷售該藥品的資格,進一步豐富了公司的產品線,有助於提升公司產品的市場競爭力。根據國家相關政策,公司注射用替加環素按新4類批准生產視同通過一致性評價,並在醫保支付方面予以適當支持,醫療機構應優先採購併在臨牀中優先選用,有利於擴大產品的市場銷售,對公司的經營業績產生積極的影響。
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