珍寶島(603567.SH):舒血寧注射液獲得藥品補充申請批准通知書
格隆匯11月12日丨珍寶島(603567.SH)公佈,近日公司獲得國家藥監局下發的《藥品補充申請批准通知書》。現將有關情況公吿如下:產品名稱:舒血寧注射液;規格:每支裝5ml(含黃酮醇苷4.2mg、銀杏內酯0.70mg);每支裝10ml(含總黃酮醇苷8.4mg、銀杏內酯1.40mg)。
舒血寧注射液是採用銀杏葉為原料,經提取精製而製成的中藥注射劑,功能主治為擴張血管,改善微循環,用於缺血性心腦血管疾病,冠心病,心絞痛,腦栓塞,腦血管痙攣等。在申報變更藥品規格的補充申請研究中,研發總投入約610萬元。心腦血管中成藥2020年市場規模為847.32億元,其中注射劑市場規模(不含零售)386.48億元,舒血寧注射液2020年市場規模16.73億元。
目前舒血寧注射液生產廠家有8家,共13個品規,廠家以神威藥業、朗致萬榮和石藥銀湖及我公司為主。2020年舒血寧注射液市場份額前三廠家市場集中度達76.16%,第一位神威藥業的舒血寧注射液的市場份額為34.72%,為市場領導品牌;朗致集團萬榮藥業為第二位,市場份額22.27%;珍寶島位居第三位,市場份額為19.19%。
舒血寧注射液新的規格,增加了臨牀使用的便利性及依從性,能夠一定程度上減少安瓿使用產生的職業傷害。目前公司舒血寧注射液產品分別有2ml、5ml和10ml三種規格,規格劑量靈活能夠促進臨牀合理用藥。上述通知書的獲得,更加豐富了公司的產品管線,擴大了產品的銷售空間。
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