魯抗醫藥(600789.SH):擬用於治療男性勃起功能障礙的CMS203片獲批臨牀試驗
格隆匯9月14日丨魯抗醫藥(600789.SH)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)核准簽發關於 CMS203片的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。
擬用適應症:男性勃起功能障礙。審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查, CMS203 片符合藥品註冊的有關要求,同意開展臨牀試驗。
該藥品於2021年7月5日受理,受理號為:CXHL2101264、CXHL2101265。該藥品為5 型磷酸二酯酶(PDE5)抑制劑,用於治療男性勃起功能障礙(ED)。
截至目前,該藥品公司已累計直接投入的研發費用約923.05萬元人民幣。
根據我國藥品註冊相關的法律法規要求,藥物在獲得臨牀試驗批准通知書後,尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。
CMS203片為1類創新藥。目前市場上同類藥品主要為西地那非、他達拉非、伐地那非。根據米內網數據顯示,2020 年國內同類藥品銷售額約35億元。
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