宣泰醫藥(688247.SH):枸櫞酸託法替布緩釋片美國仿製藥申請獲得臨時性批准
格隆匯10月16日丨宣泰醫藥(688247.SH)接受特定對象調研時表示,公司向美國FDA申報的枸櫞酸託法替布緩釋片的新藥簡略申請(ANDA,即美國仿製藥申請)於2023年8月獲得臨時性批准。
公司進行ANDA申報時,已針對製劑專利提交了PIV聲明(專利是無效的、不可執行的或仿製藥不侵犯專利),並在發送給原研的通知函中詳細説明了公司申報的枸櫞酸託法替布緩釋片不會侵犯原研的製劑專利;截至目前,專利訴訟正在審理中。如專利挑戰成功,公司的枸櫞酸託法替布緩釋片產品最早可於化合物專利到期後具備在美國市場上市銷售的資格;如專利挑戰失敗,公司的枸櫞酸託法替布緩釋片產品將於製劑專利到期後具備在美國市場上市銷售的資格。
與此同時,公司與 LANNETT COMPANY, INC.就該產品簽署了《開發、分銷及供應協議》。根據協議,針對公司研發的枸櫞酸託法替布緩釋片(11mg、22mg)產品,公司將與 LANNETT 合作推進產品的後續開發工作;同時授予 LANNETT 獨家知識產權許可,LANNETT 可在美國境內使用、分銷、進口、銷售協議產品。公司預計將獲得合計最高不超過 600 萬美元的里程碑付款以及相應比例的銷售分成。
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