康方生物(09926.HK)治療中重度斑塊型銀屑病新藥內地上市許可申請獲受理
康方生物(09926.HK)公布,國家藥監局(NMPA)已正式受理由公司自主研發的靶向IL-12 / IL-23的全人源Ig G1單克隆抗體依若奇單抗注射液(研發代號:AK101)的新藥上市許可申請(NDA)。是次申報的適應症為中度至重度斑塊型銀屑病。依若奇單抗是公司成功獲批上市或NDA的第六款自主研發的創新藥物。
研究結果表明,依若奇單抗治療中重度斑塊型銀屑病16周及52周均療效顯著,安全性良好;依若奇單抗在改善皮損的同時還可有效提高患者的生活質量。
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