復星醫藥(02196.HK):附屬參與研製的FCN-159片獲美國FDA藥品臨牀試驗批准
格隆匯5月31日丨復星醫藥(02196.HK)公佈,近日,公司控股子公司上海復星醫藥產業發展有限公司(簡稱"復星醫藥產業")收到美國FDA(即食品藥品監督管理局)關於同意其參與研製的FCN-159片(以下簡稱"該新藥")用於治療成人和兒童I型神經纖維瘤病(NF1)進行臨牀試驗的函(IND編號:151582)。復星醫藥產業擬於條件具備後於美國進行該新藥針對此次獲批適應症的臨牀試驗。
該新藥為集團(即公司及控股子公司/單位,下同)自主研發的創新型小分子化學藥物,為MEK1/2選擇性抑制劑,擬主要用於晚期實體瘤、I型神經纖維瘤的治療。截至公吿日,該新藥用於具有NRAS突變的晚期黑色素瘤、I型神經纖維瘤的治療於中國境內(不包括港澳台)處於I期臨牀試驗階段。
截至公吿日,於全球上市的MEK1/2選擇性抑制劑主要包括Novartis Pharma
Schweiz AG 的 Trametinib、Roche Pharma (Schweiz) AG 的 Cobimetinib、Pfizer Inc.的Binimetinib以及AstraZeneca PLC的Selumetinib。根據IQVIAMIDASTM最新數據,2020年度,MEK1/2選擇性抑制劑於全球的銷售額約為11.8億美元。
截至2021年4月,集團現階段針對該新藥累計研發投入約為人民幣8,227萬元(未經審計)。
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