邁博藥業-B(02181.HK):國家藥品監督管理局批准核心產品CMAB007(注射用奧馬珠單抗α)的上市註冊申請(NDA)
格隆匯5月23日丨邁博藥業-B(02181.HK)公吿,近日,公司核心產品之一,CMAB007(注射用奧馬珠單抗α)的上市註冊申請(NDA)獲中國國家藥品監督管理局批准,用於治療確診為免疫球蛋白E("IgE")介導的哮喘患者,為中國首個獲國家藥監局批准的國產過敏性哮喘治療性抗體新藥。
CMAB007為一種重組人源化抗IgE單克隆抗體,用於治療確診為IgE介導的哮喘患者的單克隆抗體新藥。CMAB007與遊離IgE相結合,形成抗IgE複合物,能抑制高親和力IgE受體,從而防止過敏反應。CMAB007的安全性及療效已經由共4項臨牀試驗,合共824名受試者接受CMAB007給藥的結果所證實,該等試驗為中國規模最大的治療哮喘的單克隆抗體("mAb")臨牀試驗。公司的臨牀試驗結果顯示,CMAB007能以較低劑量的吸入糖皮質激素改善哮喘病人的病情及降低急性哮喘發病的概率。CMAB007未來預計拓展適應症到慢性特發性蕁麻疹、季節性過敏性鼻炎以及食物過敏。
公司旗下泰州邁博太科藥業有限公司位於江蘇泰州中國醫藥城之抗體藥物生產基地亦已順利通過江蘇省藥品監督管理局對於CMAB007的GMP符合性檢查。
於公吿日期,CMAB007為首個由中國國內公司開發並在中國上市的mAb哮喘療法。CMAB007上市後將有望為超過2000萬中國過敏性疾病患者提供療效更佳的可負擔的生物特效治療藥物。
CMAB007(注射用奧馬珠單抗α)為邁博藥業第二個獲批上市的藥物,亦為首個由中國國內公司開發並在中國上市的mAb哮喘療法,療效顯著,安全便捷,將大大提升中國超過2,000萬過敏性疾病患者福祉。
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