先聲藥業(02096.HK):侖伐替尼聯合恩沃利單抗臨牀試驗申請獲批
格隆匯6月17日丨先聲藥業(02096.HK)宣佈,於2021年6月17日,公司與思路迪(北京)醫藥科技有限公司("思路迪(北京)醫藥")及江蘇康寧傑瑞生物製藥有限公司("江蘇康寧傑瑞")合作的一項評價恩沃利單抗聯合侖伐替尼治療晚期實體瘤的多中心、開放標籤、Ib/II期臨牀研究的試驗申請已獲得中國國家藥品監督管理局批准。根據該批准,公司擬使用恩沃利單抗聯合侖伐替尼治療經PD-(L)1抑制劑治療耐藥的局部晚期或轉移性非小細胞肺癌(NSCLC)、腎細胞癌(RCC)和肝細胞癌(HCC)患者以及既往未接受過針對晚期疾病系統性治療的局部晚期或轉移性RCC患者。
公司於2020年3月30日與思路迪(北京)醫藥及江蘇康寧傑瑞就恩沃利單抗簽訂了一份三方合作協議,同時單獨與思路迪(北京)醫藥簽訂了一份營銷及推廣協議。上述協議為我們提供了恩沃利單抗在中國大陸於腫瘤治療適應症方面的獨家推廣權。
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