基石藥業-B(02616.HK)：PD-L1抗體舒格利單抗治療T細胞淋巴瘤獲美國FDA授予孤兒藥資格認定
格隆匯 10 月 19日丨基石藥業-B(02616.HK)發佈公告，美國食品藥品監督管理局(“FDA”)授予其PD-L1舒格利單抗(CS1001)孤兒藥資格，用於治療T細胞淋巴瘤。這是繼2020年7月美國FDA授予其抗PD-1單抗CS1003用於治療肝細胞癌的孤兒藥資格後，基石藥業免疫療法產品線獲得美國FDA授予的第二個孤兒藥資格認定。
美國FDA孤兒藥資格認定源自“孤兒藥法案”，是美國FDA鼓勵開發用於治療罕見病創新藥的措施。凡獲得孤兒藥資格認定的新藥，其贊助人可獲得七年市場獨佔權。除此之外，美國FDA對孤兒藥有税費優惠、減免處方藥使用者費用、研發資助、方案協助和快速審批通道等一系列的配套措施。
CS1001-201研究是一項評估舒格利單抗單藥治療復發或難治性(「R/R」)結外自然殺傷細胞/T細胞淋巴瘤(“ENKTL”)有效性及安全性的單臂、多中心、II期關鍵性研究，研究主要終點為獨立影像評估委員會評估的客觀緩解率(「ORR」)。於2020年8月31日，II期關鍵性研究的試驗性新藥申請已經通過美國FDA的審評，並取得了開展研究的許可函。
基石藥業首席醫學官楊建新博士表示：“T細胞淋巴瘤包含不同的病理亞型，ENKTL是其中預後較差的一種亞型，患者正面臨着顯着的未被滿足的治療需求，舒格利單抗相比現有藥物的療效資料是一個巨大的突破。此次美國FDA授予舒格利單抗孤兒藥資格，充分證明了這款藥物的巨大臨牀價值。我們將繼續全力推進該研究，並與美國FDA和中國國家藥品監督管理局密切協作，力爭早日把舒格利單抗帶給全球患者。”
在中國，ENKTL約佔所有淋巴瘤的6%。R/R ENKTL惡性程度高且侵襲性強，預後較差，一年生存率不足20%。目前在中國獲批的靶向單藥治療完全緩解率(“CR”)約為6%。CS1001-201研究作為全球首個針對R/RENKTL的舒格利單抗單藥治療研究，在2020年中國臨牀腫瘤協會年會上，口頭彙報了最新的研究結果。截至2020年7月1日，在38例療效可評估患者中，ORR為44.7%，CR為31.6%，中位緩解持續時間為16.8個月，67.8%的緩解持續時間超過一年。接受給藥的43例患者，中位總生存期19.7個月，一年生存率為55.5%。
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