中國生物製藥(01177.HK)：1類創新藥枸櫞酸依奉阿克膠囊"Envonalkib (TQ-B3139)"獲批上市
格隆匯6月19日丨中國生物製藥(01177.HK)宣佈，集團自主研發的1類創新藥枸櫞酸依奉阿克膠囊"Envonalkib (TQ-B3139)"(商品名：安洛晴)已獲得中國國家藥品監督管理局的上市批准，用於未經過間變性淋巴瘤激酶(ALK)抑制劑治療的ALK陽性的局部晚期或轉移性非小細胞肺癌(NSCLC)患者的治療。
依奉阿克是集團自主研發的一款新型ALK抑制劑，此次一線治療ALK陽性NSCLC適應症的獲批，是基於一項依奉阿克對比克唑替尼一線治療ALK陽性晚期NSCLC的多中心、隨機、對照III期臨牀研究(NCT04009317)結果。該研究結果於2023年8月14日發表在Signal Transduction and TargetedTherapy(IF：39.3)。
臨牀數據：療效明顯優於克唑替尼，腦轉移患者獲益顯著
截止2022年8月31日，該III期研究的主要終點獨立評審委員會(IRC)評估的中位無進展生存期(mPFS)結果顯示，依奉阿克對比克唑替尼的mPFS分別為24.87月vs. 11.60月，HR=0.47(P＜0.0001)，腫瘤復發風險降低53%，兩組差異具有顯着的統計學意義。同時，在所有關鍵亞組分析中，依奉阿克均體現出明顯優勢，特別是針對基線存在腦轉移的患者，依奉阿克表現出顯着的獲益(HR=0.36)。兩組基線存在可評估腦轉移病灶的患者總緩解率(ORR)為78.95% vs. 23.81%，緩解持續時間(DoR)為25.82月vs. 7.39月(HR=0.12)；兩組基線具有腦轉移病灶的患者至疾病進展時間(TTP)為30.32月vs. 8.28月(HR=0.31)。結果表明，依奉阿克可顯著延緩腦轉移患者疾病進展或降低新發腦轉移進展的風險。本研究的安全性結果顯示，與研究藥物相關的不良事件與既往同類藥物基本相似，整體安全性可控，未出現新的安全性信號。
市場格局：中國肺癌發病率高，腦轉移患者未滿足需求
大肺癌是中國和全球範圍內發病率和病死率較高的惡性腫瘤，2022年國家癌症中心發佈的《Cancerincidence and mortality in China, 2016》研究報吿顯示，中國肺癌每年新發病例數高達82.8萬人，每年死亡人數65.7萬人，發病率與死亡率均居於所有癌種首位。在NSCLC患者中，ALK突變發生率為3%~7%，隨着我國人口老齡化的加劇和分子診療技術的普及，新發ALK陽性NSCLC患者確診率已展現出逐年升高的趨勢[3]。克唑替尼是第一代ALK抑制劑，其療效顯著優於化療，但仍有接近一半的患者用藥1年左右出現疾病進展，且克唑替尼對中樞神經系統穿透能力較弱，無法有效控制腦轉移的發生和發展，患者獲益有限，仍存在未被滿足的臨牀需求。
枸櫞酸依奉阿克膠囊是繼鹽酸安羅替尼膠囊、富馬酸安奈克替尼膠囊、貝莫蘇拜單抗注射液等產品之後，集團獲批的又一款1類創新藥，意味着集團在肺癌領域的創新產品佈局不斷豐富，對集團的創新發展具有重要意義。
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