6月7~12日，默沙東的帕博利珠單抗皮下注射制劑（MK-3475A）在CDE提交24條上市申請并獲受理。這是國內(nèi)首款申報上市的皮下注射PD-1抗體藥物。

此前，今年3月美國 FDA 已受理該皮下制劑的上市申請，覆蓋 Keytruda 已獲批的全部實(shí)體瘤適應(yīng)癥，PDUFA 日期為2025年9月23日。

K藥是由默沙東自主研發(fā)的一款PD-1人源化單克隆抗體，它通過與PD-1受體結(jié)合來阻斷受體PD-1與PD-L1、PD-L2這兩配體之間的作用，從而起到抑制腫瘤細(xì)胞的效果。K藥在全球范圍內(nèi)獲批的適應(yīng)癥更是種類繁多，目前K藥在全球范圍內(nèi)已獲批近40項適應(yīng)癥。自2018年7月20日正式進(jìn)入國內(nèi)市場后，它已覆蓋黑色素瘤、肺癌、食管癌、結(jié)直腸癌、頭頸部癌、胃癌、肝癌、乳腺癌、膽道癌及MSI-H實(shí)體瘤領(lǐng)域的治療。

帕博利珠單抗注射液（Pembrolizumab）是K藥的皮下制劑，是由K藥和Alteogen公司開發(fā)的透明質(zhì)酸酶變體（berahyaluronidase alfa，ALT-B4）結(jié)合而成的配方，旨在增加藥物使用的方便性。

今年3月份，默沙東在2025年ELCC（歐洲肺癌大會上）宣布帕博利珠單抗皮下注射液一線治療轉(zhuǎn)移性非小細(xì)胞肺癌（NSCLC）患者3期臨床研究MK-3475A-D77試驗頂線結(jié)果：

該研究達(dá)到了主要終點(diǎn)：MK-3475A+化療非劣于K藥靜脈注射液（IV）+化療；

在次要終點(diǎn)方面：兩組的療效也一致。皮下和靜脈組的 ORR 分別為 45.4% vs 42.1%、中位 DOR 分別為 9.1 個月 vs 8.0 個月，中位 PFS 分別為 8.1 個月 vs 7.8 個月，兩組的中位 OS 均未達(dá)到。兩組也表現(xiàn)出一致的安全性，其中≥3 級不良事件發(fā)生率方面，皮下和靜脈組分別為 47%、47.6%。

此外，與 3475A-D77 研究同時進(jìn)行的前瞻性觀察性時間和動作描述性分析結(jié)果表明，與靜脈注射 Keytruda 相比，皮下注射帕博利珠單抗使患者在椅旁的停留時間分別減少了 49.7%（59.0 分鐘 vs 117.2 分鐘），在治療室的停留時間減少了 47.4%（周平均：66.7 分鐘 vs 126.9 分鐘），并使醫(yī)護(hù)人員在治療準(zhǔn)備、給藥過程和患者監(jiān)護(hù)上的總活動時間減少了 45.7%（周平均：14.0 分鐘 vs 25.8 分鐘）。

K藥在2024年的銷售額高達(dá)294.82億元，儼然逼近300億美元大關(guān)，成為了全球銷售額最高的處方藥。K藥皮下注射劑獲批，有望帶來銷售額的提升，還有可能帶來專利期延長。不過，2024年透明質(zhì)酸酶技術(shù)霸主Halozyme以專利侵權(quán)為由發(fā)難，要求默沙東支付3%-7%特許權(quán)使用費(fèi)，否則將申請禁令，阻止默沙東銷售K藥皮下制劑。K藥皮下注射劑最紅能否再次上演后發(fā)先至，或許要取決于這場專利糾紛。

目前全球已有三款皮下PD-1/L1藥物獲批：羅氏阿替利珠單抗（PD-L1）、BMS納武利尤單抗（PD-1）及康寧杰瑞/思路迪的恩沃利單抗（PD-L1）。默沙東K藥若成功上市，將成為國內(nèi)首款皮下PD-1抑制劑，而國內(nèi)企業(yè)如君實(shí)生物的特瑞普利單抗皮下制劑也已進(jìn)入III期臨床。

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