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2025年国家医保目录调整的预申报应当已经开始了。

4月14日,康诺亚向健识局确认:司普奇拜单抗将参与2025年的国谈。这是第一个获批的国产IL-4单抗,去年9月,司普奇拜单抗首次获批成人中重度特应性皮炎,没能赶上那一年的国谈。

在IL-4靶点上,司普奇拜单抗的竞争对手只有赛诺菲的度普利尤单抗。但在适应症上,司普奇拜单抗的竞争对手不少。特异性皮炎有不少特效药,包括乌帕替尼、阿布昔替尼、克立硼罗软膏等,并且都已进入医保。

康诺亚绝对不能错过今年这个窗口期。正大天晴、恒瑞医药、康方生物、三生国健等8家企业的IL-4Rα单抗都到了临床三期,随时可能冲击康诺亚的市场份额。

目前,司普奇拜单抗还拿到了慢性鼻窦炎伴鼻息肉、季节性过敏性鼻炎两项适应症,康诺亚表示,司普奇拜单抗三项适应症都会申请今年的医保谈判。

对打自免“药王”

根据财报,2024年司普奇拜单抗上市销售3个半月内收入约4300万元。

能做到这个数字,康诺亚已经算很努力了,自免药物在中国的市场向来不好做。自免疾病往往不像肿瘤那样危重,患者对价格敏感,临床上一般用便宜的糖皮质激素等老药为主。创新药即使进入医保,销售放量也不是很明显。

更何况,司普奇拜单抗面对的是自免药物的“药王”度普利尤单抗。

度普利尤单抗2020年在中国获批,用于成人中重度特应性皮炎,当年即谈判成功进入医保。之后的四年里,赛诺菲度普利尤单抗逐步扩大适应症并参加谈判,几次续约降价后,300mg度普利尤单抗的价格已降至1508元。

为了和“药王”掰手腕,司普奇拜单抗在尽力降价,算上赠药每针价格1208元。如果在医保谈判后能维持这个价格,就能比对手便宜300元。

但康诺亚还必须在铺货上与赛诺菲竞争。度普利尤单抗基本在2021年就在大三甲实现了广覆盖,2023年时业界估计就有25亿元的销售额。要想和赛诺菲过招,康诺亚还需花不少成本。

动作要快

司普奇拜单抗去年9月获批,错过了当年医保谈判周期,是比较吃亏的。

IL-4R领域竞争者很多,丝毫不亚于PD-(L)1。据统计,在研的IL-4R单抗有十余个品种,其中8个已经到了临床三期,大部分首发适应症都是特应性皮炎。

对抗特应性皮炎,还有不少其他靶点药物在竞争,包括PDE-4抑制剂、IL-13单抗、JAK1抑制剂、OX40单抗等。康诺亚高管十分清楚,司普奇拜单抗领先其他国产IL-4R厂家约2到3年,这段时间是黄金窗口期,也是康诺亚能争取到的最大空间。

从康诺亚的后续布局来看,在2025国谈中,司普奇拜单抗会充当“开路先锋”的角色。2024年,度普利尤单抗成为全球自免药物领域销冠,靠的不仅仅是特应性皮炎,而是哮喘、慢阻肺、慢性鼻窦炎等多个适应症。

慢阻肺才是IL-4的最大市场。国家卫健委公布的数据显示,我国40岁及以上居民的慢阻肺病患病率达13.6%,患者人数近1亿,但患病知晓率只有0.9%。

去年9月,度普利尤单抗在中国获批慢阻肺适应症,销售如虎添翼。健识局注意到,2023年,赛诺菲其实还启动了度普利尤单抗在中国用于慢性鼻窦炎伴鼻息肉的三期临床。

要跟巨头竞争,先要站稳脚跟。用相对较小的适应症换来进院,在大适应症上收获销售额,是康诺亚最实惠的市场策略。因此,今年的医保谈判,司普奇拜单抗必须拿下。

2024年12月以来,司普奇拜单抗相继获批慢性鼻窦炎伴鼻息肉,以及季节性过敏性鼻炎。这两个适应症是度普利尤单抗在中国没有的,既避免了和度普利尤单抗正面冲突,也能在司普奇拜单抗进院上有推动作用。

这一场面对自免“药王”的突袭,国产药做好准备了吗?

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