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4月15日,美国传出消息:特朗普政府通过美国商务部启动了针对“进口半导体和半导体制造设备”和“药品”共232项条款调查。在“药品”方面,调查涵盖了所有美国进口药品,包括成品仿制药、原研药、生产这些药品的成分,以及关键药用成分的进口情况。

根据外媒报道,调查结果将在270天内出炉。

虽然目前只是开展调查,但外界都认为,调查结论将赋予特朗普限制这些产品进口的实权。

关税战下,医药人的神经本就紧绷已久。有业内人士表示,该文件对药品市场的冲击有限,反而更像是向中国制药行业发起冲锋号角。

文件直接触及到了原料药企业的利益,该类企业主要就是原料药、中间体、成品的出口。中国有超过90%的医药产品以及维生素类、氨基酸类等大宗原料药向美国出口。此前,原料药曾免于征收税款,但现在情况可能会发生变化。

另一方面,征收高额关税将直接提升产品成本,对依赖美国市场的中国CDMO企业而言,也无疑是巨大打击。严重赋税威胁下,一些跨国药企制造业已经回流美国本土。4月10日,诺华还对外宣布:计划在未来五年内斥资230亿美元建造和扩建工厂。

中国CXO企业成为了这场政治博弈中最显眼的靶子。

杀敌一千,自损八百

文件提到的药品调查,能切实影响到我国药品市场吗?业内人士基本保持乐观态度。

以原料药为例,原料药是我国出口的重点产品,据中国海关数据,2024年,我国原料药出口额429.8亿美元,主要就是对美国出口,去年一年就达到了45.2亿美元。一旦征收关税,一些抗癌药、心脏病药物以及阿莫西林等产品及市场都将会受到影响。

美国是全球仿制药处方量占比最高的国家,高达90%,但大型跨国药企一般不生产过专利期的药品。美国约30%的仿制药药品原料依赖从中国、印度进口,其中印度的70%原料药依赖中国。

对仿制药、原料药开展调查,只能令美国医药短缺的情况雪上加霜,对美国本土医药市场百害而无一利。更何况,以授权“知识产权使用费”出海为主的国产的原研药,虽然地缘政治影响下肯定也会影响“卖相”,但并不会太深。

据美国组织BIO最近的一项调查,近90%的美国生物制药公司依赖进口原料药来生产FDA批准的产品。如果对中国征收高额关税,79%与中国签订合约的公司将受到极大影响。

有业内人士表示,最终不太可能向中国市场大面积加收药品关税。

一个现实问题是:美国短时间内建立不起来一个低成本制造体系。

中国CDMO,海外风险再升级

药品高关税对我国医药市场影响的直接风险很小,最重要的可能在药品之外:海外的中国CXO企业业务面或会直接受到冲击。

4月10日,诺华就正式对外宣布:计划在未来五年内斥资230亿美元建造和扩建工厂,产能主要覆盖原料药和生物制剂的原料药,以及二次生产和包装等,确保诺华从前依赖全球供应链生产的关键药物,以后都能在美国生产。

这不是个例,同日,强生也同样宣布今后四年内在美国的投资将增加25%,达到550亿美元以上。今年3月,默沙东在美国北卡罗来纳州达勒姆开设了一家价值约10亿美元的新制药工厂,并计划到2028年在美投资80亿美元;礼来宣布将投资至少270亿美元在美国新建4个生产基地。

跨国药企制造业已经回流美国,这对中国CDMO企业是个挑战。

临床前研究、临床试验管理的CRO业务并不涉及实物出口报关,因此直接受关税冲击较小。整体看,本就受地缘政治限制的中国CDMO企业,在美国市场的不确定性会更大。

值得一提的是,基因合成类CDMO在此前的核心设备限制下,反而相对平稳。如Illumina测序仪等核心设备受中美双向禁令影响,转为依赖国产替代,倒逼国内企业技术升级。

网传的药品“104%高关税”更可能的是直接压缩一些专注多肽、酶技术等,以原料药、中间体等输出实体的CDMO企业利润空间。这部分的CDMO公司在海外的发展及业绩。

在去年年报中,药明康德美国地区仍然是主要收入来源,占总收入的64%,公司已经部署了美国的米德尔顿基地,将于2026年投产。届时,该基地主要就是提供原料药生产、口服制剂和无菌注射剂生产及包装服务,就将会与美国本土制造业直面竞争。

去年药明康德刚刚兑现了业绩承诺,投资者能不能经受住新考验,是个问题。

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