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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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神舟二十号载人飞船发射圆满成功 航天员王杰母校师生共庆航天日重庆将打造“低空经济创新发展之城”
王沪宁会见越共中央委员、越南祖国阵线中央副主席兼秘书长阮氏秋荷成都国际铁路港五金产品专线首发新文旅电影《风起秋浦河》专家研讨会在京举行
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  • 神舟二十号载人飞船发射圆满成功 航天员王杰母校师生共庆航天日重庆将打造“低空经济创新发展之城” 神舟二十号载人飞船发射圆满成功 航天员王杰母校师生共庆航天日重庆将打造“低空经济创新发展之城” 神舟二十号载人飞船发射圆满成功 航天员王杰母校师生共庆航天日重庆将打造“低空经济创新发展之城” 神舟二十号载人飞船发射圆满成功 航天员王杰母校师生共庆航天日重庆将打造“低空经济创新发展之城” 神舟二十号载人飞船发射圆满成功 航天员王杰母校师生共庆航天日重庆将打造“低空经济创新发展之城”