Hydrocortisone

4月7日，A股所有板块都迎来大跌，美国关税大棒的影响开始显现。但从“对等关税”细则来看，医药板块大部分公司属于被错杀。按照4月2日，美国政府宣布的内容：大部分药品制剂、维生素、抗生素等原料药被纳入豁免清单。这可能是因为此前美国曾因为药品短缺多次向中国药企直接求助，如今如果对药品加关税，将可能重新导致美国临床药品短缺。不过特朗普此前曾多次表示，针对医药产品的特定关税“总有一天”会出台。美国大部分的医药供应链的确离不开中国，但对于医疗器械、IVD这些细分领域就没有这么幸运了。大部分医用耗材、敷料、医疗设备及其零部件、康复用品等产品没能被豁免，叠加美国政府过往的加税措施，部分产品关税已飙升至企业难以承受的极高水平。这将严重影响国内低值耗材和IVD企业的生存状况。医药“豁免”背后按照美国的说法，包括维生素、抗生素、氨基酸类等在内的大多数原料药类，以及各类化合物和药物等，都被豁免加征关税。这并非是中国药品首次躲过美国的关税制裁。早在2018年，抗生素类药物、含胰岛素类药物、青霉素、链霉素等中国产药品就被列入拟加征关税清单。但最终这些产品没有被实际划入清单。图源：浙商证券不是美国不想对医药产品加征关税，而是不能。因为美国暂时还离不开中国的药物。美国的医药制造能力全球独树一帜，但大部分都集中在创新药上，而且产业已经高度分散到全球。大部分仿制药，美国是没有生产能力的，严重依赖进口。2021年，中国成为美国药品进口的主要来源国，按重量计算，占总进口药品的23%，达到4.18亿磅。一份报告指出，对于布洛芬、氢化可的松这些常用仿制药，基本都是从中国进口的。此外，中国还向美国出口各种治疗艾滋病、糖尿病、化疗药物。即便是全球最大的仿制药生产国印度超七成原料药也来自中国。一旦供应链出现问题，美国就可能面临严重的缺药危机。这样的事情不是没有先例，2023年，美国化疗药顺铂短缺，只能直接向中国药企求助，紧急从中国进口了一批包装盒还贴着中文的药瓶。美国对来自中国的药物暂缓加收关税，正是考虑到了当前美国医药制造的短板，因此这并不意味着中国的药品彻底安全，可能只是获得了暂时的喘息机会。不过，IVD和医疗器械行业就没有这么幸运。绝大部分医用耗材、IVD、敷料、医疗设备和零部件及康复用品等都面临加关税命运。例如，注射器及其零附件关税水平目前为120%，此次加征后将达到 154%；医用、外科用手套关税水平目前为70%，加征后将达到 104%。受冲击最大的，包括诊断试剂行业。国内IVD被盯上新冠疫情后，国内IVD企业不少都建立了海外市场的销售团队。据不完全统计，超50%的IVD企业涉足海外业务，又以美国为主要市场。中国医疗器械行业协会数据显示，2023年出口国家中美国占比最高，约24.43%。不少企业早就在美国打下了市场基础。三诺生物2023年海外收入占到总营收的43%，其中美国市场收入就占到35%。更多的企业则是在疫情这几年才从贴牌加工到自主申请批件，逐渐开拓美国市场。如做快速诊断试剂的安旭生物、奥泰生物，2023年近九成的收入都来自海外市场，来自美国的比重都不小。但是，IVD行业常年遭受美国关税的“讹诈”，不少企业已经早就有了应对策略。迈瑞医疗董秘表示：今年初美国对中国商品加征两次10%关税生效前，公司已提前根据意向订单在美国前瞻备货，因此今年美国销售的产品并不受到本轮关税影响。此外，迈瑞还在全球布局了几十家生产基地，其中包括已获FDA认证的工厂，可满足包括美国在内的全球市场需求。对中小企业来说，大幅增加关税可能会产生不利影响。不过有危也有机：对于美国原产的IVD产品，想要进入国内也需要加征34%关税。罗氏、雅培、西门子等行业巨头，实际不少产品还是美国本土生产的，中国采取的反制措施将给这些产品带来成本上升和断供的巨大不确定性，反而给国内供应商带来机会。真正有实力的国内IVD企业将会获得机会，进一步实现国产替代。撰稿丨方涛之编辑丨江芸 贾亭运营｜廿十三插图｜视觉中国声明：健识局原创内容，未经许可请勿转载医保飞检启动；进口CT厂商被立案；恒瑞新任总经理来自阿斯利康花粉引发过敏性鼻炎，引爆下一个治疗风口国家发重大利好，疫苗企业有救了！

Esteve Pharmaceuticals, S.A. will commercialize Increlex in all markets outside the U.S.DEER PARK, Ill., April 01, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the out-licensing of commercial rights to Increlex® in territories outside of the U.S. to Esteve Pharmaceuticals, S.A. (“Esteve”). “Esteve shares Eton’s dedication to putting patients first and we’re excited to partner with them to distribute this important treatment outside of the U.S. Esteve has the global infrastructure and established presence necessary to successfully commercialize Increlex in countries outside the U.S. This transaction will allow Eton to focus its efforts on the Company’s compelling growth opportunities within the U.S., including its three rare disease product launches planned for 2025, and eliminates the need for significant infrastructure investments that would have been required to commercialize Increlex outside the U.S.,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. Esteve will license the ex-U.S. rights for up to ten years and will also be receiving an option to acquire the international rights in the future. Eton will supply product to Esteve at a fixed transfer price, and the transaction does not impact the Company’s expectation to exit 2025 at an approximately $80 million annual revenue run rate. About Eton Pharmaceuticals Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has seven commercial rare disease products: INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has six additional product candidates in late-stage development: ET-400, ET-600, Amglidia®, ET-700, ET-800 and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations:Lisa M. Wilson, In-Site Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com Source: Eton Pharmaceuticals, Inc.