Cetrorelix

Merck KGaA’s U.S. arm EMD Serono is the latest to join President Donald Trump's most-favored nation pricing push, following AstraZeneca and Pfizer. Merck KGaA’s U.S. arm EMD Serono is joining President Donald Trump’s most-favored nation drug pricing push with an agreement to sell its fertility therapies at a sharp discount through the government’s TrumpRx direct-to-consumer purchasing platform.The company will offer its full in vitro fertilization (IVF) drug portfolio, including Gonal-f, Cetrotide and Ovidrel, to eligible patients, with an 84% discount for the use of all three therapies in a typical IVF regimen when TrumpRx goes live in 2026. Citing the Centers for Medicare & Medicaid Services, the White House said the price cuts could save patients up to $2,200 per IVF cycle. Fertility medications make up almost 20% of the total cost of treatment, which can total between $15,000 and $30,000 for one round, according to GoodRx. The new public-private partnership with EMD Serono complies with Trump’s February executive order on expanding access to IVF, the company said in a Thursday press release. The White House said EMD Serono will offer other drugs at deep discounts when sold directly to patients and guarantee MFN prices on new medicines, while the company separately said it reached a Commerce Department agreement to exclude its products from Section 232 tariffs in return for U.S. manufacturing and research investments.EMD Serono already has a strong U.S. presence and looks “forward to growing our footprint here even further with future fertility manufacturing,” CEO of Merck KGaA, Darmstadt, Germany’s Belén Garijo said in the company's release.“We are committed to working with the U.S. administration to add value over the long term, ensuring that our patients and customers continue to have access to and benefit from the innovations within our portfolio,” Garijo added.According to the White House, the agreement marks the “first time in history” that EMD Serono is investing in U.S. manufacturing. The company has long operated in the U.S. and moved its headquarters to Boston in 2023.EMD Serono’s Gonal-f was first approved in the late 90s as one of the first recombinant human products used to treat infertility. Since then, the Merck KgaA unit has built out its fertility franchise to include other complementary products and devices, with the next addition now coming to the U.S. sooner, with a potential FDA Commissioner’s National Priority Voucher (CNPV).CNPV for IVF  The company’s Pergoveris, a combination of recombinant human follicle-stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH) that’s designed to “mimic reproductive physiology,” will soon be filed for FDA review under its CNPV program. The program applies to products that align with U.S. national health priorities and reduces the FDA’s review timeline from about 10 to 12 months to one to two months. FDA Commissioner Marty Makary, M.D., launched the CNPV program in June and announced the first nine recipients on Oct. 16. Other than EMD Serono’s Pergoveris for infertility, investigational products from Regeneron, Sanofi and others made the cut to treat diseases ranging from diabetes, deafness and blindness, to name a few.Pergoveris is already widely available outside the U.S. If it wins U.S. approval, the White House said patients could benefit further from lower prices thanks to increased competition in the fertility drug market.Along with the administration’s deal with EMD Serono, it announced new guidance for employers to offer standalone benefit packages for IVF and infertility. One in 8 U.S. couples struggles with fertility, according to EMD Serono, which describes itself as “the leader in fertility therapeutics.”EMD Serono joins AstraZeneca and Pfizer in complying with Trump’s MFN pricing demands, which look to tie U.S. prices to lower costs overseas. Much of the deal implores companies to sell their drugs directly to patients, which many have already embraced. Others, like Bristol Myers Squibb, will roll out their drugs in the U.K. at higher U.S.-linked prices. 

精彩内容 10月17日，国家药监局发布最新药品获批信息，扬子江药业集团广州海瑞药业的注射用醋酸西曲瑞克顺利获批，是集团今年第8个新品。注射用醋酸西曲瑞克是下丘脑激素类TOP4产品，2024年在中国公立医疗机构终端的销售额超过了3.6亿元。 图1：扬子江药业最新获批的产品 来源：国家药监局官网 注射用醋酸西曲瑞克是第三代GnRH拮抗剂，临床上可提高辅助生殖治疗中的获卵数、优质胚胎数及活产率，同时降低卵巢过度刺激综合征（OHSS）发生率。 图2：注射用醋酸西曲瑞克的销售情况（单位：万元） 来源：米内网中国公立医疗机构终端竞争格局 在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端，注射用醋酸西曲瑞克的销售额在2021-2024年保持3亿元以上，2025上半年成为了下丘脑激素类市场TOP4产品。 图3：扬子江药业早前在下丘脑激素类市场获批的产品 来源：米内网中国上市药品（MID）数据库 扬子江药业旗下江苏海岸药业的注射用生长抑素获批多年，2017-2019年在中国公立医疗机构终端的销售额达到了6亿元水平，近几年有下滑态势，2025上半年是下丘脑激素类市场TOP8品牌。集团在2024年再添新品，扬子江药业集团江苏紫龙药业的醋酸加尼瑞克注射液获批，该产品是下丘脑激素类市场TOP5产品。随着辅助生殖越趋火热，该类药物的市场空间巨大。 表1：扬子江药业集团今年以来获批的新品 来源：米内网中国申报进度（MED）数据库 米内网数据显示，2025年至今，扬子江药业集团已陆续拿下1个化药1类新药和7个高端仿制药。集团今年以来申报上市的新品还有7个，其中包括了化药1类新药法赞雷生片。 资料来源：国家药监局官网、米内网数据库 注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！ 免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦