Naproxen Sodium/Sumatriptan Succinate

精彩内容近日，康缘药业公告称，其1类化药新药注射用AAPB（两种规格）获批临床，拟用于治疗急性缺血性脑卒中。米内网数据显示，2022年中国三大终端六大市场（统计范围详见本文末）心脑血管系统药物（化药+生物药）销售额接近1300亿元。注射用AAPB是康缘药业和中国药科大学联合开发的一种新型抗缺血性脑卒中神经保护剂，是公司2024年首款获批临床的1类新药，其临床申请于2024年1月获得CDE承办受理，同年3月获得临床试验默示许可，拟用于治疗急性缺血性脑卒中。米内网数据显示，近年来中国三大终端六大市场（统计范围详见本文末）心脑血管系统药物（化药+生物药）销售额呈逐年上涨态势，2022年接近1300亿元，2023年上半年超过670亿元。近年来中国三大终端六大市场心脑血管系统药物（化药+生物药）销售情况（单位：亿元）来源：米内网格局数据库在心脑血管系统化药方面，康缘药业拥有10余个品种的生产批文，包括尼莫地平缓释片、卡托普利片、苯磺酸氨氯地平片等高血压用药，多烯酸乙酯软胶囊、辛伐他汀片等血脂调节剂等。此外，公司还有2个高血压用药以新注册分类报产在审，分别为呋塞米口服溶液、替米沙坦氨氯地平片，这2个品种目前均仅1家国产企业拥有生产批文，1类新药SIPI-2011片处于I期临床，用于治疗室性心律失常。康缘药业申报的部分心脑血管系统化药来源：米内网中国申报进度（MED）数据库作为国内中药创新龙头企业，康缘药业在持续专注中药新药研发的同时，在化学药、生物药等方面也有所布局。在过去的2023年，康缘药业有1款中药新药申报NDA并顺利获批，为古代经典名方中药复方制剂济川颗粒；此外，5款中药1类新药栀黄贴膏、乌鳖还闺颗粒、小儿佛芍和中颗粒、小儿健脾颗粒、五味益心颗粒，2款化药1类新药KY0135片、KY1702胶囊，以及1款生物药1类新药KYS202002A注射液相继申报IND并获得批准。仿制药方面，吡仑帕奈片、吸入用异丙托溴铵溶液、米诺地尔搽剂3个品种获批上市并视同过评，甲磺酸仑伐替尼胶囊、琥珀酸舒马普坦萘普生钠片、替米沙坦氨氯地平片、西格列汀二甲双胍片(Ⅱ)4个品种以新分类报产在审。步入2024年，康缘药业研发动态频频，目前已有2款中药1类新药七味脂肝颗粒、羌芩颗粒，1款化药1类新药注射用AAPB，以及1款生物药1类新药KYS202003A注射液申报IND，其中注射用AAPB已获批临床。资料来源：米内网数据库、CDE官网等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至3月28日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，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

EUR600K upfront payment upon signing the new amendment agreement EUR400K payment once launched in significant E.U. markets Deal also includes sales-based milestone payments, royalties and revenue pursuant to the supply agreement New amendment expands the agreement to all E.U. territories MONTREAL--(BUSINESS WIRE)-- Searchlight Pharma Inc. (“Searchlight” or the “Company”), a private Canadian specialty pharmaceutical company today announced that Orion Corporation (“Orion”) has launched Suvexx® in select countries covered in the 2020 exclusive license and supply agreement (the “License Agreement”) between Nuvo Pharmaceuticals (Ireland) DAC (“Nuvo Ireland”) and Orion, with the product launches continuing into 2024. Orion is headquartered in Espoo, Finland with its products marketed in over one hundred countries worldwide. In FY2022, Orion generated over EUR1.34 billion in net sales. Orion maintains its own commercial infrastructure in most key European markets with a focus on neurology, oncology, respiratory, pain and women’s health. Orion is a public company trading on the Nasdaq Helsinki exchange under the HEL:ORNBV and HEL:ORNAV ticker symbols. In December 2020, Searchlight’s wholly owned subsidiary, Nuvo Ireland entered into the License Agreement with Orion for the exclusive right to package, distribute, market and sell Suvexx in Finland, Sweden, Denmark, Norway, Poland, Hungary, Latvia, Lithuania and Estonia (the “Territory”). Under the terms of that agreement, Orion is responsible for obtaining and maintaining the marketing authorizations for Suvexx in the Territory and for managing all Territory specific commercial activities. The relevant acute migraine prescription treatment market in Europe was valued at over EUR220 million in the past 12 months based on Company estimates. Nuvo Ireland and Orion have also entered into an amendment to the original License Agreement for the exclusive right to package, distribute, market and sell Suvexx in all remaining E.U. countries outside of the original License Agreement Territory. Orion anticipates filing the marketing authorization application immediately and expects to commercially launch Suvexx in Austria, Belgium, the Czech Republic, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Slovakia, Spain, Switzerland and the U.K. during 2024, subject to receipt of marketing authorization and pricing approval. The signing of the amendment triggered an upfront payment of EUR600K by Orion to Nuvo Ireland. Under the terms of the amendment, Nuvo Ireland will be entitled to future sales-based milestone payments, royalties and revenues pursuant to the supply agreement between the parties. "The launch of Suvexx in Europe is another important milestone for Searchlight and a further indication of the value arising out of the acquisition of Miravo Healthcare earlier this year,” said Mark Nawacki, Searchlight’s President and Chief Executive Officer. “A key component of our growth strategy is to create options for the diversification of our business beyond its Canadian market search, acquisition and commercialization roots. In this vein, we are pleased to expand our Suvexx agreement to encompass the entirety of the E.U. market, and to work with Orion, a partner with proven therapeutic area expertise and an established commercial infrastructure, as a license and distribution partner across the E.U." About Suvexx Suvexx is a patent protected, fixed dose combination of naproxen sodium and sumatriptan that was originally developed by the Aralez Pharmaceuticals Inc. wholly owned subsidiary POZEN, Inc. (POZEN) in collaboration with Glaxo Group Limited, d/b/a GSK (GSK). The product is formulated with POZEN's patented technology (now owned by Searchlight) of combining a triptan, sumatriptan 85 mg, with an NSAID, naproxen sodium 500 mg and GSK's RT Technology in a single tablet. In 2008, the U.S. Food and Drug Administration (FDA) approved Treximet (the U.S. brand name for Suvexx) for the acute treatment of migraine attacks, with or without aura, in adults. Treximet is currently commercialized in the U.S. by Currax Holdings USA LLC. Searchlight owns the product and intellectual property rights to Suvexx in Canada and its wholly owned subsidiary Nuvo Ireland owns the intellectual property rights to Suvexx outside of Canada. About Orion Corporation Orion is a globally operating Finnish pharmaceutical company – a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and self-care products. The core therapy areas of its pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. Orion's net sales in 2022 amounted to EUR1.34 billion and the company had about 3,500 employees at the end of the year. Orion's A and B shares are listed on Nasdaq Helsinki. About Searchlight Pharma Searchlight Pharma Inc., headquartered in Montreal, is a leading Canadian-based specialty healthcare company that executes best-in-class search, acquisition, commercialization, and focused development of innovative and unique specialty healthcare products. Following its acquisition of Miravo Healthcare in March 2023, Searchlight’s core promoted products now focus on women’s health, dermatology, allergy, pain management and hospital specialty markets, and its team is committed to improving people’s lives by bringing the right products to market. Follow Searchlight, learn more about what it does, and get to know its product portfolio at View source version on businesswire.com: Contacts FOR MORE INFORMATION, PLEASE CONTACT: Mark Nawacki President & CEO info@searchlightpharma.com Source: Searchlight Pharma Inc. View this news release online at: