Toremifene Citrate

Kyowa Kirin will no longer sell breast cancer drug Fareston, or toremifene, in the U.S. Breast cancer treatments have evolved dramatically over the years, so Kyowa Kirin has decided to stop selling a decades-old drug in the U.S.Starting Aug. 31, Kyowa Kirin will no longer distribute or fulfill orders for Fareston, or toremifene, presented in 60 mg tablets, in the U.S., the company said Friday. The last day for placing orders will be Aug. 29.“The decision aligns with the company’s Vision for 2030 and its focus on the discovery, development and delivery of novel therapies for patients,” the company said in a statement.Fareston is a hormone therapy that blocks estrogen receptors. Other drugs in the same selective estrogen receptor modulators (SERMs) class include tamoxifen, known under the brand names Nolvadex and Soltamox.These old therapies have been around for decades and have largely been replaced by newer meds, including selective estrogen receptor degraders (SERDs) such as AstraZeneca’s Faslodex. Fareston was approved by the FDA in 1997 to treat postmenopausal women with estrogen receptor-positive breast cancer.Kyowa Kirin has been selling Fareston in the U.S. through an agreement with Finish company Orion Corporation. The Japanese pharma has previously notified Orion and the FDA of its decision to discontinue Fareston. Kyowa Kirin stopped promoting Fareston more than five years ago, and demand has since declined thanks to generics and other available treatments, a company spokesperson told Fierce Pharma.“These conditions, along with the company’s forward-looking strategy focusing on novel medicines with life-changing value, informed our decision to stop distribution,” the spokesperson said.  In 2023, Kyowa Kirin recorded no revenue from Fareston after reporting 0.1 billion Japanese yen (around $700,000) for two consecutive years prior. The number was again zero in the first half of 2024. Kyowa is shifting its focus on to novel antibody technologies and cell and gene therapies. As a result, the company recently unveiled a plan to significantly reduce its small molecule drug discovery research activities.The Japanese pharma also recently restructured its Asia-Pacific business, selling its entire operations in the Chinese mainland, including its five established brands in the country, to local firm WinHealth Pharma for about $104 million. Rights to several established medicines in South Korea, Malaysia, Thailand, Hong Kong, Macau and Taiwan were also offloaded.Editor's Note: The story has been updated with additional comments from a Kyowa Kirin spokesperson.

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 8月17日，据CDE官网显示，成都倍特药业提交的4类仿制药枸橼酸托瑞米芬片上市申请已获受理（受理号CYHS2402686）。据药融云数据库显示，该品种在2023年全国院内市场的销售额达3.28亿元。 截图来源：CDE官网 枸橼酸托瑞米芬片由日本KYOWA KIRIN公司研发，商品名为法乐通® (FARESTON®)，是一种非类固醇三苯乙烯衍生物，可与雌激素竞争性的与雌激素受体结合从而阻止癌细胞的增殖，适用于治疗绝经后妇女雌激素受体阳性或不详的转移性乳腺癌，属于国家医保乙类品种。1997年6月于美国上市，2018年7月国家药监局批准芬兰Orion Corporation公司药物FARESTON®进口注册上市。据药融云数据库显示，枸橼酸托瑞米芬片在2023年全国院内市场的销售额达3.28亿元，同比增长达2.94%。 截图来源：药融云全国医院销售数据库 目前，枸橼酸托瑞米芬片有3家药企拥有生产批文，其中有福安药业集团宁波天衡制药、江苏奥赛康药业2家药企过评。在仿制药布局方面，枸橼酸托瑞米芬片有成都倍特药业、重庆圣华曦药业、福安药业集团庆余制药、重庆士立德医药4家药企提交了4类仿制药注册申请，均在审评审批中。 截图来源：药融云中国药品审评数据库 今年以来，成都倍特药业（含子公司）在仿制药布局方面提交了枸橼酸托瑞米芬片、吸入用盐酸氨溴索溶液 、乳果糖口服溶液、二甲硅油乳剂、布洛芬混悬液等超20款品种的仿制申请，均在审评审批中。 截图来源：药融云中国药品审评数据库 2024年至今，成都倍特药业（含子公司）有26个品种过评，其中注射用头孢唑肟钠、呋塞米口服溶液、钆贝葡胺注射液3个品种为首家过评。 END 本文为原创文章，转载请留言获取授权  近期热门资源获取 后台回复关键词“报告”，获取数十篇药融云出品独家报告 后台回复关键词“CSCO”，获取2023CSCO指南 后台回复关键词“ASCO”，获取2023ASCO分癌种摘要 后台回复关键词“2023首仿”，获取2023年首仿药物获批名单 后台回复关键词“医保”，获取2022年医保目录    联系我们，体验药融云更多专业服务 会议 合作 园区 服务 数据库 咨询 定制 服务 媒体 合作 点击阅读原文，申请药融云企业版免费试用！