Irinotecan Hydrochloride Lioposome

精彩内容 日前，国家药监局官网显示，石药集团中诺药业申报的4类仿制药注射用两性霉素B脂质体获批生产并视同过评，为国产第2家获批并首家视同过评。这是一款多烯类抗真菌药，2024一季度在重点省市公立医院终端的销售额增速超过190%。 注射用两性霉素B脂质体是内含两性霉素B的双层脂质体，与普通注射剂相比，可减少药物肾毒性、输液反应，提高治疗指数。其有效成分两性霉素B属于多烯类抗生素，用于治疗敏感真菌引起的系统性真菌感染、不明原因发热且高度提示存在系统性真菌感染的中性粒细胞减少症患者、内脏利什曼病等。 米内网数据显示，2023年重点省市公立医院终端注射用两性霉素B脂质体的销售额增速超过65%，2024第一季度继续以超190%的增速继续放量，市场潜力可期。 近年来重点省市公立医院注射用两性霉素B脂质体销售情况（单位：万元） 来源：米内网重点省市公立医院药品终端竞争格局 目前国内拥有注射用两性霉素B脂质体生产批文的国内企业仅上海上药新亚药业、石药集团中诺药业2家，其中石药集团中诺药业的产品视同过评，为国内首家；此外，江西艾施特制药、北京泰德制药、Taiwan Liposome等企业的产品以新注册分类报产，目前还在审评审批中。 脂质体技术具有提高药物稳定性、降低药物毒性、提高药物疗效等优势。目前国内已有多款脂质体产品获批上市，盐酸多柔比星脂质体注射液、注射用紫杉醇脂质体已成长为超10亿大品种，其中盐酸多柔比星脂质体注射液2023年在中国三大终端六大市场的销售额超过43亿元。 目前，石药集团已有注射用两性霉素B脂质体、盐酸伊立替康脂质体注射液、盐酸米托蒽醌脂质体注射液、盐酸多柔比星脂质体注射液等多款脂质体产品获批上市；此外，注射用柔红霉素阿糖胞苷脂质体、注射用前列地尔脂质体、注射用紫杉醇阳离子脂质体等在开展临床试验。 今年以来，石药集团有8个品种获批生产并视同过评，分别为达格列净片、奥拉帕利片、注射用右雷佐生、罗沙司他胶囊（首仿）、哌柏西利片（首仿）、帕拉米韦注射液、阿瑞匹坦注射液、注射用两性霉素B脂质体（首家过评）。 资料来源：米内网数据库、国家药监局官网等 注：米内网重点省市公立医院化学药终端竞争格局数据库是以20+省市，近700家样本省市公立医院的化学药采购数据为基础，对化学药全品类进行连续监测的样本省市样本医院数据库。数据统计截至9月19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

Cancer is a big part of Ipsen’s growth strategy, evident in a series of business deals struck by the company in recent years to expand its oncology portfolio and drug pipeline. An Ipsen worker who allegedly profited from stock transactions based on non-public knowledge of his employer’s $247 million buyout of a cancer drug developer has now been charged with insider trading. The Securities and Exchange Commission on Tuesday filed a complaint against Ipsen employee Dishant Gupta. Gupta has agreed to plead guilty, according to a separate court filing. The monetary penalty has yet to be decided. The U.S. Attorney’s Office for the District of Massachusetts has also filed criminal charges against Gupta for his alleged conduct. Paris-based Ipsen maintains U.S. operations in Cambridge, Massachusetts. In early 2022, Ipsen started talking with Epizyme about acquiring that Cambridge-based company’s drug, Tazverik, according to the SEC complaint. Tazverik won FDA approval in 2020 for the treatment of follicular lymphoma. Negotiations between Ipsen and Epizyme progressed from a potential acquisition of the cancer drug to a buyout of the entire biotech company. The Epizyme acquisition was announced on June 27, 2022. presented by Sponsored Post The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani - mHUB Gupta lives in New Jersey and often worked from home, the SEC said in the complaint. He is director of data strategy and operations, a role that involves the marketing and strategic pricing of products. Through this position, Gupta allegedly learned about the market potential and marketing strategy for a drug that appeared to be Tazverik. In the months leading up to the acquisition announcement, the SEC said Gupta ran numerous internet searches using the phrases “Epizyme buyout” and “Epizyme takeover.” Nine days before the deal was announced, Gupta searched the phrase “Ipsen acquired Epizyme,” according to the complaint. While the companies negotiated the transaction, Gupta allegedly accumulated Epizyme shares. From April to June of 2022, the complaint notes that Gupta purchased Epizyme stock on 27 different days. “While Gupta built a position in Epizyme throughout this period, he was most aggressive in the weeks leading up to the announcement,” the SEC said in the complaint. “Specifically, between June 16, 2022, and June 24, 2022, Gupta purchased approximately 200,000 shares, spending nearly $160,000.” The acquisition announcement came in the early morning hours of June 27, timed to happen ahead of the stock market open in Europe. By 9:30 am Eastern time, Gupta had sold all of his Epizyme shares for a profit of $260,078.27, the SEC said. presented by Health Tech What’s Keeping Healthcare CIOs Up at Night: How to Improve Patient Satisfaction by Handling Calls More Efficiently Health systems have spent billions on portals while investments in modernizing the voice channel — the dominant preference of healthcare consumers — have taken a backseat. By Stephanie Baum The SEC complaint, filed in the U.S. District Court for the District of Massachusetts, is case number 24-cv-12316. According to a court filing, Gupta has entered a written agreement to plead guilty to one count of securities fraud. He must give up the money he gained illegally and also pay a civil fine. Per terms of the plea, Gupta is barred from serving as am executive or director of any publicly traded company. The terms of this settlement are still subject to court approval. Oncology products are the biggest driver of revenue for Ipsen, accounting for more than €2.3 billion of the company’s €3.1 billion in 2023 sales. Besides the deal that brought the company Tazverik, Ipsen had acquired the approved Merrimack Pharmaceuticals pancreatic cancer drug, Onivyde. the company has also struck deals for programs still in development. In July, Ipsen reached an agreement for global rights to a Phase 1-ready antibody drug conjugate (ADC) from Foreseen Biotechnology. That deal followed the April acquisition of global rights to an ADC from Sutro Biopharma. Ipsen’s oncology interest extends to other types of drugs. In 2022, months after the Epizyme acquisition, Ipsen began a partnership with Marengo Therapeutics focused on the R&D of T cell receptor therapies for cancer.