Cytarabine/Daunorubicin

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

The appointments of Dr. Karen Smith and Dr. Luke Walker to the Board bring extensive operational and clinical development experience to support corporate and pipeline strategyPHILADELPHIA, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced the appointments of Karen Smith, MD, PhD, MBA, LLM and Luke Walker, MD, to its Board of Directors. “Karen and Luke’s vast experience and proven leadership in the biopharmaceutical industry are tremendous assets for Context at this pivotal stage of our growth," said Martin Lehr, CEO of Context Therapeutics. “Karen’s extensive oncology drug development, regulatory, and strategy experience will be invaluable as Context continues to advance its pipeline. Luke brings an extensive track record in oncology drug development, including recent experience developing T cell engaging bispecific antibodies.” Mr. Lehr continued, “These additions supplement our ongoing effort to build Context into a leading oncology company and advance potential best-in-class T cell engaging bispecifics.” Dr. Karen Smith is a biopharmaceutical thought leader with over 20 years of experience bringing drugs into the clinic and through commercialization. She has been a key contributor to the successful development of multiple approved products in several therapeutic areas, including oncology (Herceptin, Vyxeos), rare disease (Defitelio), cardiology (Irbesartan), dermatology (Voluma, Botox), neuroscience (Abilify) and anti-infectives (Teflaro). Previously, she was Global Head of Research & Development and Chief Medical Officer of Jazz Pharmaceuticals. Earlier in her career, Dr. Smith held senior leadership roles at Allergan, AstraZeneca, and Bristol Myers Squibb. Previously, Dr. Smith served on the Board of Directors of Antares Pharma (acquired by Halozyme for $960 million), Acceleron Pharma (acquired by Merck for $11.5 billion), Mariana Oncology (acquired by Novartis for $1 billion upfront), and Sucampo Pharmaceuticals (acquired by Mallinckrodt for $1.2 billion). Dr. Smith currently serves on the Board of Directors of Aurinia Pharmaceuticals, Capstan Therapeutics, Sangamo Therapeutics, and Skye Bioscience. Dr. Luke Walker has more than 20 years of clinical development experience as both an executive and board member. Most recently, he was the Chief Medical Officer of Harpoon Therapeutics, an oncology-focused biopharmaceutical company where he was responsible for oversight of all aspects of clinical development programs using Harpoon’s TriTAC T-cell engager platform, which was acquired by Merck in 2024 for $680 million. Previously, Dr. Walker was Vice President of Clinical Development at Seagen, where he was the global development lead for Tukysa (tucatinib) through the program’s successful completion of a pivotal registrational trial and successful regulatory approvals. Earlier, Dr. Walker was Senior Vice President of Clinical Development at Cascadian Therapeutics, which was acquired by Seagen in 2018 for $614 million. Dr. Walker began his career as a practicing medical oncologist and hematologist at Providence Regional Medical Center and with the Everett Clinic. Dr. Walker currently serves on the Board of Directors of Zentalis Pharmaceuticals. About Context Therapeutics®Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing medicines for solid tumors. The Company is building an innovative portfolio of clinical-stage T cell engaging bispecific therapeutics, including CTIM-76, a Claudin 6 (CLDN6) x CD3 bispecific antibody, and CT-95, a Mesothelin (MSLN) x CD3 bispecific antibody. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on X (formerly Twitter) and LinkedIn. Forward-looking StatementsThis press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the ability of the new appointments to support the Company and the advancement of its product candidates; (ii) the ability of the Company to become a leading oncology company; (iii) the potential benefits, characteristics, safety and side effect profile of our product candidates, (iv) the ability of our product candidates to have benefits, characteristics, manufacturability, and a side effect profile that is differentiated and/or better than third party product candidates, (v) the likelihood data will support future development of our product candidates, and (vi) the likelihood of obtaining regulatory approval for our product candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we therefore cannot assure you that our plans, intentions, expectations, or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise. Investor Relations Contact:Jennifer Minai-AzaryContext TherapeuticsIR@contexttherapeutics.com