Agomelatine

精彩内容 近日，湖北科伦药业的复合磷酸氢钾注射液3类仿制上市申请获批并视同过评，公司为该产品第二家过评企业。复合磷酸氢钾注射液是矿物质补充剂热销产品，2022-2024上半年在中国公立医疗机构终端的销售额保持正增长。据米内网统计，科伦药业及子公司今年以来已有11个产品过评，成绩优异。 图1：科伦药业最新获批的产品 来源：国家药监局官网 复合磷酸氢钾注射液主要用于完全胃肠外营养疗法中作为磷的补充剂，如中等以上手术或其他创伤需禁食5天以上病人的磷补充剂，亦可用于某些疾病所至低磷血症。米内网数据显示，截至目前该产品已有超过10家国内药企获得生产批文，石四药的3类仿制上市申请于2025年1月获批为首家过评，本次科伦药业获批成为该产品第二家过评企业。 图2：科伦药业的复合磷酸氢钾注射液审评情况 来源：米内网中国申报进度（MED）数据库 图3：复合磷酸氢钾注射液的销售情况（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，复合磷酸氢钾注射液近三年的销售额保持正增长态势，2023年销售额达3.4亿元，2024上半年增长率超过35%。在矿物质补充剂市场，复合磷酸氢钾注射液为TOP7产品。 表1：今年以来科伦药业及子公司过评（含视同过评）的产品 来源：米内网中国申报进度（MED）数据库 今年以来，科伦药业及子公司新增了11个过评产品，其中阿瑞匹坦注射液、芦曲泊帕片、阿戈美拉汀片、复方氨基酸注射液(18AA-Ⅸ)、米诺地尔搽剂、利丙双卡因乳膏、阿帕他胺片、他克莫司缓释胶囊、注射用亚胺培南西司他丁钠/氯化钠注射液、复合磷酸氢钾注射液均为按新分类报产获批。截至目前，科伦药业及子公司已过评（含视同过评）的产品数量超过170个（按产品名统计），在业内名列前茅。 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》，统计范围是：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。数据统计截至3月2日，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

MOUNTAIN VIEW, Calif.--( BUSINESS WIRE )--Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced a favorable outcome from the planned interim analysis for the Phase 2b trial of ALTO-300 as an adjunctive treatment for patients with major depressive disorder (MDD). Based on the results of the interim analysis, the Phase 2b trial will continue with an increase of approximately 50 biomarker positive patients in the final analysis sample. Topline results are expected in mid-2026. “The outcome of this interim analysis marks an important milestone for the ALTO-300 program,” said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. “The interim analysis was an opportunity to leverage valuable insight from the completed ALTO-100 Phase 2b trial, and we are encouraged by these results. We look forward to reporting topline data in mid-2026.” Prior to the interim analysis, a blinded committee conducted an in-depth site and patient eligibility review that resulted in the prospective exclusion of sites and patients from the analysis population. Following the eligibility review, the biomarker positive population in the interim analysis consisted of 87 patients. The double-blind, placebo-controlled study (NCT05922878) is enrolling patients characterized by an electroencephalogram (EEG) biomarker signature. The company expects to enroll approximately 200 biomarker positive patients in the final analysis sample. Patients are randomized to receive ALTO-300 or placebo in addition to a background antidepressant, to which they have had inadequate response, over a six-week treatment period. The primary outcome is the change from baseline on the Montgomery-Åsberg Depression Rating Scale, or MADRS, score. ALTO-300, an oral, small molecule designed to act as a melatonin agonist and 5-HT2C antagonist, is being developed as an adjunctive treatment in the United States for patients with MDD, characterized by an EEG biomarker. About Alto Neuroscience Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto’s Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto’s clinical-stage pipeline includes novel drug candidates in depression, schizophrenia, and other mental health conditions. For more information, visit www.altoneuroscience.com or follow Alto on X . Forward-Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “expects,” “plans,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto’s expectations about the potential benefits, activity, effectiveness and safety of its product candidates and Precision Psychiatry Platform (“Platform”); Alto’s expectations with regard to the design and results of its clinical trials, including the timing and availability of data from such trials and the quality of related participants, sites, and analyses; Alto’s business strategy, financial position and the sufficiency of its financial resources to fund its operations through expected milestones; Alto’s preliminary estimate of cash and cash equivalents as of December 31, 2024 and anticipated cash runway, and other statements that are not historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including uncertainties inherent in the progress and completion of clinical trials and clinical development of Alto’s product candidates; availability and timing of results from clinical trials; quality of participants and sites engaged in its clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that clinical trials may have unsatisfactory outcomes; the risk that Alto’s projections regarding its financial position and expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Alto’s actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section titled “Risk Factors” in Alto’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2024 filed with the Securities and Exchange Commission (“SEC”) as well as in other filings Alto may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alto expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as required by law. Our actual consolidated financial results as of December 31, 2024 are not yet available. Our financial closing procedures for the year ended December 31, 2024 are not yet complete and, as a result, our final results upon completion of those procedures may differ materially from this preliminary estimate. The preliminary consolidated financial data presented above as of December 31, 2024 is not a comprehensive statement of our financial position or operating results; reflects our preliminary estimate based on information available as of the date hereof; and is subject to change, and those changes may be material. Accordingly, you should not place undue reliance upon this preliminary estimate. The preliminary consolidated financial data presented above has been prepared by, and is the responsibility of, our management. Our independent registered public accounting firm, Deloitte & Touche LLP, has not audited, reviewed, compiled or performed any procedures, and do not express an opinion or any other form of assurance with respect to any of such data. Availability of Information on Alto’s Website Alto routinely uses its investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, Alto encourages investors and others interested in Alto to review the information it makes public on its investor relations website.