Clozapine

精彩内容近日，国家药监局官网显示，华润双鹤利民药业（济南）申报的4类仿制药间苯三酚注射液获批生产并视同过评。间苯三酚为非罂粟碱、非阿托品类纯平滑肌解痉药物，2023年在中国公立医疗机构终端的销售额超过13亿元。间苯三酚为非罂粟碱、非阿托品类纯平滑肌解痉药物，可直接作用于泌尿、生殖及胃肠道平滑肌，适用于消化系统和胆道功能障碍引起的急性痉挛疼痛；急性痉挛性尿道、膀胱、肾绞痛；妇科痉挛性疼痛等。国内已获批上市的间苯三酚制剂主要有间苯三酚注射液及注射用间苯三酚。米内网数据显示，近年来间苯三酚注射剂在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端的销售额均超过13亿元。近年来在胃肠解痉药/抗胆碱药/胃动力药TOP10通用名药品中，间苯三酚稳居第二。近年来中国公立医疗机构终端间苯三酚注射剂销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局间苯三酚注射剂暂未纳入国采，目前已有倍特药业、江苏万高、仁合益康、中润药业、华夏生生、华润双鹤等21家企业过评或视同过评，满足国采初步入围条件。间苯三酚注射剂过评情况来源：米内网一致性评价进度数据库米内网数据显示，2024年以来，华润双鹤（含子公司）动态频频，间苯三酚注射液、盐酸利多卡因注射液、利奈唑胺葡萄糖注射液、米拉贝隆缓释片、丙戊酸钠注射用浓溶液、甲磺酸多沙唑嗪缓释片、左乙拉西坦缓释片、阿哌沙班片、格列吡嗪控释片9个品种获批生产并视同过评；吡拉西坦注射液、腹膜透析液(乳酸盐-G1.5%)、腹膜透析液(乳酸盐-G2.5%)、腹膜透析液(乳酸盐-G4.25%)、异烟肼片、注射用更昔洛韦、氯氮平口腔崩解片、枸橼酸西地那非片等品种以补充申请获批，通过一致性评价，其中氯氮平口腔崩解片为国内首家过评。今年以来华润双鹤（含子公司）获批上市的品种来源：米内网中国申报进度（MED）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5月22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

Ad hoc announcement pursuant to Art. 53 LR Further study analysis reveals significant multi-domain benefits in PANSS and Clinical Global Impression of Change (CGI-C) ratings Benefit on efficacy measures increased over time, suggesting larger and enduring patient effects to be expected during long-term treatment MILAN--(BUSINESS WIRE)-- Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), presents additional results from the international, randomized, double-blind, placebo-controlled study 008A that evaluated the efficacy and safety of evenamide (30 mg bid) as add-on treatment in 291 patients not benefitting from their second-generation antipsychotic medication, including clozapine. Initial top line data announced on 30th April 2024 demonstrated that the study met its primary endpoint, an improvement of the Positive and Negative Syndrome Scale (PANSS) Total Score as well as the key secondary endpoint, an improvement of the Clinical Global Impression of Severity (CGI-S), in the a-priori defined regulatory analysis. Additional analyses for the secondary endpoints indicate significant effects achieved at the endpoint (Day 29), on all the following measures: - PANSS total: Proportion of patients with a clinically relevant improvement (more than 20% improvement from baseline); p-value < 0.05; - Clinical Global Impression of Change (CGI-C): Mean rating at endpoint; evenamide 3.3 versus placebo 3.5; p-value < 0.001; - Clinical Global Impression of Change (CGI-C): Proportion of patients rated as showing any improvement; p-value < 0.05; - Clinical Global Impression of Change (CGI-C): Proportion of patients rated as at least “much improved”; evenamide: 31.3% versus placebo: 17.3%; p-value = 0.006; - PANSS Positive subscale: Mean change from baseline; p-value < 0.05; - PANSS Negative subscale: Mean change from baseline; p-value < 0.05. The sensitivity analyses for the PANSS total (primary endpoint) and CGI-S (secondary endpoint) confirmed a statistically significant improvement for evenamide irrespective of the population analyzed and the statistical methods used; some examples are provided below: - PANSS total worst observation carried forward (WOCF) ANCOVA p-value = 0.008; - PANSS total Multiple Imputation (MI) ANCOVA: p-value = 0.006; - CGI-S Multiple Imputation (MI) ANCOVA: p-value = 0.014. In the study, the addition of 30 mg (bid) of evenamide to the patients’ current antipsychotic medication was very well tolerated, with a similar pro placebo with no increases in EPS, weight gain, blood glucose, metabolic syndrome, sexual dysfunction, CNS or cardiac effects, or laboratory abnormalities. Study 008A is the first well-designed study demonstrating efficacy of an adjunctive treatment in benefiting patients who do not respond to their current antipsychotic. Evenamide also is the first glutamate modulator to demonstrate efficacy in inadequately responding patients with schizophrenia in a placebo-controlled study. Ravi Anand, MD, Chief Medical Officer of Newron, stated: “These new efficacy results from study 008A attest to the clinical relevance of the benefits for patients, based on the primary and key secondary endpoints. The results for the CGI-C rated by an experienced psychiatrist who assesses not only the symptoms of psychosis, but also the impact of treatment on social interactions, insight, and functioning, indicated a significant proportion of evenamide patients were considered as at least ‘much improved’. Significant improvement was also noted on both positive and negative symptoms of schizophrenia. Most importantly, the benefits noted on the efficacy measures increased up to Day 29, thus suggesting larger and enduring effects during longer term treatment. These findings, along with those noted in study 014/015, where patients with treatment resistant schizophrenia treated with evenamide for 1-year experienced progressive, sustained and long-lasting clinically significant important benefits, further highlight the growing importance of glutamate modulation for the development of novel treatments for patients with schizophrenia.” About evenamide Evenamide, an orally available new chemical entity, specifically blocks voltage-gated sodium channels (VGSCs) and is devoid of biological activity at >130 other CNS targets. It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels, due to inhibition of VGSCs. Combinations of ineffective doses of evenamide and other APs, including clozapine, were associated with benefit in animal models of psychosis, suggesting synergies in mechanisms that may provide benefit in patients who are poor responders to current APs, including clozapine. About Newron Pharmaceuticals Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near Milan, Italy. Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea, and is commercialized by Newron’s Partner Zambon. Supernus Pharmaceuticals holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with symptoms of schizophrenia. For more information, please visit: Important Notices This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron's strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron's research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever. View source version on businesswire.com: Contacts For more information: Newron Stefan Weber – CEO +39 02 6103 46 26 pr@newron.com UK/Europe Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting +44 20 3727 1000 SCnewron@fticonsulting.com Switzerland Valentin Handschin, IRF +41 43 244 81 54 handschin@irf-reputation.ch Germany/Europe Anne Hennecke / Caroline Bergmann, MC Services +49 211 52925222 newron@mc-services.eu USA Paul Sagan, LaVoieHealthScience +1 617 374 8800, Ext. 112 psagan@lavoiehealthscience.com Source: Newron Pharmaceuticals S.p.A. View this news release online at: