Safinamide mesylate

证券代码：301263 证券简称：泰恩康 公告编号：2025-066 广东泰恩康医药股份有限公司 关于全资子公司收到药品注册受理通知书的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整，没有虚假 记载、误导性陈述或者重大遗漏。 广东泰恩康医药股份有限公司（以下简称“公司”）全资子公司安徽泰恩 康制药有限公司于近日收到国家药品监督管理局（以下简称“国家药监局”） 签发的甲磺酸沙非胺片境内生产药品注册上市许可申请《受理通知书》，国家 药监局根据《中华人民共和国行政许可法》第三十二条的规定，对上述药品的 药品注册上市许可申请进行了审查，决定予以受理。现将相关情况公告如下： 一、申请注册药品的基本情况 受理号：CYHS2503455、CYHS2503456 药品名称：甲磺酸沙非胺片 申请事项：境内生产药品注册上市许可 许可药品注册分类：化学药品4 类 规格：50mg、100mg 申请人：安徽泰恩康制药有限公司 审核结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审 查，决定予以受理。 二、药品相关情况简介 甲磺酸沙非胺片是一种选择性抑制B 型单胺氧化酶（MAO-B）抑制剂，主 要用于治疗成年特发性帕金森氏病（PD）患者，作为稳定剂量的左旋多巴（L- dopa）单独或与其他PD 治疗联合的附加疗法，用于中晚期波动患者。 米内网数据显示，近年来中国三大终端六大市场抗帕金森氏病化药销售额 呈逐年上涨态势，2024 年超过35 亿元，同比增长约11%；2025 年一季度接近 10 亿元，同比增长约15%。 三、同类药品情况 经查询国家药监局网站数据，截至目前甲磺酸沙非胺片国内仅原研厂家拥 有生产批文。 四、对公司的影响及风险提示 根据国家相关法规规定，上述药品已获得注册申请受理，报送国家药监局 药品审评中心进行审评审批。上述药品获得受理通知书对公司近期业绩不会产 生影响，相关药品的注册批件取得时间和结果均具有不确定性。 公司将积极推进该项目进展并对该项目的后续进展情况及时履行信息披露 义务，敬请广大投资者谨慎决策，注意投资风险。 五、备查文件 1、《受理通知书》。 特此公告。 广东泰恩康医药股份有限公司 董事会 2025 年9 月18 日

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, today announced its financial results and operational highlights for the half-year ended June 30, 2025, and provided a business update for 2025 and beyond. “We are very excited about our continued achievements, and we are one step closer to potentially bringing enormous benefits to schizophrenia patients who are insufficiently served by the treatments currently available. Highlights H1 2025: Evenamide Clinical trials: In May, the Company announced regulatory approval for its pivotal Phase III ENIGMA-TRS program with evenamide as add-on therapy in patients with treatment-resistant schizophrenia (TRS). The program consists of two pivotal studies: ENIGMA-TRS 1, an international, one-year, double-blind, placebo-controlled Phase III study in at least 600 patients. Following a successful screening period, patient enrolment began post-period, in August 2025, with 12-week study results expected in Q4 2026 ENIGMA-TRS 2, approved by the US Food and Drug Administration, to be performed at centers in the US and selected additional countries. This 12-week, double-blind, placebo-controlled Phase III study in at least 400 patients is expected to start by October 2025 ENIGMA-TRS 1, an international, one-year, double-blind, placebo-controlled Phase III study in at least 600 patients. Following a successful screening period, patient enrolment began post-period, in August 2025, with 12-week study results expected in Q4 2026 ENIGMA-TRS 2, approved by the US Food and Drug Administration, to be performed at centers in the US and selected additional countries. This 12-week, double-blind, placebo-controlled Phase III study in at least 400 patients is expected to start by October 2025 Strategic licensing and partnerships: In January, the Company announced a licensing agreement with Myung In Pharm to develop, manufacture and commercialize evenamide in South Korea Under the terms of the agreement, Myung In Pharm will contribute 10% of the total patient population to be enrolled into Newron’s upcoming Phase III ENIGMA-TRS 1 study and will cover the costs related to this population Under the terms of the agreement, Myung In Pharm will contribute 10% of the total patient population to be enrolled into Newron’s upcoming Phase III ENIGMA-TRS 1 study and will cover the costs related to this population Following the execution (in December 2024) of the licensing agreement with EA Pharma, a subsidiary of Eisai, to develop, manufacture and commercialize evenamide in Japan and other designated Asian territories, Newron in the reporting period received the upfront payment of EUR 44 million and invoiced the first milestone achievement Newron continues to actively explore additional partnership opportunities for the global development and commercialization of evenamide in other territories Industry engagement and scientific exchange: In January, evenamide’s exceptional results in study 014/015 and study 008A were published in the peer reviewed International Journal of Neuropsychopharmacology Post-period, in August 2025, new preclinical data from researchers at the University of Pittsburgh was published in the peer-reviewed journal Neuropsychopharmacology . The research suggests that evenamide ameliorates schizophrenia-related dysfunction, targeting the key site of schizophrenia pathology in the hippocampus, and so could be an ideal therapeutic agent for the treatment of schizophrenia Corporate In April, Dr. Chris Martin was elected as the Chairman of Newron’s Board of Directors, succeeding Dr. Ulrich Köstlin who served as Chairman of the Company from 2013 Stefan Weber, CEO of Newron, commented: “Since the beginning of the year, Newron has continued to make exciting progress in the development of our novel drug candidate evenamide. Most notably, we announced the approval of our pivotal ENIGMA-TRS Phase III development program evaluating evenamide as an add-on therapy in patients with treatment-resistant schizophrenia (TRS) and recently we began enrolling patients into the first study from the program, ENIGMA-TRS 1. We’re delighted to have achieved this crucial milestone on evenamide’s clinical development journey and continue to believe that this new chemical entity has blockbuster potential and could bring enormous benefits to patients who are insufficiently served by the treatments currently available.” Evenamide – advancing schizophrenia treatment In January, Newron announced its licensing agreement with Myung In Pharm to develop, manufacture and commercialize evenamide as an add-on therapy for TRS and poorly responding patients with schizophrenia in South Korea. Under the terms of the agreement, Myung In Pharm, besides the usual financial terms for such agreement, will contribute 10% of the total patient population to be enrolled into Newron’s pivotal ENIGMA-TRS 1 clinical trial and cover the costs related to this population. There has also been strong progress from EA Pharma, who Newron has entered into a license agreement with to develop, manufacture and commercialize evenamide in Japan and other designated Asian territories. EA Pharma expects to initiate its clinical development program for evenamide in Japan. Also, the first milestone under the license agreement became due and was invoiced in the reporting period. In May, Newron announced the regulatory approval of its pivotal Phase III ENIGMA-TRS program with evenamide as add-on therapy in patients with TRS. More than one third of schizophrenia patients suffer from TRS and are not responding to the existing second-generation antipsychotics on the market. Consequently, these patients are in great need of the development and approval of new therapeutic treatments. If approved, evenamide would be the first medication added to existing antipsychotics that improves the symptoms of TRS. The ENIGMA-TRS Phase III development program consists of two pivotal studies, ENIGMA-TRS 1 and ENIGMA-TRS 2: ENIGMA-TRS 1 is an international, 52-week, randomized, double-blind, placebo-controlled Phase III study evaluating the efficacy, tolerability, and safety of the 15mg BID and 30mg BID therapeutic doses of evenamide as an add-on treatment to current antipsychotics, compared to placebo. Patients on second-generation antipsychotics (SGAs), including clozapine, will meet Treatment Response and Resistance Psychosis (TRRIP) international consensus criteria for TRS. The study will enroll at least 600 patients at study centers in Europe, Asia, Latin America and Canada. The primary assessment of efficacy and safety of ENIGMA-TRS 1 will be performed 12 weeks after randomization to treatment. Following this initial period, the study will continue double-blind and placebo-controlled until the 52-week time point. The primary efficacy endpoint of the trial will be the change from baseline in the Positive and Negative Syndrome Scale (PANSS) scores at 12 weeks. Newron expects to announce 12-week results from the study in Q4 2026. ENIGMA-TRS 1 is actively screening across all target continents. Post-period, in August 2025, Newron announced that the first patients have been successfully enrolled following the completion of a 42-day screening period. Newron’s partner Myung In Pharm has also received the necessary approvals in South Korea to move towards enrolling patients in this region. ENIGMA-TRS 2 , the second study in Newron’s pivotal Phase III development program, has been approved by the US Food and Drug Administration (FDA), and will be performed at centers in the US and selected additional countries. ENIGMA-TRS 2 will include at least 400 patients in a 12-week, randomized, double-blind, placebo-controlled Phase III study, designed to evaluate the efficacy, tolerability, and safety of the 15mg BID dose of evenamide as an add-on treatment to current antipsychotics, compared to placebo. Patients will undergo the same screening as the ENIGMA-TRS 1 trial. The efficacy and safety analysis will be performed at the 12-week point following successful completion of the study. US investigational centers are expected to initiate the study by October 2025. Shortly after the reporting period, in August 2025, new preclinical data from Dr. Anthony Grace and other researchers at the University of Pittsburgh was published in the peer-reviewed journal Neuropsychopharmacology. The data suggests that evenamide ameliorates schizophrenia-related dysfunction, and for the first time demonstrates that evenamide targets the key site of schizophrenia pathology in the hippocampus. Using the neurodevelopmental MAM model of schizophrenia, researchers demonstrated that evenamide could offer a novel therapeutic strategy capable of addressing the positive, cognitive, and negative symptoms of schizophrenia, a key advantage over existing antipsychotic drugs which only target positive symptoms. Importantly, time-course analysis indicates effects of a single dose of evenamide last long after elimination of drug, suggesting effect on neuronal plasticity. These findings help explain the robust and sustained symptom improvements observed in Newron’s Phase II and Phase III studies in patients with chronic schizophrenia, reinforcing evenamide’s potential as a transformative therapy for treatment-resistant and poorly responding patients, and offering a promising alternative to traditional dopamine D2-based antipsychotics. Xadago®/safinamide – Parkinson’s disease In partnership with Zambon and Meiji Seika, Newron continues to develop and market its product, Xadago®/safinamide. Corporate At the Annual General Meeting 2025, Dr. Chris Martin was elected as the new Chairman of the Board following his nomination by the Company. Chris Martin took over from Dr. Ulrich Köstlin, who served as Chairman of Newron’s Board since 2013. Dr. Martin is a recognized leader in the biopharma industry who has taken therapeutic technology from the lab bench through to regulatory approval and global market sales. He co-founded ADC Therapeutics in 2012 and served as its CEO from its inception until 2022, growing the company from a private biotech start-up to a New York Stock Exchange listed leader in the field of antibody-drug conjugates with products marketed worldwide. Chris Martin also co-founded and was the CEO of Spirogen, an innovator of antibody-drug conjugate payload technology, which was subsequently sold to AstraZeneca for a total of up to $440 million. Outlook Following the approval of the pivotal Phase III ENIGMA-TRS program for evenamide and the subsequent initiation of the ENIGMA-TRS 1 study, Newron’s key focus for the coming months is on progressing this study and initiating ENIGMA-TRS 2, initially in the US study centers. In addition to its licensing agreements with Myung In Pharm and EA Pharma, Newron continues to be supported by one of world's leading full-service investment banking and capital markets firms in a structured process to secure the most attractive, value creating transactions for the Company’s shareholders. Furthermore, to comprehensively protect the future value of evenamide for shareholders and new investors, Newron is currently in the process of filing additional patent applications to further extend the Intellectual Property protection around evenamide as a novel treatment for schizophrenia. Additionally, the existing patent applications pertaining to evenamide continue to be granted within the European Union and the US. Newron CEO Stefan Weber concluded: “We are very excited about our continued achievements, and we are one step closer to potentially bringing enormous benefits to schizophrenia patients who are insufficiently served by the treatments currently available. The financial position of our Company remains strong – Newron’s total available cash resources are expected to fund our planned development programs and operations well towards the end of the year 2026.” Financial Summary (IFRS) H1 2025 and 2024: In thousand EUR (except per share information) H1 2025 H1 2024 Licence income/Royalties/Other income 11,898 3,407 Research and development expenses (6,081) (6,453) General and administrative expenses (4,423) (4,579) Net loss (73) (9,557) Loss per share (0.00) (0.51) Cash generated/(used) in operating activities 33,353 (8,828) As of June 30, 2025 As of December 31, 2024 Cash and Other current financial assets 43,195 9,826 Total assets 61,394 63,908 Newron’s Half-Year Report 2025 is available for download on the Company’s website at: www.newron.com/investors/reports-and-presentation/year/2025 About Newron Pharmaceuticals Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on developing novel therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso, near Milan, Italy, Newron is advancing its lead compound, evenamide, a first-in-class glutamate modulator, which has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently in Phase III development and clinical trial results to date demonstrate the benefits of this drug candidate in the TRS patient population, with significant improvements across key efficacy measures increasing over time, as well as a favourable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron has a proven track record in bringing CNS therapies to market. Its Parkinson’s disease treatment, Xadago® (safinamide), is approved in over 20 markets, including the USA, UK, EU, Switzerland, and Japan, and commercialized in partnerships with Zambon and Meiji Seika. For more information, please visit: www.newron.com 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.