Safinamide mesylate

精彩内容 近期，山东鲁抗医药集团赛特的米诺地尔搽剂顺利获批，成为了鲁抗医药首个皮肤病用药，集团成功进军300亿新市场，意义重大。米诺地尔是皮肤病用药（化+生）市场TOP2品种，2024年在中国三大终端六大市场的销售额超过了23亿元。 图1：鲁抗医药获批的新产品 来源：国家药监局官网 米诺地尔通过扩张头皮血管、延长毛囊生长期，改善脱发问题，常用于治疗男性型脱发（雄激素性脱发）和斑秃，近年来逐渐成长为治疗脱发的明星药。米内网数据显示，目前在国内市场已有米诺地尔搽剂、米诺地尔酊、米诺地尔喷雾剂、米诺地尔凝胶、米诺地尔泡沫剂获批。 图2：国内市场已上市的米诺地尔制剂 来源：米内网中国上市药品(MID)数据库 图3：米诺地尔的销售情况（单位：万元） 来源：米内网格局数据库 在中国三大终端六大市场（统计范围见文末），米诺地尔的销售额在2020-2023年实现了高速增长，2024年微跌6%左右，销售额达到了23.6亿元，2025年Q1-Q3跌幅扩大，但依然是超10亿大品种。从渠道来看，零售药店终端（城市实体药店+网上药店）一直是米诺地尔的销售主战场，2022-2025年Q1-Q3均占了八成以上。 近几年在中国三大终端六大市场，皮肤病用药（化+生）的市场规模一直稳步上涨，2024年首次突破310亿元，2025年Q1-Q3米诺地尔为该大类市场TOP2品种。鲁抗医药早前在这个百亿市场无产品获批，米诺地尔搽剂是公司首个皮肤病用药，意义重大。 表1：2024年至今鲁抗医药报产在审的新品（按大类统计） 来源：米内网中国申报进度(MED)数据库 米诺地尔搽剂是鲁抗医药在2026年首个获批的新品，成功助力公司进军300亿皮肤病用药（化+生）市场。目前，鲁抗医药报产在审的仿制药新品还有22个，涉及6个大类，其中阿瑞匹坦胶囊、托吡酯口服溶液、甲磺酸沙非胺片有望助力公司新开拓止吐药和止恶心药、抗癫痫药、抗帕金森氏病药3个亚类市场，值得期待。 资料来源：国家药监局官网、米内网数据库 注：米内网《中国三大终端六大市场药品竞争格局》，统计范围：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。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

Newron Pharmaceuticals S.p.A. (“Newron”, or the “Company”) (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 that it has entered into an agreement for the subscription of newly issued shares for proceeds of up to EUR 38 million with a group of existing and new shareholders from Europe and Asia, strengthening the Company’s financial position as it advances the ENIGMA-TRS Phase III program. “This financing is expected to extend our operational runway well beyond the upcoming 12-week results from the ENIGMA-TRS 1 and 2 pivotal studies and support continued execution of our Phase III development program.” Under the agreement, the investor group will initially subscribe to up to 779,624 newly issued shares at a subscription price of EUR 19.24 per share, which corresponds to gross proceeds of up to EUR 15 million. Alongside the progress of the ENIGMA-TRS 1 and 2 pivotal studies towards the 12-week results, expected in Q4 of this year, and no later than November 30, 2026, the group will subscribe to an additional number of newly issued shares for total proceeds of EUR 11 million, at a subscription price to be calculated pursuant to an agreed formula. Finally, the group will subscribe to an additional number of newly issued shares for total proceeds of EUR 12 million upon disclosure of results from the ENIGMA-TRS pivotal studies, conditional to such results being positive, and at a subscription price to be calculated pursuant to the agreed formula*. The share subscriptions are governed by the capital increase authorized by Newron’s shareholders in 2018 and approved and empowered by the Company’s board of directors in 2025. “The investment by this group of existing and new shareholders is further validation of our development strategy for evenamide as the potential first add-on therapy in schizophrenia and as a new treatment option for the vast majority of patients who are poorly responding or resistant to available treatment options,” said Roberto Galli, CFO of Newron. “Importantly, this financing is expected to extend our operational runway well beyond the upcoming 12-week results from the ENIGMA-TRS 1 and 2 pivotal studies and support continued execution of our Phase III development program.” The initial up to 779,624 newly issued shares are expected to be listed and traded on the SIX Swiss Exchange under the same ISIN as the Company’s existing shares (ISIN: IT0004147952) in the next few days, upon payment and settlement. Furthermore, the new shares are expected to be listed and traded on the Primärmarkt of the Düsseldorf Stock Exchange, as well as traded on the Quotation Board of the Frankfurt Stock Exchange (Xetra). The total number of shares to be issued under the Transaction will depend on the share price at the time of execution of the additional tranches. Applying the subscription price of the initial tranche, Newron would issue up to 1,971,052 shares. The ENIGMA-TRS pivotal Phase III program consists of ENIGMA-TRS 1 and ENIGMA-TRS 2. ENIGMA-TRS 1, initiated in August 2025, is an international, one-year, double-blind, placebo-controlled study in at least 600 patients to evaluate the efficacy, tolerability, and safety of evenamide 15 mg and 30 mg twice daily as an add-on therapy to current antipsychotics, including clozapine, compared to placebo. ENIGMA-TRS 2, initiated in December 2025, is a Phase III, international, 12-week, randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of evenamide 15 mg twice daily as an add-on therapy to current antipsychotics, including clozapine, compared to placebo, in patients suffering from TRS. ENIGMA-TRS 2 will enroll at least 400 patients. Evenamide is a novel, orally available new chemical entity with a unique mechanism of action distinct from all currently marketed antipsychotics. It acts by selectively blocking voltage-gated sodium channels (VGSCs) and exhibits no biological activity at more than 130 other central nervous system (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 subtherapeutic doses of evenamide and other APs, including clozapine, were associated with benefit in animal models of psychosis, suggesting synergies in mechanisms that may provide meaningful benefits for patients who do not adequately respond to current APs, including those on clozapine. Importantly, the benefits seemed to persist for a substantial time after evenamide had been degraded, explaining the long-term effects seen in clinical studies. Through its novel glutamatergic modulation, evenamide represents a first-in-class approach aimed at addressing the unmet needs of patients with schizophrenia who are resistant to existing treatments. A significant proportion of patients with schizophrenia show virtually little to no beneficial response to currently available antipsychotic (AP) treatments, leading to a diagnosis of treatment-resistant schizophrenia (TRS). TRS is defined as no or inadequate symptom relief despite treatment with therapeutic doses of two APs from two different chemical classes for an adequate period. It is estimated that approximately 15% of patients develop TRS from the onset of illness, and about one-third to 50% of patients with schizophrenia overall. Emerging scientific evidence supports abnormalities in glutamate neurotransmission in TRS, not targeted by current APs, along with normal dopaminergic synthesis, to explain the lack of clinical benefit of most typical and atypical antipsychotics, which act primarily on dopamine receptors. These insights underline the need for novel therapeutic approaches that target the underlying glutamatergic dysfunction in schizophrenia, offering hope for patients who currently have limited or no effective treatment options. Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso near Milan, Italy, the Company has a strong track record of advancing neuroscience-based treatments from discovery to market. Newron’s lead compound, evenamide, is a first-in-class glutamate modulator and 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 developed in the global pivotal ENIGMA-TRS Phase III development program. Clinical trial results to date demonstrate the benefits of this drug candidate in the TRS as well as poorly responding patient population, with significant improvements across key efficacy measures increasing over time, as well as a favorable 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’s first marketed product, 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. The product is commercialized by Newron’s partner Zambon, with Supernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika responsible for development and commercialization in Japan and other key Asian territories. The content above comes from the network. if any infringement, please contact us to modify.