Aripiprazole

药通社盘点：每月首仿获批情况。 2026年3月，共计451条受理号过评/视同过评，涉及273个品种，其中首家过评品种20个，其中11款为首仿。 ↓ 扫码加入药通社交流群 ↓ 1 地奈德洗剂 3.6 3月6日，江苏知原药业的地奈德洗剂获批，成为国内首仿，同时也成为国内独家。 地奈德洗剂原研高德美，早在2004年曾在国内上市，商品名莱索文，但到了2020年注册证到期后未续，退出了中国市场，自此之后，国内地奈德洗剂剂型一直处于“无原研、无仿制”的空白状态。 地奈德洗剂原研在国内上市过，有临床使用基础，但这些年没有其他仿制药申请，江苏知原成功获批成为首仿，算是补上了原研的缺失。 目前，国内已上市的地奈德制剂主要为乳膏剂型，对于头皮、毛发等旺盛部位特殊区域，存在涂抹不便、易沾染衣物等弊端，而洗剂剂型流动性更强、更易涂抹，更适合头皮等特殊部位的炎症治疗。 经查，目前地奈德洗剂除了知原外，尚无其他企业有进度，因此知原仍能独家很长时间。此外知原也同时拥有地奈德乳膏剂，两种剂型形成很好互补。 2 双氯芬酸钠双释放肠溶胶囊 3.13 双氯芬酸钠是经典非甾体抗炎成分，早就被熟知，特殊的是双释放这一技术，其肠溶包衣使得药物在胃内酸性环境中保持完整，直至到达小肠碱性环境才开始释放。这一设计有效避免了药物对胃黏膜的直接刺激，从而在源头上减少了胃肠损伤的可能。 双氯芬酸钠双释放肠溶胶囊由Klinge Pharma（Aenova集团前身）研发，凭着其独特的双释放技术脱颖而出，在国内独家了二十多年。 此次，福元医药终于打破了原研的技术垄断，拿下国内首仿，国内还有上海惠永制药、天津梅花生物医药、海南先声药业三家企业提交了仿制上市申请。 3 乙酰半胱氨酸片 3.20 乙酰半胱氨酸片终于有首仿企业出现了，这一成分赞邦在1996年引入了口服制剂，片剂2008年获批，海南赞邦作为原研地产化企业，其持有的乙酰半胱氨酸片却不具备参比资格，2023年确定参比制剂后，到现在才有首仿出现，已经属于进度偏慢，详见分析：乙酰半胱氨酸口服制剂：BE试验深度分析 2024年，杭州沐源提交了仿制上市申请，顺利斩获首仿，而福元药业提交上市时间更早，目前仍在走流程，错失首仿，杭州沐源这家B证公司已获多款品种首仿，实力不容小觑。 4 注射用阿立哌唑 3.20 阿立哌唑曾是全球最畅销的精神疾病用药之一，峰值销售额超过80亿美元，针对阿立哌唑有多种剂型。 注射用阿立哌唑则由大冢制药原研，2023年国内上市，该制剂采用纳米晶长效技术，通过控制药物晶体粒径实现缓释效果，肌注一次可维持治疗浓度长达4周。 这一复杂制剂仿制难度颇高，齐鲁制药提交的两项注射用阿立哌唑申请，历时300余天，且未获得发补机会即被否，即便是国内仿制药龙头，也不能轻易攻克，目前齐鲁已重新提交申请。 齐鲁未成功，但科伦却成功了，3月顺利获批首仿上市，在抗精神病药物上，齐鲁和科伦目前是强竞争关系，同在3月，另一款抗精神病药物，布瑞哌唑口溶膜，齐鲁先于科伦获批，但也就仅隔了一周。 5 苯磺酸美洛加巴林片 3.20 3月，年销售额超3.8亿美元的DPNP止痛药苯磺酸美洛加巴林片，正大天晴顺利获批，成为国内首仿。 糖尿病周围神经病理性疼痛（DPNP）作为糖尿病常见隐匿性并发症，严重影响患者生活质量，苯磺酸美洛加巴林片是少有的获批成人DPNP的药物。 2024年6月，第一三共原研的苯磺酸美洛加巴林片正式获批进入中国市场，8月，正大天晴就提交了仿制上市，并顺利获批，后续还有齐鲁、苑东等多家企业在走审评流程。 详见分析：原研国内独家，14家药企抢首仿！ 6 甲磺酸贝舒地尔片 3.27 甲磺酸贝舒地尔片是慢性移植物抗宿主反应的新药，为全球首个且唯一获批用于12岁及以上糖皮质激素治疗应答不充分的慢性移植物抗宿主病患者的ROCK2抑制剂。 贝舒地尔片是被赛诺菲看中的品种，原研Kadmon公司，2019年BK Pharma获得贝舒地尔在中国大陆地区的开发权利，2021年赛诺菲收购Kadmon将贝舒地尔纳入旗下，2023年贝舒地尔在国内获批，同年赛诺菲收回贝舒地尔在中国大陆的开发权利。其市场表现也不负赛诺菲期望，2024年全球销售额5亿美元。 齐鲁于3月顺利首仿获批，齐鲁近些年的首仿品种从大而广的治疗领域走向了更细分的治疗领域。 7 其他 5款 康哲药业的德度昔司他片，由康哲药业合作伙伴Zydus Lifesciences Limited研发，适用于非透析的成人慢性肾脏病（CKD）患者的贫血治疗。康哲药业全资附属公司康哲国际发展管理有限公司于2020年1月20日获得了该产品在中国大陆、香港、澳门和台湾的独家许可权利，康哲药业国内按照3类仿制进行了申报，顺利获批。 另外，浙江普洛的硫酸麻黄碱注射液、江苏华泰的氯甲西泮注射液、石家庄四药的乳酸钠林格冲洗液是三款按照化药3类获批的品种，原研均未在国内上市，仿制独家，其中硫酸麻黄碱注射液和氯甲西泮注射液均属于手术用药，除了过评企业外无其他企业入局，能保持很久的独家。 枸橼酸西地那非口溶膜，科伦首仿获批，本号有过分析：口溶膜，爆了 ↓⭐关注药通社，洞见行业趋势↓ 投稿/企业合作/内容沟通： 药通社总编—华籍美人（Ww_150525） *添加请注明备注及来意

Roluperidone has been de-risked by consistent positive results in two prior pivotal trials and remains the only late-stage drug candidate for this high-need population Efficacy topline data expected 2H 2027 BURLINGTON, Mass., March 31, 2026 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today announced that the first patient has been screened in its global, confirmatory Phase 3 clinical trial evaluating roluperidone as monotherapy for the treatment of negative symptoms of schizophrenia. Negative symptoms, including avolition (severe lack of motivation), anhedonia (inability to experience pleasure) and social withdrawal can lead to profound personal and functional impairment and represent one of the greatest unmet needs in schizophrenia. There are currently no FDA-approved treatments with this indication. The Phase 3 trial will enroll approximately 380 patients across roughly 40 clinical sites worldwide, including the United States (US) and multiple European countries. This confirmatory Phase 3 trial follows productive discussions with the FDA on the overall design and efficacy assessments. It builds directly on Minerva’s clinical success in the prior pivotal Phase 2b and Phase 3 trials (C03 and C07), both of which demonstrated consistent improvements in negative symptoms with the 64 mg dose of roluperidone. “Initiation of this confirmatory Phase 3 trial is an important milestone for Minerva and for patients living with persistent and impairing negative symptoms of schizophrenia,” said Dr. Remy Luthringer, Executive Chairman and CEO of Minerva Neurosciences. “With no approved treatments for this indication in the US, roluperidone remains the only late-stage candidate in development for this population. The study builds directly on our prior experience showing consistent results across the two earlier trials and our execution strategy gives us confidence in our timelines.” “Patients with schizophrenia often live with persistent negative symptoms such as avolition and anhedonia - challenges that remain even when positive symptoms are controlled with current therapies,” said Dr. Elan Cohen, Principal Investigator at CenExel Marlton, New Jersey and Lead Coordinating Investigator for the trial. “By evaluating roluperidone in a population with stable positive symptoms, this trial isolates its potential to improve these core drivers of disability while laying the groundwork for a broader treatment strategy. Strengthening motivation, cognition, and functioning may ultimately support more comprehensive symptom control over time, and the consistency seen in prior studies makes this confirmatory Phase 3 trial especially compelling.” About the Phase 3 MIN-101C19 Trial The global Phase 3 MIN-101C19 trial will enroll approximately 380 adults aged 18–55 with moderate to severe negative symptoms of schizophrenia, confirmed by a Positive and Negative Syndrome Scale (PANSS) negative subscale score greater than 20 and stable positive symptoms for at least six months. The trial utilizes a two-part design. The overall objective of the study is to confirm the effect of roluperidone on primary negative symptoms at 12 weeks compared to placebo and to evaluate longer-term relapse of positive symptoms compared with commonly prescribed antipsychotic medications for an additional 40 weeks. The trial is designed to minimize variability and maximize sensitivity to treatment effect, including standardized assessments, and comprehensive caregiver engagement. Topline data from the 12-week Phase A portion (i.e., primary efficacy endpoint) of the trial are expected in the second half of 2027. The trial’s operational model includes intensive rater training, real-time monitoring of scoring data, and structured caregiver outreach to support safety tracking, functional assessments, and adherence. Phase A is a12-week, randomized, double-blind, placebo-controlled phase during which patients will receive 64 mg of roluperidone or placebo to evaluate the primary endpoint: change from baseline in the Marder Negative Symptoms Factor Score (NSFS), which is a factor-analytic composite created from selected PANSS items. The sole key secondary endpoint is the change from baseline in the Personal and Social Performance (PSP) total score. Other secondary endpoints include a broad set of additional clinical measures, including PANSS subscales, Clinical Global Impression – Severity (CGI-S), Clinical Global Impression – Improvement (CGI-I), the Calgary Depression Scale, avolition-specific analyses, and patient and caregiver treatment-satisfaction ratings. Phase B extends the trial for 40 weeks using a double-dummy, active-controlled, randomized design comparing continued roluperidone with three commonly prescribed antipsychotic medications (risperidone, aripiprazole, or olanzapine). This phase is designed to compare relapse rates between treatment groups. Relapses of positive symptoms will be evaluated using a rigorous, multi-component definition incorporating psychometric endpoints based on PANSS score worsening, and clinically meaningful events such as hospitalization or dangerous behavior. About Minerva Neurosciences Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing product candidates to treat CNS diseases. Minerva’s goal is to transform the lives of patients with improved therapeutic options, including roluperidone for negative symptoms of schizophrenia. For more information, please visit the Company’s website . Forward-Looking Safe Harbor Statement This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include, but are not limited to, statements herein with respect to implied or express statements regarding the anticipated clinical benefits and market opportunities associated with roluperidone, including its potential to address clinical and regulatory challenges; and the expected timeline, design, and conduct of Minerva’s Phase 3 trial of roluperidone. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, trials and studies may be delayed and may not have satisfactory outcomes, and earlier trials and studies may not be predictive of later trials and studies; the design and rate of enrollment for clinical trials, including the current design of the confirmatory Phase 3 trial evaluating roluperidone may not enable successful completion of the trial(s); the commercial opportunity for roluperidone in negative symptoms of Schizophrenia may be smaller than anticipated; Minerva may be unable to obtain and maintain regulatory approvals; Minerva may experience uncertainties inherent in the initiation and completion of clinical trials and clinical development; Minerva’s future financial performance and position may not improve, resulting in difficulties in implementing Minerva’s business strategy, and plans and objectives for future operations; the expected sufficiency of Minerva’s existing cash resources and runway may not be accurate resulting in the need for additional financing sooner than anticipated or unexpected liquidity constraints; the internal and external costs required for Minerva’s ongoing and planned activities, and the resulting impact on expense and use of cash, may be higher than expected, which may cause the company to use cash more quickly than expected or to change or curtail some of Minerva’s plans or both; the need to align with collaborators or partners may hamper or delay development and regulatory efforts or increase costs; uncertainties of patent protection and litigation; general economic conditions; and other factors that are described under the caption “Risk Factors” in Minerva’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission. Copies of reports filed with the SEC are posted on Minerva’s website at The forward-looking statements in this press release are based on information available to the Company as of the date hereof, and the Company disclaims any obligation to update any forward-looking statements, except as required by law. Contacts: Investor inquiries: Frederick Ahlholm Chief Financial Officer Minerva Neurosciences, Inc. info@minervaneurosciences.com Corey Davis, Ph.D. LifeSci Advisors, LLC 212-915-2577 cdavis@lifesciadvisors.com