Gabapentin

氨基观察-创新药组原创出品 作者 | 黄恺 DLL3 ADC再现大额BD。 继恒瑞医药之后，1月2日，信达生物宣布与罗氏达成全球独家合作与许可协议，将DLL3 ADC IBI3009的全球开发、生产和商业化的独家权益授权给罗氏。双方将共同负责IBI3009的早期开发，后续临床开发将由罗氏负责。 根据协议，信达生物将获得8000万美元的首付款，和最高达10亿美金的开发和商业化潜在里程碑付款，以及未来基于全球年度销售净额的梯度式销售提成。 吉利德长效HIV疗法国内获批上市。 1月2日，NMPA官网显示，吉利德申报的来那帕韦片和来那帕韦注射液上市申请已获得批准。这款长效HIV疗法当选了《科学》杂志近期公布的2024年度科学突破。 吉利德此前介绍，来那帕韦将为对现有疗法无有效应答的HIV感染者提供一种每年仅需给药两次的全新治疗方案。 在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。 / 01 / 市场速递 1）海普瑞获加巴喷丁胶囊美国商业化许可 1月2日，海普瑞公告称，公司于2024年12月31日与永太药业签订分销协议，永太药业授予海普瑞在美国全境商业化加巴喷丁胶囊的许可。海普瑞将向永太药业以约定价格购买该标的药品，并负责标的药品在美国市场的商业化工作。加巴喷丁是一种常用的抗癫痫药物，被广泛用于治疗神经痛和其他疼痛性疾病。 2）佐力药业乌灵胶囊拟中选甘肃省第六批药品集中带量采购 1月2日，佐力药业公告称，公司参与了甘肃省第六批药品集中带量采购工作，产品乌灵胶囊拟中选本次集中带量采购。乌灵胶囊主要用于治疗心肾不交所致的失眠、健忘、心悸心烦等症状，为国家医保及国家基药目录产品。 / 02 / 资本信息 1）普祺医药完成超3亿元B轮融资 1月2日，普祺医药宣布完成超3亿元B轮融资。根据新闻稿介绍，本轮融资款项将用于现有核心产品普美昔替尼（PG-011，pumecitinib）凝胶治疗成人及青少年轻中度特应性皮炎的3期临床研究及NDA申报、拓展PG-011在其他适应症的应用及后续其他创新管线的临床推进。此外，该公司拟准备在北交所进行IPO申报，工作正在有序地推进之中。 2）和黄医药6.08亿美元出售和黄药业45%股权 近日，和黄医药宣布，达成两项协议以6.08亿美元现金向上海金浦健服股权投资管理有限公司和上海医药出售其在上海和黄药业45%的股权。 和黄医药计划将上述交易所得的款项用于进一步开发其内部产品管线，并推动发展其核心业务战略。 / 03 / 医药动态 1）先博生物CD19 CAR-NK一期临床完成两例给药 1月2日，先博生物宣布，其自主研发的通用型异体CD19 CAR-NK药物SNC103已成功完成两例一期临床给药，该疗法针对复发和/或难治性大B细胞淋巴瘤，两位复发难治的患者均取得较好疗效。 2）信达生物/葆元医药ROS1抑制剂新适应症获批 1月2日，NMPA官网显示，信达生物/葆元医药（已被 Nuvation Bio收购）申报ROS1抑制剂己二酸他雷替尼胶囊新适应症获批上市，用于一线治疗未经ROS1-TKI治疗的ROS1阳性局部晚期或转移性非小细胞肺癌的成人患者。 3）阿斯利康奥希替尼新适应症获批 1月2日，NMPA官网显示，阿斯利康申报的奥希替尼新适应症在国内获批上市，用于治疗接受含铂放化疗期间或之后未出现疾病进展、具有表皮生长因子受体（EGFR）外显子19缺失或外显子21（L858R）置换突变的局部晚期、不可切除（III 期）非小细胞肺癌的成人患者。 4）GSK美泊利珠单抗新适应症获批 1月2日，NMPA官网显示，GSK的美泊利珠单抗注射液在国内获批新适应症。 5）国药现代控股子公司药品上市申请被拒 1月2日，国药现代公告称，公司控股子公司国药致君收到国家药品监督管理局签发的《药品上市申请不予批准通知书》，其申报的磷霉素氨丁三醇颗粒上市申请不符合药品注册的有关要求，不予批准。 6）复星医药注射用雷替曲塞注册申请受理 1月2日，复星医药公告称，控股子公司吉斯美（武汉）制药有限公司的注射用雷替曲塞的药品注册申请于近日获国家药品监督管理局受理，拟用于治疗不适合5-Fu/亚叶酸钙的晚期结直肠癌患者。 7）百利天恒BL-B01D1被纳入突破性治疗品种名单 1月2日，百利天恒公告称，公司自主研发的EGFR×HER3的双抗ADC BL-B01D1已被国家药品监督管理局药品审评中心纳入突破性治疗品种名单。该药拟定适应症为既往经含铂化疗及抗PD-1/PD-L1单抗治疗失败的复发性小细胞肺癌患者。 8）新诺威子公司SYS6010被纳入突破性治疗品种名单 1月2日，新诺威公告称，控股子公司巨石生物研发的SYS6010(抗人EGFR人源化单抗-JS-1 偶联注射剂)被国家药品监督管理局药品审评中心纳入突破性治疗品种名单 ，该药拟定适应症为单药用于经EGFR-TKI和含铂化疗治疗失败的EGFR突变阳性晚期非小细胞肺癌。 9）劲方医药GDF15/IL-6双抗临床申报获受理 近日，CDE官网显示，劲方医药递交的GDF15/IL-6双抗新药GFS202A的临床试验申请，已经获得受理，用于恶病质的治疗。 / 04 / 器械跟踪 1）九强生物试剂盒取得医疗器械注册证书 1月2日，九强生物公告称，公司收到北京市药品监督管理局颁发的心肌肌钙蛋白I测定试剂盒(荧光免疫层析法)《医疗器械注册证》。该试剂盒用于体外定量测定人血清、血浆或全血样本中的心肌肌钙蛋白I（cTnI)含量。 / 05 / 海外药闻 1）Kazia Therapeutics脑癌药物paxalisib不适用加速审批 近日，FDA指出Kazia Therapeutics开发的脑癌药物，总体生存（OS）数据不适用于加速审批途径。此消息导致公司股价暴跌超过40%。 为了获得传统审批，Kazia需要进行注册性III期临床试验来进一步评估这款PI3K/Akt/mTOR通路抑制剂。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

MIAMI, FL / ACCESSWIRE / December 19, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Ketamir-2, its novel oral ketamine analog for the treatment of neuropathic pain. The IND submission marks a major step in advancing Mira's lead drug candidate while reflecting its commitment to meeting milestones and timelines.Erez Aminov, Chairman & CEO of Mira, stated: "This IND submission highlights our team's commitment to executing efficiently as we advance transformative therapies. Ketamir-2 not only has demonstrated remarkable potential for neuropathic pain but also offers a broad opportunity across other major neuropsychiatric conditions. We look forward to beginning Phase I trials and continuing to deliver on our mission to address unmet medical needs."The IND application includes comprehensive data and reports detailing Ketamir-2's pharmacology, pharmacokinetics, and toxicology, along with results from both in vitro and in vivo studies, including validated neuropathic pain disease models. In parallel with the submission, the company is preparing to conduct a complementary neurotoxicity study, as required by the FDA's written feedback to the pre-IND documentation.According to a market analysis report from Fortune Business Insights, the neuropathic pain market in North America, including the United States, Canada, and Mexico, is valued at $3.1 billion and is expected to grow at a 6-7% compound annual growth rate (CAGR), reaching $4.5 billion by 2030. Despite this growth, existing treatments remain inadequate. Gabapentin and pregabalin, while widely prescribed, provide limited efficacy and are associated with side effects such as sedation, dizziness, and weight gain. Opioids remain a common treatment option but come with well-known risks of dependency, addiction, and respiratory depression. Intravenous ketamine, though effective for some patients, requires invasive administration and is often associated with psychotropic side effects, including hallucinations and dissociation.Ketamir-2 is specifically designed to address the limitations of existing treatments through its selective targeting of the NMDA receptor. By binding to a specific site on the NMDA receptor with low affinity, Ketamir-2 significantly reduces the risk of psychotropic effects commonly associated with traditional ketamine. Furthermore, it is not a substrate for P-glycoprotein (P-gp), which allows for better oral absorption and enhanced blood-brain barrier penetration. Unlike traditional ketamine, Ketamir-2 does not cause sedation or hyperactivity-side effects often linked to psychiatric conditions such as schizophrenia, bipolar mania, and ADHD. As a non-opioid therapy, Ketamir-2 is designed to eliminate the risks of dependency and addiction. Additionally, the DEA has determined that Ketamir-2 is not a controlled substance, streamlining accessibility and minimizing regulatory hurdles.Preclinical studies have demonstrated Ketamir-2's ability to achieve 100% pain reversal, fully normalizing pain thresholds in validated neuropathic pain models. Furthermore, Ketamir-2 has shown a strong safety and toxicological profile, observed across cardiovascular, CNS, respiratory, or toxicology assessments.Dr. Itzchak Angel, Chief Scientific Advisor at Mira, commented: "Ketamir-2's selective mechanism of action, strong safety profile, and ability to achieve full pain reversal underscore its potential as a transformative therapy."With the IND submitted, MIRA expects to initiate Phase I Clinical Trials in Q1 2025 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers. Phase IIa trials are expected to follow in late 2025 to assess efficacy in neuropathic pain patients. Beyond neuropathic pain, the company is exploring additional indications for Ketamir-2, including MDD, MDD-SI, TRD and PTSD.About MIRA Pharmaceuticals, Inc.MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. MIRA holds the exclusive U.S., Canadian, and Mexican rights for Ketamir-2, a novel, patent-pending oral ketamine analog under investigation to treat neuropathic pain (NP), treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDD-SI), and post-traumatic stress disorder (PTSD).MIRA's novel oral pharmaceutical marijuana analog, MIRA-55, is currently under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated with early-stage dementia. If approved by the FDA, MIRA-55 could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders.The U.S. Drug Enforcement Administration's scientific review concluded that both Ketamir-2 and MIRA-55 would not be considered controlled substances or listed chemicals under the Controlled Substances Act and its governing regulations.Additional information about MIRA Pharmaceuticals is available at www.mirapharmaceuticals.com.Cautionary Note Regarding Forward-Looking StatementsThis press release and the statements of MIRA Pharmaceuticals' (or the "Company") management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding the anticipated benefits of the study results described herein as well as the timing for the Company's other preclinical studies and the filing of an IND for Ketamir-2. Any forward-looking statements in this press release are based on the Company's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond the Company's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These and other risks concerning the Company's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2023, and other SEC filings, which are on file with the SEC at www.sec.gov and the Company's website at https://www.mirapharmaceuticals.com/investors/sec-filings. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.Contact InformationHelga Moya [email protected](786) 432-9792SOURCE: Mira Pharmaceuticals, Inc.