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Company extends BRII-179 license to global rights and introduces preventive vaccine, PreHevbri® in Greater China and Asia Pacific markets New data from BRII-835 + PEG-IFN-α study have demonstrated that robust anti-HBs antibody responses at the end of treatment are associated with sustained HBsAg loss 24 weeks post treatment Company owns exclusive global rights of BRII-693 in development for difficult-to-treat carbapenem-resistant Gram-negative bacterial infections Dr. David Margolis appointed as Chief Medical Officer to lead organization's late-stage clinical programs towards commercialization DURHAM, N.C. and BEIJING, July 5, 2023 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet need, today provided updates on its diverse pipeline of infectious disease (ID) and central nervous system (CNS) disease candidates and announced a pivotal leadership transition that will further advance its strategic priorities. "We are proud to announce our latest achievements in advancing our mission to improve patient health and address critical public health issues. With expanded collaborations and acquisitions, including the worldwide license extension of BRII-179, the introduction of PreHevbri® vaccine in Greater China and Asia Pacific markets, and the acquisition of global rights for BRII-693, we are making remarkable progress in our infectious disease portfolio," said Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio. "Additionally, it is with great pleasure that I introduce Dr. David Margolis as our new Chief Medical Officer. With his extensive experience and expertise both as a licensed ID specialist and a drug developer, Dr. Margolis will play a pivotal role in leading the successful execution of our late-stage clinical programs towards commercialization. Together, these strategic moves align seamlessly with our growth plans and represent important progress for our broader global strategy." Core Clinical Development Updates Hepatitis B Virus (HBV) Led by Brii Bio's team in China and partners, Vir Biotechnology, Inc. ("Vir,"NASDAQ: VIR) and VBI Vaccines, Inc. ("VBI,"NASDAQ: VBIV), the Company is addressing the full range of disease impact for HBV by progressing multiple combination studies to achieve a best-in-class functional cure in broad patient populations, as well as to commercialize a prevention vaccine in Greater China and Asia Pacific region. China and many Asia Pacific countries have the highest prevalence of HBV globally, with over 150 million people impacted by this disease (China ~86 million, Southeast Asia ~69 million HBsAg positive population1). Currently, there is no effective HBV functional cure available, highlighting the urgent need for a better prophylactic vaccine. In July 2023, Brii Bio announced substantial expansion of its HBV portfolio in collaboration with VBI. Under the terms of the agreements, Brii Bio extends its exclusive license to worldwide markets for BRII-179 (VBI-2601). Additionally, Brii Bio also acquires exclusive rights to develop and commercialize PreHevbri® in Greater China and Asia Pacific countries including Australia, Indonesia, Malaysia, New Zealand, Philippines, Singapore, South Korea, Thailand and Vietnam, among others. PreHevbri® is a clinically differentiated 3-antigen adult HBV prophylactic vaccine recently approved for use in the United States, European Union/European Economic Area, United Kingdom, Canada, and Israel. In June 2023, Vir and VBI presented multiple clinical study results at the European Association for the Study of the Liver (EASL) Congress™ 2023: In follow-up data from Vir's Phase 2 trial of combination 24 or 48 weeks of VIR-2218 (BRII-835) on top of a course of up to 48 weeks of pegylated interferon alpha (PEG-IFN-α), 16% (5/31) of participants demonstrated sustained HBsAg loss 24 weeks after end of treatment. Anti-HBs titers greater than 500 mIU/mL at the end of treatment were associated with sustained HBsAg loss at 24 weeks after the end of treatment. Data from Part A of Vir's Phase 2 MARCH trial evaluating short treatment duration of combinations of VIR-2218 (BRII-835) and VIR-3434 (BRII-877) in chronic HBV participants demonstrated a 2.7-3.1 log10 IU/mL decline in HBsAg levels and 90% of participants achieved HBsAg reduction below 10 IU/mL at the end of treatment. VBI presented follow-up data in a subset of participants from the pivotal Phase 3 study, PROTECT, up to 3.5 years after completion of immunization with PreHevbrio® (also known as PreHevbri® in the European Union/European Economic Area and United Kingdom, and Sci-B-Vac® in Israel), a prophylactic 3-antigen HBV vaccine. The mean anti-HBs titers in participants vaccinated with PreHevbrio® were more than 5x higher than those vaccinated with Engerix-B (1287 vs. 254 mIU/mL) suggesting that T-cell responses of PreHevbrio® may contribute to long lasting and strong humoral immune responses and greater durability compared with Engerix-B. In May 2023, Brii Bio submitted an IND application to the NMPA of China for the development of BRII-877 (VIR-3434), and a Phase 1 clinical study is expected to start by the end of 2023. In the second half of 2023, the Company expects data readouts from two Phase 2 trials: Additional data from the Phase 2 study evaluating BRII-835 (VIR-2218) and BRII-179 (VBI-2601) combination. Topline results from the Phase 2 study evaluating BRII-179 (VBI-2601) in combination with PEG-IFN-α. Brii Bio plans for additional combination studies with the earliest to start in 2H 2023. Postpartum Depression (PPD) and Major Depressive Disorder (MDD)/Other CNS Disorders Brii Bio is developing its internally-discovered BRII-296 therapeutic candidate as a first-of-its-kind one-time injection treatment with the potential to expand the PPD and MDD treatment landscapes for patients in the U.S. In June 2023, Brii Bio announced the dosing of the first subject in a Phase 1 clinical trial for BRII-297, a long-acting injectable (LAI) being developed to treat anxiety and depressive disorders. The study, currently underway, aims to evaluate the safety, tolerability, and pharmacokinetics of BRII-297 in healthy volunteers. Brii Bio is working closely with the U.S. Food and Drug Administration (FDA) to align and agree on a PPD treatment protocol in preparation for its Phase 2 proof-of-concept (POC) study to be initiated in the second half of 2023. Brii Bio is actively working to expand the clinical indications for BRII-296 and plans to initiate additional studies in the U.S. in 2024. Additional Pre-Clinical and Clinical Development Updates Human Immunodeficiency Virus (HIV) Infection In December 2022, Brii Bio successfully lifted the U.S. FDA clinical hold, enabling the conduct of the Company's planned Phase 1 study to investigate a lower oral dose of once-weekly BRII-732, with dosing initiated in 2Q 2023. The Company is exploring partnership opportunities to continue developing BRII-732 as part of a potential oral, once-weekly, long-acting combination treatment option for HIV patients. The Company is pursuing partnership opportunities for BRII-753 as part of a long-acting, subcutaneous injection with potential for dosing once monthly, once quarterly, or twice-yearly combination treatment option for HIV patients. MDR/XDR Gram-Negative Bacteria Infections In June 2023, Brii Bio announced definitive agreements with Qpex Biopharma ("Qpex") to acquire exclusive global rights of BRII-693 (QPX-9003), expanding its existing rights in Greater China. The Company returns its exclusive rights of BRII-636 (QPX-7728 or OMNIvance) and BRII-672 (QPX-7831 or ORAvance) in Greater China to Qpex in connection with the acquisition of Qpex by Shionogi. In April 2023, Brii Bio submitted a pre-IND to the NMPA of China for the development of BRII-693 in China. BRII-693 has a highly differentiated safety and efficacy profile to address the most difficult-to-treat Acinetobacter baumannii and Pseudomonas aeruginosa infections resistant to carbapenem. Nontuberculosis Mycobacteria (NTM) Lung Disease Brii Bio's partner, AN2 Therapeutics, Inc. ("AN2,"NASDAQ: ANTX) is enrolling its Phase 2/3 pivotal trial evaluating once-daily, oral epetraborole (BRII-658) for treatment-refractory MAC lung disease. AN2 reported in May that there were nearly 80 sites active in its pivotal Phase 2/3 trial of epetraborole in treatment-refractory MAC lung disease. Corporate Update Dr. David Margolis has been appointed Chief Medical Officer (CMO) after serving as Brii Bio's Head of Infectious Diseases Therapy Area for nearly three years. As the CMO, Dr. Margolis will play a critical role in the Company's late-stage clinical development towards commercial growth across the pipeline. In addition, he will continue to fulfill existing responsibilities that he previously held as Head of Infectious Diseases Therapy Area. Meanwhile, Dr. Li Yan will leave the company to pursue other interests. Brii Bio expresses sincere gratitude to Dr. Yan for his contributions to the Company in the past 5 years. About Brii Bio Brii Biosciences is a biotechnology company developing therapies to address some of the world's most common diseases where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious and central nervous system diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs to develop a novel functional cure for hepatitis B viral infection (HBV) and first-of-its-kind treatment options for postpartum depression (PPD) and major depressive disorder (MDD). The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit . 1 Lancet Gastroenterol Hepatol. 2018; 3(6): 383-403 SOURCE Brii Biosciences Limited

▎药明康德内容团队编辑时光如梭，2023年已经进入下半年。在2023年上半年，美国FDA的药物评价和研究中心（CDER）已经批准了26款创新疗法，远超过2022年同期的水平（16款）。2023年下半年，有哪些批准决定值得关注？今天这篇文章里，药明康德内容团队将结合公开资料，与读者分享未来6个月值得关注的十大FDA批准决定。药物：Leqembi适应症：阿尔茨海默病研发机构：卫材，渤健FDA预计将在7月6日之前决定是否完全批准卫材和渤健联合开发的淀粉样蛋白抗体Leqembi（lecanemab），用于治疗阿尔茨海默病患者。今年1月，基于显著降低患者大脑淀粉样蛋白沉积的临床试验结果，Leqembi已经获得FDA的加速批准。验证性3期临床试验的结果显示，Leqembi显著延缓患者的认知能力和日常生活能力的衰退速度。今年6月，FDA的专家委员会全票支持完全批准Leqembi。如果获得批准，Leqembi将成为20年来首款获得FDA完全批准的阿尔茨海默病新疗法。药物：Zuranolone适应症：抑郁症，产后抑郁症研发机构：渤健，Sage Therapeutics今年2月，渤健和Sage Therapeutics宣布zuranolone的新药申请（NDA）已获FDA接受并授予优先审评资格，用以治疗抑郁症（MDD）及产后抑郁症（PPD）。Zuranolone是一种每日一次、为期两周的在研疗法。它是一种口服神经活性类固醇γ-氨基丁酸A型（GABAA）受体阳性别构调节剂。GABA系统是大脑和中枢神经系统（CNS）的主要抑制性信号通路，对调节CNS功能有重要作用。Zuranolone具在14天快速缓解抑郁症状的潜力，与市面上大部分抑郁药物需要约6-8周才能见效相比，具有差异性。在针对MDD的研究中，此前公布的关键性3期临床试验WATERFALL的结果显示，在第15天时，通过17项汉密尔顿抑郁量表（HAMD-17）评估，与安慰剂相比，zuranolone使患者抑郁症状获得统计显著且具有临床意义的减轻（p=0.0141）。在针对PPD患者的SKYLARK试验中，zuranolone达成主要终点以及所有的关键次要终点。试验参与者在第3天开始便有快速与显著的抑郁症状改善，并一直持续至第45天。药物：皮下注射Tecentriq适应症：非小细胞肺癌研发机构：罗氏罗氏的重磅PD-L1抗体Tecentriq已经获得批准治疗非小细胞肺癌（NSCLC）、小细胞肺癌、肝细胞癌、尿路上皮癌、PD-L1阳性转移性三阴性乳腺癌和BRAF V600突变的晚期黑色素瘤等多种癌症。通常患者需要通过输液的方式接受治疗，标准静脉输液需要30-60分钟。Tecentriq皮下注射制剂将Tecentriq与Halozyme Therapeutics的Enhanze药物输送技术相结合。Enhanze药物输送技术基于一种专有的重组人透明质酸酶PH20（rHuPH20），该酶可暂时降解人体内的透明质酸，从而使Tecentriq皮下制剂能够迅速分散并吸收到血液中。与静脉注射相比，皮下注射可将治疗时间缩短至3-8分钟。去年8月公布的3期临床试验IMscin001的结果显示，在未接受过癌症免疫治疗的铂类治疗失败的局部晚期或转移性非小细胞肺癌（NSCLC）患者中，皮下注射Tecentriq与静脉输注相比，在药代动力学检测中达到非劣效性标准。药物：Patisiran适应症：伴有心肌病的转甲状腺素蛋白介导的淀粉样变性研发机构：AlnylamPatisiran是一种靶向转甲状腺素蛋白（TTR）的RNAi静脉注射疗法，旨在靶向并沉默表达TTR的mRNA，从而阻止野生型和突变TTR蛋白的产生。这有助于清除外周组织中的TTR淀粉样蛋白沉积物，并恢复这些组织的功能。目前，patisiran已在多个国家和地区获批用于治疗患有遗传性转甲状腺素蛋白介导（hATTR）的淀粉样变性引起的多发性神经病成年患者。在全球3期临床研究APOLLO-B中，治疗12个月后，接受patisiran治疗的hATTR淀粉样变性心肌病患者相比于接受安慰剂的患者在功能和生活质量方面均有改善。药物：Eplontersen适应症：转甲状腺素蛋白介导的淀粉样变性多发性神经病研发机构：Ionis Pharmaceuticals，阿斯利康Eplontersen为一款一月一次，可由患者自己皮下注射的在研反义寡核苷酸（ASO）药物，其采用的反义寡核苷酸配体偶联（LICA）技术，可以将ASO药物与能和细胞表面特定受体结合的配体分子偶联在一起。LICA技术能有效地将ASO选择性递送到表达这些受体的细胞中。Eplontersen可用以抑制TTR蛋白的生产，从而治疗遗传性与非遗传性的淀粉样变性多发性神经病。在3期临床试验中，eplontersen在66周时达到了所有共同主要终点和次要终点。Eplontersen使血清TTR浓度从基线降低平均82%，而外部安慰剂组从基线降低了11%（p<0.0001）。与基线相比，66周时eplontersen组患者中有47%的神经病损伤获得改善，而外部安慰剂组为17%。药物：Lifileucel适应症：晚期黑色素瘤研发机构：Iovance BiotherapeuticsLifileucel是基于患者自身的肿瘤浸润淋巴细胞（TIL）构建的细胞疗法，这些TIL在癌症发生时会迁移到肿瘤处并且对肿瘤发起攻击。然而，通常患者体内的TIL数目不足以消灭肿瘤，而且肿瘤微环境会抑制TIL的功能。这款疗法通过从患者体内获取肿瘤组织并且提取TIL，然后在体外使用IL-2细胞因子以刺激TIL的扩增。这一体外刺激手段不但增加了TIL的数量，还能激活TIL的抗肿瘤能力。然后这些TIL被注回患者体内，更有效地杀伤肿瘤细胞。在晚期黑色素瘤患者中进行的临床试验结果显示，一次性注射lifileucel，在接受过PD-1抑制剂和BRAF/MEK靶向疗法的难治性患者中，达到34.3%的总缓解率。Lifileucel的生物制品许可申请已经获得美国FDA授予的优先审评资格，如果获得批准，将成为首款获得FDA批准的TIL疗法。药物：NurOwn适应症：肌萎缩侧索硬化研发机构：BrainStorm Cell TherapeuticsNurOwn来源于肌萎缩侧索硬化（ALS）患者自身骨髓的间充质干细胞，这些细胞在体外进行扩增和分化，并且通过该公司独有的技术刺激分泌高水平的多种神经营养因子。这些分化的细胞在输注回到患者体内后，可能激活神经保护和免疫调节信号通路，从而减轻ALS患者的症状。在此前结束的3期临床试验中，NurOwn未达到试验的主要终点，接受NurOwn治疗的患者达到临床缓解标准的比例（31%）与接受安慰剂治疗的患者组（28%）无显著区别。在对次要终点的分析中，研究人员发现，在症状较轻的患者亚群中，NurOwn治疗导致评估ALS症状的ALSFRS-R评分的变化获得统计显著改善（p=0.050）。此外，研究发现患者的神经营养因子水平显著增加、神经退行性和神经炎症生物标志物减少。基于研究的整体结果，该公司决定向美国FDA递交生物制品许可申请（BLA）。美国FDA将在今年9月召开专家委员会会议，讨论这一BLA。药物：Nirsevimab适应症：预防呼吸道合胞病毒感染引起的下呼吸道疾病研发机构：阿斯利康，赛诺菲Nirsevimab是一款针对呼吸道合胞病毒（RSV）的长效抗体疗法。作为一种单克隆抗体药物，它无需激活免疫系统便能提供及时、快速和直接的疾病免疫保护。它已经获得中国国家药品监督管理局（NMPA）与美国FDA的突破性疗法认定。在去年11月首次在欧盟获得批准上市。美国FDA在今年1月接受了nirsevimab的生物制品许可申请，这一申请得到MELODY临床3期、MEDLEY临床2/3期与一项临床2b试验结果的支持。根据去年3月所公布的数据，MELODY临床3期试验达主要终点，与安慰剂相比，nirsevimab单次给药将RSV引起的需要接受治疗的婴幼儿下呼吸道感染发生率降低了74.5%（95% CI：49.6-87.1，p<0.001）。此外，MELODY临床3期和2b期试验的预定汇总分析显示，推荐剂量的nirsevimab可减少RSV引起的住院。药物：Exagamglogene autotemcel（exa-cel）适应症：严重镰刀型细胞贫血病，输血依赖性β地中海贫血研发机构：Vertex Pharmaceuticals，CRISPR TherapeuticsExa-cel是一款自体细胞疗法，它利用CRISPR/Cas9基因编辑系统，在体外对来自患者的造血干细胞进行编辑，使血红细胞生产高水平的胎儿血红蛋白（HbF）。HbF是携带氧气的血红蛋白的一种形式，在出生时自然存在，随着婴儿的长大，血液中的血红蛋白转换为成人形式的血红蛋白。通过exa-cel治疗，可以提高HbF水平，有可能缓解输血依赖性β地中海贫血患者的输血需求，并减少镰刀型细胞贫血病患者的疼痛和使人衰弱的血管闭塞性危象。此前公布的临床试验结果显示，exa-cel具有一次性治疗，提供功能性“治愈”的潜力。在接受治疗的44名输血依赖性β地中海贫血患者中，42名在随访时间为1.2~37.2个月时，不再需要接受输血，剩余两名患者接受的输血水平分别降低75%和89%。所有31名接受治疗的严重镰刀型细胞贫血病患者在随访时间为2.0~32.3个月时，均未出现血管闭塞性危象。如果获得批准，exa-cel将成为首款获得FDA批准的CRISPR基因编辑疗法，代表着基因编辑技术临床转化的重要里程碑。药物：Lovotibeglogene autotemcel（lovo-cel）适应症：严重镰刀型细胞贫血病研发机构：bluebird bioLovo-cel是一种在研、用于治疗镰刀型细胞贫血病（SCD）的一次性基因疗法，其设计目的是将改良形式的β-珠蛋白基因（βA-T87Q珠蛋白基因）的功能拷贝添加到患者自身的造血干细胞（HSCs）中。一旦患者具有表达βA-T87Q珠蛋白的基因，他们的红细胞可以产生能够抵抗血红细胞镰刀化的血红蛋白（HbAT87Q），从而降低镰状血红蛋白（HbS）的比例，目标是减少镰刀型红细胞、溶血和其他并发症。BLA的递交是基于HGB-206临床1/2期试验中C队列36名患者的疗效结果，中位随访时间为32个月，以及临床3期试验HGB-210中的2名患者，每名患者的随访时间为18个月。BLA递交还包括整个lovo-cel项目中50名接受治疗患者的安全性数据，其中6名患者的随访时间达到或超过6年。大家都在看▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料：[1] 9 Highly Anticipated FDA Decisions in Second Half of 2023. Retrieved June 29, 2023, from https://www.biospace.com/article/fda-gears-up-for-more-potentially-historic-decisions-this-year/免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

TAMPA, Fla., June 20, 2023 /PRNewswire/ -- Neurolief, a medical neurotechnology innovator, today announced new data released at the 65th Annual Scientific Meeting hosted by the American Headache Society (June 15-18, 2023, Austin, TX). The real-world, open label analysis presents clinically meaningful data on both the acute treatment and prevention of migraine. Relivion MG is a novel wearable digital therapeutic neurostimulation system, intended to treat migraine and reduce the need for drug therapies. Continue Reading "This real-world data is extremely promising," says Roni Sharon, a board-certified neurologist and headache specialist, and assistant professor of neurology at Tel Aviv University's Slackler School of Medicine. "The remarkable results achieved in this subset of more difficult to treat patient population underscore the immense potential of Relivion's innovative technology in helping millions of people living with migraine." "At the heart of our mission lies a deep dedication to our patients," said Scott Drees, Neurolief's CEO. "We will continue to partner with the migraine community to expand access to Relivion and together, we will embark on a journey to help shape the future of migraine care." Tweet this Neurolief's eCOT-NS technology is the first external, combined occipital and trigeminal neurostimulation system (eCOT-NS) which applies electrical impulse to 6 major nerve branches in the head associated with migraine. Combined occipital and trigeminal neurostimulation was previously possible only by an invasive high-risk procedure. Poster 1: Initial Efficacy and Safety Evidence of Long-Term Migraine Preventive Treatment Using External Combined Occipital and Trigeminal Nerve Stimulation (poster #: P-252) This post-hoc analysis included sixteen subjects with high frequency episodic or chronic migraine who self-administered daily treatments with Relivion MG for a 9-month period. Mean Monthly Migraine Days (MMD) decreased by 75%, from 17.8 days per month at baseline to 4.8 days at the end of the third treatment month (p<0.0001). Observed MMDs during treatment months 4-6 were stable despite the reduced frequency of treatment. Mean monthly rescue medication intake days decreased by 80%, from 14 days per month at baseline to 4 days at the end of the third treatment month (p<0.0001). Observed monthly rescue medication intake days during treatment months 4-6 were stable despite the reduced frequency of treatment. No serious adverse events were reported. Poster 2: Real-world Efficacy of Abortive Migraine Treatment with External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) in High-Frequency Episodic and Chronic Migraine by treatment initiation timing (poster #P-255) This post-hoc analysis included analysis of 497 migraine attacks across 56 subjects who self-administered abortive treatment sessions with the eCOT-NS system upon the onset of a migraine and record their migraine outcomes as well as the timing of treatment initiation from migraine onset (<1 hour or >1 hour after pain onset). 78% of treatments which were initiated less than 1 hour after migraine onset achieved relief of migraine pain and 40% of treatments were pain-free. 62% of treatments which were initiated more than 1 hour after migraine onset achieved relief of migraine pain and 25% of treatments were pain-free. There were no reported serious adverse events. "At the heart of our mission lies a deep dedication to our patients" said Scott Drees, Neurolief's CEO. "We will continue to partner with the migraine community to expand access to Relivion and together, we will embark on a journey to help shape the future of migraine care." Relivion MG is cleared by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine for patients 18 years of age and older and has received CE Mark. Neurolief will pursue an expanded indication for the preventive treatment of episodic and chronic migraine. For more information on Relivion MG, visit Relivion.com. About Neurolief Neurolief is a neuromodulation company, dedicated to improving the lives of patients suffering from Neurological and Neuropsychiatric disorders such as migraine and depression. The company has designed and manufactures the Relivion device which is the world's first neuromodulation system designed to concurrently stimulate the occipital and trigeminal nerve branches to modulate brain regions associated with migraine and depression. Currently FDA and CE approved for the acute treatment of migraine, Relivion is intended to provide a highly effective alternative to pharmaceutical therapies. The system also incorporates a patient mobile app and clinical software with cloud enabled data-tracking feature sets, enabling next generation AI incorporation. The company is currently pursuing additional FDA and CE mark approvals for migraine prevention and for treatment of major depression (MDD). SOURCE Neurolief Inc.