Vancomycin Hydrochloride

日本在创新医药和医疗器械方面拥有显著的全球优势，不仅体现在技术研发、产品质量上，还体现在其企业的国际化合作战略上。日本拥有世界领先的生物技术和医药研发能力，特别是在再生医疗、基因治疗、细胞治疗等领域，日本企业取得了显著进展。能够不断推出具有创新性的医药产品和医疗器械。 日本医药行业注重国际化开放合作：日本企业积极寻求国际合作，通过与国际知名企业建立战略伙伴关系，共同研发新产品、拓展新市场。日本在医药和医疗领域与中国企业的有广泛而深入的合作历史。 前途汇将邀约国内医药企业的有志之士共同赴日考察，通过合作，双方可以共享研发资源、技术和市场经验，加速新产品的推出和上市速度。中国企业也可以借助日本企业的技术优势和产品质量，提升自身产品的竞争力。还可以通过合作培养高素质的研发和管理人才，为未来的合作和发展奠定基础，实现互利共赢的合作发展。 <<<往届参访团照片回顾>>> 本期行程安排 第1天 3月9日 国内出发~大阪 第2天 3月10日 ★ 上午：日本未来医疗推进机构 未来医疗国际据点 Nakanoshima Qross 由政府提倡，大阪大学为学术背景的最先端医药及医疗器械孵化器（参观+座谈） 【亮点】是日本政府重点推广的生物制药及再生医疗的孵化器。除了大阪大学、京都大学和理化学研究所等相对集中的研究机构外，还聚集了大量制药公司在开发治疗癌症和疑难杂症的突破性新药。各家公司还与大学和研究机构联合开展再生医学研究。为了在日趋激烈的再生医学国际竞争中立于不败之地，推进产业化进程并形成一个国际未来医学中心。 通过未来医学的创造、实践和分享，推动未来医疗前沿技术的产业化，为国内外患者提供未来医学服务，做出国际贡献。中之岛Qross由2个中心和1个论坛构成，拥有能够“汇集”、“连接”世界各地的多样化人才和最新信息的系统。 未来医疗研发中心是创造未来医疗的场所，将致力于再生医学相关产品和细胞产品研究开发的公司聚集在这里。为了积累和培育初创企业，我们还拥有一个结合实验室和办公室的租赁空间，可以进行细胞实验。 未来医学付诸实践的地方就是未来医学MED中心。除了与未来医疗研发中心合作提供尖端医疗服务的医院和诊所外，还将设有会员制的高级体检中心。 中之岛国际论坛负责共享医学未来的最新成果。它由用于举办活动、国际学术会议等的会议中心和交流的场所Qrossover Lounge 梦组成。会议中心是举办与未来医疗相关的学术会议和研讨会等活动和会议的场所，而“Qrossover Lounge 梦”是未来医疗国际据点相关人士可以自由交流思想，碰撞火花，不断产生新想法的地方。 ★ 下午：日本盐野义制药株式会社 【亮点】大多数制药公司的内部药物研发比例为 20%-30%，而盐野义制药的创药比率为71%。盐野义的研究优势在于其小分子药物研发引擎，它能够高效地开发创新药物。药物化学、药理学和安全性与药代动力学团队的高水平技术能力及其通过合作解决问题的经验是盐野义竞争力的源泉。 日本盐野义制药株式会社创立于1878年，于1919年成立，注册资本212亿日元，年销售额达1993亿日元。目前设有中央研究所，神崎川研究所，医学科学研究所，油日实验农场及杭濑，摄津，赤穗，金崎等四个工厂。产品主要涵盖[循环代谢]、[感染/免疫]、[癌/疼痛]三个专业领域。公司的主要产品有:头孢卡品(cefcapene，Flomox)、万古霉素(vancomycin)和氟氧头孢钠(flomoxef，Flumarin)。其抗生素类药在日本市场具有较高知名度和美誉度。 在中国和亚洲其他地区，我们将及时申报新药并获得批准，让更多患者能够用上新药。为此，我们积极推进与当地企业的合作，为人们的健康做出贡献。 第3天 3月11日 ★ 上午：日本新药株式会社 【亮点】日本新药致力于开发及引进难病的孤儿药。同时，最主要的研发方向是核酸药物。2016 年，日本新药推出了自主发现和开发的肺动脉高压治疗药物 Uptravi®。Uputravi® 是世界上第一种口服选择性前列环素受体激动剂，目前正在向全球患者提供。 日本新药株式会社位于京都市南区，成立于1919年10月1日，主要从事药品、功能性食品的制造、销售。会长：前川重信，社长：中井彻，注册资金51.74亿日元，员工人数2,213人（截至2024年3月，合并），销售收入1,482.55亿日元（2023财年，合并） IFRS 日本新药是一家研究开发型新药的制药企业，1919年公司创立100多年来，秉持着“用自己的双手研究开发新药”的理念，努力进取，不断创新，致力于向尚未有治疗药物的医疗领域提供创新药品和服务，开发具有高附加值的独特功能药品，为人类的健康不断的做出贡献。这就是日本新药的DNA。 公司的经营理念：为创造人类的健康和富裕的生活努力奋斗。创新医疗：积极挑战尚未有治疗药物的领域，提供革新性新药和服务。开发高品质功能食品，满足市场需求。 ★ 下午：京都创药研究所 【亮点】京都创药研究所，是由日本京都大学产业基金投资的一家围绕眼科疾病的创新药企业。利用京都大血开发的新型小分子化合物「KUS（Kyoto University Substances）」，开发治疗视网膜中央动脉闭塞症和视网膜色素变性等罕见疾病以及青光眼等难治性眼病的新药的公司。 株式会社 京都创药研究所位于大阪市中央区淡路町，2015年5月15日成立，法人代表CEO 武藤荣，注册资金6960万日元，主营业务有：药品、诊断试剂、再生医疗等制品，医疗器械，研究用消耗品等的研究开发等。 经营理念：京都创药研究所从世界基础研究中发现药物，以眼科为中心，进行创新药研究，开发难治性眼镜疾病的治疗方法，让笑容浮现在每个患者的脸上。 第4天 3月12日 ★ 上午：向富山移动 ★ 下午：富山医药品联合会座谈 【亮点】日本药都富山县的官方行业制药协会，其会员均为日本代表性的骨干型制药企业。通过访问可以快速建立起与药都内各个企业的沟通通道。 在日本，有一种说法叫“药在富山”，它指的是位于日本海沿岸北陆地区的制药强县——富山县。这个人口仅有109万的小县，却享有日本“药都”美誉，与传统中医药有莫大的关系。 本会于1952年6月由富山县医药工业协会和富山县家庭医学协同组合会合并成立，并经富山县知事批准为社团法人。作为富山县医药行业的中心组织，联合会积极实施指导教育、拓展销售渠道、完善管理等扩销工程，着力促进行业的健康发展，提高国民的卫生保健水平。 截止2024年4月1日，本协会有制药企业会员62家  药品批发和关联企业 84家 其他组织团体5家。 第5天 3月13日 ★ 上午：前田药品工业 【亮点】日本市场占有率第一的外用膏体的制造商，积极参与和拓展国际业务以及对围绕健康的创新商业模式。 前田药品工业株式会社成立于1966年2月8日（创业1958年），注册资金9300万日元，董事长 前田 大介，主要从事医药品及医药部外品的制造、销售，员工人数177人（男性81人・女性96人) 【2023年10月1日节点】，总公司（富山工厂）位于富山县富山市向新城町 1-18-47，A 栋（一般制剂），B 栋（一般液体制剂），C 栋（类固醇制剂），D 栋（化妆品）。立山工厂位于富山县中新川郡立山町冢越。 <<往期前途汇参访照片>> ★ 下午：日医工&阳进堂 【亮点】阳进堂是是日本为数不多的拥有从原药开发到最终产品制造的一体化生产系统的制药厂家，可稳定供应高质量的非专利药品。此外，在输液透析等所有医疗领域都不可或缺的基本药物业务方面，近年来，公司还挑战进入生物制药等新领域。 从高品质的非专利药品到输液、透析的精华药物，进而研究开发生物医药品。 阳进堂常年致力于仿制药的生产和销售，为人民的健康和社会做出贡献。建立了从原料药到制剂的完整的研究开发、生产、销售体制，作为生产高品质、低价格的仿制药的厂家，获得了广大的信赖。 现在，阳进堂株式会社正在推进输液、透析等精华药物，以及生物医药的研究和开发。通过独自的研究开发积累新的技术和技术，以成为今后日本“不可或缺的制药企业”为目标。阳进堂敢于挑战超越非专利的新领域。 此外，通过生物医药品的受托生产，获得生产技术和管理经验，进行生物仿制药的临床开发等，这些企业今后也将成为社会不可或缺的企业。 【亮点】日本第一大仿制药生产企业。 日本日医工株式会社发明生产的一款安眠药剂。“日医工”，1965年，由田村四郎先生创立，原名“日本医薬品工业株式会社”，1980年上市，总部位于富山县富山市。日医工的意思是日本日医工株式会社发明生产的一款安眠药剂日医工（Nichi-lko）是日本最大的仿制药商，2017财年营业收入达1647亿日元，有1028个产品上市销售，市场份额约为12.9%。 第6天 3月14日 ★ 上午：富山向东京移动 ★ 下午：银座游览，自由活动 ★ 晚上：入住台场日航大酒店 第7天 3月15日 东京返回国内 往届考察团中国企业家名单 费用及说明 人民币46800元每人此次学习费用包含以下费用： (1)会议租用费、培训费、参观费、翻译费、资料用品费、案例费等 (2)行程内餐饮(日式精美套餐)、住宿(五星级酒店双人间，单间差1080元/晚/人)及日本地面交通费 (3)人身意外伤害保险费 (4)指定景点观光旅游费：门票、导游费及小费 (5)税费 (6)单次签证办理费用 学费费用不包含以下费用： (1)往返日本的机票费用 (2)往返国内城市的交通、住宿 (3)行程列明以外的所有私人费用及个人原因引起的额外费用 【付款账户】 开户名称：前途汇医药科技（北京）有限公司 开户银行：中国建设银行股份有限公司北京自贸区高端产业片区支行 银行账号：11001184100052501294 报名方式 游学咨询：姚美丽185 0090 0639

Following the previously announced successful End of Phase 2 Meeting achieving agreement with FDA on non-clinical and clinical Phase 3-readiness, Acurx has now also received written positive feedback from FDA regarding acceptability of our CMC (Chemistry Manufacturing and Controls) plan and data package proposed to support the Phase 3 clinical program Acurx has initiated the Scientific Advice procedure with the European Medicines Agency (EMA) to discuss the readiness for initiation of the Phase 3 clinical program in the European Union (EU). Acurx has been notified that we should expect to receive the final written advice letter in the coming few weeks Acurx is also in the process of discussing the pediatric development plans for ibezapolstat in C. difficile Infection with FDA and EU health authorities, per regulatory requirements. Phase 3 international trial planning continues to advance, using AI and other state-of-the-art techniques to identify and qualify clinical trial sites with the highest potential for patient enrollment Acurx is also preparing to request regulatory guidance to initiate clinical trials in Japan, Canada and the United Kingdom Ibezapolstat has previously been granted FDA QIDP and Fast-Track Designation from FDA and Acurx has received SME (Small and Medium-sized Enterprise) designation by the EMA to benefit from fee incentives and other support from the EMA for EU Marketing Authorization STATEN ISLAND, N.Y., Dec. 9, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, with its lead antibiotic candidate, ibezapolstat, preparing to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). The Company today announced updates on Phase 3 Readiness for Ibezapolstat in C. difficile Infection based on recent FDA and EMA Communications. Written communications are used by both regulatory agencies in lieu of face-to-face or teleconference/video conferences when these agencies determine that a written response to the sponsor's questions would be the most appropriate means for providing feedback and advice to the sponsor. (FDA Guidance on Formal Meetings, EMA Guidance on Centralised Procedure) Acurx's Executive Chairman, Bob DeLuccia, stated: "We are very pleased with these latest favorable communications from both regulatory agencies and in our opinion are a testament to the strength of our clinical data to date, our robust regulatory submissions, and adherence to current regulatory guidance." He further added: "We anticipate, and are confident, that with final EMA advice for our ibezapolstat Phase 3 trials for adult patients with CDI and the pediatric development plans from both regulatory agencies, Acurx will have a clear international roadmap for conduct of our Phase 3 program and, if successful, requirements for US NDA submission and EU Marketing Authorization." Acurx has previously announced that it had a successful FDA End-of-Phase 2 Meeting and Phase 3 Readiness for ibezapolstat for the Treatment of C. difficile Infection. Agreement with FDA was reached on key elements to move forward with its international Phase 3 clinical trial program. Agreement was also reached with FDA on the complete non-clinical and clinical development plan for filing of a New Drug Application (NDA) for marketing approval. Planning continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI). Acurx is also preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, to be followed by requests to be submitted in the United Kingdom, Japan and Canada. Key elements for the two Phase 3, non-inferiority, pivotal trials were confirmed and included agreement on the protocol design, patient population, primary and secondary endpoints, and size of the registration safety database. Based on FDA recommendations, and in anticipation of an EMA Scientific Advice Meeting, the primary efficacy analysis will be performed using a Modified Intent-To-reat (mITT) population consistent with EMA requirements. This will result in an estimated 450 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard-of-care vancomycin, enrolled into the initial Phase 3 trial. The trial design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment, but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority. About the Ibezapolstat Phase 2 Clinical Trial The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial. (Link to Clinicaltrials.gov/NCT042447542) This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline. from study centers in the United States. In the Phase 2a trial segment,10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment). In the Phase 2b trial segment, which was discontinued due to success, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind. The Company previously reported that the overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Ibezapolstat was well-tolerated, with three patients each experiencing one mild adverse event assessed by the blinded investigator to be drug- related. All three events were gastrointestinal in nature and resolved without treatment. There were no drug-related treatment withdrawals or no drug-related serious adverse events, or other safety findings of concern. In the Phase 2b vancomycin control arm, 14 out of 14 patients experienced Clinical Cure. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96% and the historical vancomycin cure rate of approximately 81% (Vancocin® Prescribing Information, January 2021), we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials in accordance with the applicable FDA Guidance for Industry (October 2022). In the Phase 2 clinical trial (both trial segments), the Company also evaluated pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, emerging data show an increased concentration of secondary bile acids during and following ibezapolstat therapy which is known to correlate with colonization resistance against C. difficile. A decrease in primary bile acids and the favorable increase in the ratio of secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood of CDI recurrence when compared to vancomycin. The company also recently reported positive extended clinical cure (ECC) data for ibezapolstat (IBZ), its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. This exploratory endpoint showed that 12 patients who agreed to be followed up to three months following Clinical Cure of their infection, 5 of 5 IBZ patients experienced no recurrence of infection. In the vancomycin control arm of the trial, 7 of 7 patients experienced no recurrence of infection. ECC success is defined as a clinical cure at the TOC visit (i.e., at least 48 hours post EOT) and no recurrence of CDI within the 56 ± 2 days post EOT (ECC56) and 84 ± 2 days post EOT (ECC84) in patients who consented to extended observation. In the Phase 2b trial, 100% (5 of 5) of ibezapolstat-treated patients who agreed to observation for up to three months following Clinical Cure of CDI experienced no recurrence of infection. Furthermore, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients. About Ibezapolstat Ibezapolstat is the Company's lead antibiotic candidate planning to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic, being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome. In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI. About Clostridioides difficile Infection (CDI) According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%. About the Microbiome in C. difficile Infection (CDI) and Bile Acid Metabolism C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi: 0.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa. Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (CID, 2022). In the Ph2b trial, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients. About Acurx Pharmaceuticals, Inc. Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug-resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials next year. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel. To learn more about Acurx Pharmaceuticals and its product pipeline, please visit . Forward-Looking Statements Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2023, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law. Investor Contact: Acurx Pharmaceuticals, Inc. David P. Luci, President & CEO Tel: 917-533-1469 Email: [email protected] SOURCE Acurx Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED