Levamlodipine Maleate

精彩内容 今年以来石药集团创新研发进展不断：1类新药恩朗苏拜单抗获批上市，5个品种批产并视同过评（2个首仿）、12款1类新药申报IND……创新研发进入收获期，目前石药集团有9款1类新药、5款高端创新药物处于NDA/Ⅲ期临床阶段，上市可期。此外，公司累计有120个品种过评（31个首家），26个品种备战第十批集采。 拿下7个重磅品种！120个过评品种亮眼 日前，NMPA官网显示，石药集团中诺药业的罗沙司他胶囊获批上市，拿下国内首仿+首家过评。罗沙司他是全球首个小分子HIF-PHI类肾性贫血治疗药物，2023年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售额超过19亿元，同比增长33.65%。 今年以来，石药集团已有7个品种获批上市，进一步丰富了公司的产品线。其中，1类新药恩朗苏拜单抗注射液是一款PD-1单抗，用于治疗宫颈癌；2类改良型新药注射用重组人TNK组织型纤溶酶原激活剂新增治疗急性缺血性卒中适应症，为同类产品在中国首家获批；哌柏西利片、罗沙司他胶囊为国内首仿+首家过评，奥拉帕利片为国产第3家。 2024年至今石药集团获批产品来源：米内网中国申报进度（MED）数据库 截至目前，石药集团已有120个品种通过/视同通过一致性评价。其中，31个品种为国内首家过评，玛巴洛沙韦片、哌柏西利片、双嘧达莫片、盐酸阿比多尔片、注射用两性霉素B胆固醇硫酸酯复合物、马来酸左氨氯地平片、琥珀酸地文拉法辛缓释片、盐酸伊立替康脂质体注射液等11个品种为独家过评。 石药集团通过/视同通过一致性评价品种注：标*为首家过评 从治疗领域上看，120个品种主要集中在全身用抗感染药物（39个）、抗肿瘤和免疫调节剂（17个）、神经系统药物（16个）、消化系统及代谢药（15个）。米内网数据显示，2023年中国公立医疗机构终端全身用抗感染药物销售额超过1500亿元。 第十批集采即将启动，石药集团已有26个过评品种满足集采门槛，符合申报资格企业数达5家及以上，包括帕拉米韦注射液、乙磺酸尼达尼布软胶囊、沙库巴曲缬沙坦钠片、磷酸西格列汀片、氢溴酸伏硫西汀片等近年新获批品种，可借助集采中标快速抢占市场。 5款1类新药首亮相！猛攻1100亿市场 作为一家创新驱动型制药企业，石药集团坚信创新研发是未来发展的最重要引擎，并持续加大研发投入。2023年公司研发费用48.30亿元，同比增长21.17%，约占成药业务收入18.8%。2024年一季度公司研发费用11.69亿元，同比增长16.04%。 石药集团研发费用情况（单位：亿元） 持续的研发投入下，石药集团研发效率持续提升，创新药物的研发和临床开发稳步推进，喜讯不断传来。 1类创新药方面，除了恩朗苏拜单抗的注册批准，今年以来石药集团已有12款1类新药申报IND。其中5款1类新药SYS6020注射液、SYS6023、SYH2039片、JMT202注射液、呼吸道合胞病毒mRNA疫苗为首次递交IND申请，目前均已获得临床试验默示许可。 2024年至今石药集团首次获批临床的1类新药 5款首次获批临床的1类新药中，抗肿瘤创新药有3款。米内网数据显示，2023年中国公立医疗机构终端抗肿瘤药（化药+生物药）销售额超过1100亿元。 2类改良型新药方面，今年以来石药集团有5款新药司美格鲁肽注射液（减重适应症）、盐酸伊立替康脂质体注射液、注射用多西他赛（白蛋白结合型）、注射用西罗莫司（白蛋白结合型）、缬沙坦马来酸左氨氯地平片相继申报IND。 新注册分类仿制药方面，今年以来石药集团有4个品种丁酸氯维地平注射用乳剂、他克莫司缓释胶囊、美洛昔康注射液、尼莫地平注射液为首次递交注册申请。其中，美洛昔康注射液在国内暂无仿制药获批，石药集团有机会夺得首仿。 130款创新药在研，9款1类新药上市可期 目前，石药集团在研创新药项目约130项，创新研发逐渐进入兑现期。其中大分子超40个、小分子超40个、新型制剂超30个，聚焦抗肿瘤、精神神经、心血管、免疫与呼吸、消化代谢和抗感染等重点治疗领域，并深度布局单抗、双抗、ADC等抗体领域。 2款1类创新药上市申请在审中，具体为普卢格列汀片（DPP-4抑制剂）、巴托利单抗注射液（FcRn单抗），有望于2024年内获批上市。 石药集团处于NDA/Ⅲ期临床阶段1类新药 7款1类创新药CM310（IL-4Rα单抗）、SKLB1028胶囊（多靶点蛋白激酶抑制剂）、KN026（HER2双抗）、DP303c（HER2 ADC）、M701（EpCAM/CD3双抗）、TG103注射液（GLP-1 RA）、JMT101（EGFR单抗）已处于Ⅲ期临床阶段，上市可期。 5款高端创新药物处于NDA/Ⅲ期临床阶段，其中奥马珠单抗已提交上市申请，帕妥珠单抗、乌司奴单抗、司美格鲁肽、司库奇尤单抗均处于Ⅲ期临床阶段。这5个品种2023年在中国公立医疗机构终端合计销售额超过109亿元，其中司美格鲁肽注射液销售额超过40亿元、帕妥珠单抗注射液销售额超过30亿元、司库奇尤单抗销售额超过19亿元。 资料来源：米内网数据库、公司公告注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。 本文为原创稿件，转载请注明来源和作者，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

CINCINNATI, July 06, 2023 (GLOBE NEWSWIRE) -- Blue Water Biotech, Inc. (“Blue Water” or the “Company”) (Nasdaq: BWV), a biotechnology and pharmaceutical company focused on developing and commercializing transformational therapies to address significant health challenges globally, today announced the signing of a Master Services Agreement with bfw Advertising Inc. (“bfw”) to generate marketing and advertising material for Blue Water’s commercial stage drug portfolio. Based in Boca Raton, Florida, bfw has more than three decades of experience supporting clinical and commercial stage life science companies, generating effective and impactful brand campaigns, including digital, direct to consumer, and health care provider content. Bfw will work with Blue Water’s commercial team to increase awareness for its commercial products through patient-facing materials, website updates, social ads, targeted provider engagement, as well as materials to support Blue Water’s sales team, among other services. “Signing this agreement and generating an action plan with bfw is a critical step in the execution of our commercial launch strategy for our products,” said Joseph Hernandez, Chairman and Chief Executive Officer of Blue Water. “By creating targeted, effective marketing materials, we can maximize patient, healthcare provider, and payor awareness to ensure long-term success for Blue Water. With their impressive history of campaigns in the life science industry, we are confident that bfw is the right firm for this endeavor, and we look forward to the official launches of these programs in the coming months.” “With their recent acquisitions and shift into a commercial-stage as well as clinical-stage company, this is certainly an exciting time for the team at Blue Water,” said Christian Boswell, President and Creative Director at bfw. “Through decades of working in the life science industry, we understand the intricacies of marketing and advertising in this space and how challenging it can be for pharmaceutical companies to create cohesive brands. Blue Water has built a strong portfolio of products in recent months, and we are honored to utilize our institutional knowledge to support them and to help them navigate the commercial arena.” Blue Water recently expanded its operations to become a commercial stage company with the acquisition of several FDA approved assets across multiple indications, including urology, cardiology, inner ear infections and pain management. Blue Water’s commercial team will work closely with BFW to identify key areas where targeted advertising and marketing support can enhance product uptake and utilization in each respective market. About Blue Water Biotech Blue Water Biotech, Inc. is a biotechnology and pharmaceutical company focused on developing and commercializing transformational therapies to address significant health challenges globally. Headquartered in Cincinnati, OH, the Company owns ENTADFI®, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia. This combination allows men to receive treatment for their symptoms of benign prostatic hyperplasia without the negative sexual side effects typically seen in patients on finasteride alone. The Company also has a robust vaccine pipeline. Blue Water holds the rights to proprietary technology developed at the University of Oxford, Cincinnati Children’s Hospital Medical Center, St. Jude Children’s Hospital, and The University of Texas Health Science Center at San Antonio. Blue Water is developing a Streptococcus pneumoniae vaccine candidate, designed to specifically prevent highly infectious middle ear infections, known as AOM, in children, and prevention of pneumonia in the elderly. The Company is also developing a universal flu vaccine that will provide protection from all virulent strains in addition to licensing a novel norovirus S&P nanoparticle versatile virus-like particle vaccine platform from Cincinnati Children’s to develop vaccines for multiple infectious diseases, including Marburg and monkeypox, among others. Additionally, the Company is developing a Chlamydia vaccine candidate with UT Health Science Center San Antonio to prevent infection and reduce the need for antibiotic treatment associated with contracting Chlamydia disease. For more information about Blue Water, visit www.bwbioinc.com. About BFW Advertising Bfw is a full-service integrated branding and communications agency with a strong grounding in healthcare and pharma, supporting both clinical and commercial stage companies. Bfw has worked across a broad range of brands and therapeutic areas, including men’s and women’s health, CNS, pediatrics, oncology, pain management, pulmonary and HIV-associated disorders, as well as leading recruiting campaigns for clinical trial participants. Cautionary Note Regarding Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements (including, without limitation, the anticipated benefits of the Company’s agreement with BFW and the Company’s sales and marketing efforts as described herein) are based on Blue Water’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to Blue Water’s ability to realize the benefits of its acquisitions of ENTADFI®, ZONTIVITY®, OTOVEL®, CETRAXAL®, CONJUPRI®, TREZIX™ and NALFON®; risks related to Blue Water’s ability to expand its business scope, commercialize ENTADFI® and integrate the assets and commercial operations being acquired from WraSer into Blue Water’s business; risks related to Blue Water’s ability to attract, hire and retain skilled personnel and establish an effective sales team; risks related to Blue Water’s ability to enter into a definitive agreement with IQVIA and optimize its collaboration with IQVIA; risks related to the development of Blue Water’s vaccine candidates; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations;; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any commercial-stage pharmaceutical product or any product candidate under clinical development, there are significant risks in the development, regulatory approval and commercialization of pharmaceutical products. Blue Water does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Blue Water’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 9, 2023 and periodic reports filed with the SEC on or after the date thereof. All of Blue Water’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Media Contact Information:Blue Water Media RelationsTelephone: (646) 942-5591 Email: Nic.Johnson@russopartnersllc.com Investor Contact Information:Blue Water Investor RelationsEmail: investors@bwbioinc.com