Sildenaifl Citrate

每周药品注册获批数据，分门别类呈现，一目了然。（4.7-4.14）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号重组人血小板生成素注射液沈阳三生制药有限责任公司2.2CXSS2200088国;CXSS2200088重组人血小板生成素注射液沈阳三生制药有限责任公司2.2CXSS2200089国;CXSS2200089特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSS2300050特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSS2300051新药临床申请药品名称企业注册分类受理号HSK31858片西藏海思科制药有限公司1CXHL2400075锝[99mTc]肼基烟酰胺双链Ark肽注射液广东瑞迪奥科技有限公司1CXHL2400080HRS2398缓释片上海恒瑞医药有限公司1CXHL2400097SYH2043片石药集团欧意药业有限公司1CXHL2400098SYH2043片石药集团欧意药业有限公司1CXHL2400099盐酸杰克替尼乳膏上海泽璟医药技术有限公司1CXHL2400101盐酸杰克替尼乳膏苏州泽璟生物制药股份有限公司1CXHL2400102盐酸杰克替尼乳膏苏州泽璟生物制药股份有限公司1CXHL2400103QLC1101胶囊齐鲁制药有限公司1CXHL2400107QLC1101胶囊齐鲁制药有限公司1CXHL2400108FHND6091胶囊江苏正大丰海制药有限公司1CXHL2400118FHND6091胶囊江苏正大丰海制药有限公司1CXHL2400119HSK31858片西藏海思科制药有限公司1CXHL2400125HRS-5965胶囊成都盛迪医药有限公司1CXHL2400127HRS-5965胶囊成都盛迪医药有限公司1CXHL2400128HRS-5965胶囊成都盛迪医药有限公司1CXHL2400129HRS-5965胶囊成都盛迪医药有限公司1CXHL2400130KEM2104凝胶贴膏长沙晶易医药科技股份有限公司2.2CXHL2400049KEM2104凝胶贴膏长沙晶易医药科技股份有限公司2.2CXHL2400050左乙拉西坦缓释颗粒杭州百诚医药科技股份有限公司2.2CXHL2400079KC-2201西安远大德天药业股份有限公司2.2CXHL2400104KC-2201西安远大德天药业股份有限公司2.2CXHL2400105度他雄胺坦索罗辛胶囊昆明积大制药股份有限公司2.3CXHL2400121醋酸阿比特龙片(Ⅱ)成都盛迪医药有限公司2.4CXHL2400071注射用QP-6211南京清普生物科技有限公司2.1;2.2CXHL2400072硫酸依替米星雾化吸入溶液无锡济煜山禾药业股份有限公司2.2;2.4CXHL2400100HKG-320注射液武汉海特生物创新医药研究有限公司2.2;2.4CXHL2400106注射用RGL-2102上海瑞宏迪医药有限公司1CXSL2400028HS-20117注射液常州恒邦药业有限公司1CXSL2400036重组L-IFN腺病毒注射液上海元宋生物技术有限公司1CXSL2400044注射用MK-2870默沙东研发(中国)有限公司1CXSL2400055PT217凡恩世制药(北京)有限公司1CXSL2400056注射用DB-1303映恩生物制药(苏州)有限公司1CXSL2400063注射用DB-1310映恩生物制药(苏州)有限公司1CXSL2400065SCTB14注射液神州细胞工程有限公司1CXSL2400069输注用SN-001浓缩冻干粉昆明赛诺制药股份有限公司1CXSL2400077SHR-3276注射液苏州盛迪亚生物医药有限公司1CXSL2400081注射用TRS005浙江特瑞思药业股份有限公司1CXSL2400084仿制药申请药品名称企业注册分类受理号甘露醇山梨醇注射液湖北欣泽霏药业有限公司;湖北华仁同济药业有限责任公司3CYHS2300536乙酰半胱氨酸口服液安徽茂康药业有限公司;华益药业科技(安徽)有限公司3CYHS2301370瑞加诺生注射液博瑞制药(苏州)有限公司3CYHS2302096枸橼酸西地那非片江西施美药业股份有限公司4CYHS2300916左氧氟沙星滴眼液湖北远大天天明制药有限公司4CYHS2301689注射用培美曲塞二钠福建基诺厚普生物科技有限公司4CYHS2302213盐酸阿莫罗芬搽剂江苏知原药业股份有限公司4CYHS2400545重组人促甲状腺素注射液苏州智核生物医药科技有限公司;康宁杰瑞(吉林)生物科技有限公司3.2CXSS2200069国;CXSS2200069注射用罗普司亭齐鲁制药有限公司3.4CXSS2200029国;CXSS2200029注射用罗普司亭齐鲁制药有限公司3.4CXSS2200030国;CXSS2200030人生长激素注射液上海联合赛尔生物工程有限公司3.4CXSS2200074国;CXSS2200074普瑞巴林缓释片石药集团欧意药业有限公司3CYHL2400017普瑞巴林缓释片石药集团欧意药业有限公司3CYHL2400018普瑞巴林缓释片石药集团欧意药业有限公司3CYHL2400019米诺地尔泡沫剂广东红珊瑚药业有限公司3CYHL2400021氟比洛芬凝胶贴膏云南白药集团无锡药业有限公司4CYHL2400020门冬胰岛素注射液江苏恒瑞医药股份有限公司3.3CXSL2400058人纤维蛋白粘合剂深圳市卫光生物制品股份有限公司3.4CXSL2400057进口申请药品名称企业注册分类受理号AMG 193Amgen Inc.1JXHL2400021AMG 193Amgen Inc.1JXHL2400022AMG 193Amgen Inc.1JXHL2400023BRII-835 (VIR-2218) 注射液Brii Biosciences Limited1JXHL2400027布地格福吸入气雾剂AstraZeneca AB2.4JXHL2400013TarlatamabAmgen Inc.1JXSL2400025TarlatamabAmgen Inc.1JXSL2400026TarlatamabAmgen Inc.1JXSL2400027GSK1070806注射液GlaxoSmithKline Research & Development Limited1JXSL2400028BRII-179注射液Brii Biosciences Limited1JXSL2400029帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSL2400023Ravulizumab注射液Alexion Pharmaceuticals, Inc.2.2JXSL2400032Ravulizumab注射液Alexion Pharmaceuticals, Inc.2.2JXSL2400033中药相关申请药品名称企业注册分类受理号青杏颗粒广州中医药大学(广州中医药研究院)1.1CXZL2400007羌芩颗粒江苏康缘药业股份有限公司1.1CXZL2400009西帕依固龈液新奇康药业股份有限公司2.3CXZL2400006注：灰色字体部分结论为不批准或收到通知件；

Published data shows that Ovaprene was safe and effective in a postcoital test study of 33 women Pivotal Phase 3 contraceptive efficacy clinical study of Ovaprene currently enrolling Ovaprene has the potential to be the first FDA-approved hormone-free monthly intravaginal contraceptive for women SAN DIEGO, April 11, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced the publication of data from the postcoital test clinical study of Ovaprene in two original research articles in the journal Contraception. Publication Details: Mauck, et al. “Successful postcoital testing of Ovaprene: An investigational non- hormonal monthly vaginal contraceptive.” Contraception. Vol. 132, April 2024, 110373. https://doi.org/10.1016/j.contraception.2024.110373 Mauck, et al. “Safety Testing of Ovaprene: an Investigational Non-Hormonal Monthly Vaginal Contraceptive.” Contraception. Advance online publication, 110440. https://doi.org/10.1016/j.contraception.2024.110440 “We are very pleased to have the postcoital test study results for our investigational, hormone-free intravaginal contraceptive Ovaprene published in a leading reproductive health journal,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Our published results show Ovaprene was safe and prevented essentially all sperm from entering the cervical canal across all women and cycles evaluated without disrupting the vaginal microbiome. PCT studies have been used as surrogate markers for contraceptive effectiveness and, based on comparable PCT studies, Ovaprene is expected to deliver efficacy approaching hormonal methods. The published results were seminal in enabling us to commence the pivotal Phase 3 clinical study of Ovaprene, which is now enrolling across the United States as we continue to advance this innovative candidate for women who want or need a hormone-free contraceptive.” The pivotal study is a single arm, open-label contraceptive efficacy study of Ovaprene® which aims to enroll sufficient participants across approximately 20 study sites in the U.S. to have approximately 250 participants complete approximately 12 months (13 menstrual cycles) of use. Daré plans to provide updates on anticipated timing for study completion as enrollment progresses. If successful, Daré expects the pivotal study to support marketing approvals of Ovaprene in the U.S. and other countries. In July 2021, Daré entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Health and Human Services, as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH), to collaborate on the pivotal Phase 3 study of Ovaprene. The agreement gives Daré access to the contraceptive clinical trial expertise of NICHD’s Contraceptive Clinical Trial Network while also sharing the costs of the Phase 3 pivotal study with NICHD. In January 2020, Daré and Bayer announced an exclusive licensing agreement for U.S. commercial rights to Ovaprene. Under the agreement, Daré received an upfront payment and access to Bayer’s extensive clinical and market capabilities while retaining control over Ovaprene’s development and regulatory approval process. Bayer received the right to obtain exclusive rights to commercialize the product in the U.S. following completion of the pivotal clinical trial being undertaken by Daré if Bayer, in its sole discretion, pays Daré $20 million. In addition, Daré may receive from Bayer up to $310 million in commercial milestone payments, plus double-digit, tiered royalties on net sales. If Ovaprene is approved by the FDA, it could be the first monthly hormone-free contraceptive product for women and a first-in-category option for women seeking a hormone-free, self-administered and monthly birth control method. About Ovaprene® Ovaprene is an investigational hormone-free, intravaginal monthly product candidate currently in clinical development for pregnancy prevention. Ovaprene releases a locally acting, non-hormonal agent to impede sperm motility and features a proprietary knitted polymer barrier to physically block sperm from entering the cervical canal. Ovaprene completed a successful postcoital test (PCT) clinical study where, in all women and across all cycles evaluated, it prevented virtually all sperm from entering the cervical canal, a surrogate marker for contraceptive effectiveness.1, 2 The results from the PCT clinical study support continued clinical development of Ovaprene and its potential to be the first FDA-approved hormone-free, monthly contraceptive option for women. 1 Mauck C, Vincent K. The postcoital test in the development of new vaginal contraceptives. Biol. Reprod. (August 2020); 103: 437–444. https://doi.org/10.1093/biolre/ioaa0992 ClinicalTrials.gov ID: NCT03598088, Safety and Acceptability Study of a Non-Hormonal Ring. (Results Posted) About Daré Bioscience Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility. The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Organon commenced U.S. marketing of XACIATO in the fourth quarter of 2023. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil, the active ingredient in Viagra®, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about XACIATO, Daré’s full portfolio of women’s health product candidates, and Daré’s mission to deliver differentiated therapies for women, please visit www.darebioscience.com. Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023, Daré's CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space. Daré Bioscience placed #1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards. Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, product and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website. Forward-Looking Statements Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to Ovaprene’s potential to be the first FDA-approved hormone-free monthly contraceptive product for women, the expectation that Ovaprene will demonstrate contraceptive efficacy approaching the contraceptive efficacy of hormone-based birth control products in its pivotal clinical study, target enrollment in the pivotal clinical study of Ovaprene, plans to provide updates on anticipated timing for completion of the pivotal clinical study of Ovaprene, Daré’s expectation that the pivotal clinical study of Ovaprene, if successful, would serve as the primary clinical support for future applications for marketing approval in the U.S. and other countries, the potential market opportunity for Ovaprene, if approved, and potential payments from Bayer under the license agreement between Bayer and Daré. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré’s ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other developments concerning Daré’s intellectual property rights. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Contacts: Media and Investors on behalf of Daré Bioscience, Inc:Camilla White / Simona KormanikovaDentons Global AdvisorsDareBioscience@dentonsglobaladvisors.com / 1.212.466.6450 Source: Daré Bioscience, Inc.