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点击上方关注，了解更多兽药信息， PART 01 2025年度国产品牌宠物新兽药 （含变更注册） 新兽药注册名录 2025 年注册的这批国产品牌宠物新兽药共 21 个品种，呈现出 “聚焦宠物健康、创新分层覆盖、产学研协同布局” 的特点。 从适用领域看，这批新兽药覆盖了宠物消化道调理（西沙必利胶囊、奥美拉唑肠溶胶囊）、皮肤与驱虫管理（恩康唑及溶液、氟雷拉纳及溶液）、行为 / 精神类问题（米氮平软膏、加巴喷丁片、盐酸氯米帕明片）、传染病检测与预防（猫泛白细胞减少症等检测试剂盒、猫三联灭活疫苗），以及中药辅助治疗（芭蕉补骨胶囊、夏桑菊颗粒等），契合国内宠物行业快速发展下的细分健康需求。 从创新与类别分布看，4个品种（恩康唑系列、氟雷拉纳系列）属于二类新兽药，代表国产宠物用兽药在新成分、新剂型上的创新突破；其余则以三类、四类、五类为主，覆盖了改良型新药、仿制药及中药制剂，形成 “高创新 + 实用型” 的产品矩阵，其中盐酸氯米帕明片、甲泼尼龙片（犬用）还被纳入处方药管理，体现了用药规范的强化。 从研发主体看，这批新兽药多由企业联合高校（如华中农业大学）、科研机构共同研发，产学研协同的模式既提升了产品的技术含金量，也加快了宠物医疗细分领域的国产替代进程。 兽药变更注册名录 PART 02 2025年度国际品牌宠物新兽药 （含再注册/变更） 2025 年注册 / 变更的这批国际品牌宠物药，呈现出 “头部品牌集中布局、注册行为适配市场与监管” 的鲜明特征。 从适用场景看，所有产品均瞄准犬猫细分健康需求，核心覆盖体外 / 体内驱虫（如勃林格殷格翰的阿福拉纳系列咀嚼片、复方非泼罗尼犬猫用滴剂，德国 KVP 的吡虫啉氟氯苯氰菊酯项圈）、抗炎镇痛（新西兰阿吉塔的格拉匹仑片、法国威隆的西米考昔片）、传染病预防（美国硕腾的犬四联活疫苗）及消化道治疗（法国 DELPHARM 的甲硝唑犬用混悬液），且剂型以咀嚼片、滴剂为主，适配宠物便捷给药的实际需求。 从品牌与产地看，勃林格殷格翰（法国）、硕腾（美国）、KVP Kiel（德国）等国际动保头部企业是主力，产品产地集中于法、美、德、新西兰等动保产业成熟国家，体现了国际一线品牌对国内宠物用进口兽药市场的持续深耕。 从注册行为看，类型呈现 “新准入 + 存量优化” 的多元结构：既有甲硝唑内服混悬液、格拉匹仑片等新品的首次注册（2025 年新获证），也包含复方非泼罗尼滴剂、犬四联疫苗等成熟产品的再注册，同时不乏阿福拉纳系列调整有效期（24 个月延至 30 个月）、复方非泼罗尼滴剂更换包装材料、阿福拉纳咀嚼片补充原料药供应商等变更注册，既实现了宠物医疗新需求的产品覆盖，也通过合规性优化、供应稳定性调整，精准适配国内兽药监管要求与市场使用习惯。 PART 03 2026 年度待审查兽药梳理 （基于农业农村部 2025 年政策及动态） 根据农业农村部 2025 年发布的规章修改、动物诊疗管理、兽药使用整治及新兽药批准公告，官方暂未直接公示 “2026 年度待审查兽药” 的具体产品清单（待审查兽药多为申报后未审结的动态流程，需通过农业农村部 “兽药注册申报系统” 实时查询，官方公告通常仅公示已批准 / 驳回产品）。以下结合 2025 年政策导向、已获批产品关联主体及行业监管重点，梳理 2026 年可能进入审查流程的兽药（含国产 / 国际），推测依据均来自 2025 年官方文件，具体以农业农村部 2026 年正式审查公告为准。 2026 年度待审查国产宠物药（推测） 2026 年度待审查国际宠物药（推测） PART 04 当前临床缺少的宠物药品 （未在 2025-2026 年注册清单中体现）  药品类别 临床需求场景 缺口原因分析 犬瘟热 / 猫瘟特效抗病毒药 犬瘟热病毒、猫泛白细胞减少症病毒感染的特异性治疗（现有以支持疗法为主） 病毒变异快，研发难度高，现有疫苗无法完全覆盖变异株，缺乏直接抑制病毒复制的药物 宠物靶向抗癌药 犬淋巴瘤、猫黑色素瘤、犬骨肉瘤等常见宠物肿瘤的精准治疗（现有以化疗为主，副作用大） 宠物肿瘤研发投入低于人药，靶点验证和临床试验数据积累不足 老年宠物认知障碍治疗药 犬认知功能障碍综合征（CDS）的记忆衰退、行为异常改善（现有仅靠营养补充剂） 神经退行性疾病机制复杂，宠物脑部疾病临床评价体系不完善 抗蜱虫 / 跳蚤抗性的新型驱虫药 现有阿维菌素类、拟除虫菊酯类药物对耐药寄生虫效果下降 寄生虫耐药性监测滞后，新型作用机制药物研发周期长 长效低毒宠物止痛药 慢性骨关节炎、术后疼痛的长期管理（现有非甾体抗炎药长期使用易致肝肾损伤） 宠物肝肾功能代谢特点特殊，长效制剂的药代动力学研究难度大 来源：兽药资讯。 免责申明：      北京万牧源生物科技有限公司设立于2006年，旗下运营产品--兽药智库，本微信公众号所发资料信息来自互联网收集，主要用于供给大家学习、交流。本公众号对所转载内容的真实性、准确性和完整性不做保证，您在阅读和使用过程中可能面临财产损失、数据丢失、名誉损害等风险，对此类后果，本公众号不予承担责任，敬请用户自行判断并承担相应风险。我们尊重原创作者和单位，支持正版。若本文侵犯了您的权益，请直接留言或电话联系我们，立刻删除！如果您有什么需求、意见或建议，欢迎反馈给我们。 北京万牧源生物科技 中国兽药专业咨询服务平台 业务板块 新兽药研发、注册咨询服务 兽药GMP/GCP/GLP咨询服务 企业及行业发展规划，企业尽调 专业的科技成果孵化平台 进口兽药及饲料添加剂注册咨询服务 兽药智库、万牧源CCT 专项技术培训及营销策划 市场调研与分析等 万牧源服务热线： 010-62146513/62146681

NASHVILLE, Tenn., Feb. 25, 2026 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on developing new products for rare diseases, today announced the launch of its national sales promotional for Talicia ®. Cumberland has assumed responsibility for the distribution and sales promotion of the brand in the U.S. under the co-commercialization agreement with RedHill Biopharma. Talicia is an FDA-approved oral capsule indicated for the treatment of Helicobacter pylori infection in adults, a bacterial infection and leading risk factor for gastric cancer. Talicia is the only all-in-one treatment containing omeprazole, amoxicillin and rifabutin and is now listed as a first-line option in the American College of Gastroenterology guidelines for H. pylori infections. Talicia is patent protected through 2042 and received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product designation. "We believe this represents an important catalyst for the next phase of Talicia's growth," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "We are executing the full breadth of sales and marketing initiatives underway to support Talicia's continued momentum. Our focus is on strengthening prescription growth while expanding number of patients helped by this treatment." The launch expands Cumberland's specialty product portfolio and reflects the company's strategy of leveraging its established commercial infrastructure to drive growth from its differentiated, FDA-approved brands. As part of the launch, Cumberland is utilizing its existing field sales force division with supporting marketing initiatives designed to increase awareness among gastroenterologists and other prescribing physicians. H. pylori infection affects approximately 35% of the U.S. adult population and is a leading cause of gastric cancer, contributing to an estimated 11,000 related deaths annually in the U.S. Cumberland and its commercialization partner are aligning key commercial resources to ensure broader access to this clinically differentiated therapy. About H. pylori H. pylori is a bacterial infection that affects approximately 35% of the U.S. adult population (an estimated 1.6 million U.S. patients are treated annually) rising to more than 50% globally. Classified by the World Health Organization (WHO) as a Group 1 carcinogen, H. pylori is the strongest known risk factor for gastric cancer (between 70% to 90% of cases with more than 27,000 Americans diagnosed with gastric cancer annually and approximately 800,000 deaths globally per year), a major risk factor for peptic ulcer disease (90% of cases) and gastric mucosa-associated lymphoid tissue (MALT) lymphoma. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics, especially clarithromycin, which is still commonly used in standard combination therapies. About Talicia® Approved by the FDA for the treatment of H. pylori infection in adults in November 2019, Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole). Talicia received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents extending patent protection through 2042 with additional patents and applications pending and granted in various territories worldwide. Talicia is also approved by the United Arab Emirates (UAE) Ministry of Health. For full prescribing information, visit . About Cumberland Pharmaceuticals Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes: Acetadote® (acetylcysteine) injection, for the treatment of acetaminophen poisoning; Caldolor® (ibuprofen) injection, for the treatment of pain and fever; Kristalose® (lactulose) oral, a prescription laxative, for the treatment of constipation; Sancuso® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; Vaprisol® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; Vibativ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections; and Talicia® (omeprazole, amoxicillin and rifabutin) oral capsule, for the treatment of H. pylori infection. The company also has a series of Phase 2 clinical programs underway evaluating its ifetroban product candidate in patients with Systemic Sclerosis and Idiopathic Pulmonary Fibrosis, in addition to Duchenne muscular dystrophy. For more information on Cumberland's approved products, including full prescribing information, please visit the individual product websites, which can be found on the company's website at . Forward-Looking Statements This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include macroeconomic conditions, including rising interest rates and inflation, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission ("SEC"), as well as the company's other filings with the SEC from time to time. There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. SOURCE Cumberland Pharmaceuticals Inc. 21% more press release views with Request a Demo