Penicillin G Benzathine

精彩内容近期，集采消息频出：第十批国采多省公布执标时间，山西将开展26省联盟集采，广东拟组建超200个品种集采，四川等6省联盟集采拉开序幕，涉及万古霉素注射剂、肌苷注射剂等2023年在6省（市、自治区）公立医院终端销售额超6000万元的畅销药。2025年集采持续推进“提质扩面”：第十一批国采如箭在弦，120余个品种基本满足准入条件；省采/省联采热浪不断，覆盖范围加速向短缺药、生物药、中成药、未过评药等品种延伸。集采评标再细化，引入“双向选择、带量联动”规则日前，四川省药械招采中心发布《关于开展66个化学药品省际联盟带量联动采购项目企业及品种信息采集工作的通知》，由四川、重庆、贵州、云南、西藏、青海6省（市、自治区）组成的省际采购联盟，已正式启动新一轮药品带量联动采购工作。来源：四川省药械招采中心据悉，本次联盟集采对纳入带量联动目录的药品按目录序号区分竞价组，同目录序号过评药品为A组，未过评药品为B组；采购周期原则上为两年，可视情况延长。采购方式上，通过“双向选择、带量联动”确定拟中选产品。即依据采购主体使用需求，参照市场总体价格水平等因素，联动全国相关省（市、区）省际、省级联盟集采或联采中选价格（下文简称“外省中选价”），企业申报价格≤同竞价组获得入围资格有外省中选价的所有企业外省最低中选价*1.8倍，获得拟中选资格。此外，医疗机构选择中选产品后，中选企业不得拒绝供应；中选企业拒绝的，则视同放弃本轮中选资格，由医疗机构在其他中选产品中自主选择。这样的规则下，中选企业是否会有医疗机构选择将成为一个不定数。非中选产品的挂网管理上，中选结果执行后，过评产品中选企业≥3家时，采购主体原则上不再选用其余非中选未过评产品。随着过评产品及过评企业的不断增加，留给未过评产品的市场空间无疑越来越小。超6亿市场迎洗牌，东北制药、鲁南......表现亮眼此次6省联盟集采拟纳入66个品种，其中医保甲类药有27个，医保乙类药有34个；从剂型上看，注射剂为主力军，有48个品种在列；药品类型方面，除破伤风人免疫球蛋白注射剂为生物药，其余均为化学药。按治疗大类统计，心脑血管系统药物在数量上领跑，占据21个席位；血液和造血系统药物、全身用抗感染药物、消化系统及代谢药、抗肿瘤和免疫调节剂则分别占11个、8个、5个和4个。拟纳入6省联盟集采药品目录来源：四川省药械招采中心，米内网整理66个拟纳入集采的品种，既有磷霉素注射剂、苄星青霉素注射剂同为国家基药和医保甲类药品种，也有万古霉素注射剂、肌苷注射剂等2023年在上述6省（市、自治区）公立医院终端销售额超6000万元的畅销药，以及表柔比星注射剂、苯海拉明注射剂等2023-2024年前三季度销售额增速均达两位数及以上的潜力品种，亦有垂体后叶注射剂、米托蒽醌注射剂等临床（易）短缺药。磷霉素注射剂属于氨基糖苷类抗生素，用于敏感菌所致的呼吸道感染、尿路感染、皮肤软组织感染，也可用于由敏感菌所致重症感染如败血症、腹膜炎、骨髓炎等；2023-2024年前三季度在6省（市、自治区）公立医院终端销售额同比增长58.74%和85.59%，产品市场均由东北制药一家独揽。6省（市、自治区）公立医院终端磷霉素注射剂销售趋势（单位：万元）来源：米内网重点省市公立医院药品终端竞争格局万古霉素注射剂属于糖肽类抗菌药，用于治疗对万古霉素敏感的耐甲氧西林的葡萄球菌引起的严重或致命感染，以及由葡萄球菌、草绿色链球菌、牛链球菌或类白喉杆菌引起的心内膜炎等；2021-2023年在6省（市、自治区）公立医院终端销售额均在6000万元以上，2024前三季度拿下近5000万元。米内网数据显示，目前已有8家企业拥有注射用盐酸万古霉素的生产批文，浙江医药、倍特药业等7家企业已通过/视同通过一致性评价，华润三九、重庆药友制药等5家企业以新分类报产在审。注射用盐酸万古霉素一致性评价申报情况来源：米内网一致性评价进度数据库表柔比星注射剂具有广谱抗肿瘤作用，适用于治疗恶性淋巴瘤、乳腺癌、肺癌、肝癌、胰腺癌、黑色素瘤、多发性骨髓瘤、白血病等；2024年前三季度在6省（市、自治区）公立医院终端销售额约1500万元，同比增长27.81%；品牌格局方面，鲁南制药以超40%的份额领跑市场，辉瑞和瀚晖制药则分别以约25%的市场份额位居其后。值得一提的是，鲁南制药已有2款表柔比星注射剂通过/视同通过一致性评价，其中盐酸表柔比星注射液为独家过评。2024年前三季度6省（市、自治区）公立医院终端表柔比星注射剂品牌格局来源：米内网重点省市公立医院药品终端竞争格局在重点省市公立医院终端，上述6省（市、自治区）2021-2023年合计销售规模均在200亿元以上，2024年前三季度收获超150亿元；本次联盟集采拟纳入66个品种，2023年在6省（市、自治区）公立医院终端的合计销售规模超过6亿元。6省（市、自治区）公立医院终端销售规模（单位：亿元）来源：米内网重点省市公立医院药品终端竞争格局集采持续提质扩面，短缺药、未过评药、生物药......不落空2025年年初，国家医保局组织召开的“保障人民健康 赋能经济发展”新闻发布会指出，将在今年适时开展第十一批国家组织药品集采，在地方层面开展具备专业特色的全国联盟采购预计达到20个左右，包括中成药、中药饮片以及高值耗材等，预计2025年国家和联盟组织开展的药品集采品种将达到700个......可见，2025年仍是医药集采的大年。来源：国家医保局官网从国家层面上看，第十批国采中选结果于今年4月起全国落地，第十一批国采亦如箭在弦。据不完全统计，截至4月15日，已有120余个品种满足7家及以上的竞争格局，初步具备纳入第十一批国采的条件，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）终端的销售额合计超过850亿元，其中25个品种竞争企业数（按集团计，下同）达15家及以上，涉及过评品种数超（含）20个的企业包括倍特药业、科伦药业、齐鲁制药、正大制药等。从地方层面上看，省采/省联采品种覆盖范围不断扩大，并逐步向短缺药、急（抢）救药、中成药、生物药（单抗、干扰素、生长激素）等多个新领域、专项品种延伸。比如：今年2月，安徽公布“2025年重点工作任务”明确，将在年内开展省级省际药品集采，牵头全国生物药联盟集采；今年1月，广东组建的16省中成药联盟集采结果出炉，拟中选的63个品种323个品规平均降幅超50%；2024年8月，陕西启动的14省联盟集采拟纳入19组共27个品种，包括肝素钠注射剂、谷胱甘肽注射剂等24个未过评品种......总体而言，“全国一盘棋”背景之下，省际/省联盟集采和国采联动补充的趋势愈发明显。落实并推进省采/省联采，正体现了国家提出的“坚持带量采购，保证质量，促进创新驱动，稳定供应，确保临床使用，针对特定的品种以及竞争格局来设置竞价规则”的指导原则。来源：米内网数据库、四川省药械招采中心等注：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；米内网重点省市公立医院化学药终端竞争格局数据库是以20+省市，近700家样本省市公立医院的化学药采购数据为基础，对化学药全品类进行连续监测的样本省市样本医院数据库；上述销售额以产品在终端的平均零售价计算。数据统计截至4月16日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，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

While large-molecule therapeutics capture most headlines, small-molecule drugs face significant challenges, struggling with funding cuts, supply chain disruptions, and growing demand. At the same time, the small molecule market is projected to grow significantly over the next decade, fueled by a renewed focus on patient-centric drug discovery and innovation in areas like oncology, cardiology, and neurology. The small molecule drug discovery market is on track to grow to $106 billion by 2031, up from $57.41 billion in 2023. This growth highlights the critical need for small-molecule-focused contract development and manufacturing organizations (CDMOs) to strategically navigate a rapidly evolving landscape so they can continue developing the medications many patients require to live healthy, fulfilling lives. Pharmaceutical fallout: Shortage of essential drugs Healthcare Using Data to Help Healthcare Practices Succeed A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices. By Relatient The United States is experiencing an unparalleled drug shortage, with more than 250 essential medications — including small-molecule drugs like Penicillin, Adderall, and Methotrexate — in short supply, and over half of those since October 2022. The demand for chronic condition treatments, including those targeting an aging population, continues to rise, yet the resources allocated to small-molecule development have dwindled. Recent legislative shifts, such as the Inflation Reduction Act (IRA), have compounded these issues. The IRA has inadvertently penalized small-molecule manufacturers by reducing certain incentives and making production less profitable. While large-molecule drugs, such as those targeting diabetes and obesity, continue to attract investment, small molecules have seen a sharp decline in funding. This leaves drug developers and their partner contract development and manufacturing organizations (CDMOs) scrambling to adapt. The role of small-molecule CDMOs In the face of these challenges, small-molecule-focused CDMOs must adapt quickly to the changing landscape by embracing innovation, streamlining operations, and ensuring flexibility and scalability in their production processes. In particular, smaller, more agile CDMOs hold a strategic advantage in meeting this demand through a high-science, high-touch (HSHT) approach — a strategic model that balances scientific rigor with the personalized, adaptable, and scalable customer service needed to navigate industry pressures. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech By improving manufacturing techniques and integrating advanced technologies, small-molecule CDMOs can mitigate an uncertain funding environment, regulatory shifts, and the current drug shortages – while maintaining quality and ensuring speed to market for their developer partners. At the heart of this strategy is the focus on delivering customized solutions that address specific client needs, from complex drug formulations to streamlined production processes. This approach requires advanced technology, personalization, and investing in talent. Innovating to improve the patient experience through personalization For many patients, small-molecule drugs are a lifeline, and maintaining a healthy early-phase and pre-clinical development pipeline is essential, especially as the population ages and the prevalence of chronic conditions and cancer continue to rise. In 2023 alone, there were nearly two million new cancer cases in America. CDMOs are pivotal in ensuring that these drugs are available and optimized for patient use, offering faster-acting, more effective treatments. Further, new, previously “undruggable” molecules can now make it through the development cycle and land in clinics and pharmacies with the right strategy and technology in place. Technological improvements in molecule solubility and bioavailability enhancements enable CDMOs and their developer partners to unlock new potential medications, making treatments easier to absorb and more accessible to a broader patient base. One key area of innovation is the development of more personalized and patient-friendly formulations, such as IV-to-oral drug conversions or formulation technology to reduce pill burden. CDMOs can help pharmaceutical developers provide more convenient, effective treatments by making medications easier to administer and reducing the pill burden. While patient-centric innovations are essential, they must be framed as part of a broader strategy for differentiation. By focusing on creating faster-acting, more effective treatments that cater to evolving patient demands, CDMOs can strengthen their market position and long-term viability. Navigating legislative and economic pressures While innovation and patient-centric solutions are essential, CDMOs must contend with the broader legislative and economic pressures reshaping the pharmaceutical industry. The IRA’s impact on small molecule research and manufacturing has left many CDMOs vulnerable. Supply chain disruptions and rising regulatory demands have further complicated operations, making it essential for CDMOs to adopt agile strategies to navigate difficult, and unpredictable economic, and regulatory influences. By optimizing processes and integrating advanced technologies, CDMOs can offset rising production costs and navigate the challenges posed by regulatory changes. Sustainability initiatives, such as reducing solvent use in manufacturing, offer an additional avenue for improving cost-efficiency while meeting environmental goals, a critical factor in future-proofing operations against shifting industry demands. The outlook for small molecule pharma As the pharmaceutical landscape evolves, small-molecule CDMOs will be essential in balancing supply and demand, driving innovation, and improving patient outcomes. They must continue embracing innovation and strategic agility to survive and thrive in this complex environment. The key to overcoming drug shortages lies in scientific excellence and operational flexibility. By investing in advanced manufacturing technologies, leading with a high-touch, high-science approach, optimizing processes, and improving the patient experience, CDMOs can ensure that critical small-molecule drugs not only remain available, but new, more complex molecules are developed into new, life-changing medications.