Budesonide/Formoterol Fumarate Dihydrate

10月9日，华东医药宣布与畅溪制药达成合作，就畅溪的CXG87（改良型布地奈德/福莫特罗吸入粉雾剂）达成中国大陆地区的独家商业化合作。 华东医药选择这款改良药物，想必是看中了这一个品种的潜力，业内针对布地奈德成分的研究从未停止过。 布地奈德这一糖皮质激素极其出名，从1972年Bofors Nobel-Pharma(后并入阿斯利康)发现这一有效成分开始就是超级明星。 该成分出现过老牌王者，曾年入百亿的吸入用布地奈德混悬液。 也出现过耀眼新星，比如云顶新耀月销达5亿以上的比地奈德肠溶胶囊。 吸入用布地奈德混悬液，目前已被集采，参与竞争企业过多，已不是最好的立项选择，此时布地奈德与一些β肾上腺素类受体激动剂形成的复方吸入制剂，进入了企业的立项范围。 而吸入粉雾剂，由于是药械组合产品，号称拥有“最强”技术壁垒，布地奈德复方＋粉雾剂，壁垒高，竞争企业少，对于有实力的企业，是最好的立项选择。 ↓ 扫码加入药通社交流群 ↓ 布地奈德福莫特罗粉雾剂原研是阿斯利康，2000年8月获得FDA批准上市，2004年在国内上市，商品名“信必可都保”，目前仍旧是阿斯利康独家品种，近十年合计销售额超过200亿元。 图：布地奈德福莫特罗粉雾剂医院端销售趋势；图源：摩熵医药 布地奈德福莫特罗粉雾剂是一款药械组合产品，阿斯利康采用的是Turbuhaler®DPI装置，是干粉吸入领域最具特殊的装置之一。 布地奈德和福莫特罗的专利早已到期，后来者的挑战只剩下了装置的技术壁垒。 2025年2月7日，上海新黄河制药有限公司按注册分类4类申报的布地奈德福莫特罗吸入粉雾剂（Ⅱ）上市申请获受理，国内首家冲击首仿的企业。 早在2022年，上海新黄河制药就备案了布地奈德福莫特罗吸入粉雾剂的生物等效实验，2024年11月完成了入组人数338例的III期临床试验。 另外有珠海瑞思普利医药的III期临床试验也于9月正式开始招募。 华东医药在仿制该品种进度上已经落后，选择跟畅溪制药合作，看中的是畅溪制药针对该品种的改良升级。 根据畅溪制药公告，相比于原研，CXG87具有更低的流速依赖性，对吸气流速受限的患者更加友好，CXG87采用简洁的单剂量药粉吸入器，具有更低的使用错误率以及更稳定的治疗表现。 虽然Turbuhaler®DPI装置提供了良好的沉积和足够的吸气流量，但是存在有一些缺点。例如，操作较为复杂，装填与吸入分两步进行，且没有向患者反馈药物已成功递送。 此次畅溪制药的改良，推测是针对给药装置的改良，更为简单便捷的给药方式更能提升患者依从性。 目前，CXG87已经完成中国地区III期临床试验入组，预计2026年上半年递交上市申请。 提到布地奈德，就免不了提及成分原研阿斯利康公司，吸入巨头阿斯利康，手上的吸入制剂王牌，正在一张张丢失。 吸入用布地奈德混悬液，阿斯利康在2019年单品销售额78亿元，是国内吸入制剂的绝对霸主。但在2021年第五批集采中，阿斯利康未中标。2022年销量跌至14亿元，2024年只剩12亿元，三年间市场蒸发超过66亿元。 而在吸入用布地奈德混悬液全面失守后，年销售仍有20亿的布地奈德福莫特罗粉雾剂被称为吸入巨头阿斯利康最后的退路，现在看来这条后路也快被堵死了。 参考：畅溪制药、邴药说 ↓⭐关注药通社，洞见行业趋势↓ 投稿/企业合作/内容沟通： 药通社总编—华籍美人（Ww_150525） *添加请注明备注及来意

HANGZHOU, China, Oct. 9, 2025 /PRNewswire/ -- Chance Pharmaceuticals ("Chance" or "Chance Pharma"), a clinical-stage biotechnology company dedicated to the research and development of innovative inhalation therapies, today announced that it has reached an exclusive commercialization agreement with Huadong Medicine (Hangzhou) Co., Ltd., a wholly owned subsidiary of Huadong Medicine Co., Ltd. (000963.SZ, "Huadong Medicine"), to commercialize CXG87 in Mainland China. Under the terms of the agreement, Chance Pharma, as the MAH (Marketing Authorization Holder), will be responsible for the research and development, registration, manufacturing, and supply of the CXG87. Chance will receive an upfront fee, regulatory and commercial milestone payments, and a share of sales profits. Huadong Medicine will be responsible for the commercialization and marketing of CXG87 in mainland China. CXG87 is an improved therapy of budesonide/formoterol powder. It is a Class 2.2 new drug independently developed by Chance Pharma for the treatment of respiratory diseases such as asthma. Currently, the Phase III clinical trial for the asthma indication has completed enrollment of all subjects, and the new drug application is expected to be submitted in the first half of 2026. Mr. Liang Lv, Chairman and General Manager of Huadong Medicine, commented: "We see significant potential for CXG87 in respiratory treatment. This partnership will strategically enhance our respiratory pipeline and, by leveraging our nationwide commercial network and specialized promotion team, will enable CXG87 to achieve rapid market access and broad coverage upon launch. We are dedicated to building a strong and synergistic partnership with Chance, harnessing our respective strengths to expedite the launch of this innovative product in China and make its significant clinical benefits available to patients at the earliest opportunity." Dr. Donghao Chen, Founder and CEO of Chance Pharma, stated: "As the first product developed on our unique VFC platform, CXG87 is a key differentiated asset that validates the platform's strong scientific and commercial value. It holds several advantages over the originator product, such as lower flow rate dependency. Our collaboration with Huadong Medicine is a testament to its significant commercial potential and will allow us to leverage their respiratory expertise to maximize its commercial and clinical value. We are committed to working closely together to bring this product to patients suffering from respiratory diseases as quickly as possible." Dr. Lan Chen, Co-founder and Head of R&D at Chance Pharma, stated: "Symbicort® Turbuhaler® is an excellent inhalation therapy. We are proud to have optimized and improved upon it. Through our comprehensive preclinical, Phase I, and Phase III studies, we aim to build a compelling body of evidence to demonstrate its enhanced clinical value. We look forward to making CXG87 a better treatment option for asthma patients with impaired inspiratory flow, ultimately providing a superior treatment choice for the asthma community worldwide." About CXG87 CXG87, an improved therapy of budesonide/formoterol dry powder, is a Class 2.2 new drug independently developed by Chance Pharmaceuticals. Compared to the originator product, Symbicort® Turbuhaler®, CXG87 has the advantage of significantly lower flow rate dependency, making it more user-friendly for patients with impaired inspiratory flow. Furthermore, CXG87 utilizes a simple, easy-to-use and mono-dose inhaler, which is designed to minimize operational errors and ensure more consistent therapeutic performance. The product has now completed patient enrollment for its Phase III clinical trial in China, with a New Drug Application (NDA) expected to be submitted in the first half of 2026. About Chance Pharmaceuticals Chance Pharmaceuticals is a clinical-stage biotech company dedicated to the research and development of innovative dry powder inhalation (DPI) therapies. Leveraging two core technology platforms—milling/blending and spray drying—the company has built a diversified product pipeline. Its proprietary spray drying platform enables the transformation of biological macromolecules, low-activity drugs, and deep lung/systemic delivery drugs into highly efficient dry powder inhalation formulations. The company's modern manufacturing facility, designed and built in compliance with CDE, FDA, and EMA standards, provides end-to-end capabilities from R&D to commercial production. Founded in 2015 by seasoned industry experts, Chance Pharma is driven by the mission to "harness respiratory delivery technology to deliver clinical value." Through both internal innovation and strategic partnerships, the company is committed to providing groundbreaking therapies that significantly improve the quality of life for patients worldwide. For more information, please visit . About Huadong Medicine Huadong Medicine Co., Ltd. (000963.SZ) is a leading integrated pharmaceutical company headquartered in Hangzhou, China. Founded in 1993 and guided by the mission "Science Driven, Patient Centered," the company organizes its operation into four core business segments: Pharmaceutical Manufacturing, Pharmaceutical Commerce, Medical Aesthetics, and Industrial Microbiology. Huadong Medicine has grown to become a large, listed pharmaceutical company that integrates R&D, manufacturing, and commercialization. In 2024, the company reported revenue of RMB 41.9 billion and employs over 10,000 people, possessing extensive commercial coverage and marketing capabilities. Contact Information: Hangzhou Chance Pharma Guobao Zhao [email protected] +86 571-8630-9565 SOURCE Chance Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED