Budesonide/Formoterol fumarate/Glycopyrronium Bromide

BFC Group简介BFC Group是一家立足于中国的精品投行，专注于医疗健康领域的并购、专利许可、融资。我们的业务板块涉及中国、美国和欧洲，曾与国内外众多领先的医疗健康公司有过合作并保持着良好的关系。随着在美国和中国一线运营经验的不断积累，我们对客户在本土之外建立公司或扩展业务所面临的挑战有着深刻的理解。立于塔顶，高瞻之见。使命愿景紧跟医疗健康领域趋势，通过合作推动科学突破与创新。依客户需求制定战略拓展计划，并在目标市场全方位落实与执行。成为专注医疗健康行业最优秀的投资银行。No.1香港资本市场香港股市总体概览上周港股延续升势，恒生指数累计上涨1.6%。随着中美高层即将在瑞士会面，市场对关税问题的担忧有所缓解。此外，美国财政部表示关税战“将在短时间内缓和”，释放出降温信号，提升了市场情绪。5月7日，中国政府发布了一揽子金融政策，旨在“稳市场、稳预期、扩内需、促科创、扶企业”，进一步为港股市场提供有力支撑。2025年至今，恒生指数累计上涨14.0%。上周，恒生医疗保健指数(HSHCI)累计下跌3.7%。远大医药上周股价累计上涨25.97%，受多项利好消息推动。5月6日，集团宣布全球创新药物STC3141在中国开展的用于治疗脓毒症的II期临床研究成功达到临床终点。STC3141为远大医药自主开发的、拥有全球知识产权的、具有全新作用机制的小分子化合物，通过中和胞外游离组蛋白和中性粒细胞诱捕网来逆转机体过度免疫反应造成的器官损伤，可用于多种重症适应症。5月7日，集团宣布加入国际多中心 III 期临床试验的申请近日已获得中华人民共和国国家药品监督管理局正式受理。TLX591 (177Lu-rosopatamab tetraxetan)是一款基于放射性核素-抗体偶联技术的PSMA靶向治疗性放射性药物。本次III期试验拟在中国、美国、澳大利亚、新西兰等全球多个国家入组500余名患者，旨在评估TLX591联合标准治疗与仅接受标准治疗相比，在既往接受过雄激素受体通路抑制剂(ARPI)治疗进展的转移性去势抵抗性前列腺癌患者(mCRPC)中的疗效和安全性。2025年至今，医药板块领先大盘，恒生医疗保健指数累计上涨24.3%，高于恒生指数10.3个百分点。香港股市医疗健康板块概览2025年4月恒生医疗保健指数上涨1.1%。上周市值前20个股涨跌互现，部分个股显著下跌。5月1日，翰森制药宣布，公司自主研发的B4-H4靶向抗体-药物偶联物（ADC）注射用HS-20089获国家药品监督管理局（NMPA）批准纳入“突破性治疗药物”，拟定适应症为用于治疗铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌患者。HS-20089是一款B7-H4靶向ADC，其有效载荷为拓扑异构酶抑制剂（TOPOi），正于中国开展用于治疗卵巢癌以及其他妇科肿瘤的多项临床研究，其中最高研究阶段为临床Ⅲ期。香港股市医疗健康板块证券发行2024年共计有12家企业上市(其中3家为依照18A新规上市的未盈利生物医药公司)，共募集金额54.0亿港元。2025年截至目前，共有3家企业上市(其中2家为依照18A新规上市的未盈利生物医药公司)，数量与去年同期持平，金额总数上领先去年同期131.4%。上周无新增IPO。2024年共计19家企业完成定增，共募资金额80.9亿港元。2025年至今，共有9家企业完成定增，数量领先去年同期28.6%，金额总数上领先去年同期143.6%。5月6日，一脉阳光宣布按配售价每股配售股份20.00港元向不少于六名承配人成功配售975万股配售股份，共募集资金1.95亿港元，所募资金将用于影像中心业务投资及并购、海外业务拓展、医学影像AI研发以及营运。香港股市医疗健康板块IPO动态港股医疗板块拟上市企业No.2沪深资本市场沪深股市总体股市概览上周，上证指数上涨1.9%，沪深300上涨2.0%。第八届数字中国建设峰会闭幕。本届峰会共吸引超36万人次参会观展，创历史新高，峰会成果丰硕。在产业对接方面，本届峰会共签约数字经济重点项目455个、总投资额2280亿元，比上届峰会分别增长8%和12%，项目涵盖新一代人工智能、机器人、算力基础设施、互联网医疗等多个领域。截至目前，2025年上证综指下跌0.3%，沪深300下跌2.3%。上周，上证医药上涨0.5%，医药中信指数上涨1.0%。近日，工业和信息化部、商务部、国家卫生健康委、国家医保局、国家数据局、国家中医药局、国家药监局等七部门联合发布实施《医药工业数智化转型实施方案（2025—2030年）》（以下简称《实施方案》）。《实施方案》提出，到2030年，规上医药工业企业基本实现数智化转型全覆盖，数智技术融合创新能力大幅提升，医药工业全链条数据体系进一步完善，医药工业数智化转型生态体系进一步健全。2025年，A股医药板块回暖。上证医药上涨4.7%，领先上证综指5个百分点。医药中信指数上涨1.3%，领先沪深300指数3.6个百分点。沪深股市医疗健康板块概览2024年医药中信指数下跌6.77%。继2025年3月回升1.3%后，4月再度转弱，下降1.9%。上周市值前20个股涨跌互现。今年以来，复星医药多项创新成果持续兑现，近日发布2025Q1财报显示，一季度实现营业收入94.20亿元，同比下滑7.26%；归母净利润7.65亿元，同比增长25.42%；经营活动现金流10.56亿元。营收下滑主要是受药品集采续标及部分地方药品集采开展的影响。报告期内，复星医药持续推进非战略非核心资产的退出和整合，持续推进资产结构优化，加速现金回流。5月7日，百济神州发布2025年一季报，在美国通用会计准则（GAAP）下首次实现了季度盈利。期内营收80.48亿元，同比增长50.2%，其中产品收入79.85亿元，同比增长49.9%。百济神州的业绩增长主要得益于其核心自研产品BTK抑制剂百悦泽（泽布替尼）和PD-1抗癌药百泽安（替雷利珠单抗），以及安进授权产品的销售增长。今年第一季度，泽布替尼全球销售额为56.92亿元，同比增长63.7%。百济神州称，泽布替尼本季度首次位居美国BTK抑制剂领域市场份额首位。沪深股市医疗健康板块概览上周，创新药指数上涨1.4%，医疗器械指数上涨1.5%。恒瑞医药羟乙磺酸达尔西利片上市许可申请获受理：5月8日，恒瑞医药公告称，公司自主研发的CDK4/6（细胞周期蛋白依赖性激酶4/6）抑制剂羟乙磺酸达尔西利片药品上市许可申请获国家药监局受理。该药品拟定适应症为联合内分泌治疗用于激素受体（HR）阳性，人表皮生长因子受体2（HER2）阴性的早期或局部晚期乳腺癌的辅助治疗。该药未来有望为乳腺癌治疗领域带来革命性突破。CDK4/6耐药和术后辅助大市场也有望成为公司新的增长点。沪深股市医疗健康板块新股发行2024年，共4家企业申报IPO。总体数量同比减少71.4%。共募集资金2.47亿元人民币，总体金额同比减少87.7%。上周无新增IPO。2024年，有7家企业发行定增，总体数量同比减少65%。累计定增金额4.95亿元人民币，总体金额同比减少67.6%。上周无新增定增。沪深股市医疗健康板块IPO动态沪深股市医疗板块IPO排队企业情况No.3NASDAQ美国股市总体股市概览美联储金融稳定报告显示全球贸易战和政策不确定性是金融稳定的最大风险，在4月初对等关税引发资本市场巨震后不久，美国总统特朗普决定推迟实施90天，缓和了市场担忧情绪。上周三大指数集体收跌，标普500指数累计下跌约0.5%，纳指跌幅约为0.3%，道指则下跌近0.2%。2025年截至目前，纳指累计下跌7.2%。上周纳斯达克生物技术指数 (NBI）大幅下挫，周内累计下跌8.5%。5月2日，阿斯利康宣布固定剂量三联组合疗法Breztri Aerosphere（布地奈德+福莫特罗+格隆溴铵）在III期KALOS和LOGOS研究中达到所有主要终点，与吸入性糖皮质激素/长效 β2 受体激动剂（ICS/LABA）药物相比，该三联组合疗法在改善肺功能方面具有统计学意义和临床意义。5月9日，阿斯利康宣布 Imfinzi（度伐利尤单抗）方案在 III 期临床验  POTOMAC 中显示出对高风险非肌层浸润性膀胱癌（NMIBC）患者无病生存期（DFS）具有统计学显著和临床意义的改善。2025年截至目前，NBI累跌9.4%，跌幅相比纳指加深2.2个百分点。美国股市医疗健康板块概览2025年开年至今，纳斯达克生物技术指数 (NBI)表现稳定，3月总体震荡6.1%，4月总体维稳。上周NBI指数速降，指数成分公司股价大多下跌。2025年5月8日，Iovance Biotherapeutics发布2025年第一季度财报，其首款TIL疗法Amtagvi一季度销售额4360万美元，与去年四季度的4870万美元环比下降10%，并将2025年的收入指引从此前的4.50-4.75亿美元下调至2.50-3.00亿美元。受此消息影响，Iovance Biotherapeutics股价盘后大跌44.8%，市值5.8亿美元。美国股市医疗健康板块新股发行2024年全年NGS&NGM医疗健康板块累计有30支新股发行，累计募资超55.13亿美金。2025年截至目前，NGS&NGM医疗健康板块共有11支新股发行，累计募资10.276亿美元，相较去年同期数量上落后8.3%，金额下降67.7%。上周Nasdaq无新增IPO。2024年共有322家企业完成定增，累计募集资金约293.8亿美元。2025年截至目前共有102家企业完成定增，总体数量上比去年同期下降37%，金额较去年同期下降83%。上周共有5起新增定增。其中募资金额最高的是Nexalin Technology, 一家专注于设计和开发创新的神经刺激产品的公司，以独特有效地帮助对抗持续的全球心理健康流行病。公司以1.3美元每股的价格募集了500万美元。医疗健康板块IPO动态No.4近期融资事件

AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF), already licensed for the treatment of chronic obstructive pulmonary disease (COPD) in adults, has now been approved for use in the UK with an innovative, next-generation propellant with near-zero Global Warming Potential (GWP).1,2 This is the first medicine delivered by a pressurised metered-dose inhaler (pMDI) approved with the propellant that has 99.9% lower GWP than propellants used in currently available pMDIs.2 Trixeo with the next-generation propellant will have a low carbon footprint, comparable to inhaled medicines that do not require a propellant.3 Trixeo, a fixed-dose triple-combination therapy, is marketed as Breztri Aerosphere in the US, China and Japan. The approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) was based on results from the next-generation propellant clinical development programme, which demonstrated bioequivalence between Trixeo with the next-generation propellant, HFO-1234ze(E), and Trixeo with the current propellant, HFA-134a.4,5 The safety and tolerability profile for Trixeo with the next-generation propellant was consistent with the known profile of the medicine. Beyond the UK, regulatory applications for Trixeo/Breztri with the next-generation propellant are currently under review in Europe, China and additional countries. Omar Usmani, Professor of Respiratory Medicine at Imperial College London, said: “Pressurised metered-dose inhaled medicines are essential for millions of people living with respiratory diseases in the UK. The transition of Trixeo to the propellant with near-zero Global Warming Potential means that healthcare professionals can focus on optimising outcomes for their COPD patients based on clinical need, while also supporting climate goals. Clinicians and their patients shouldn’t feel that they have to choose between the most appropriate treatment and the planet.” Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “The UK approval of Trixeo Aerosphere with the next-generation propellant is an industry first and a major milestone in AstraZeneca’s commitment to transition our pMDI portfolio to the propellant with near-zero Global Warming Potential. Starting with Trixeo, we are addressing the needs of both patients and the environment in devastating diseases like COPD, which affects hundreds of millions of people and is a leading cause of death globally.” Tom Keith-Roach, President, AstraZeneca UK, said: “The UK approval of Trixeo Aerosphere with the near-zero Global Warming Potential propellant marks a world ‘first’ and an important step in improving the environmental impact of our portfolio of inhaled respiratory medicines to support the NHS in achieving its net zero carbon goals. Trixeo with our next-generation propellant allows us to address the needs of both patients and the planet.” Trixeo is the first medicine in AstraZeneca’s portfolio of pMDIs to transition to the new propellant. AstraZeneca aims to transition its wider pMDI portfolio to the near-zero GWP propellant by 2030 as part of the Company’s Ambition Zero Carbon strategy. In the UK, the Company plans to initiate the transition of Trixeo to the next-generation propellant in the coming months. Chronic respiratory diseases, including COPD, affect hundreds of millions of people around the world.6 Respiratory inhaled medicines delivered by pMDIs account for 78% of inhaler usage globally and contribute 0.04% of global greenhouse gases.7,8 In the UK, pMDIs make up 70% of all inhaled medicines use with inhaler emissions representing 3% of the total NHS carbon footprint.9 Studies show that the largest environmental contribution from respiratory diseases comes from patients not being adequately controlled and resulting increased healthcare utilisation.10,11 Implementing evidence-based guidelines into clinical practice can reduce exacerbations and unscheduled healthcare utilisation, and the resulting improved patient outcomes may also decrease the overall carbon footprint associated with respiratory care.12 Notes AstraZeneca’s next-generation propellant clinical development programme The clinical development programme has been initiated to assess the efficacy and safety of the next-generation, near-zero Global Warming Potential propellant, HFO-1234ze(E), with the AstraZeneca portfolio of inhaled medicines delivered by pressurised metered-dose inhalers (pMDIs). The first medicine to be assessed in the programme was Breztri/Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) through in vitro, in vivo bioequivalence (PK), safety and efficacy clinical studies.13-18 The programme established bioequivalence between Breztri/Trixeo with the next-generation propellant, HFO-1234ze(E), and Breztri/Trixeo with the current propellant, HFA-134a.4,5 The safety and tolerability profile for Breztri/Trixeo withthe next-generation propellant was consistent with the known profile of the medicine. Additional studies are underway to assess the bioequivalence of HFO-1234ze(E) to the current propellant with AstraZeneca’s other medicines delivered by pMDIs. Breztri/Trixeo Aerosphere Budesonide/glycopyrronium/formoterol fumarate (BGF), approved under the brand name Trixeo Aerosphere in the EU and Breztri Aerosphere in Japan, China and the US, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a long-acting β2 agonist (LABA), glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), with budesonide, an inhaled corticosteroid (ICS), and delivered via the Aerosphere pMDI. Breztri/Trixeo Aerosphere is approved to treat COPD in more than 80 countries worldwide including the US, EU, China and Japan, and has been prescribed to more than five million patients globally. Breztri/Trixeo Aerosphere with the next-generation propellant, HFO-1234ze(E), will maintain the same indication, product strength and dosage regimen as Breztri/Trixeo Aerosphere with the current propellant, HFA-134a. AstraZeneca’s Collaboration with Honeywell Developed and patented by Honeywell, the medical grade version of HFO-1234ze(E) is a critical propellant to enable the transition of pMDI medicines with reduced climate impact, given its near-zero GWP. AstraZeneca announced in 2022 its collaboration with Honeywell to develop respiratory inhaled medicines using the new propellant. Ambition Zero Carbon Through its Ambition Zero Carbon strategy, AstraZeneca is pursuing bold, science-based decarbonisation targets, accelerating progress towards net zero. The Company is on track to reduce greenhouse gas (GHG) emissions from its global operations and fleet (Scope 1 and 2) by 98% by 2026 (from a 2015 baseline). AstraZeneca aims to halve its entire value chain footprint (Scope 3) by 2030, on the way to a 90% absolute emissions reduction (from a 2019 baseline) by 2045. By 2030, the Company will become carbon negative for residual emissions. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard. AstraZeneca in Respiratory & Immunology Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company. AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Matthew Bowden Company Secretary AstraZeneca PLC Corporate and financial