Aspen Pharmacare Holdings Ltd.

近期，种种迹象表明，中国创新药市场的确庞大，但要想分得更大的蛋糕，越来越难了。跨国药企“躺赚”时代早已不复，必须重新打起精神，制定出符合中国创新药市场规律的新战略。 撰文| Erin 十一假期结束至今，约一周时间，就有三家跨国药企中国区先后传出裁员消息，一家是关停整条产品线，伴随裁员；另两家则是裁撤成熟产品的人员，将岗位调整到新晋管线之中。 2015年开启药审改革以来，我国药品审评审批政策逐步接轨国际，创新药市场持续扩容，越来越多海外药企将中国市场放入关键位置。然而，机遇与挑战始终并存，集采、国谈政策持续挤压利润；本土创新研发突飞猛进，市场竞争愈发激烈；药价治理的“尺度”也始终如达摩克利斯之剑般，高悬于想要在零售市场寻找新增长曲线的各类药企头上…… 一切迹象都在暗示一个现状：中国创新药市场的确庞大，但要想分得更大的蛋糕，越来越难了。就算是商业化体系成熟的跨国药企，“躺赚”时代早已不复，必须重新打起精神，重新制定出符合中国创新药市场规律的新战略。 谁在撤离？谁在进击？ 围绕产品布局，大抵可以将如今跨国药企中国区所做的“减法”分为两个类型：裁员，关停部门，撤掉业务线；打包出售。另外，为了将资源更好与创新这一大方向匹配，不少跨国药企也开始选择各种方式纵深在中国市场的布局，值得关注的“加法”是：开设新部门；以及同步早期研发。 2023年辉瑞的“裁撤”，是在当时较为紧张的市场情绪中，一件颇具代表性的大事。当年5月，辉瑞才更换新任中国区疫苗事业部总经理，同年11月就裁撤了整个在华疫苗线业务，并将其核心产品13价肺炎疫苗（沛儿13）交给了本土合作伙伴科园信海代理。 上月底，有消息称，强生全球正在关闭其心血管和代谢药物部门，而在去年，强生还关停了其传染病和疫苗部门。强生全球的这次调整，未来将以何种方式传导至其中国市场，备受业界期待。毕竟，在去年西安杨森更名强生创新制药之际，心血管业务还作为与肿瘤、免疫同等重要的未来新药研发方向。但伴随强生全球将“聚焦创新”作为发展关键词，强生中国无论是制药还是医疗科技，都已经发生了多起人事变动。 而对于一些腰部跨国药企来说，比起将单一事业部关停，或裁掉整个业务线，将冗余业务线“打包出售”可能是更具性价比的方式，甚至还有跨国药企借此从中国市场“撤退”。 这件事在今年以来就时有发生，例如优时比中国出售成熟管线，聚焦创新药；协和麒麟中国通过“中间角色”，将股权出售给维健医药；爱尔康以8款产品换了欧康维视股份…… 优时比与协和麒麟中国的调整代表了两个方向：前者为了集中资源，聚焦创新；后者则是伴随协和麒麟在全球的市场重心调整。 具体来看，优时比在中国的成熟业务包括两大领域，分别是神经和过敏领域。此次出售涉及神经系统成熟产品开浦兰、维派特、优普洛及抗过敏产品仙特明、优泽，以及位于珠海的生产基地，将这一系列产品以6.8亿美元（约48.43亿元人民币）价格出售、剥离和许可给亚洲最大的医疗保健专用资产管理集团康桥资本和全球投资机构穆巴达拉投资公司。 可以看到，优时比的成熟产品在如今的中国市场要么已经触发集采，要么已经被众多仿制药企抢占市场。而相对来讲，优时比的创新药产品却正在以迅猛之势进驻中国市场，例如其双靶点 IL-17A/F 抑制剂比奇珠单抗，在今年7月获得国家药监局批准用于强直性脊柱炎，与该产品在美国获批时间仅相差一年；紧接着，在今年8月，优时比的重症肌无力新药C5补体抑制剂泽勒普肽注射液也在国内获批，同样距离FDA批准时间不到一年。 相比之下，面对集采与中国市场激烈的竞争，协和麒麟在全球战略的调整已经将重心放到欧美市场。协和麒麟发布公告称：“考虑到未来增长战略与外部环境的变化，自去年以来，已经在欧洲与已建立的制药业务的合作伙伴建立了合资联盟，这次将在中国和其他亚洲地区许可产品，包括已建立的制药公司，并由合作伙伴开展销售活动。” 此外，去年12月，老牌仿制药企山德士中国被爱施健收购的发生的逻辑也同样如此。 不过，有撤退，也有进击。例如今年以来人事调整频繁的礼来，伴随2023年10月，其重磅阿尔茨海默新药Donanemab在中国的上市申请获受理，以及今年1月，治疗偏头痛的新药Galcanezumab获批上市，神经科学作为礼来在全球的四大板块之一，似乎也将在中国市场迎来突飞猛进的发展。在此契机下，礼来中国在9月正式官宣了神经科学事业部从跨生化事业部中独立。礼来中国未来将在此领域中“大干一场”的决心已然昭示。 希冀在中国市场扬帆起航的绝非礼来一家，BI早在数年前就提出“中国关键（China Key）”战略，决定在中国不分治疗领域进行全球同步早期研究的大型跨国药企，由此诞生的罕见皮肤病创新靶向药佩索利单抗注射液已在中国获批并进入医保目录。第一三共也在今年提出，中国研发团队也已经成为集团全球开发计划的第一梯队，正在逐步加入全球早期临床研究开发。 进退背后 跨国药企们密集调整，动作不同，方向各异，但都在指向同一个原因：更迅速地抓住机遇，更灵活地应对挑战。 机遇人尽皆知，中国医药市场规模已经成为全球第二大医药市场，仅次于美国，并且市场需求还在不断扩大；中国的新药审评审批机制不断向国际接轨；临床亟需的创新药物临床转化落地也在受到全方位支持…… 但同时，挑战更加不容忽视。 首先是来自集采、医保国谈等政策压力。结合目前的消息，第十批国采也将到来，届时一批跨国药企原研药又将面临“审判”。 集采的压力实际早已具像化，前有礼来治疗注意缺陷多动障碍（ADHD）的药物择思达（盐酸托莫西汀胶囊，Strattera）停止在中国供应，后有BI沐舒坦（盐酸氨溴索注射液）停止销售。 同时，胰岛素国采也给了跨国药企一记重创。在2021年首次全国胰岛素集采中，跨国药企赛诺菲、礼来、诺和诺德都积极参与，其中诺和诺德的门冬胰岛素紧贴“降幅不低于40%”的要求中标，打破了其全球价格体系，实现全球最低价。 然而在集采结果执行当年（2022年），诺和诺德中国市场业绩增长就呈现疲软态势，整体收入仅为162.09亿丹麦克朗（约合22.69亿美元），同比增幅仅为1.2%。其中占据绝大部分的胰岛素产品总收入为103.02亿丹麦克朗（约14.42亿美元），较2021年有所下滑，甚至还不如2020年的业绩。赛诺菲和礼来也在2022年相继遭遇下滑，其中礼来的中国市场降幅高达10%。 政策的压力在2024年也进一步升级，随着医保部门的药价治理触手从挂网伸向了零售端，跨国药企药品想要在零售市场实现新的增长路径似乎也在收窄。 一方面，在“四同”药价治理的威力下，包括原研药在内的非中选药品的挂网价格，正在向集采产品趋近；另一方面，各地医保局纷纷通过上线“比价系统”或是鼓励门诊统筹药店药品销售价格不高于挂网价格销售的方式，让药价在全国范围内实现趋同。 而面对成熟产品价格被“钳制”的命运，大型跨国药企已经洞悉：多年以前“躺赚”的模式不复存在，早早将有限资源转舵至聚焦创新药。以优时比为代表的腰部企业，如今也走上了相似的道路。 最后，尤其值得一提的是，来自中国本土创新力量的竞争，如今也已在不同程度上能够与跨国药企一决高下。 例如，肺癌创新治疗药物琥珀酸莫博赛替尼胶囊，作为全球范围EGFR 20号外显子插入突变晚期非小细胞肺癌治疗史上二十年来的重大突破，在2023年获得优先审评审批程序附条件批准上市。然而，莫博赛替尼最终却因确证性研究数据不达标，无奈于同年4月在全球主动退市。 莫博赛替尼的背后，其实也离不开中国本土创新药的竞争压力。据悉，同年8月，中国本土Biotech的同靶点新药舒沃替尼就获得了国家药监局的正式批准。 近期，中国创新药“头对头”临床挑战跨国药企的消息也层出不穷。先是康方PD-1/VEGF双抗新药依沃西成为全球首个且唯一在III期单药“头对头”临床研究中证明疗效显著优于K药的药物；9月，恒瑞也开启了其补体B因子（CFB）抑制剂HRS-5965胶囊“头对头”对比补体抑制剂王牌产品依库珠单抗注射液的III期临床试验。 其实从今年上半年跨国药企中国区业绩情况来看，默沙东夺下第一宝座，半数MNC重回两位数增长，他们近几年的调整效力是显著的。然而，跨国药企所面临的挑战从未消失，甚至更为严峻了，毕竟谁也不知药价治理的风暴还将以何种形式刮向何方，又是否会有一匹又一匹兼具商业化与创新实力的中国本土药企奔赴而来，与他们进行正面博弈。 一审| 黄佳 二审| 李芳晨 三审| 李静芝 精彩推荐 CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化 ｜ 猎药人系列专题 | 出海 启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册 创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖 ｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 |  荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药 ｜再鼎医药｜亚虹医药 跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

DUBLIN--( BUSINESS WIRE )--The "United States Endometriosis and Uterine Fibroids Market (2024 Edition): Analysis By Drug Type, By Route of Administration, By Distribution Channel, By Region, By Country: Market Insights and Forecast (2020-2030)" report has been added to ResearchAndMarkets.com's offering. The United States Endometriosis and Uterine Fibroids Market showcased growth at a CAGR of 4.09% during 2020-2023. The market was valued at USD 415.70 Million in 2023 which is expected to reach USD 568.07 Million in 2030. The research report provides a complete analysis for the historical period of 2020-2023, the estimates of 2024 and the forecast period of 2025-2030. The United States has been experiencing a significant boom in recent years, driven by growing prevalence of the disease due to technological advancements in the diagnostics techniques in the United States, increased awareness towards reproductive disorders, and increased expenditure of capital in the Research and Development organizations in the United States. Due to the limited number of drugs available for the treatment of Endometriosis and Uterine Fibroids, it becomes imperative to find novel treatment outcomes for enhancing the quality of life of the patients. Surgical removal of the fibroids is the only effective treatment option available for treating the disease. However, many females prefer drug therapies over surgical procedures as they are non-invasive. Endometriosis, on the other hand not only affects the uterus but, it also spreads to other reproductive organs, if not treated properly. Increased investments by pharmaceutical companies on exploring the efficacy of different classes of hormonal drugs can pave way for a new drug in the market through different routes of administration such as oral, and parenteral. The emergence of newer technologies such as nanocarrier delivery of drugs, skin patches for epidermal drug delivery have increased the preference for drug therapies in the United States. The landscape of drug development in United States has changed dramatically. Precision medicine has emerged as a result of the elimination of conventional treatment options available for endometriosis and uterine fibroids. Clinicians can prescribe medications based on the clinical presentation, genetic profile, and the severity or stage of endometriosis. Scientists have focused their research on developing tailored medicines for the treatment of endometriosis and uterine fibroids by utilising high resolution omics data and meta-analysis of disease profile. New avenues in the research and development for endometriosis and uterine fibroids treatment have been made possible by incorporating artificial intelligence and machine learning in drug manufacturing processes. Various distribution channels such as Hospital pharmacies, retail pharmacies or online pharmacies offers widespread delivery of medicine to the consumers especially for those living in remote areas or facing time constraints. In the coming years, the online channels have the potential to elevate the market sales of drugs. Furthermore, the use of biodegradable implants for delivering hormonal drugs such as progesterone, Gonadotrophin releasing hormone agonists, and Gonadotrophin releasing agonists is one of the trends in the United States endometriosis and uterine fibroid market. These biodegradable implants are biocompatible and non-invasive in nature. In addition to these benefits, drug implants consume less time and can be implemented in the case of controlling the symptoms associated with the diseases. Scope of the Report The report analyses the Global, Americas and United States Endometriosis and Uterine Fibroids Market by Value (USD Million). The report includes a detailed assessment of United States Endometriosis and Uterine Fibroids Market by Value (USD Million). The report analyses the United States Endometriosis and Uterine Fibroids Market by Epidemiology. The report analyses the United States Endometriosis and Uterine Fibroids Market by Pipeline Scenario. The report presents the analysis of United States Endometriosis and Uterine Fibroids Market for the historical period of 2020-2023, the estimated year 2024, and the forecast period of 2025-2030. The report analyses the United States Endometriosis and Uterine Fibroids Market, By Drug Type (GnRH Antagonists, Progesterone, GnRh Agonist and Others). The report analyses the United States Endometriosis and Uterine Fibroids Market By Route of Administration (Oral and Parenteral). The report analyses the United States Endometriosis and Uterine Fibroids Market By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies). The key insights of the report have been presented through the frameworks of SWOT and Porter's Five Forces Analysis. Also, the attractiveness of the market has been presented By Drug Type, by Route of Administration & by Distribution Channel. Also, the major opportunities, trends, drivers, and challenges of the industry has been analyzed in the report. The report tracks competitive developments, strategies, mergers and acquisitions and new Drug development. Analyst Recommendations Augment the availability of combinational drugs Escalate Distribution through Online services Competitive Positioning Companies Product Positioning Market Position Matrix Market Share Analysis of United States Endometriosis and Uterine Fibroids Market Company Profiles AbbVie Inc. Pfizer Inc. AstraZeneca plc. Tolmar Inc. Glenmark Pharmaceuticals Ltd. Aspen Pharmacare Holdings Ltd. Agile Therapeutics Inc Medicines 360 Cipla Ltd Takeda Pharmaceuticals For more information about this report visit https://www.researchandmarkets.com/r/giumio About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Healthcare business global roundup Eli Lilly's experimental cardiovascular drug ‘promising’; Aspen Pharmacare to manufacture mpox vaccines; Novo Nordisk says Ozempic shortage ‘worsening’ Eli Lilly's experimental cardiovascular drug ‘promising’ In a significant development for obesity treatment , Eli Lilly 's experimental GLP-1 drug, retatrutide, has demonstrated promising results beyond weight loss. At the European Society of Cardiology meeting, researchers reported that the drug significantly reduced blood lipid levels and cardiovascular risks in a mid-stage trial. After 48 weeks, patients experienced reductions in triglycerides by up to 40.6% and in apoC-III, a protein linked to glucose metabolism and inflammation, by 38%. These findings complement earlier data showing substantial weight loss and improvements in liver fat. Retatrutide's unique mechanism, mimicking three hormones instead of one or two, positions it as a potential advancement over current popular weight-loss medications. Question over tube tying as birth control method In contraceptive news, a study published in NEJM Evidence challenges the reliability of tubal ligation as a permanent birth control method. The research, involving 4,184 women who underwent tubal sterilisation between 2002 and 2015, found that 3% to 5% of participants reported unplanned pregnancies post-procedure. Dr. Eleanor Bimla Schwarz of UCSF and Zuckerberg San Francisco General Hospital emphasised that contraceptive arm implants or intrauterine devices may offer superior pregnancy prevention compared to tubal ligation. Aspen Pharmacare to manufacture mpox vaccines African pharmaceutical company Aspen Pharmacare is exploring partnerships to manufacture mpox vaccines at its facilities, according to CEO Stephen Saad. This initiative comes as the African continent faces pressure to address the mpox outbreak , with 13 countries reporting over 22,800 mpox cases and 622 deaths this year. Aspen's involvement is contingent upon volume commitments and financial support for technology transfer, reflecting lessons learned from its experience with COVID-19 vaccine production. Pneumococcal vaccine study sees Vaxcyte's shares soar Vaxcyte's shares rose by 48% to a record high after the company said its experimental pneumococcal vaccine showed promising results in an early-stage study. The drug has a safety profile similar to rival Pfizer's shot. Pneumococcal disease is a serious bacterial infection caused by bacteria called streptococcus pneumoniae. It spreads through direct contact with respiratory secretions such as saliva and mucus. Vaxcyte's stock rose to $119.27 – its highest level since its Nasdaq debut in 2020. It closed up 36.4%. As a result the vaccine developer added more than $4 billion to its market capitalisation. Novo Nordisk says Ozempic shortage ‘worsening’ Novo Nordisk has reported an worsening of the Ozempic shortage, and says intermittent supply issues are likely to run into the fourth quarter of 2024 across all strengths of the diabetes medication. The company attributes this to increased demand and manufacturing capacity constraints. Healthcare professionals are advised to limit treatment initiation for new patients on both Ozempic and Victoza until the supply situation improves, as per recommendations published by the European Medicines Agency.