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40%退货率,卖到海外的国产创新药遭遇“分手”危机?
36氪· 2025-04-29 09:17
中国创新药License-out交易现状 - 2025年第一季度中国药企全球授权交易已超20笔,包括罗氏10亿美元合作信达生物、乐普生物12亿美元ADC合作等[2] - 2023年百利天恒与BMS达成84亿美元天价协议,首付8亿美元,推动公司净利增长575%至37.08亿元[2] - 映恩生物成立六年通过license-out累计交易超60亿美元,港交所上市首日涨幅达113%创纪录[2] License-out交易风险与终止情况 - 2020年完成的62起交易中40%已终止(25起),2021-2022年退货率约20%[5] - 典型终止案例包括诺诚健华奥布替尼、石药集团ADC项目EO-3021等[5] - 2023年中国创新药里程碑达成率仅22%,后期阶段达成率更低[9][11] 交易终止核心原因 - 临床数据不及预期:石药Claudin18.2 ADC美国I期ORR仅22.2%,较初期47.1%大幅下降[6] - 管线同质化竞争:默沙东退回科伦博泰SKB315因全球已有4款同类产品进入III期[7] - 买方战略调整:Coherus收购后终止君实生物TIGIT项目以优化资源分配[7] - FDA政策变化:信迪利单抗因仅基于中国临床数据被拒,礼来退回信达生物[8] 终止交易的影响 - 石药集团Claudin18.2 ADC仅获2700万首付(占总额2.3%),11.68亿里程碑款落空[11] - 天境生物终止CD47合作后砍管线至3条,暂停CD73单抗开发[12] - 市场信心受损导致后续融资困难,需优异临床数据才可能重启合作[12] NewCo模式兴起 - 2024年通过NewCo模式交易额突破600亿元,同比增长54%[12] - 康诺亚半年完成3笔NewCo交易,潜在总额11.4亿美元占营收95%[14] - 与License-out相比,NewCo模式实现风险共担、利益长期化,含股权收益[13] 行业趋势与建议 - 2024年1-11月BD首付款62.73亿美元,超直接融资额(39.77亿)近一倍[17] - 成功出海需具备全球领先研发进度、优质临床数据或显著商业前景[18] - 早期管线交易风险极高,辉瑞等MNC临床成功率不足5%[15]
Why Novo Nordisk Stock Dropped Today
The Motley Fool· 2025-04-25 22:58
Ignore the noise. Novo Nordisk stock is a bargain.Novo Nordisk (NVO -1.88%), the Danish drugmaker of GLP-1 weight loss drugs Ozempic and Wegovy, slipped 2% through 10:30 a.m. ET Friday after suffering a one-two punch from Reuters and a bank analyst.On Thursday, Reuters reported weak U.S. prescription data is contributing to investor concerns that Novo Nordisk is no longer a growth stock. Taking a quick cue from the report, Singapore's DBS Bank has flipped 180 degrees, cutting its rating on Novo Nordisk stoc ...
Novo Nordisk scores major legal win that bars many compounded versions of Wegovy, Ozempic
CNBC· 2025-04-25 22:07
Flags with the logos of Danish drugmaker Novo Nordisk, maker of the blockbuster diabetes and weight-loss treatments Ozempic and Wegovy are pictures while the company presents the annual report at Novo Nordisk in Bagsvaerd, Denmark, on February 5, 2025.Novo Nordisk scored a huge legal victory that largely restricts compounding pharmacies from marketing or selling cheaper, unapproved versions of the drugmaker's blockbuster weight loss drug Wegovy and diabetes treatment Ozempic. A federal judge in Texas late T ...
The Best Stock to Buy With Less Than $60 in the Market Sell-Off
The Motley Fool· 2025-04-25 18:03
Plenty of stocks with attractive businesses trade on the market for hundreds of dollars per share -- or more. However, it's possible to find excellent stocks that may become undervalued when either the market undergoes a deep correction, including in a bear market, or in company-specific situations where temporary problems seem to hinder the business, muddling its longer-term outlook.One such example is Novo Nordisk (NVO 2.01%), the Denmark-based pharmaceutical leader whose shares are exchanging hands for j ...
Novo Nordisk Plunges 17% in a Month: Buy, Sell or Hold the Stock?
ZACKS· 2025-04-25 00:20
In the past month, Novo Nordisk (NVO) shares have lost 16.7%, attributable to both sector-specific developments and broader macroeconomic headwinds. A key catalyst was last week’s announcement from rival Eli Lilly (LLY) , which reported first phase III success for its oral GLP-1 candidate, orforglipron, in lowering blood glucose and promoting weight loss in type II diabetes (T2D) patients. Oral pills, being more convenient than injectables, tend to boost patient adherence.Novo Nordisk also markets Rybelsus ...
全球制药业洞察 | 中国药企瞄准肥胖症领域研发管线引起诺和诺德和默克的关注
彭博Bloomberg· 2025-04-24 09:27
中国药企在肥胖症领域的研发进展 - 中国药企正积极开发肥胖症治疗药物,信达生物、恒瑞医药、联邦制药和甘李药业等公司的GLP-1类药物研发管线最具吸引力 [3][4] - 信达生物的玛仕度肽有望于2025年在中国获批,恒瑞医药的HRS9531、联邦制药的UBT251和甘李药业的GZR18预计2028年前上市 [4] - 中国肥胖症患病率持续上升,预计到2030年受影响成年人将达1.4亿,2035年患病率可能翻倍 [4][5] 国际药企在中国市场的布局 - 诺和诺德的Wegovy和礼来的Zepbound分别于2024年第二和第三季度在中国获批,疗效优于本土竞品 [4][5] - 诺和诺德、默克等国际巨头已通过许可协议获取中国药企的减肥药资产,如诺和诺德获得联邦制药UBT251的全球许可(除大中华区) [6][10] - 阿斯利康获得诚益生物口服GLP-1许可,恒瑞医药将减肥药资产全球权利(除中国外)出售给Hercules(现为Kailera) [5][6] GLP-1类药物研发竞争格局 - 全球100多家药企研发减肥药,160多种药物处于临床阶段,中国药企占研发管线资产的30% [6] - GLP-1类药物在肥胖症治疗领域占据核心地位,但竞争已趋饱和,胰淀素等新疗法可能成为差异化关键 [6] - 华东医药的利鲁平需每日注射一次,上海仁会生物的菲塑美需每日三次,菲塑美16周减重幅度达6%(安慰剂组-2.4%) [5][6] 重点药物临床数据表现 - 恒瑞医药HRS9531中期研究显示可使中国成年人体重减轻16.7%(经安慰剂校正),24周后可能进一步改善 [8] - HRS9531在36周时8毫克剂量组体重减轻率达21%(经安慰剂校正),疗效超过信达玛仕度肽和礼来Zepbound [8] - 联邦制药UBT251(GLP-1/GIP/胰高血糖素)12周体重减轻率达16.6%(经安慰剂校正),优于其他下一代GLP-1类药物 [10][13] 行业交易与合作动态 - 中国药企与西方同业达成多项交易,包括诺和诺德与联邦制药、默克与翰森、恒瑞与Hercules等 [6] - 上海民为、恒瑞医药与江苏中新等中国药企均在开发三重激动剂药物,加剧GLP-1类药物赛道竞争 [10][13] - 联邦制药计划2028年在中国推出UBT251,该药物已获准在中美两国进行临床试验 [13]
全球制药业洞察 | 中国药企瞄准肥胖症领域研发管线引起诺和诺德和默克的关注
彭博Bloomberg· 2025-04-24 09:27
中国药企在肥胖症领域的研发进展 - 中国药企正积极开发肥胖症治疗药物,信达生物、恒瑞医药、联邦制药和甘李药业等公司的GLP-1类药物研发管线最具吸引力 [3][4] - 信达生物的玛仕度肽有望于2025年在中国获批,恒瑞医药的HRS9531、联邦制药的UBT251和甘李药业的GZR18预计2028年前上市 [4] - 恒瑞医药的HRS9531在中期研究中显示可使中国成年人体重减轻16.7%(经安慰剂校正),疗效超过信达生物的玛仕度肽和礼来的Zepbound [8] 国际药企对中国市场的关注与布局 - 诺和诺德的Wegovy和礼来的Zepbound分别于2024年第二季度和第三季度在中国获批,疗效和便利性优于上海仁会生物和华东医药的竞品 [4][5] - 诺和诺德、默克等国际巨头已通过许可协议或收购方式获取中国药企的减肥药资产,如诺和诺德获得联邦制药UBT251的全球许可(除大中华区外) [6][9] - 阿斯利康获得诚益生物口服GLP-1的许可,恒瑞医药将其减肥药资产的全球权利(除中国外)出售给Hercules(现为Kailera) [5][6] 中国肥胖症市场潜力与竞争格局 - 中国肥胖症患病率不断上升,预计到2030年受影响的成年人可能达1.4亿,到2035年患病率将增加近一倍 [4][5] - 全球有100多家药企研发减肥药,160多种药物处于临床阶段,其中近三分之一为中国药企,占研发管线资产的30%左右 [6] - 中国本土研发管线以GLP-1类药物为主,但竞争激烈且趋于饱和,胰淀素等新疗法可能是未来差异化关键 [6] 重点药物研发数据与进展 - 联邦制药的UBT251(GLP-1/GIP/胰高血糖素三重激动剂)在I期研究中12周体重减轻率达16.6%(经安慰剂校正),疗效优于其他下一代GLP-1类药物 [9][14] - 华东医药的利鲁平需每日注射一次,上海仁会生物的菲塑美需每日注射三次,菲塑美在16周时减重幅度最高达6%(安慰剂组为-2.4%) [5] - 恒瑞医药HRS9531的8毫克剂量36周初期数据显示经安慰剂校正的体重减轻率达21%,验证了其疗效优势 [8]
Novo Nordisk Investors Just Got Terrible News. Should You Sell the Stock?
The Motley Fool· 2025-04-23 17:50
Denmark-based pharmaceutical giant Novo Nordisk (NVO 2.66%) has been struggling during the past year. Its financial results -- though strong by comparison to most of its peers -- haven't been as good as investors expected. The company has also faced clinical trial setbacks: An otherwise promising weight loss medicine it developed failed to impress the market with its late-stage results.Now, Novo Nordisk is getting even more bad news, thanks to developments from its biggest competitor in the diabetes and obe ...
Why Novo Nordisk Stock Popped Today
The Motley Fool· 2025-04-23 00:17
Novo Nordisk has a GLP-1 Ozempic pill. That's both good and bad news for Novo Nordisk stock.Novo Nordisk (NVO 2.76%), the Danish drugmaker that's been riding high ever since it began putting out Ozempic and Wegovy GLP-1 injectables for treatment of diabetes and weight loss, got another shot in the arm yesterday -- one that helped the stock dodge the market downturn entirely and end the day somewhat in the green. The same news that helped Novo stock out yesterday, moreover, is today turning into solid gains ...
Down 60%, Is This Growth Stock Too Cheap to Ignore?
The Motley Fool· 2025-04-22 17:15
In this video, I will cover recent updates regarding Novo Nordisk (NVO 0.48%). Watch the short video to learn more, consider subscribing, and click the special offer link below.*Stock prices used were from the trading day of April 18, 2025. The video was published on April 18, 2025. ...