昂戈瑞西单抗(君适达)

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一周医药速览(09.08-09.12)
Cai Jing Wang· 2025-09-12 09:41
君实生物:上半年民得维实现全渠道覆盖,探索社区和县域市场医疗合作模式 君实生物举办2025半年度业绩说明会。会上有投资者提问,特瑞普利单抗之外,公司其他3款款已实现 商业化上市的产品如何为公司持续造血。公司现阶段在 BD 策略上是否有明确的规划或预期。对此,管 理层回应,特瑞普利单抗以外,公司及合作伙伴亦积极拓宽其他商业化产品的销售渠道。民得维(氢溴 酸氘瑞米德韦片)、阿达木单抗( 商品名: 君迈康)、昂戈瑞西单抗( 商品名: 君适达)现阶段商业 化进展如下: 民得维于2023年1月获得国家药品监督管理局附条件批准上市后,公司积极组建商业化团队,不断探索 销售模式。2025年上半年,民得维实现全渠道覆盖,完成在美团、京东、阿里健康等药品零售电商平台 上线,与全国级医药公司及连锁药店达成战略合作,积极探索社区和县域市场医疗合作模式,帮助患者 更便捷的接受诊疗。 长春高新:GS3-007a干混悬剂境内生产药品注册临床试验申请获受理 太极集团发布关于获得司美格鲁肽注射液药物临床试验批准通知书的公告。披露公司全资子公司太极集 团重庆涪陵制药厂有限公司收到国家药品监督管理局关于司美格鲁肽注射液的《药物临床试验批准通知 ...
君实生物(1877.HK):PD-1单抗销售明显提速 管线整体进入关键期
Ge Long Hui· 2025-08-30 03:18
机构:长江证券 研究员:彭英骐/刘长洪 事件描述 2025 年8 月26 日,君实生物发布2025 年中期业绩公告:2025 年上半年实现营业收入11.68亿元,同比增 长49%,归母净亏损减少至4.13 亿元,同比下降36%。 事件评论 营收继续稳健增长,特瑞普利单抗销售明显提速。2025H1 公司实现营业收入11.68 亿元(同比 +49%),其中药品销售收入10.59 亿元。2025H1 归母净亏损减少至4.13 亿元(同比-36%)。公司四款 商业化产品放量明显,2025H1 特瑞普利单抗(拓益)国内销售收入9.54 亿元(同比+42%),上半年新 增两项适应症,共计12 项适应症上市,其中10 项已纳入医保。昂戈瑞西单抗(君适达)为首个覆盖他 汀不耐受人群的国产抗PSCK9 单抗,上半年新增两项适应症获批,共计3 项适应症上市;氢溴酸氘瑞米 德韦片(民得维)由附条件批转为常规批准,上半年实现全渠道覆盖;阿达木单抗(君迈康)8 项已获 批适应症并全部纳入医保。 核心产品引领海内外商业化网络建设。2025 上半年特瑞普利单抗相继在新加坡、澳大利亚、科威特及 阿联酋获批上市,目前累计在全球40 个国家和地 ...
药盒里的潮汐进退:进口原研药高溢价神话崩塌与国产药逆袭
Hua Xia Shi Bao· 2025-08-12 11:07
Core Insights - The shift from imported original research drugs to domestic generics and innovative drugs is significant, with the market share of imported original cancer drugs in top-tier hospitals dropping from 68% in 2021 to 34% in 2024, while domestic generics and innovative drugs now account for 66% [1][5][10] - The decline of imported original drugs is attributed to aggressive pricing strategies by multinational pharmaceutical companies and the cost advantages of domestic generics [1][6][10] - Patients are increasingly accepting domestic drugs, with many reporting satisfactory treatment outcomes and reduced financial burdens [4][12] Industry Dynamics - Multinational pharmaceutical companies are accelerating localization efforts, expanding production bases, and upgrading R&D centers to balance cost and innovation [2][13] - The Chinese government's policies, including centralized drug procurement and price negotiations, are effectively reducing drug prices and reshaping the market landscape [10][16] - The acceptance of domestic drugs is growing among patients, driven by improved quality and increased awareness [5][12] Market Trends - The usage of imported original cancer drugs has significantly decreased, with one hospital reporting a drop from over 200 units per month to around 50 units, while the usage of domestic innovative drugs has more than doubled [4][5] - The market for imported original drugs is facing challenges, with a low bid success rate in centralized procurement, leading to many companies withdrawing from public hospital markets [6][10] - The trend of patients preferring cost-effective domestic drugs is supported by studies showing equivalent efficacy and safety compared to original drugs [12][16] Future Outlook - The pharmaceutical industry is expected to continue evolving, with multinational companies adapting their strategies to maintain market presence through innovation and collaboration with local firms [13][14] - The Chinese market is becoming increasingly competitive, with domestic companies focusing on differentiated innovation to capture market share [11][14] - Ongoing reforms in the healthcare system aim to ensure that patients have access to a wider range of affordable and high-quality medications [16]
特稿 | 药盒里的潮汐进退:进口原研药高溢价神话崩塌与国产药逆袭
Hua Xia Shi Bao· 2025-08-12 04:19
Core Viewpoint - The article highlights a significant shift in the pharmaceutical market in China, where the market share of imported original research cancer drugs in top-tier hospitals is projected to drop from 68% in 2021 to 34% in 2024, while the combined share of domestic generic and innovative drugs is expected to rise to 66% [5][10]. Group 1: Market Dynamics - The transition from imported original drugs to domestic alternatives reflects deeper changes in the pharmaceutical market, driven by cost advantages of domestic generics and innovations [1][6]. - In the first half of 2025, over 30 original research drugs from multinational companies are expected to withdraw from the market, including those from Takeda, Pfizer, and GlaxoSmithKline [1]. - The declining market share of imported drugs is attributed to multinational companies' pricing strategies and the competitive pricing of domestic generics [6][10]. Group 2: Patient Perspectives - Many patients are initially hesitant to switch from imported to domestic drugs due to concerns about efficacy and safety, as illustrated by the experiences of patients like Ms. Zhou and an elderly male patient [3][4]. - However, some patients have reported positive outcomes after switching to domestic drugs, noting both cost savings and effective treatment [4][12]. Group 3: Policy and Regulatory Environment - The article discusses the impact of national drug procurement policies, which have significantly reduced the market presence of imported original drugs, with a low winning rate of 3.7% in recent procurement rounds [6][10]. - The ongoing reforms in the healthcare payment system, including DRG and DIP models, are pushing hospitals to prioritize lower-cost drugs, further squeezing the space for imported original drugs [10][12]. Group 4: Industry Adjustments - Multinational pharmaceutical companies are adapting by localizing their operations, including expanding production bases and upgrading research centers in China [13][14]. - Companies like Sanofi and Roche are shifting their focus towards innovative drugs and adjusting their product portfolios in response to market changes [8][14]. Group 5: Future Outlook - The article emphasizes the need for a transparent and competitive market environment to foster the development of high-quality, reasonably priced drugs, whether domestic or imported [16]. - The ongoing evolution in the pharmaceutical landscape suggests that both multinational and domestic companies will continue to adapt their strategies to meet changing patient needs and regulatory requirements [9][16].