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特立妥单抗注射液
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药物受理最新动态:Janssen Research & Development, LLC特立妥...
Xin Lang Cai Jing· 2026-02-24 23:25
声明:市场有风险,投资需谨慎。本文基于第三方数据库自动发布,不代表新浪财经观点,任何在本文 出现的信息均只作为参考,不构成个人投资建议。如有出入请以实际公告为准。如有疑问,请联系 biz@staff.sina.com.cn。 国家药品监督管理局药品审评中心数据显示,2026年2月25日,Janssen Research & Development, LLC的 特立妥单抗注射液申请已获受理,受理号为JXSB2600030。 受理号JXSB2600030药品名称特立妥单抗注射液药品类型治疗用生物制品申请类型补充申请注册分类无 企业名称Janssen Research & Development, LLC;Patheon Manufacturing Services LLC;承办日期2026年2月 25日 来源:新浪财经-鹰眼工作室 ...
2025年国谈落幕:双目录同步 创新药目录降价建议区间或为15%~50%
Di Yi Cai Jing· 2025-11-04 02:49
Core Insights - The national medical insurance negotiation for 2025 has introduced a dual-directory system, marking a significant change in the negotiation process for innovative drugs and commercial insurance [1][2][15] - The negotiation process for innovative drugs has seen a price reduction range suggested by the National Medical Insurance Administration (NMIA) of 15% to 50%, with a focus on the CAR-T drugs [3][4] - The introduction of the innovative drug directory is expected to create a more sustainable market payment mechanism for new drugs, with companies needing to reassess their product positioning and market strategies [15] Summary by Sections National Medical Insurance Negotiation - The negotiation took place from October 30 to November 3, 2025, with the first three days dedicated to the national medical insurance directory and the last two days for the commercial insurance innovative drug directory [1] - This year marks the first introduction of an innovative drug directory, which has altered the negotiation dynamics for drug pricing [1][15] Price Negotiation Mechanism - The NMIA has introduced a new price negotiation mechanism for innovative drugs, allowing for price discussions between drug companies and commercial insurance [1][3] - Companies have been advised to consider a price reduction of 15% to 50% during negotiations, with some expressing skepticism about achieving reductions below 15% [3][4] CAR-T Drugs - CAR-T drugs have been a focal point in the negotiations, with successful negotiations reported for some products, such as the CAR-T drug from HeYuan Biotech priced at 999,000 yuan [3][4] - A limited number of CAR-T drugs are expected to be included in the innovative drug directory, with estimates suggesting around 20 drugs may be approved [1][3] Commercial Insurance Dynamics - The dual-directory negotiation allows companies to choose between reporting to the basic medical insurance directory, the innovative drug directory, or both, creating strategic options for different companies [2][10] - The commercial insurance market has shown limited interest in covering rare disease drugs due to their high costs and small patient populations, which may affect their inclusion in the innovative drug directory [14][15] Focus on ADC and Bispecific Antibodies - ADC (Antibody-Drug Conjugates) and bispecific antibodies remain key focus areas in the negotiations, with several innovative drugs vying for inclusion in the directories [8][10] - Companies are adopting varied strategies based on their market positioning, with some prioritizing the basic medical insurance directory for broader market access, while others focus on maintaining high-end product positioning through the innovative drug directory [10][11]