--- title: "北京市首个试点品种获批 罕见病创新药 “跨境分段生产” 全球同步上市" description: "近日，强生制药有限公司的尼卡利单抗注射液跨境分段生产试点获国家药监局批复同意，这是全球同步上市的创新产品，也是全国首个治疗 12 岁及以上青少年和成人患者罕见病 “全身型重症肌无力” 的生物制品。记者从市药监局了解到，该品种原液在国内生产，制剂和包装在境外生产，是本市首个获批的生物制品分段生产试点。" type: "news" locale: "zh-CN" url: "https://longbridge.com/zh-CN/news/241143876.md" published_at: "2025-05-21T03:07:31.000Z" --- # 北京市首个试点品种获批 罕见病创新药 “跨境分段生产” 全球同步上市 > 近日，强生制药有限公司的尼卡利单抗注射液跨境分段生产试点获国家药监局批复同意，这是全球同步上市的创新产品，也是全国首个治疗 12 岁及以上青少年和成人患者罕见病 “全身型重症肌无力” 的生物制品。记者从市药监局了解到，该品种原液在国内生产，制剂和包装在境外生产，是本市首个获批的生物制品分段生产试点。 近日，强生制药有限公司的尼卡利单抗注射液跨境分段生产试点获国家药监局批复同意，这是全球同步上市的创新产品，也是全国首个治疗 12 岁及以上青少年和成人患者罕见病 “全身型重症肌无力” 的生物制品。记者从市药监局了解到，该品种原液在国内生产，制剂和包装在境外生产，是本市首个获批的生物制品分段生产试点。 ### Related Stocks - [JNJ.US - 强生](https://longbridge.com/zh-CN/quote/JNJ.US.md) ## Related News & Research | Title | Description | URL | |-------|-------------|-----| | BUZZ-Johnson & Johnson rises on planned $1 billion investment in Pennslyvania | Shares of Johnson & Johnson (JNJ) rose 0.3% to $244.40 following the announcement of a planned investment exceeding $1 b | [Link](https://longbridge.com/zh-CN/news/276261089.md) | | Could This Single Dividend King Make Your Portfolio Worth $1 Million in 20 Years? | Johnson & Johnson (JNJ) is a leading healthcare company known for its 62 consecutive years of dividend increases. Despit | [Link](https://longbridge.com/zh-CN/news/259050773.md) | | BREAKINGVIEWS-Software CEO wallets can help ease AI overkill | Software CEOs can mitigate the impact of AI-related stock declines by purchasing shares with their own funds, as seen wi | [Link](https://longbridge.com/zh-CN/news/276327967.md) | | PNC Financial Services Group Inc. Acquires 3,223 Shares of Alibaba Group Holding Limited $BABA | PNC Financial Services Group Inc. increased its stake in Alibaba Group Holding Limited by 7.1% in Q3, acquiring an addit | [Link](https://longbridge.com/zh-CN/news/276318339.md) | | Bitdeer Proposes $300 Million Convertible Senior Notes Offering | Bitdeer Technologies Group has proposed a private placement of $300 million in Convertible Senior Notes due 2032, with a | [Link](https://longbridge.com/zh-CN/news/276329240.md) | --- > **免责声明**：本文内容仅供参考，不构成任何投资建议。