---
title: "康寧傑瑞製藥-B：KN026(安尼妥單抗注射液) 新藥上市申請獲國家藥監局受理"
description: "康寧傑瑞製藥-B：KN026(安尼妥單抗注射液) 新藥上市申請獲國家藥監局受理"
type: "news"
locale: "zh-HK"
url: "https://longbridge.com/zh-HK/news/256914244.md"
published_at: "2025-09-11T11:38:03.000Z"
---

# 康寧傑瑞製藥-B：KN026(安尼妥單抗注射液) 新藥上市申請獲國家藥監局受理

智通財經 APP 訊，康寧傑瑞製藥-B(09966) 發佈公告，該公司與石藥集團有限公司 (01093) 附屬公司上海津曼特生物科技有限公司合作開發的 KN026 聯合化療用於治療至少接受過一種系統性治療 (必須包含曲妥珠單抗聯合化療) 失敗的人表皮生長因子受體 2(HER2) 陽性 (HER2+) 局部晚期、復發或轉移性胃/胃 - 食管結合部腺癌 (GC/GEJ) 患者的新藥上市申請 (新藥上市申請)，已獲中國國家藥品監督管理局 (國家藥監局) 受理。本次新藥上市申請主要是基於一項關鍵 II/III 期臨牀試驗，其期中分析結果顯示，與現有標準治療相比，KN026 聯合化療顯著提高臨牀療效，延長患者的無進展生存期 (PFS) 和總生存期 (OS)，且在安全性方面無新發安全性風險，心臟毒性發生率低，免疫原性低。此外，KN026 已於 2023 年 11 月 4 日獲國家藥監局藥品審評中心授予突破性治療藥物認定，並已於 2025 年 8 月 28 日獲優先審評審批資格。

目前，HER2+ 胃癌二線治療尚無獲批上市的抗 HER2 藥物，KN026 是中國首個在胃癌二線治療中獲得陽性結果的抗 HER2 雙特異性抗體藥物。KN026 的 II 期臨牀試驗結果於 2024 年歐洲腫瘤內科學會年會首次公佈，該結果顯示，KN026 聯合化療的客觀緩解率為 40.0%，經獨立評審委員會評估的中位 PFS 為 8.6 個月。

### Related Stocks

- [09966.HK - 康寧傑瑞制藥-B](https://longbridge.com/zh-HK/quote/09966.HK.md)

## Related News & Research

| Title | Description | URL |
|-------|-------------|-----|
| Alphamab Oncology Announces Positive Phase III Trial Results for KN026 in HER2+ Gastric Cancer at ESMO Congress 2025 | Alphamab Oncology has announced positive interim results from a Phase III trial of KN026 for HER2-positive gastric cance | [Link](https://longbridge.com/zh-HK/news/261644266.md) |
| Alphamab Oncology's KN026 NDA for HER2+ Gastric Cancer Accepted by China's NMPA, Achieving Breakthrough Therapy Designation and Priority Review Status | Alphamab Oncology's new drug application (NDA) for KN026, an Anbenitamab injection for HER2-positive gastric cancer, has | [Link](https://longbridge.com/zh-HK/news/256913522.md) |
| Shanghai Fosun Pharma says NMPA accepts drug registration application of moxetomidate hydrochloride injection | Shanghai Fosun Pharma says NMPA accepts drug registration application of moxetomidate hydrochloride injection | [Link](https://longbridge.com/zh-HK/news/275915279.md) |
| 23:18 ETNovel Anti-Fibrotic Drug AK3280 Cleared by FDA to Initiate Phase 2 Proof-of-Concept Clinical Trial in IPF | Shanghai Ark Biopharmaceutical Co., Ltd. announced that the FDA has cleared its IND application for AK3280, a novel anti | [Link](https://longbridge.com/zh-HK/news/275698481.md) |
| RWD and RWE are rewriting how we design and run trials | RWD and RWE are transforming clinical trial design, making it more efficient and effective. Traditional randomized contr | [Link](https://longbridge.com/zh-HK/news/275460359.md) |

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