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中国生物制药旗下南京正大天晴NTQ1062完成Ⅲ期临床首例患者入组给药

  • 2026-04-05 17:21:48
中国生物制药旗下南京正大天晴NTQ1062完成Ⅲ期临床首例患者入组给药

近日,中国生物制药(1177.HK)旗下成员企业南京正大天晴宣布,其自主研发的1类新药NTQ1062的Ⅲ期临床研究于哈尔滨医科大学附属肿瘤医院顺利完成首例受试者入组给药,用于联合氟维司群治疗内分泌耐药的HR+/HER2-乳腺癌的治疗,将为二线及以后HR+/HER2-晚期乳腺癌患者带来新的治疗选择。

PI3K/Akt/mTOR(PAM)信号通路突变在乳腺癌中很常见,其中PIK3CA突变约占30%-40%[1], AKT1激活突变和PTEN失活突变在全球研究中的发生率分别为3%和5%[2],在中国患者中AKT1激活突变率相对更高,约为3.6%-6.3%[3-4]。PAM信号通路在多种癌症中被异常激活,可增强肿瘤细胞的增殖、生长以及对化疗、免疫治疗药物的抵抗[5]。针对PAM通路抑制剂的研发是HR+/HER2-晚期乳腺癌治疗的重要里程碑,多项临床研究证实PAM通路抑制剂用于乳腺癌的疗效。

NTQ1062为南京正大天晴自主开发的泛AKT小分子抑制,临床前药理实验显示其对Akt1、Akt2及Akt3的活性均具有抑制作用,既往临床研究(CTR20211999和CTR20233816)提示该品种具有潜在的抗肿瘤疗效,相关临床数据将在2026年年中披露。AKT作为PI3K/AKT/mTOR信号通路的关键分子,激活后可磷酸化细胞核和细胞质中诸多靶点并激活多个具有调控细胞增殖功能的下游底物,从而促进肿瘤细胞生长、增殖和血管生成,同时AKT过度激活与HR阳性乳腺癌的内分泌抵抗密切相关[6]

本次启动的NTQ1062临床研究(CTR20254562)是一项随机、双盲、氟维司群单药对照的Ⅲ期临床试验,旨在评估NTQ1062联合氟维司群对比安慰剂联合氟维司群治疗内分泌治疗耐药的HR+/HER2-且PAM通路改变的局部晚期(不可手术)或转移性乳腺癌的疗效和安全性。研究计划纳入210例患者,主要终点为由研究者依据 RECIST v1.1 评估的无进展生存期(PFS)。

乳腺癌是全球女性中发病率最高的恶性肿瘤之一,其中HR+/HER2-亚型约占70%[7],CDK4/6抑制剂联合内分泌治疗已成为其一线治疗标准方案,但随着治疗的持续,多数患者会出现获得性耐药[8,9],二线及后线患者存在巨大未满足临床需求。随着乳腺癌精准治疗的发展,NCCN/CSCO指南均推荐CDK4/6抑制剂经治后患者按通路突变的不同进行后线治疗,PAM通路改变优先选择PI3Ka/AKT/mTOR抑制剂联合内分泌治疗[10,11]。公司将加速推进NTQ1062的临床开发,为二线及以后HR+/HER2-乳腺癌患者带来新的治疗选择。

参考文献:

[1] 中国乳腺癌PIK3CA检测专家共识. 中华病理学杂志. 2025;54(2):120-125.

[2] Andrikopoulou A, Chatzinikolaou S, Panourgias E, et al. The emerging role of capivasertib in breast cancer[J]. Breast, 2022, 63: 157-167. DOI: 10.1016/j. breast. 2022. 03.018.

[3] Jiang YZ, Ma D, Jin X, et al. Integrated multiomic profiling of breast cancer in the Chinese population reveals patient stratification and therapeutic vulnerabilities[J]. Nat Cancer, 2024, 5(4):673-690. DOI:10.1038/s43018-024-00725-0.

[4] Deng L, Zhu XH, Sun Y, et al. Prevalence and prognostic role of PIK3CA/AKT1 mutations in chinese breast cancer patients[J]. Cancer Res Treat, 2019, 51(1): 128-140. DOI: 10.4143/crt.2017.598.

[5] DAVOODI-MOGHADDAM Z,JAFARI-RADDANI F,DELSHAD M,et al. Inhibitors of the PI3K/AKT/mTOR pathway in human malignancies: trend of current clinical trials[J]. J Cancer Res Clin Oncol,2023,149(16):15293-15310.

[6] Manning BD, Toker A. AKT/PKB Signaling: Navigating the Network. Cell. 2017 Apr 20;169(3):381-405.

[7]Howlader N, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst 106 (2014).

[8] Gerosa R, et al. Cyclin-dependent kinase 2 (CDK2) inhibitors and others novel CDK inhibitors (CDKi) in breast cancer: clinical trials, current impact, and future directions. Crit Rev Oncol Hematol  196, 104324 (2024).

[9] Freeman-Cook K, et al. Expanding control of the tumor cell cycle with a CDK2/4/6 inhibitor. Cancer Cell  39, 1404-21. e11  (2021).

[10] National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Breast Cancer (Version 5.2025)[S]. Plymouth: NCCN, 2025.

[11] 中国临床肿瘤学会乳腺癌专家委员会. 中国临床肿瘤学会(CSCO)乳腺癌诊疗指南(2025年版)[S]. 北京: 人民卫生出版社, 2025.

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声明

1. 本新闻稿旨在促进医药信息的沟通和交流,仅供医疗卫生专业人士参阅,非广告用途。

2. 本公司不对任何药品和/或适应症作推荐。

3. 本新闻稿中涉及的信息仅供参考,不能以任何方式取代专业的医疗指导,也不应被视为诊疗建议。若您想了解具体疾病诊疗信息,请遵从医生或其他医疗卫生专业人士的意见或指导。

前瞻性声明:

本新闻稿中包含若干前瞻性陈述,包括有关【NTQ1062】的临床开发计划、临床获益与优势的预期、商业化展望、患者临床获益可能性,以及潜在商业机会等声明。“预期”、“相信”、“继续”、“可能”、“估计”、“期望”、“有望”、“打算”、“计划”、“潜在”、“预测”、“预计”、“应该”、“将”、“拟”、“会”和类似表达旨在识别前瞻性陈述,但并非所有前瞻性陈述都包含这些识别词。这些前瞻性陈述为公司基于当前所掌握的数据和信息所做的预测或期望,可能因受到政策、研发、市场及监管等不确定因素或风险的影响,而导致实际结果与前瞻性陈述有重大差异。请现有或潜在的投资者审慎考虑可能存在的风险,并不可完全依赖本新闻稿中的前瞻性陈述,该等陈述包含信息仅及于本新闻稿发布当日。除非法律要求,本公司无义务因新信息、未来事件或其他情况而对本新闻稿中任何前瞻性陈述进行更新或修改。

信息来源:南京正大天晴制药有限公司

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  1. CONNECT:[ UseTime:0.000609s ] mysql:host=127.0.0.1;port=3306;dbname=b460;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.000892s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000337s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.001287s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.000557s ]
  6. SELECT * FROM `set` [ RunTime:0.000223s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.000574s ]
  8. SELECT * FROM `article` WHERE `id` = 502496 LIMIT 1 [ RunTime:0.000421s ]
  9. UPDATE `article` SET `lasttime` = 1775751850 WHERE `id` = 502496 [ RunTime:0.018122s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 65 LIMIT 1 [ RunTime:0.000281s ]
  11. SELECT * FROM `article` WHERE `id` < 502496 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.000522s ]
  12. SELECT * FROM `article` WHERE `id` > 502496 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.005940s ]
  13. SELECT * FROM `article` WHERE `id` < 502496 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.001412s ]
  14. SELECT * FROM `article` WHERE `id` < 502496 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.000903s ]
  15. SELECT * FROM `article` WHERE `id` < 502496 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.002886s ]
0.108746s