我国创新药研究新进展

王雨杭 ,  狄斌 ,  杨勇 ,  江程

中国药科大学学报 ›› 2026, Vol. 57 ›› Issue (3) : 275 -287.

PDF (728KB)
中国药科大学学报 ›› 2026, Vol. 57 ›› Issue (3) : 275 -287. DOI: 10.11665/j.issn.1000−5048.2026042802
特邀专稿

我国创新药研究新进展

作者信息 +

Progress of innovative drug research in China

Author information +
文章历史 +
PDF (744K)

摘要

近年来,我国新药研发能力显著增强,越来越多的国产新药获批上市,在肿瘤、自身免疫性疾病、代谢性疾病等多个治疗领域取得重要突破,初步形成了与进口药物同台竞争,并逐步开拓国际市场的良好局面。本文系统回顾了2023—2024 年间我国1类创新药的最新研发进展,按疾病治疗领域分类梳理代表性获批药物的临床优势及特点,深入分析我国创新药的发展态势及现实挑战,探讨其未来发展方向,旨在为我国创新药的研究、产业发展及政策制定提供参考。

Abstract

In recent years, China’s capacity for new drug research and development has been significantly strengthened, with major breakthroughs across multiple therapeutic areas, including cancer, autoimmune diseases, and metabolic disorders. An increasing number of domestically developed innovative drugs have been approved for marketing, gradually establishing a competitive position against imported drugs and expanding into global markets. This article systematically reviews the latest research progress of Class 1 innovative drugs in China from 2023 to 2024, categorizes representative approved drugs by therapeutic area, summarizes the clinical advantages and characteristics of representative drugs approved, analyzes in depth the current development trends of and challenges for China’s innovative pharmaceutical industry, and explores future directions, aiming to provide some reference for innovative drug research, industrial development, and policy-making in China.

关键词

创新药 / 新药研发 / 化学药 / 生物制品

Key words

innovative drugs / new drug research and development / chemical drugs / biological products

引用本文

引用格式 ▾
王雨杭,狄斌,杨勇,江程. 我国创新药研究新进展[J]. 中国药科大学学报, 2026, 57(3): 275-287 DOI:10.11665/j.issn.1000−5048.2026042802

登录浏览全文

4963

注册一个新账户 忘记密码

参考文献

[1]

Chouaid C, Danson S, Andreas S, et al. Adjuvant treatment patterns and outcomes in patients with stage IB—IIIA non—small cell lung cancer in France, Germany, and the United Kingdom based on the LuCaBIS burden of illness study[J]. Lung Cancer, 2018, 124: 310-316.

[2]

Borgeaud M, Olivier T, Bar J, et al. Personalized care for patients with EGFR—mutant nonsmall cell lung cancer: navigating early to advanced disease management[J]. CA Cancer J Clin, 2025, 75(5): 387-409.

[3]

Liu SY, Gou LY, Li AN, et al. The unique characteristics of MET exon 14 mutation in Chinese patients with NSCLC[J]. J Thorac Oncol, 2016, 11(9): 1503-1510.

[4]

Yang B, Lee H, Um SW, et al. Incidence of brain metastasis in lung adenocarcinoma at initial diagnosis on the basis of stage and genetic alterations[J]. Lung Cancer, 2019, 129: 28-34.

[5]

Zhou Q, Yu Y, Xing LG, et al. First—line zorifertinib for EGFR—mutant non—small cell lung cancer with central nervous system metastases: the phase 3 EVEREST trial[J]. Med, 2025, 6(1): 100513.

[6]

Lu S, Zhou JY, Jian H, et al. Befotertinib (D—0316) versus icotinib as first—line therapy for patients with EGFR—mutated locally advanced or metastatic non—small—cell lung cancer: a multicentre, open—label, randomised phase 3 study[J]. Lancet Respir Med, 2023, 11(10): 905-915.

[7]

Pan BY, Liang JQ, Shi HC, et al. Epidemiological characteristics and therapeutic advances of EGFR exon 20 insertion mutations in non—small cell lung cancer[J]. Thorac Cancer, 2023, 14(33): 3247-3258.

[8]

Bazhenova L, Girard N, Minchom A, et al. P08.04 comparative clinical outcomes between EGFR Exon20ins and wildtype NSCLC treated with immune checkpoint inhibitors[J]. J Thorac Oncol, 2021, 16(10): S992-S993.

[9]

Wang MZ, Fan Y, Sun ML, et al. Sunvozertinib for patients in China with platinum—pretreated locally advanced or metastatic non—small—cell lung cancer and EGFR exon 20 insertion mutation (WU—KONG6): single—arm, open—label, multicentre, phase 2 trial[J]. Lancet Respir Med, 2024, 12(3): 217-224.

[10]

Haider K, Sharma A, Yar MS, et al. Novel approaches for the development of direct KRAS inhibitors: structural insights and drug design[J]. Expert Opin Drug Discov, 2022, 17(3): 247-257.

[11]

Zhou Q, Meng XJ, Sun LH, et al. Efficacy and safety of KRAS G 12C inhibitor IBI351 monotherapy in patients with advanced NSCLC: results from a phase 2 pivotal study[J]. J Thorac Oncol, 2024, 19(12): 1630-1639.

[12]

Takeuchi K, Soda M, Togashi Y, et al. RET, ROS1 and ALK fusions in lung cancer[J]. Nat Med, 2012, 18(3): 378-381.

[13]

Yang YP, Min J, Yang N, et al. Envonalkib versus crizotinib for treatment—naive ALK—positive non—small cell lung cancer: a randomized, multicenter, open—label, phase III trial[J]. Signal Transduct Target Ther, 2023, 8: 301.

[14]

Li W, Xiong AW, Yang N, et al. Efficacy and safety of taletrectinib in Chinese patients with ROS1+ non—small cell lung cancer: the phase II TRUST—I study[J]. J Clin Oncol, 2024, 42(22): 2660-2670.

[15]

Yu YF, Zhou JY, Li XY, et al. Gumarontinib in patients with non—small—cell lung cancer harbouring MET exon 14 skipping mutations: a multicentre, single—arm, open—label, phase 1b/2 trial[J]. eClinicalMedicine, 2023, 59: 101952.

[16]

Paik PK, Garassino MC, Le XN, et al. Long—term outcomes of tepotinib in patients with MET exon 14 skipping NSCLC from the VISION study[J]. J Clin Oncol, 2023, 41(16_suppl): 9060.

[17]

Zhong TT, Zhang LZ, Huang ZL, et al. Design of a fragment crystallizable—engineered tetravalent bispecific antibody targeting programmed cell death—1 and vascular endothelial growth factor with cooperative biological effects[J]. iScience, 2025, 28(3): 111722.

[18]

Fang W, Zhao Y, Luo Y, et al. Ivonescimab plus chemotherapy in non—small cell lung cancer with EGFR variant: a randomized clinical trial[J]. JAMA, 2024, 332(7): 561-570.

[19]

Xiong AW, Wang L, Chen JH, et al. Ivonescimab versus pembrolizumab for PD—L1—positive non—small cell lung cancer (HARMONi—2): a randomised, double—blind, phase 3 study in China[J]. Lancet, 2025, 405(10481): 839-849.

[20]

Wang J, Zhou CC, Yao WX, et al. Adebrelimab or placebo plus carboplatin and etoposide as first—line treatment for extensive—stage small—cell lung cancer (CAPSTONE—1): a multicentre, randomised, double—blind, placebo—controlled, phase 3 trial[J]. Lancet Oncol, 2022, 23(6): 739-747.

[21]

Wu XH, Chen XJ, Wang K, et al. Benmelstobart (TQB2450) combined with anlotinib hydrochloride capsule in the treatment of advanced, recurrent, or metastatic endometrial cancer: a multicohort, open label, multicenter, phase II clinical trial (TQB2450—II—08)[J]. J Clin Oncol, 2024, 42(16_suppl): 5593.

[22]

Shi YK, Qin XT, Peng XC, et al. Efficacy and safety of KL—A167 in previously treated recurrent or metastatic nasopharyngeal carcinoma: a multicenter, single—arm, phase 2 study[J]. Lancet Reg Health West Pac, 2023, 31: 100617.

[23]

Li GL, Li XF, Yin RT, et al. Phase II study of enlonstobart (SG001), a novel PD—1 inhibitor in patients with PD—L1 positive recurrent/metastatic cervical cancer[J]. Gynecol Oncol, 2024, 191: 165-171.

[24]

Li CR, Zhou KS, Hu YX, et al. Equecabtagene autoleucel in patients with relapsed or refractory multiple myeloma: the FUMANBA—1 nonrandomized clinical trial[J]. JAMA Oncol, 2024, 10(12): 1681.

[25]

Xia ZJ, Leng Y, Fang BJ, et al. Aponermin or placebo in combination with thalidomide and dexamethasone in the treatment of relapsed or refractory multiple myeloma (CPT—MM301): a randomised, double—blinded, placebo—controlled, phase 3 trial[J]. BMC Cancer, 2023, 23(1): 980.

[26]

DeMarsilis A, Reddy N, Boutari C, et al. Pharmacotherapy of type 2 diabetes: an update and future directions[J]. Metabolism, 2022, 137: 155332.

[27]

Dennis JM, Young KG, McGovern AP, et al. Development of a treatment selection algorithm for SGLT2 and DPP—4 inhibitor therapies in people with type 2 diabetes: a retrospective cohort study[J]. Lancet Digit Health, 2022, 4(12): e873-e883.

[28]

Wang Y, Jiang CX, Dong XL, et al. Combination of retagliptin and henagliflozin as add—on therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin: a multicentre, randomized, double—blind, active—controlled, phase 3 trial[J]. Diabetes Obes Metab, 2024, 26(7): 2774-2786.

[29]

Rezki A, Fysekidis M, Chiheb S, et al. Acute and long—term effects of saxagliptin on post—prandial glycemic response in obese patients with impaired glucose tolerance[J]. Nutr Metab Cardiovasc Dis, 2021, 31(4): 1257-1266.

[30]

Gong QH, Zhang P, Wang JP, et al. Morbidity and mortality after lifestyle intervention for people with impaired glucose tolerance: 30—year results of the Da Qing Diabetes Prevention Outcome Study[J]. Lancet Diabetes Endocrinol, 2019, 7(6): 452-461.

[31]

He QH, Cheng ZF, Li YF, et al. A biweekly DPP—4 inhibitor cofrogliptin monotherapy in Chinese patients with impaired glucose tolerance: a phase 2, multicenter, randomized, double—blind, placebo—controlled, parallel—group trial[J]. Diabetes Obes Metab, 2025, 27(2): 965-975.

[32]

Xu MT, Sun K, Xu WJ, et al. Fotagliptin monotherapy with alogliptin as an active comparator in patients with uncontrolled type 2 diabetes mellitus: a randomized, multicenter, double—blind, placebo—controlled, phase 3 trial[J]. BMC Med, 2023, 21(1): 388.

[33]

Gao LL, Cheng ZF, Su BL, et al. Efficacy and safety of janagliflozin as add—on therapy to metformin in Chinese patients with type 2 diabetes inadequately controlled with metformin alone: a multicentre, randomized, double—blind, placebo—controlled, phase 3 trial[J]. Diabetes Obes Metab, 2023, 25(3): 785-795.

[34]

Ji L, Jiang X, Hao Q, et al. Efficacy and safety of janagliflozin monotherapy in Chinese patients with type 2 diabetes mellitus inadequately controlled on diet and exercise: a multicentre, randomized, double—blind, placebo—controlled, Phase 3 trial[J]. Diabetes Obes Metab, 2023, 25(5): 1229-1240.

[35]

Abifadel M, Varret M, Rabès JP, et al. Mutations in PCSK9 cause autosomal dominant hypercholesterolemia[J]. Nat Genet, 2003, 34(2): 154-156.

[36]

Zhang YY, Pei ZH, Chen BJ, et al. Ebronucimab in Chinese patients with hypercholesterolemia: a randomized double—blind placebo—controlled phase 3 trial to evaluate the efficacy and safety of ebronucimab[J]. Pharmacol Res, 2024, 207: 107340.

[37]

Zhao W, Cheng ZF, Ji XY, et al. Efficacy and safety of ongericimab given by prefilled syringe or autoinjector in primary hypercholesterolemia and mixed hyperlipidemia[J]. Nutr Metab Cardiovasc Dis, 2024, 34(9): 2217-2225.

[38]

Liu YH, Xiao SS, Yang HK, et al. Postoperative pain—related outcomes and perioperative pain management in China: a population—based study[J]. Lancet Reg Health West Pac, 2023, 39: 100822.

[39]

Guo XH, Zhang TT, Yuan GH, et al. GABA analogue HSK16149 in Chinese patients with diabetic peripheral neuropathic pain: a phase 3 randomized clinical trial[J]. JAMA Netw Open, 2024, 7(8): e2425614.

[40]

Yan KX, Li FQ, Bi XD, et al. Efficacy and safety of vunakizumab in moderate—to—severe chronic plaque psoriasis: a randomized, double—blind, placebo—controlled phase 3 trial[J]. J Am Acad Dermatol, 2025, 92(1): 92-99.

[41]

Zhang CL, Yan KX, Diao QC, et al. A multicenter, randomized, double—blinded, placebo—controlled, dose—ranging study evaluating the efficacy and safety of vunakizumab in patients with moderate—to—severe plaque psoriasis[J]. J Am Acad Dermatol, 2022, 87(1): 95-102.

[42]

Cai L, Jiang CJ, Zhang GQ, et al. A multicentre randomized double—blind placebo—controlled phase III study of the efficacy and safety of xeligekimab (GR1501) in patients with moderate—to—severe plaque psoriasis[J]. Br J Dermatol, 2024, 191(3): 336-343.

[43]

Zhao Y, Zhang LT, Wu LM, et al. Long—term efficacy and safety of stapokibart for moderate—to—severe atopic dermatitis: 52—week results from a phase 3 trial[J]. Allergy, 2025, 80(5): 1348-1357.

[44]

Shen S, Yan B, Wang M, et al. Stapokibart for severe uncontrolled chronic rhinosinusitis with nasal polyps: the CROWNS—2 randomized clinical trial[J]. JAMA, 2025, 334(11): 962-972.

[45]

Wang FX, Xiao W, Tang YM, et al. Efficacy and safety of SIM0417 (SSD8432) plus ritonavir for COVID—19 treatment: a randomised, double—blind, placebo—controlled, phase 1b trial[J]. Lancet Reg Health West Pac, 2023, 38: 100835.

[46]

Lu HZ, Zhang G, Mao J, et al. Efficacy and safety of GST—HG171 in adult patients with mild to moderate COVID—19: a randomised, double—blind, placebo—controlled phase 2/3 trial[J]. eClinicalMedicine, 2024, 71: 102582.

[47]

Zhan YQ, Lin ZS, Liang JY, et al. Leritrelvir for the treatment of mild or moderate COVID—19 without co—administered ritonavir: a multicentre randomised, double—blind, placebo—controlled phase 3 trial[J]. eClinicalMedicine, 2024, 67: 102359.

[48]

Fan XH, Dai XH, Ling Y, et al. Oral VV116 versus placebo in patients with mild—to—moderate COVID—19 in China: a multicentre, double—blind, phase 3, randomised controlled study[J]. Lancet Infect Dis, 2024, 24(2): 129-139.

[49]

Cao ZJ, Gao WY, Bao H, et al. VV116 versus nirmatrelvir—ritonavir for oral treatment of Covid—19[J]. N Engl J Med, 2023, 388(5): 406-417.

[50]

Tan ND, Miao XP, Liao AJ, et al. Efficacy and safety of keverprazan compared with lansoprazole in the treatment of duodenal ulcer: a phase III, randomized, double—blind, multicenter trial[J]. Clin Transl Gastroenterol, 2023, 14(7): e00602.

[51]

Zhan JH, Xue JH, Wu L, et al. HS—10375, a selective EGFR C797S tyrosine kinase inhibitor, in advanced non—small cell lung cancer[J]. J Transl Med, 2025, 23(1): 628.

AI Summary AI Mindmap
PDF (728KB)

0

访问

0

被引

详细

导航
相关文章

AI思维导图

/