References

How much does it cost to research and develop a new drug? A systematic review and assessment

10.1007/s40273-021-01065-y · 2021 · External reference

10.1038/534314a

10.1038/534314a · External reference

Trends in innovative drug development in China

10.1038/d41573-022-00077-3 · 2022 · External reference

Approvals by the China NMPA in 2024

10.1038/d41573-025-00028-8 · 2025 · External reference

Technological and industrial trends in China’s pharmaceutical sector

10.3389/fphar.2025.1579037 · 2025 · External reference

A multi-dimensional comparative study of 505(b)(2) NDAs approved by FDA and Class 2 NDAs approved by NMPA from 2017 to 2023: uncovering trends, characteristics, and regulation of modified new drugs

10.1016/j.yrtph.2025.105864 · 2025 · External reference

10.1177/17588359241307818

10.1177/17588359241307818 · External reference

Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial

10.1016/s0140-6736(16)32517-x · 2017 · External reference

Efficacy and safety of 4-hydroxy 2-methyl-N-(5-methyl-2-thiazolyl)-2H-1, 2-benzothiazin-3-carboxamide 1, 1-dioxide, a fast-acting meloxicam formulation, on moderate-to-severe pain following abdominal surgery: a phase III randomized controlled trial

10.1111/cts.70081 · 2024 · External reference

Efficacy and safety of abobotulinumtoxinA for the treatment of glabellar lines in Chinese patients: a pivotal, phase 3, randomized, double-blind and open-label phase study

10.1007/s00266-022-03164-3 · 2023 · External reference

Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: a multicenter, randomized, open-label, phase III, non-inferiority trial

10.1097/cm9.0000000000002638 · 2023 · External reference

Efficacy and safety of Xiaoer Chiqiao Qingre syrup in the treatment of pedo-anemopyretic cold with stagnant syndrome in children: a multicenter, randomized, double-blind, double-dummy, parallel, positive-controlled, noninferiority trial

10.1111/jebm.70077 · 2025 · External reference

Reteplase versus alteplase for acute ischaemic stroke within 4.5 hours (RAISE): rationale and design of a multicentre, prospective, randomised, open-label, blinded-endpoint, controlled phase 3 non-inferiority trial

10.1136/svn-2023-003035 · 2024 · External reference

Safety and efficacy of a novel dexmedetomidine nasal spray for pre-anesthetic sedation in children: a randomized, double-blind, placebo-controlled trial

10.1186/s12871-024-02708-1 · 2024 · External reference

Sublingual edaravone dexborneol for the treatment of acute ischemic stroke: the TASTE-SL randomized clinical trial

10.1001/jamaneurol.2023.5716 · 2024 · External reference

Tenecteplase vs alteplase for patients with acute ischemic stroke: the ORIGINAL randomized clinical trial

10.1001/jama.2024.14721 · 2024 · External reference

Current landscape of innovative drug development and regulatory support in China

10.1038/s41392-025-02267-y · 2025 · External reference

The impact of bioequivalence regulation on pharmaceutical firm outcomes: evidence from China

10.1016/j.socscimed.2025.118242 · 2025 · External reference

Considerations on clinical pharmacology studies for improved new chemical drugs

2023 · External reference

Opportunities and challenges in the development of new drugs for syndromes of Chinese medicine

2019 · External reference

Use of real-world evidence for drug regulatory decisions in China: current status and future directions

10.1007/s43441-023-00555-9 · 2023 · External reference