
The official website of the Drug Clinical Trial Registration and Information Disclosure Platform shows that Qilu Pharmaceutical registered aA Phase III Clinical Study Comparing QL2107 or Keytruda® in Combination with Chemotherapy for the Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer(QL2107-301, Registration No.: CTR20244826)。Source:Drug Clinical Trial Registration and Information Disclosure PlatformQL2107-301 is a randomized, double-blind, multi-center Phase III clinical study designed to compare the efficacy similarity, safety, immunogenicity, and effectiveness of QL2107, a pembrolizumab biosimilar, or Keytruda®, each in combination with pemetrexed and carboplatin as first-line treatments for metastatic non-squamous non-small cell lung cancer.The study plans to enroll 464 subjects, with the primary endpoint being the Independent Radiology Review Committee.(IRC)AssessmentObjective Response Rate at 18 Weeks, secondary endpoints include progression-free survival, disease control rate, and duration of response, etc.Pembrolizumab(K Drug)Developed by Merck, this PD-1 monoclonal antibody has seen skyrocketing sales since its launch in September 2014. In 2023, its total annual sales reached $25.011 billion, surpassing Humira to claim the top spot as the best-selling drug. In the first three quarters of 2024, the product generated $21.6 billion in sales, with an estimated annual total exceeding $29 billion.
Source:Insight Database
According to the Insight database,There are 4 biosimilar drugs of Pembrolizumab in China.Research, respectively from Qilu Pharmaceutical(QL2107), Bio-Thera(BAT3306), Fuhong Hanlin(HLX17)and Zhangjiang Bio(CMAB820)Among them, BAT3306 is currently conducting a global multi-center Phase I/III clinical trial aimed at evaluating the PK similarity and clinical equivalence of BAT3306 with Keytruda in patients with advanced non-squamous non-small cell lung cancer. HLX17 was approved for clinical trials in September this year.Cover Source:Corporate Logo
Disclaimer:This article is for information sharing only and does not represent the position or viewpoint of Insight. It also does not recommend or introduce any treatment plans. If necessary, please consult and contact正规医疗机构.
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