CrystalGenomics Applies for Bridging Clinical Trial of Immuno-Oncology Drug 'Camrelizumab'

Proven Efficacy in Non-Small Cell Lung Cancer

[Asia Economy Reporter Lee Gwan-joo] CrystalGenomics announced on the 4th that it has submitted an Investigational New Drug (IND) application for a bridging clinical trial to the Ministry of Food and Drug Safety to evaluate the efficacy and safety for approval purposes of 'Camrelizumab,' a first-line treatment for non-small cell lung cancer (NSCLC), in combination with pemetrexed and carboplatin.

A bridging study refers to the final stage of clinical trials conducted to evaluate and confirm whether there are differences in domestic patients for drugs already approved overseas, in order to obtain approval domestically. Through this bridging study, CrystalGenomics plans to analyze pharmacokinetics (PK), objective response rate (ORR), progression-free survival (PFS), and other factors after administering a combination of camrelizumab, pemetrexed, and carboplatin to 40 patients with advanced or metastatic non-squamous non-small cell lung cancer.

Camrelizumab (brand name Airuika) is an immune checkpoint inhibitor targeting PD-1 developed by China's Hengrui Pharmaceuticals. It was approved by the National Medical Products Administration (NMPA) of China in June 2020 as a first-line treatment for non-small cell lung cancer. The objective response rate of the camrelizumab, pemetrexed, and carboplatin combination therapy approved in China was 60.5%. In comparison, the objective response rate for Merck's Keytruda combined with pemetrexed and carboplatin was 48%.

CrystalGenomics holds exclusive rights for clinical development and sales of camrelizumab, either as monotherapy or combination therapy, for all cancer types including lung, liver, and stomach cancers in South Korea. Additionally, it has received approval for a total of eight indications including esophageal cancer, liver cancer, and Hodgkin lymphoma as first- or second-line treatments, with regulatory procedures underway to expand indications further.

A representative from CrystalGenomics stated, “Camrelizumab has already demonstrated efficacy in non-squamous non-small cell lung cancer, and we expect approval for camrelizumab combination therapy for NSCLC through this bridging clinical trial.” They added, “Considering that the domestic market size for immune checkpoint inhibitors (including reimbursed and non-reimbursed) was approximately 500 billion KRW last year, we aim to increase sales by more than 20% market share (about 100 billion KRW).”

This content was produced with the assistance of AI translation services.