CrystalGenomics Receives Approval for Bridge Clinical Trial Plan Combining 'Camrelizumab'

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[Asia Economy Reporter Lee Chun-hee] CrystalGenomics announced on the 21st that its bridging clinical trial plan (IND) to evaluate the efficacy and safety for approval of the first-line treatment for non-small cell lung cancer (NSCLC), 'Camrelizumab,' in combination with pemetrexed and carboplatin, has been approved by the Ministry of Food and Drug Safety.

A bridging study refers to the final stage of clinical trials conducted to obtain domestic approval for drugs already approved overseas by evaluating whether there are ethnic sensitivity differences in the local population. The study will analyze objective response rate (ORR), progression-free survival (PFS), and other outcomes by administering Camrelizumab in combination with pemetrexed and carboplatin to 60 patients with advanced or metastatic non-squamous non-small cell lung cancer, assessing whether the drug's efficacy and safety differ significantly between Koreans and Chinese. The Camrelizumab administration schedule consists of a 3-week cycle, with 200 mg administered intravenously on day 1 of each cycle. The combination therapy of Camrelizumab, pemetrexed, and carboplatin for non-squamous non-small cell lung cancer was previously approved in China with an ORR of 60.5%.

CrystalGenomics holds exclusive rights for clinical development and sales of Camrelizumab, either as monotherapy or in combination therapies, for all cancer types including lung, liver, and stomach cancers in South Korea.

Camrelizumab (brand name Ailuika) is an immune checkpoint inhibitor targeting PD-1. The original developer, Hansoh Pharmaceutical, forecasts sales of $1.944 billion (approximately KRW 2.5124 trillion) this year. It is expected to grow at an average annual rate of 13.8%, reaching $2.793 billion (approximately KRW 3.6225 trillion) by 2026, ranking third in sales in the immune checkpoint inhibitor market after Keytruda and Opdivo.

A CrystalGenomics official stated, "Considering that the domestic immune checkpoint inhibitor market is about KRW 500 billion in size, we are targeting a market share of over 20% (approximately KRW 100 billion)."