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Immune checkpoint inhibitor 'Camrelizumab' by Chinese company Hansoh Pharmaceutical

[Asia Economy Reporter Lee Chun-hee] Camrelizumab, an immune checkpoint inhibitor developed by China’s Hansoh Pharmaceutical (Hengrui Pharmaceuticals), is rapidly emerging as a new immuno-oncology drug, achieving remarkable results in various combination therapies. In South Korea, attention is also focused on CrystalGenomics, the sole importer of Camrelizumab technology, amid expectations for collaboration with HLB.

Camrelizumab is an immune checkpoint inhibitor targeting PD-1. In China, it was approved in 2019 as a third-line treatment for classical Hodgkin lymphoma (cHL), followed by approval in 2020 as a first-line treatment for non-small cell lung cancer. Since then, it has received indications for first- or second-line treatment of esophageal cancer and liver cancer. Currently, approval from the U.S. Food and Drug Administration (FDA) is underway, and last year it was designated as an orphan drug (ODD) for hepatocellular carcinoma by the FDA.

At the European Society for Medical Oncology (ESMO) 2022 held in Paris, France last September, the Phase 3 clinical trial results of HLB's 'Lenvatinib' and Hansoh Pharmaceutical's 'Camrelizumab' combination for hepatocellular carcinoma were announced. (Photo by HLB)

In South Korea, the combination therapy of Camrelizumab with HLB’s Lenvatinib for hepatocellular carcinoma has drawn significant attention due to its innovative outcomes. Hansoh Pharmaceutical, which acquired the Chinese rights for Lenvatinib, announced clinical results from a Phase 3 trial combining Lenvatinib and Camrelizumab, showing a median overall survival (mOS) of 22.1 months. This is a substantial improvement compared to the control group treated with Bayer’s Nexavar (active ingredient Sorafenib), which had an mOS of 15.2 months, and it is the only successful clinical trial to date with an mOS exceeding 20 months. Additionally, median progression-free survival (mPFS) and objective response rate (ORR) also demonstrated superior efficacy compared to the control group.

Moreover, in the already approved combination therapy of Pemetrexed and Carboplatin for non-squamous non-small cell lung cancer in China, Camrelizumab showed significant results compared to the major existing immuno-oncology drug Keytruda. The Camrelizumab combination group exhibited an ORR of 60.5%, whereas the Keytruda combination group showed an ORR of 48%. Indirect comparisons suggest that Camrelizumab outperformed Keytruda in the Pemetrexed and Carboplatin combination therapy.

This is why there is growing expectation that Camrelizumab could establish itself as a new leader in the immuno-oncology market, which has been dominated by Keytruda and Opdivo. Hansoh Pharmaceutical anticipates Camrelizumab’s sales to reach $1.944 billion (approximately KRW 2.776 trillion) next year, growing further to $2.793 billion (approximately KRW 3.988 trillion) by 2026.

CrystalGenomics logo (Photo by CrystalGenomics)

In South Korea, the domestic rights to Camrelizumab are held by CrystalGenomics. In 2020, CrystalGenomics exclusively acquired the rights to Camrelizumab in Korea with an upfront payment of $1.5 million (approximately KRW 2.1 billion) and a total contract value of $87.75 million (approximately KRW 125.2 billion). This is the only technology export contract for Camrelizumab that Hansoh Pharmaceutical has signed to date, representing a successful early acquisition before Camrelizumab rose to prominence. The value of the Camrelizumab rights has reportedly surged recently due to successive positive outcomes in combination therapies.

CrystalGenomics applied for clinical trial approval (IND) from the Korean Ministry of Food and Drug Safety last September for a bridging study aimed at obtaining domestic approval for the Pemetrexed and Carboplatin combination therapy for non-small cell lung cancer. The company plans to expand indications to various cancer types in consideration of ongoing development progress.

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