Chinese Immune Checkpoint Inhibitor Gains Another Approval in South Korea; Domestic Firms Lag

A second immune checkpoint inhibitor developed by a Chinese biopharmaceutical company has gained regulatory approval in South Korea, signaling a growing presence of Chinese firms in the global immuno-oncology market. The drug, 'Surufimab' (surufalimab), imported by Alvogen Korea, received approval from the Ministry of Food and Drug Safety on July 1st. This follows the approval of another Chinese-developed PD-1 inhibitor, 'Tevimbra' (tislelizumab), in 2023.

Immune checkpoint inhibitors are a class of immuno-oncology drugs that work by blocking specific proteins like PD-1, PD-L1, and CTLA-4, which cancer cells use to evade the immune system. This mechanism helps restore the T-cells' ability to fight cancer. While South Korea has approved several immune checkpoint inhibitors since 2014, including prominent drugs developed by major Western pharmaceutical companies, all previously approved treatments were developed internationally.

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It's not that domestic companies lack capability, but rather that development has been significantly delayed. There isn't enough clinical data accumulated yet to secure approval.

Industry analysts suggest that the rapid advancement of Chinese biopharmaceutical companies is driven by factors beyond just technological prowess. They point to accelerated development timelines, faster clinical trial progression, and robust investment environments as key competitive advantages. Chinese firms have reportedly streamlined the entire process, from antibody discovery to clinical trials and data acquisition, enabling them to quickly build global competitiveness.

South Korean companies are also developing their own immune checkpoint inhibitors, with companies like ImmuneOncia and Y-Biologics conducting clinical trials for their respective PD-L1 and PD-1 inhibitors. However, the market is increasingly dominated by PD-1 and PD-L1 therapies, prompting domestic firms to diversify their strategies toward next-generation targets such as LAG-3, TIGIT, and 4-1BB, as well as bispecific antibody platforms. The primary challenge cited for the delayed commercialization of domestic drugs is insufficient investment in clinical stages, hindering the ability to secure necessary funding for large-scale trials.

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China's speed in entering clinical trials and securing data is very fast, and they are enhancing competitiveness through technology transfer based on this data. The most difficult part right now is for bio-ventures trying to enter the clinical stage, so substantial funding support for clinical trials is needed for companies to secure proof-of-concept data and achieve global competitiveness.