The scope of domestic new drug treatments is rapidly expanding. From cell and gene therapies to radiopharmaceuticals, the South Korean pharmaceutical and biotech industry is shifting towards advanced biotechnological foundations.
According to the Ministry of Food and Drug Safety on May 10, Curocell's chimeric antigen receptor T-cell (CAR-T) therapy, Limcato (active ingredient: anbalcaptagen autoleucel), and FutureChem's diagnostic radiopharmaceutical, Prostavu injection (active ingredient: florastamin (18F)), have each received approval as the 42nd and 43rd domestic new drugs, respectively.
Limcato is the first CAR-T therapy developed in South Korea, designed to genetically modify a patient's immune cells to selectively attack cancer cells, making it a personalized autologous T-cell immunotherapy.
Previously, CAR-T treatments in South Korea relied on overseas production. Major therapies like Novartis' Kymriah and Gilead Sciences' Yescarta required sending patient cells to foreign manufacturing facilities, resulting in lengthy treatment times and costs around 300 million won.
Limcato has shifted this production model to a domestic basis. With the entire manufacturing and supply process conducted within South Korea, it is expected to improve treatment timelines and supply stability. By producing directly at the Daejeon Dungok district facility, the waiting period for overseas products, which can take 4 to 6 weeks, has been reduced to about 2 weeks.
In terms of efficacy, clinical trial results from Phase 2 showed that Limcato achieved a complete response rate (the percentage of patients with no detectable cancer cells) of 67.1%, compared to approximately 40% for Kymriah and about 54% for Yescarta.
The 43rd new drug, Prostavu injection, is a radiopharmaceutical for diagnosing prostate cancer developed by FutureChem. It selectively binds to prostate-specific membrane antigen (PSMA) to detect lesions, enhancing accuracy compared to existing imaging diagnostics.
In a domestic Phase 3 clinical trial involving patients suspected of recurrence or metastasis of prostate cancer, the diagnostic accuracy (positive predictive value of 86%) demonstrated global competitiveness, surpassing the leading global prostate cancer diagnostic agent, Pillarify, which has an 81.9% accuracy rate.
FutureChem is also developing a therapeutic agent, FC705, alongside its diagnostic product. This expansion into both diagnostic and therapeutic areas signifies a meaningful advancement for domestic new drugs.
Looking ahead, Hanmi Pharmaceutical's obesity treatment, epeglanatide, is highlighted as a promising candidate among upcoming domestic new drugs. This is the first glucagon-like peptide-1 (GLP-1) class treatment independently developed by Hanmi, with plans for release in the second half of this year.
Hanmi aims to enter the market by leveraging price competitiveness and domestic production capabilities. By ensuring supply stability through its Pyeongtaek bioplant and employing a tailored strategy based on data from Korean patients, the company seeks to differentiate itself. In clinical trials, it demonstrated a weight loss rate of approximately 8.13% compared to a placebo, similar to the 8.5% weight loss efficacy of Wegovy.
Industry experts note that the trend in domestic new drug development is increasingly moving towards advanced biotechnological fields. One industry representative stated, "Domestic new drugs are expanding into areas with high technological barriers, shifting from a chemical-centric model to a structure that can expect profitability, thereby transforming the industry landscape."
* This article has been translated by AI.
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