[Edaily Reporter Minji Son ] During the first week of September (August 31–September 4), in the pharmaceutical and biotech industry, Curocell Inc.(372320)’s “Limcato,” Korea’s first domestically developed chimeric antigen receptor T-cell (CAR-T) therapy, cleared a key hurdle toward inclusion in the national health insurance coverage. Yuhan(000100)signed an active pharmaceutical ingredient (API) supply contract with a global pharmaceutical company, bringing its total API orders for the year to nearly 400 billion won.

Will Curocell Inc.’s ‘Limcato’ Be Listed on the National Health Insurance Program This Year? Curocell

Inc.’s CAR-T therapy

‘Limcato’

cleared the hurdle set by the Health Insurance Review and Assessment Service’s (HIRA) Drug Reimbursement Evaluation Committee on the 3rd. It was recognized as a treatment eligible for national health insurance coverage on the condition that the company accepts the price proposed by HIRA.

Limkato is a treatment for blood cancer patients whose cancer has recurred or who have seen little response despite undergoing multiple rounds of anticancer therapy. The treatment involves extracting the patient’s T cells—which are immune cells—genetically modifying them to attack cancer cells, and then reintroducing them into the body. Last April, it became the first CAR-T therapy developed independently by a Korean company to receive marketing authorization from the Ministry of Food and Drug Safety.

In Phase 2 clinical trials, approximately 7 out of 10 patients showed a reduction in tumor size. The objective response rate (ORR) was 75.3%, and the complete remission (CR) rate—where the cancer became undetectable—was 67.1%. Among the major side effects of CAR-T therapy—cytokine release syndrome (CRS) and neurotoxicity (NE)—the incidence of severe events (Grade 3 or higher) was 8.9% and 3.8%, respectively.

Passing this review does not mean the treatment will immediately be covered by health insurance. Future steps include negotiating the actual drug price with the National Health Insurance Service and obtaining approval from the Health Insurance Policy Deliberation Committee. If Curocell Inc. accepts HIRA’s assessed price and the subsequent procedures proceed quickly, it is expected that the drug could be added to the list of covered treatments within the year.

Since CAR-T therapies must be custom-made for each patient, treatment costs can reach hundreds of millions of won. Without health insurance coverage, it is difficult for patients to opt for the treatment, and pharmaceutical companies also face limitations in expanding prescriptions. This is why Limkato’s approval by the Drug Evaluation Committee is viewed as a significant achievement that increases the likelihood of substantial sales.

Yuhan Corporation’s API Supply Contracts Approach 400 Billion Won This Year

Yuhan Corporation announced on the 1st that it had signed an API supply contract worth $95,424,000 (approximately 131.1 billion won) with a global pharmaceutical company. The contract value represents 6.0% of the company’s consolidated revenue for last year (2.1866 trillion won).

API refers to active pharmaceutical ingredients, which are the core components that produce the therapeutic effects in finished pharmaceutical products. Under this arrangement, Yuhan produces the raw materials and supplies them to global pharmaceutical companies, which then use them to manufacture finished pharmaceutical products. The identity of the contracting party and the specific products to be supplied were not disclosed due to confidentiality clauses.

The contract term is approximately 1 year and 9 months, running from this month through the end of May 2028. With this contract, Yuhan Corporation has secured an additional source of export volume over a relatively long period. It is also noteworthy that this is a contract based on the actual supply of products, rather than a technology fee whose payment depends on the progress of new drug development.

API orders are also piling up rapidly this year. Following the consecutive signing of supply contracts worth 55.9 billion won and 210.1 billion won last May, Yuhan Corporation has secured this latest contract, bringing its cumulative order value for the year to approximately 397 billion won. This figure has already surpassed last year’s total annual order volume.

Through the technology export of “Lecraza,” a new lung cancer drug, Yuhan Corporation is expanding its position as an innovative drug developer, while simultaneously securing steady revenue in its API business as a supplier supporting the production of pharmaceuticals for global pharmaceutical companies. As the number of supply contracts—which generate revenue over the long term—increases alongside revenue sources with high volatility, such as royalties from new drugs, the company’s business stability is expected to improve.