Several major companies bucked the downturn, supported by news of a drug launch, development financing and a manufacturing contract.
SK Biopharmaceuticals’ epilepsy drug Xcopri entered the Korean market with national health insurance coverage. GC Biopharma secured KRW 170 billion to advance its subcutaneous immunoglobulin program, while Samsung Biologics signed a KRW 434.3 billion manufacturing agreement that brought its cumulative contract value since inception to $22.3 billion.
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◇SK Biopharma Brings Xcopri to Its Home Market
Xcopri, the epilepsy treatment developed by SK Biopharmaceuticals, has launched in South Korea with national health insurance coverage, expanding treatment options for patients whose seizures remain inadequately controlled by existing medications.
According to KG Zeroin’s MP DOCTOR market data service, SK Biopharmaceuticals closed at KRW 79,200, up KRW 1,700, or 2.19%, from the previous session.
Dong-A ST, which handles domestic sales, announced the launch of Xcopri tablets on November 2. The drug received Korean regulatory approval last November as the country’s 41st domestically developed novel drug.
Xcopri is approved as an add-on treatment for adults with inadequately controlled focal-onset seizures, including those that spread to both sides of the brain and develop into bilateral tonic-clonic seizures.
An estimated 360,000 people receive treatment for epilepsy in South Korea. Around 30% of patients with epilepsy are reported to continue experiencing seizures despite adequate drug treatment. Unpredictable seizures can cause injuries and disrupt education and employment, making seizure freedom a major treatment goal.
Xcopri has a dual mechanism of action that reduces excessive neuronal activity while strengthening inhibitory signaling. It is taken once daily, with the dose gradually increased according to the patient’s condition.
Clinical trials demonstrated that some patients whose seizures had persisted despite existing treatments achieved seizure freedom. In Study 017, which enrolled 437 adults with focal-onset seizures, 11% of patients in the 200 mg group and 21% in the 400 mg group remained seizure-free during the 12-week maintenance period, compared with 1% in the placebo group.
In Study 035, an Asian Phase 3 trial involving 519 patients in South Korea, China and Japan, seizure-freedom rates during the six-week maintenance period were 30.1% in the 200 mg group and 52.4% in the 400 mg group, versus 2.6% with placebo.
National health insurance coverage is expected to reduce patients’ out-of-pocket costs and improve access.
“We hope Xcopri will establish itself as a new treatment option for people with epilepsy,” a Dong-A ST spokesperson said. “We will work to help patients reduce the disruption seizures cause in their daily lives and maintain consistent treatment.”
SK Biopharmaceuticals signed a licensing agreement with Dong-A ST in January 2024 covering 30 countries, including South Korea. Dong-A ST is responsible for regulatory approvals, sales and finished-product manufacturing in those markets. The Korean launch marks a commercial milestone in that partnership.
◇GC Biopharma Secures KRW 170 Billion for U.S. Immunoglobulin Push
GC Biopharma has secured KRW 170 billion to develop a subcutaneous immunoglobulin, or SCIG, product. The company plans to expand its U.S. immunoglobulin portfolio beyond its intravenous treatment Alyglo with a formulation that patients can self-administer.
The funding will support a global Phase 3 trial and investment in manufacturing facilities.
GC Biopharma shares closed at KRW 136,400, up KRW 2,500, or 1.87%.
The company said it was selected on October 29 for support under South Korea’s National Growth Fund. The financing will back its 20% concentration SCIG program, with a submission to the U.S. Food and Drug Administration planned next year to initiate a Phase 3 trial.
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The financing provides resources for both late-stage development and manufacturing capacity as GC Biopharma prepares for a potential U.S. launch.
The National Growth Fund is a public-private financing program designed to support strategic industries, including biotechnology, artificial intelligence, semiconductors and rechargeable batteries. Its biotechnology investments include drug development programs at the global Phase 3 stage.
GC Biopharma aims to serve a broader range of patient needs by offering both intravenous and subcutaneous immunoglobulin products.
Alyglo received FDA approval in 2023 and generated more than $100 million in exports last year. The company is positioning SCIG as a further source of growth following Alyglo’s entry into the U.S. market.
SCIG is administered beneath the skin and can be self-administered by patients. According to GC Biopharma, three 20% concentration SCIG products are currently marketed in the United States. The company plans to advance clinical development alongside investment in production facilities.
“By adding 20% SCIG to Alyglo, we will complete an immunoglobulin portfolio spanning both intravenous and subcutaneous administration,” GC Biopharma CEO Huh Eun-chul said.
◇Samsung Biologics Adds KRW 434.3 Billion Manufacturing Contract
Samsung Biologics has secured a KRW 434.3 billion contract to manufacture medicines for a global pharmaceutical company. The agreement is equivalent to nearly 10% of its previous year’s consolidated revenue and brings its cumulative contract value since inception to $22.3 billion.
Shares closed at KRW 1,437,000, up KRW 15,000, or 1.05%, from the previous session.
In a regulatory filing on November 3, Samsung Biologics said it signed the $324.8 million agreement on November 2. The contract is valued at KRW 434.3 billion, equivalent to 9.53% of the company’s previous-year consolidated revenue of KRW 4.557 trillion.
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The agreement runs from the signing date through December 31, 2031, adding to the company’s long-term manufacturing commitments. The end date may be adjusted by mutual agreement.
The customer’s identity was withheld for business confidentiality. The contract includes no signing or advance payment, while payment terms and supply markets were also undisclosed.
The latest deal brings the number of contracts Samsung Biologics has disclosed this year to nine, as the company continues to expand its manufacturing business with global pharmaceutical customers.
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