[Jiwan Kim, Edaily Reporter] Most South Korean pharmaceutical and biotech stocks fell on November 3 as a broad market sell-off weighed on the sector. The pharmaceutical index edged up 0.03%, but declining stocks outnumbered gainers 124 to 27 among its 161 constituents. The life sciences index fell 1.68%, with 75 of its 92 stocks closing lower.

Several major companies bucked the downturn, buoyed 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 170 billion KRW to advance its subcutaneous immunoglobulin program, while Samsung Biologics signed a 434.3 billion KRW manufacturing agreement, bringing its cumulative contract value since inception to $22.3 billion.

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 79,200 KRW, up 1,700 KRW, 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. Approximately 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 enhancing inhibitory signaling. It is taken once daily, with the dose gradually increased based on 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, compared with 2.6% in the placebo group.

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 launch in Korea marks a commercial milestone in that partnership.

GC Biopharma Secures 170 Billion KRW for U.S. Immunoglobulin Push

GC Biopharma has secured 170 billion KRW to develop a subcutaneous immunoglobulin (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 136,400 won, up 2,500 won, or 1.87%.

The company announced on October 29 that it had been selected to receive support from South Korea’s National Growth Fund. The funding will support its 20% concentration SCIG program, with a submission to the U.S. Food and Drug Administration planned for next year to initiate a Phase 3 trial.

The funding 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 address 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 subcutaneously and can be self-administered by patients. According to GC Biopharma, three SCIG products with a 20% concentration are currently marketed in the United States. The company plans to advance clinical development while investing in production facilities.

“By adding 20% SCIG to Alyglo, we will complete an immunoglobulin portfolio that spans both intravenous and subcutaneous administration,” said GC Biopharma CEO Huh Eun-chul.

Samsung Biologics Secures 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 consolidated revenue from the previous year 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 announced that it had 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’s consolidated revenue of KRW 4.557 trillion.

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 reasons. The contract includes no signing or advance payment, and payment terms and supply markets were also not disclosed.

This 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.