[Edaily Reporter KIM JI-WAN ] On the 3rd, most domestic pharmaceutical and biotech stocks fell in the wake of a sharp market decline. Although the pharmaceutical sector index rose 0.03%, 124 of the 161 listed stocks fell, while only 27 rose. The life sciences sector index fell 1.68%, with 75 of the 92 listed stocks closing lower.

Amid the overall slump in pharmaceutical and biotech stocks, large-cap stocks managed to avoid losses, buoyed by news of new drug launches, fundraising, and new orders.

SK BIOPHARMACEUTICALS has laid the groundwork for expanded prescriptions of its epilepsy treatment “Xcopri” following its domestic launch and inclusion in the national health insurance coverage. GC Biopharma Corp. secured 170 billion won in funding for the development of a subcutaneous immunoglobulin, bolstering its investment in clinical and production facilities for its U.S. market entry. SAMSUNG BIOLOGICS signed a contract manufacturing agreement worth 434.3 billion won with a global pharmaceutical company, bringing its cumulative order volume since its founding to $22.3 billion (29.8931 trillion won).

SK BIOPHARMACEUTICALS’s Excofry Enters the Domestic Market

“Excofry

,

” an epilepsy treatment developed bySK BIOPHARMACEUTICALS(326030)

,

has entered the

domestic

market following its inclusion in the national health insurance coverage. Expectations for increased prescriptions have grown as this opens up new treatment opportunities for patients whose seizures have not been sufficiently controlled by existing medications.

According to KG Zeroin’s MP DOCTOR on that day, SK BIOPHARMACEUTICALS closed at 79,200 won, up 1,700 won (2.19%) from the previous trading day.

Donga ST, which is handling domestic sales, announced on the 2nd that it had launched “Xcopri Tablets” (active ingredient: cenobamate). The product was approved last November as Korea’s 41st domestically developed new drug. It is used as an adjunctive therapy—taken in combination with other medications—for adult patients with partial seizures that are not controlled by existing treatments. It is also indicated for patients with secondary generalized seizures, in which partial seizures spread to the entire brain.

It is estimated that approximately 360,000 patients in South Korea are receiving treatment for epilepsy. It is known that about 30% of epilepsy patients continue to experience seizures even with adequate medication. Seizures that occur without warning increase the risk of injury and can also affect academic performance and employment. This is why “complete seizure freedom”—the absence of seizures—is cited as a primary treatment goal.

Xcopri features a dual mechanism of action that reduces excessive neuronal excitation while simultaneously strengthening the signals that inhibit it. It is taken once daily, with the dosage increased gradually according to the patient’s condition.

Clinical trials confirmed the potential for complete seizure freedom in patients whose seizures were not controlled by existing medications. In “Study 017,” which enrolled 437 adult patients with focal seizures, the proportion of patients who remained seizure-free during the 12-week maintenance period was 11% in the 200 mg group and 21% in the 400 mg group. The placebo group showed a rate of 1%.

In “Study 035,” an Asian Phase 3 clinical trial involving 519 patients from South Korea, China, and Japan, the rate of complete seizure freedom during the 6-week maintenance period was 30.1% in the 200 mg group and 52.4% in the 400 mg group. The placebo group recorded a rate of 2.6%.

With this domestic launch, the drug is covered by national health insurance, which is expected to reduce the financial burden on patients and improve access to treatment. A representative from Donga ST stated, “We hope Excofry will establish itself as a new treatment option for patients with epilepsy,” adding, “We will contribute to helping patients reduce the difficulties in their daily lives caused by seizures and continue stable treatment.”

In January 2024, SK BIOPHARMACEUTICALS signed a technology transfer agreement with Donga ST for Excofry in 30 countries, including South Korea. Under this agreement, Donga ST is responsible for regulatory approval, sales, and the production of finished pharmaceutical products in these regions. With this launch, the collaboration between the two companies has led to their entry into the domestic prescription market.

GC Biopharma Corp. Secures 170 Billion Won… Targets U.S. Market with ‘Self-Administered’ Immunoglobulin

#GC Biopharma Corp. has secured 170 billion won to invest in the development of a subcutaneous immunoglobulin (SCIG). Following the launch of its intravenous product “Aliglo” in the U.S., the company is expanding its market reach with a subcutaneous formulation that patients can administer themselves. The funds will be allocated to global Phase 3 clinical trials and the construction of production facilities.

On that day, GC Biopharma Corp. closed at 136,400 won, up 2,500 won (1.87%) from the previous day.

GC Biopharma Corp. announced today that it was selected on the 29th of last month as a company eligible for support from the National Growth Fund, enabling it to secure 170 billion won in development funding. The investment will be directed toward the 20% high-concentration SCIG. Development is proceeding with the goal of submitting an Investigational New Drug (IND) application for a Phase 3 clinical trial to the U.S. Food and Drug Administration (FDA) next year.

With this funding, the company has secured the resources to simultaneously advance late-stage clinical trials and establish a production infrastructure. The company plans to accelerate clinical development for entry into the U.S. market while also investing in the facilities necessary for future product supply.

The National Growth Fund is a public-private financial program designed to foster national high-tech strategic industries such as biotechnology, artificial intelligence (AI), semiconductors, and rechargeable batteries. In the biotechnology sector, it supports projects such as the development of pharmaceuticals in the global Phase 3 clinical trial stage.

GC Biopharma Corp.’s strategy is to establish a product portfolio covering various administration methods in the U.S. immunoglobulin market. The company plans to meet patient demand based on preferred administration methods by complementing the intravenous AliGlo with the subcutaneous SCIG.

Aliglo received FDA marketing approval in 2023, and its export sales exceeded $100 million last year. Following Aliglo’s entry into the U.S. market, GC Biopharma Corp. is now positioning SCIG as its next growth driver.

SCIG is a formulation administered subcutaneously and is characterized by the fact that patients can self-administer it. According to the company, there are currently three 20% high-concentration SCIG products sold in the U.S. GC Biopharma Corp. plans to prepare for entry into this market by simultaneously developing high-concentration subcutaneous products and investing in production facilities.

Heo Eun-cheol, CEO of GC Biopharma Corp., said, “Following Aliglo, we will secure the 20% SCIG to complete our immunoglobulin portfolio, which encompasses both intravenous and subcutaneous injections.”

SAMSUNG BIOLOGICS Secures Additional Orders

Worth

434.3 Billion Won… Production Contracts Through 2031

SAMSUNG BIOLOGICS(207940)has secured a contract worth 434.

3 billion won

for contract manufacturing of pharmaceuticals from a global pharmaceutical company. The contract represents approximately 10% of last year’s consolidated revenue, bringing the company’s cumulative order value since its founding to $22.3 billion.

SAMSUNG BIOLOGICS closed at 1,437,000 won, up 15,000 won (1.05%) from the previous trading day.

According to a regulatory filing released today, SAMSUNG BIOLOGICS signed a contract worth $324.8 million with a global pharmaceutical company on the 2nd. The amount converted to Korean won is 434.32256 billion won. This represents 9.53% of last year’s consolidated revenue of 4.557 trillion won.

The contract period runs from the date of signing through December 31, 2031. Through this contract, SAMSUNG BIOLOGICS has secured additional long-term production volume. However, the contract’s end date may be adjusted based on future mutual agreement between the two companies.

The name of the client was not disclosed to maintain business confidentiality. There is no separate contract deposit or advance payment, and the payment terms and product supply regions are also confidential.

With this new order, SAMSUNG BIOLOGICS has now announced a total of nine contracts this year. Its cumulative order value since its founding has reached $22.3 billion, and the company continues to expand its manufacturing contracts with global pharmaceutical companies.