SAMSUNG BIOLOGICS Reports Third-Quarter Revenue of 1.4903 Trillion WonSAMSUNG BIOLOGICS announced on the 21st that it recorded consolidated revenue of 1.4903 trillion won and operating profit of 640.1 billion won in the third quarter of this year. Compared to the same period last year, revenue increased by 18.5% and operating profit by 1.0%. Compared to the previous quarter, they rose by 12.8% and 9.1%, respectively.
Revenue nearing 1.5 trillion won marks a record high for a single quarter. The company also maintained high profitability, with an operating profit margin of approximately 43%.
Revenue growth was driven by the gradual increase in production volume at Plant 5—which began operations last year—while Plants 1 through 4 were operating at full capacity. Results from the Rockville, Maryland, production facility acquired in March of this year were also reflected in this quarter’s earnings for the first time, further bolstering the company’s performance.
Plant 5 has a biopharmaceutical production capacity of 180,000 liters. With Plant 5 now fully operational, SAMSUNG BIOLOGICS’ total production capacity in Songdo has expanded to 785,000 liters. Including the Rockville facility in the U.S., global production capacity reaches 845,000 liters.
Cumulative order intake also reached $22 billion. This is the result of the company continuously securing new and expanded contracts by leveraging its large-scale production capacity and quality competitiveness, as global pharmaceutical companies diversify their drug supply chains.
Reflecting its strong performance, SAMSUNG BIOLOGICS raised its revenue growth forecast for this year from 15–20% year-over-year to 20%. By raising the lower end of its forecast, the company has demonstrated confidence in achieving its annual growth target.
The company is also continuing to expand its global operations, including the recent establishment of a U.S. production hub and the planned acquisition of Polypeptide Group, a contract development and manufacturing organization (CDMO) specializing in peptides. The company plans to conduct a 3 trillion won rights offering to fund the Polypeptide acquisition and investments in additional production facilities.
Once the acquisition of Polypeptide Group is completed, the company’s business scope will expand from its existing antibody drugs and antibody-drug conjugates (ADCs) to include peptide drugs. Peptides are used as key raw materials in obesity and diabetes treatments, a market that has been growing rapidly in recent years.
However, the financial burden resulting from expanded investment and labor-management conflicts remain potential variables. The SAMSUNG BIOLOGICS labor union has decided to postpone the second general strike scheduled to begin on the 26th and resume negotiations with management.
HANALL BIOPHARMA CO.,LTD’s ‘Batoclimab’ Receives Marketing Approval in China“Batoclimab,” an autoimmune disease treatment developed by HANALL BIOPHARMA CO.,LTD, received
marketing approvalon the 23rd from China’s National Medical Products Administration (NMPA) as a treatment for generalized myasthenia gravis (gMG).
The approval applies to adult patients with generalized myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor antibodies. This achievement comes approximately nine years after HANALL BIOPHARMA CO.,LTD licensed the technology to China’s Harbour Biomed in 2017.
Generalized myasthenia gravis is a rare autoimmune disease characterized by muscle weakness resulting from the improper transmission of signals from nerves to muscles. Symptoms can range from drooping eyelids and double vision to muscle weakness in the limbs and difficulty breathing.
Batoclimab is a novel antibody drug that inhibits the neonatal Fc receptor (FcRn). FcRn is a protein that protects immunoglobulin G (IgG) from being broken down in the body. The drug works by blocking FcRn to reduce the blood concentration of pathogenic antibodies that trigger autoimmune diseases.
This approval was based on the results of a Phase 3 clinical trial conducted at 27 hospitals in China. In the trial, 58.2% of patients treated with batoclimab maintained an improvement of 3 points or more on the MG-ADL score—which assesses the ability to perform activities of daily living—for at least 4 weeks during the first treatment cycle. In the placebo group, this figure was 31.3%.
The proportion of patients who reached an MG-ADL score of 0–1—indicating virtually no symptoms—was also higher in the batoclimab group at 25.4%, compared to 4.7% in the placebo group.
Marketing and sales of batoclimab in Greater China (Mainland China, Hong Kong, Macau, and Taiwan) will be handled by NBP Pharma, pursuant to an agreement between Harbor BioMed and NBP Pharma, a subsidiary of the Chinese pharmaceutical group CSPC. HANALL BIOPHARMA CO.,LTD will receive milestone-based technology fees and running royalty fees tied to batoclimab’s annual net sales following this approval.
This approval marks the first time a new drug licensed by HANALL BIOPHARMA CO.,LTD to a global partner has received regulatory approval. Development of batoclimab had faced growing uncertainty after it failed to demonstrate efficacy in a U.S. Phase 3 clinical trial for thyroid-associated ophthalmopathy (TED) last April.
