[Edaily Reporter SHIN MIN JOON ] Mid-sized pharmaceutical company HANDOK Inc.(002390)is continuing its trend of improved performance, driven by its dual focus on anticancer drugs and treatments for rare diseases. HANDOK Inc. has traditionally focused on the markets for diabetes treatments and topical anti-inflammatory analgesics. However, as market competition has become extremely fierce, the company has identified anticancer drugs and treatments for rare diseases as new growth engines and is accelerating their development.

As a latecomer to the anticancer drug market, HANDOK Inc. is actively targeting the markets for rare and gastrointestinal anticancer drugs, where it can maintain a competitive edge. In the short term, HANDOK Inc. plans to boost performance and secure financial resources through the sale of licensed anticancer drugs, and in the medium to long term, it will embark on the development of its own innovative new drugs.

First-Quarter Revenue Up Year-Over-Year...Return to Operating Profit

According to the pharmaceutical industry on the 21st, HANDOK Inc.’s revenue for

the first quarter of this year

, based on consolidated financial statements, reached 135.4 billion won, a 12.9% increase compared to the

same period last year

. Operating profit for the same period was 800 million won,

marking a return to profitability

from a 1.7 billion won loss in the prior-year period.

This is attributed to the sales of Eloxatin and Zaltrop, global blockbuster treatments for colorectal, gastric, and pancreatic cancers, for which HANDOK Inc. secured exclusive domestic distribution rights from global pharmaceutical giant Sanofi earlier this year. Eloxatin is a platinum-based anticancer drug whose main ingredient is oxaliplatin. It is widely used as one of the standard treatments for colorectal cancer. Eloxatin binds to the DNA of cancer cells, interfering with replication and transcription, thereby inhibiting the proliferation of cancer cells and inducing cell death.

Eloxatin recorded annual sales of approximately $2.3 billion (about 3.4 trillion won) in 2006. Currently, with the expiration of its patent, most of the market has shifted to generics. However, oxaliplatin—the active ingredient in Eloxatin—is still used as a core drug in the FOLFOX regimen, a standard treatment for colorectal cancer, and the global market size remains at over $1 billion (approximately 1.5 trillion won).

Zaltrap is an anti-angiogenic targeted anticancer drug containing Zib and Aplibreccept as its main ingredients; it is used as a second-line treatment for metastatic colorectal and rectal cancer that has progressed or developed resistance following oxaliplatin-based anticancer therapy. Eloxatin and Zaltrap generated 8.6 billion won in new sales in the first quarter of this year. Eloxatin and Zaltrop are considered standard-of-care treatments for inoperable advanced and metastatic colorectal cancer, gastric cancer, and pancreatic cancer.

Given that colorectal cancer, gastric cancer, and pancreatic cancer—the cancers targeted by these two anticancer drugs—rank as the second, fifth, and eighth most common cancers in South Korea, respectively, analysts note that HANDOK Inc. is expanding its presence in the domestic anticancer drug market. HANDOK Inc.’s anticancer drug portfolio has been expanding rapidly in recent years. In 2022, HANDOK Inc. introduced and began marketing Pemazire, a bile duct cancer treatment, and Minjuvie, a treatment for diffuse large B-cell lymphoma, from the U.S. biotech company Insight. This year, HANDOK Inc. signed an additional contract for Zainiz, a treatment for anal cancer, and is preparing for domestic marketing authorization.

Beyond introducing products, HANDOK Inc. is also developing its own anticancer drugs. HANDOK Inc. is jointly developing Tobesimig (HDB001A), a second-line treatment for the rare cancer bile duct cancer, with Compass Therapeutics. Tobesimig is currently undergoing a global Phase 2/3 clinical trial. Bile duct cancer is a rare cancer with very limited treatment options, and its five-year survival rate is known to be less than 20%.

Establishment of Korea’s First Joint Venture for Rare Diseases... Reducing Cost and Time Burdens

Treatments for rare diseases are also contributing to HANDOK Inc.’s improved performance. HANDOK Inc. currently supplies Empavelly, a treatment for paroxysmal nocturnal hemoglobinuria, and Doptelet, an oral thrombopoietin receptor agonist for adult patients, in the domestic market. Empaveli is the first complement factor 3 (C3) protein-targeted therapy for the treatment of adult patients. Empaveli injection binds to complement proteins (C3 and C3b)—part of the innate immune system that eliminates pathogens such as bacteria and viruses—to inhibit the complement cascade, thereby suppressing intravascular and extravascular hemolysis.

Paroxysmal nocturnal hemoglobinuria (PNH) is a condition in which red blood cells become sensitive to the complement response due to a somatic mutation on the X chromosome, leading to intravascular and extravascular hemolysis. Clinically, it manifests as aplastic anemia with a reduced number of hematopoietic stem cells. Doptelet is used to treat thrombocytopenia associated with chronic liver disease (CLD) and immune thrombocytopenia (ITP). Globally, Empaveli recorded sales of approximately 190 billion won, and Doptelet recorded sales of approximately 390 billion won (as of 2023). HANDOK Inc. has received marketing authorization for Vibgat, Korea’s first Fc receptor (FcRn) inhibitor for the treatment of adult generalized myasthenia gravis (gMG), and is pursuing reimbursement coverage.

HANDOK Inc. has also established Korea’s first joint venture for rare diseases with Sobi, a Swedish company specializing in rare diseases. Establishing this joint venture helps mitigate the risk of a revenue gap resulting from the expiration of licensing agreements for imported therapies, while also reducing the cost and time burdens associated with conducting global clinical trials.

Through its first collaboration with Sovii, HANDOK Inc. successfully secured domestic approval and health insurance coverage for the rare disease treatments Empavelly and Doptelet. Sovii achieved sales of approximately 4.31 trillion won last year. Sovii currently markets rare disease treatments in the U.S., Europe, and other regions. HANDOK Inc.-Sovii plans to continue introducing Sovii’s new rare disease drugs to the Korean market.

According to market research firm EvaluatePharma, the global rare disease drug market is projected to grow from 266 trillion won last year to 389 trillion won by 2028.

HANDOK Inc. officials stated, “Since the start of this year, we have been generating new revenue from our anti-cancer drugs and rare disease treatments, which serve as new growth engines,” adding, “We expect to continue the upward trend in performance seen last year into this year.”