Kolon Pharma's active portfolio expansion…new drug·co-dev

Introduced 'YORVIPATH,' a treatment for hypoparathyroidism, under exclusive rights in Korea

Expanded target area, including COPD, allergies, and anti-cancer drugs

Kolon Pharma is increasing its efforts to secure competitiveness in immunology and oncology by combining new drug in-licensing with in-house R&D.

 

Following the introduction of treatments for chronic obstructive pulmonary disease (COPD) and allergies, the company has recently secured a new drug for hypoparathyroidism.

 

Kolon Pharma plans to continuously expand its portfolio through its own pipelines and co-development of new anti-cancer drugs.

 

Active In-Licensing of Drugs for Immune Diseases

According to industry sources, on August 27, Kolon Pharma recently secured the exclusive domestic sales rights for 'YORVIPATH,' a treatment for hypoparathyroidism, from Ascendis Pharma of Denmark.

 

YORVIPATH is an innovative new drug that received approval in Europe in 2023, the U.S.

 

in 2024, and Australia this year.

 

Hypoparathyroidism is a rare disease in which a lack of parathyroid hormone (PTH) disrupts the balance of calcium and phosphorus in the blood.

 

Until now, patients have relied on taking dozens of calcium and active vitamin D tablets a day, but this has been problematic due to the long-term strain on the kidneys and incomplete symptom control.

 

YORVIPATH is characterized by a mechanism that addresses the fundamental cause of the disease by naturally secreting PTH over 24 hours.

 

Following its FDA approval, over 3,000 patients are receiving treatment as of Q2 2025.

 

Commercialization is also expanding in Europe and Australia.

 

COPD dual comb therapy

Kolon Pharma's new drug-licensing strategy has already been proven effective in immunological diseases, such as COPD and allergies.

 

The company in-licensed the COPD combination products Foster (dual comb therapy) and Trimbow (triple comb therapy) from Italy's Chiesi, securing domestic approval in 2019 and establishing them in the market after reimbursement.

 

In 2020, Kolon Pharma introduced Bilastine from Spain's Faes Farma, creating a new dynamic in the domestic allergy treatment market.

 

Bilastine is a new antihistamine drug that is currently sold in over 100 countries.

 

Kolon Pharma has also in-licensed new drugs in the gastroenterology and dermatology sectors.

 

In 2011, the company launched Clipper SR Tabs, a locally-acting oral steroid for ulcerative colitis, in Korea.

 

In 2012, Kolon Pharma also introduced Veregen Ointment, an HPV (human papillomavirus) treatment based on green tea extract, strengthening its dermatology and urology drug lines.

 

Veregen Ointment has established itself as a differentiated treatment option, as it has been proven to not only treat common warts but also reduce the recurrence rate.

 

Kolon Pharma Continues Co-Development and In-house New Drug Development Efforts Kolon Pharma is not stopping at simply in-licensing in the immunological field.

 

The company is also strengthening its own capabilities in new drug development.

 

In 2023, Kolon Pharma signed a co-development agreement with GBiologics for GB930, a treatment for systemic lupus erythematosus.

 

Kolon Pharma signed a co-development agreement with Gbiologics for the treatment of systemic lupus erythematosus

GB930 is a new drug candidate based on a stabilized galectin-9 protein, which has a dual-action mechanism that simultaneously suppresses B cells and plasmacytoid dendritic cells.

 

The two companies aim to submit an Investigational New Drug (IND) application to the U.S.

 

FDA and are also open to global out-licensing opportunities.

 

Kolon Pharma is also venturing into the development of new anti-cancer drugs.

 

Last year, the company partnered with Estrium, a small molecule drug development company, to co-develop AON-MB23, a new drug for triple-negative breast cancer (TNBC).

 

AON-MB23 is a new drug candidate that offers new possibilities for TNBC, for which treatment options are limited.

 

Preclinical studies are underway to submit an IND in 2027.

 

TNBC is an aggressive subtype that accounts for 15-20% of all breast cancers, making it an area of great interest in the global market due to high treatment demand.

 

Additionally, Kolon Pharma partnered with Aptamer Sciences last year to co-develop the Antibody-Drug Conjugate (ADC) candidate 'AST-203.' The two companies plan to conduct clinical studies on AST-203 to secure a pancreatic cancer indication.

 

AST-203 targets the TROP2 protein, which is primarily expressed in breast, pancreatic, gastric, and lung cancers.

 

This new drug candidate has a mechanism that selectively binds to TROP2-positive tumors, penetrates the cell, and releases the cell-division-inhibiting drug MMAE, thereby inducing cancer cell death.

 

In addition to co-development, Kolon Pharma is also securing its medium- to long-term growth engines through in-house new drug development.

 

Active compound identification and optimization for PBS203, an in-house development project, was completed in 2021, and the project entered the CMC (Chemistry, Manufacturing, and Controls) and preclinical stages in 2022.

 

After submitting an IND in 2023, it entered the clinical stage, with clinical trials having been underway since last year.

 

Currently, PBS203 is in clinical trials for solid tumors, including pancreatic and colorectal cancer.

 

Kolon Pharma is also developing PBL201 and PBL211 for major solid tumors, such as pancreatic cancer and melanoma.