inno.N

HK inno.N’s Investigational New Drug for Atopic Dermatitis in Companion Animals Enters Phase 3, Targeting ₩30 Trillion Global Market*

*Based on the global companion animal pharmaceutical market

IN-115314 Advances to Phase 3 Clinical Trial for Oral Formulation in Dogs, Following Phase 2 Human Ointment Study

HK inno.N Expands Pipeline Beyond K-CAB, Korea’s Only JAK-1 Inhibitor for GERD, by Entering the Companion Animal Drug Market

HK inno.N is advancing into the ₩30 trillion global companion animal pharmaceutical market with the development of a novel JAK-1 inhibitor for the treatment of atopic dermatitis in dogs. The company is currently the only Korean firm developing an atopic dermatitis treatment targeting both humans and companion animals through JAK-1 inhibition.

On May 28, HK inno.N announced that its atopic dermatitis treatment for companion animals, IN-115314, has received approval for a Phase 3 clinical trial under an Investigational New Drug (IND) application from the Animal and Plant Quarantine Agency.

Following this approval, the company will assess the efficacy and safety of IN-115314 compared to Apoquel (oclacitinib) through oral administration in dogs with atopic dermatitis, focusing on improvements in pruritus and skin lesions. Approximately 10 veterinary hospitals in Korea are participating as study sites for this trial.

IN-115314 is a novel compound that selectively inhibits Janus Kinase 1 (JAK-1), a key enzyme in intracellular signaling pathways. While existing treatments inhibit both JAK-1 and JAK-2, raising concerns about side effects and limiting dosage flexibility, IN-115314’s high selectivity and potent JAK-1 inhibition are expected to provide effective anti-inflammatory action with a lower risk of adverse effects. HK inno.N is developing IN-115314 in parallel as an ointment for human atopic dermatitis and as an oral tablet for companion animals.

The global market for canine atopic dermatitis treatments is valued at USD 1.6485 billion (approximately KRW 2.27 trillion) in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 10.3%, reaching USD 3.2763 billion (approximately KRW 4.5 trillion) by 2032.

Currently, Apoquel (oclacitinib) by global pharmaceutical leader Zoetis is the only JAK inhibitor-based treatment available for canine atopic dermatitis. Apoquel achieved global sales of USD 1.108 billion (approximately KRW 1.4 trillion) last year, making it one of the leading blockbuster drugs in the veterinary market. Zoetis continues to grow steadily, reporting annual revenue of USD 9.256 billion (approximately KRW 13 trillion).

An HK inno.N representative stated:

“Just as our novel GERD treatment K-CAB has become a success story in its market, we believe IN-115314 has the potential to become the next breakthrough in the companion animal pharmaceutical sector. We aim to provide a new alternative with a domestically developed product in a market currently dominated by multinational pharmaceutical giants.”

In March, HK inno.N received approval from the Ministry of Food and Drug Safety (MFDS) to conduct a Phase 2 clinical trial of IN-115314 in ointment form for treating atopic dermatitis in humans. The companion animal formulation, which recently received Phase 3 approval from the Animal and Plant Quarantine Agency, is being developed as an oral tablet. (END)

Reference Information

▶ JAK Inhibitors:

A class of therapies that inhibit Janus kinase (JAK), an enzyme in the body, to treat various inflammatory diseases. They are primarily used for autoimmune conditions such as rheumatoid arthritis and atopic dermatitis.

▶ Global Companion Animal Pharmaceutical Market (including feed additives):

Valued at USD 21.6 billion (approximately KRW 30 trillion) in 2022, accounting for 46% of the total animal health market. It is projected to reach USD 50.3 billion (approximately KRW 69 trillion) by 2032, with a compound annual growth rate (CAGR) of 9.2%.

Source: Global Information, Global Animal Health Market Report, 2023

▶ Global Market for Canine Atopic Dermatitis Treatments:

Estimated at USD 1.6485 billion (approximately KRW 2.27 trillion) in 2024, projected to grow at a CAGR of 10.3% to reach USD 3.2763 billion (approximately KRW 4.5 trillion) by 2032.

Source: Global Information, “Global Atopic Dermatitis in Dogs Market: By Drug Type, Route of Administration, Formulation, Distribution Channel, and Region,” 2025

▶ Exchange Rate:

KRW 1,374 per USD 1

▶ Korean Veterinary Pharmaceutical Market Size (Domestic Production + Imported Drug Products):

KRW 963.8 billion in 2023

Source: Status of the General Veterinary Pharmaceutical Industry, Ministry of Agriculture, Food and Rural Affairs, August 22, 2024

▶ Market Competitor – Apoquel:

Active Ingredient: Oclacitinib

Manufacturer: Zoetis

FDA Approval Year: 2013

▶ Zoetis’s Revenue in 2024:

USD 9.256 billion (approximately KRW 12.76 trillion).

Apoquel accounted for 11% of total revenue, generating USD 1.018 billion (approximately KRW 1.4 trillion) in sales.

Source: Zoetis 2024 Annual Report