"US next after India" — HK inno.N eyes 'KRW 1 trillion club' as global expansion accelerates

[Korea Financial Times, Yang Hyunwoo] HK inno.N is on the verge of breaking through KRW 1 trillion in sales, driven by the global market expansion of its gastroesophageal reflux disease treatment K-CAB Tab. The launch of K-CAB Tab. in India and the upcoming US Food and Drug Administration approval application, combined with improving performance and a robust new drug pipeline, are providing momentum for entry into the 'KRW 1 trillion club'.

According to industry sources on the 24th, HK inno.N recently launched K-CAB Tab. in India under the local product name 'PCAB 50mg'. The company had previously obtained product approval in India in May for indications including erosive gastroesophageal reflux disease, non-erosive gastroesophageal reflux disease, and gastric ulcer treatment.

Based on last year's figures, India's peptic ulcer treatment market is estimated at approximately KRW 1.52 trillion, ranking fourth globally after China, the US, and Japan. With about 38 per cent of India's population suffering from gastroesophageal reflux disease, demand for K-CAB Tab. is expected to increase further.
Beyond India, K-CAB Tab. is also targeting the US market. HK inno.N's US partner Phathom Pharmaceuticals announced last month that K-CAB Tab. achieved positive results in the US Phase III clinical trial 'TRIUMpH'.

The TRIUMpH trial was conducted by Sevela Pharmaceuticals's gastroenterology subsidiary Braintree following a technology transfer agreement signed in 2021. The clinical study was conducted on patients with completely healed erosive esophagitis (EE) after initial treatment of up to eight weeks.

In the trial, patients were randomly assigned to receive either 100mg or 50mg of tegoprazan (P-CAB class) or 15mg of lansoprazole (PPI class) for 24 weeks of maintenance therapy.

The primary endpoint measuring 24-week treatment efficacy maintenance rate (remission maintenance rate) showed that all tegoprazan dosage groups demonstrated statistically superior effects compared to the lansoprazole group across all patient populations (LA grades A-D).

Particularly in patients with moderate to severe esophagitis (LA grades C-D), meaningful improvement was confirmed in all tegoprazan dosage groups compared to the lansoprazole group. Statistical superiority was proven in the tegoprazan 100mg group.

Based on these clinical results, Sevela Pharmaceuticals plans to proceed with a New Drug Application (NDA) to the US FDA for erosive esophagitis and non-erosive gastroesophageal reflux disease indications during the fourth quarter of this year. Final FDA product approval typically takes about one year, suggesting commercialisation could be possible in the second half of next year.

Meanwhile, in the US, the exclusivity period for K-CAB Tab.'s competitor 'Voquezna' has been extended by five years, blocking generic product launches for seven years. When generic products are launched, P-CAB class drug prices decline. For K-CAB Tab., which plans to target the market with price competitiveness, generic launches would be negative factors.

However, with generic launches blocked, K-CAB Tab. will only compete with Voquezna. Currently, Voquezna is the only P-CAB product with FDA approval. Voquezna recorded sales of KRW 80 billion last year.

According to global market research firm WiseGuy Reports, the global P-CAB market size is estimated to grow from $8.8 billion (approximately KRW 12 trillion) in 2023 to $15.5 billion (approximately KRW 21 trillion) by 2032. This is directly linked to P-CAB class product growth and is expected to have a positive impact on sales.

For the first half of this year, HK inno.N's sales increased 18 percent year-on-year to KRW 510.4 billion. Operating profit grew 7.9 percent to KRW 44.9 billion. According to financial information company FnGuide's compilation, the 2025 consensus forecast for HK inno.N is sales of KRW 1.0194 trillion and operating profit of KRW 103.4 billion. Sales would increase 13 per cent and operating profit 17 percent compared to the previous year.

Beyond K-CAB Tab., HK inno.N is actively developing follow-up pipeline products. A representative example is the atopic dermatitis new drug candidate 'IN-115314'. IN-115314 recently proved efficacy and safety in Phase I clinical trials.

An HK inno.N official said: "We are currently conducting Phase II clinical trials at 12 domestic institutions with 162 patients to explore appropriate dosages, and are also preparing US clinical trials for global market expansion."

Yang Hyunwoo (yhw@fntimes.com)