HK inno.N, which has continued its growth with the gastroesophageal reflux disease treatment "K-CAB (ingredient tegoprazan)," is speeding up efforts to find a "second K-CAB."
Expectations are rising for expanding overseas markets, including entry into the United States for K-CAB, but reliance on K-CAB is growing as growth slows for existing flagship hangover remedies "Condition" and "Hutgae-su." The company said it will reorganize its research and development (R&D) organization and move to strengthen its next-generation new drug pipeline, including obesity treatments.
According to the pharmaceutical industry on the 8th, HK inno.N carried out an R&D organizational reshuffle last month. With Executive Vice President Song Geun-seok overseeing all R&D, the head of the New Drug Research Institute, which is responsible for discovering and developing future growth engines, was replaced from the former Senior Managing Director Kim Bong-tae to the new head, Park Byung-cheol.
Kim, a former senior managing director with a doctorate in veterinary pathology from Seoul National University, served as a principal researcher at Yuhan and then as K-CAB strategy team leader and head of clinical development at HK inno.N, leading the development and launch of K-CAB. Kim is known to have recently left the company.
Newly appointed head Park Byung-cheol is regarded as having extensive experience in discovering early-stage candidates with promising biotechs. Park worked as a researcher at CJ CheilJedang's Pharmaceutical Research Institute, then served as Head of Team for the VC (Value Creation) unit at Kolmar Holdings and as head of the nonclinical development center at HK inno.N's New Drug Research Institute. Park also currently serves as an investment expert member at the K-Bio Lab Hub.
K-CAB, HK inno.N's flagship product, is a novel potassium-competitive acid blocker (P-CAB) for gastroesophageal reflux disease launched in March 2019. First-quarter prescriptions this year totaled 58.5 billion won, up 13.9% from a year earlier. It has been approved in 22 countries, including Korea, and launched in 19 of them. It is also accelerating global expansion by signing technology export agreements with 55 countries. In particular, in China, it is said to have risen to the top tier by prescription amount, outpacing competing products.
Expectations for entering the U.S. market are also growing. U.S. partner Sebela Pharmaceuticals submitted a new drug application (NDA) for K-CAB to the Food and Drug Administration (FDA) early this year. A decision on approval is expected in early next year. The industry expects that if entry into the United States materializes, K-CAB's global sales will expand further.
However, the company's performance being concentrated around K-CAB is cited as a challenge. Now in its seventh year on the market, K-CAB's market share is estimated at about 15%. While prescription volume continues to grow, growth has slowed in the health and beauty (H&B) business institutional sector, including the former flagship hangover remedy "Condition" and Hutgae-su. First-quarter revenue and operating profit this year fell 8.4% and 94.2%, respectively, from a year earlier.
HK inno.N plans to reinvest cash secured from K-CAB into follow-up new drug development. Last year's cash flow from operating activities was 162 billion won, up 53% from the previous year. During the same period, investment in research and development (R&D) was 85.9 billion won, putting about half of cash inflows into research and development.
Work to secure follow-up pipelines is also underway. HK inno.N recently signed a joint development agreement with NEXTGEN Bioscience Inc. for the idiopathic pulmonary fibrosis (IPF) treatment candidate "NXC680." In November last year, it also signed a joint development agreement with KINE SCIENCES for the sarcopenia treatment candidate "KINE-101."
The field the company is focusing on most is obesity treatments. HK inno.N plans to develop "Ecnoglutide," currently in phase 3 clinical trials in Korea, into a next-generation core product. Ecnoglutide is a glucagon-like peptide (GLP)-1 class obesity and diabetes treatment introduced from the Chinese company Sciwind Biosciences, and HK inno.N secured exclusive rights for development and commercialization in Korea in 2024.
Recently, it also began joint development of next-generation obesity treatment candidates with the AI new drug development corporations Atometrics. The goal is to discover small-molecule candidates that can complement the limitations of GLP-1 class therapies. In addition, it is developing a diverse new drug pipeline, including treatments for atopic dermatitis and Non-small cell lung cancer (NSCLC).