Tegoprazan

December 12, 2024 HK inno.N’s K-CAB, new drug for Gastroesophageal Reflux Disease (GERD) treatment, launched in 6 additional Latin American countries Product launch in 6 countries including ▲Dominican Republic ▲Nicaragua ▲Honduras … K-CAB now available in 15 countries worldwide Ranked 3rd in the Mexican market within a year of its launch… market share of 10% in sight HK inno.N announced on 12 December that K-CAB (tegoprazan) for gastroesophageal reflux disease (GERD), was launched in six additional Central and South American countries. The six countries in the region with the recent product launch of K-CAB are ▲Dominican Republic ▲Nicaragua ▲Honduras ▲Guatemala ▲El Salvador ▲Colombia. K-CAB already obtained the marketing authorization under the local product name "Ki-CAB" in September. K-CAB’s bold strides of market expansion in Latin America include 18 countries, either in the form of exporting finished products or technology export. Following its launch in Mexico and Peru last year, the product was released in Chile in the second half of this year and is now launched in 6 more countries in the continent, establishing its market presence across 9 countries of Latin America at a remarkable pace. Carnot, HK inno.N's partner that signed a contract with HK inno.N for exporting and distribution of K-CAB to 17 Latin American countries excluding Brazil, has been active in its marketing campaigns to lead the market growth of K-CAB (the local product name "Ki-CAB.") in the Central and South American markets. As part of the partnership, HK inno.N and Carnot have jointly hosted an academic conference for medical specialists in South Korea and Latin America since the last year. In October this year, a symposium was held in Bogota, Colombia, in celebration of K-CAB’s launch in the country. A number of eminent gastroenterologists from the Americas attended the event, gave presentations, and had lively discussions on the clinical benefits of K-CAB and the areas where it can be used as a new treatment option. Dr David A. Peura, an emeritus professor in gastroenterology at University of Verginia, Charlottesville, the U.S., presented in his lecture at the Colombia symposium, “K-CAB should be considered as an option for all cases of Helicobacter pylori eradication therapy requiring acid suppression.” Dr. Marcelo Vela of the Mayo Clinic in the U.S. reported, “K-CAB has a faster onset of action in suppressing gastric acid than other potassium competitive acid blockers (P-CAB) and has greater benefits than proton pump inhibitors (PPIs) in the treatment of GERD in patients with moderate to severe reflux esophagitis (LA grade B/C/D).” An official from Carnot stated, "K-CAB landed on its position as the top 3 peptic ulcer medicines in Mexico within a year from its launch and is close to achieving the 10% market share," and added, " the rapid pace of growth of K-CAB has had a positive impact on the Latin American market, and medical specialists in other countries in the continent where K-CAM has not been introduced yet have expressed great interest and expectations. HK inno.N’s CEO Dalwon Kwak commented, “K-CAB has quickly gained prominence in the Central and South American market, and our efforts to promote the value of the Korean new drug in the global peptic ulcer market will continue to expand, beyond Latin America.” K-CAB, the 30th new drug of South Korea, is a P-CAB class new drug for GERD treatment. It is characterized by rapid onset of action within one hour after administration and proven efficacy and safety even with long-term use for up to six months. Recently, the Mexican Association of Gastroenterology (the Asociación Mexicana de Gastroenterología) published a guideline recommending P-CAB class drugs from the early stage in the treatment course of GERD, which is expected to further increase the influence of K-CAB in the market of peptic ulcer medications in Central and South America. Following its first launch in South Korea, K-CAB succeeded in the market entry to a total of 46 countries worldwide, including the U.S. and China. The product has been officially released in 15 countries to date, demonstrating its growing global market presence. K-CAB recorded a total outpatient prescription sales of KRW 177.7 billion from January to November for this year alone in South Korea. The product has been the steady No. 1 market leader in peptic ulcer medications for four consecutive years since its launch. [The End] [Reference information] ■ P-CAB: Potassium Competitive Acid Blocker ■ PPI: Proton Pump Inhibitor ■ The Mexican Association of Gastroenterology: Asociación Mexicana de Gastroenterología ■ Overview of K-CAB’s market presence worldwide (46 countries in total): - South Korea, China, Mongolia, India, South Africa, the U.S, Canada - 6 Southeast Asian countries: Indonesia, Thailand, the Philippines, Vietnam, Singapore, Malaysia - 5 Eastern European countries: Russia, Kazakhstan, Uzbekistan, Ukraine, Belarus - 10 Middle Eastern/North African countries - 18 Central and South American countries (see below) ■ K-CAB’s market entry to Central and South America includes the following 18 countries: Brazil, Mexico, Argentina, Colombia, Peru, Chile, Ecuador, Uruguay, Paraguay, Bolivia, Venezuela, Dominican Republic, Guatemala, Honduras, Nicaragua, Costa Rica, Panama, and El Salvador (Of these, Carnot is an exporter for 17 countries, which excludes Brazil). ■ Overview of K-CAB’s market presence in Central and South America - Technology transfer (1 country): Brazil - Product release (9 countries): Mexico, Peru, Colombia, Chile, Dominican Republic, Nicaragua, Honduras, Guatemala, and El Salvador.

December 2, 2024 K-CAB, HK inno.N’s new GERD treatment received recommendation for marketing authorization in India K-CAB Tablet 25mg & 50mg, close to obtaining MA from India, the world’s most populous country Export contract between HK inno.N and Dr. Reddy’s Laboratories, an India-based pharmaceutical company, already in place from 2022 HK inno.N announced on Monday (December 2nd) that it received a recommendation for granting marketing authorization of its gastroesophageal reflux disease (GERD) treatment, K-CAB Tablet, from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) of India. The recommendation applies to K-CAB Tablet 25 mg and 50 mg. The SEC recommended approval for the 50 mg tablet under indications of erosive GERD, non-erosive GERD, and gastric ulcers. For the 25 mg tablet, the recommendation is for △maintenance therapy after treatment of erosive GERD. For antibiotic combination therapy for eradication of Helicobacter pylori, the SEC recommended conducting a local phase 3 clinical trial for K-CAB, citing limited global data available in relation to the eradication of Helicobacter pylori using K-CAB Tablet and varying patterns of antimicrobial-resistant H. pylori across different countries. In 2022, HK inno.N signed an export contract with Dr. Reddy’s Laboratories, a pharmaceutical company in India, for distribution of the products across seven countries, including India, South Africa, and Eastern Europe. India, with the largest population in the world at 1.45 billion, is the fourth-largest market for peptic ulcer medications, following China, the U.S., and Japan. An official of HK inno.N said, “we expect that K-CAB will obtain marketing authorization in India next year following the recommendation for granting MA this time,” and “K-CAB’s marketing presence will grow even stronger with the drug obtaining more MA and the subsequent product release across major countries in the global market.” K-CAB, the 30th new drug in South Korea, is a novel potassium competitive acid blocker (P-CAB) for GERD treatment. It is characterized by the rapid onset of action within one hour after administration and proven efficacy and safety even with long-term use for up to 6 months. Following its first launch in South Korea, K-CAB succeeded in the market entry to a total of 46 countries worldwide, including China, US, India and Latin America. For each country of market entry, approval from the relevant authority and product release are in progress, and K-CAB has been officially released in 15 countries to date. K-CAB recorded a total outpatient prescription sales of KRW 160.2 billion from January to October for this year alone in South Korea. The product has been the steady No. 1 market leader in peptic ulcer medications for four consecutive years since its launch. (The End) [Reference information] ■ P-CAB: Potassium Competitive Acid Blocker ■ CDSCO: Central Drugs Standard Control Organization ■ SEC: Subject Expert Committee ■ Size of the global peptic ulcer medications market at a glance (※ Source: IQVIA, for 2021) : Total $18 billion (approx. KRW 25 trillion) - China: approx. $3.1 billion (approx. KRW 4.6 trillion, ranked 1st) - United States: approx. $2.8 billion (approx. KRW 3.9 trillion, 2nd) - Japan: approx. $2.2 billion (approx. KRW 3 trillion, 3rd) - India: approx. $760 million (approximately KRW 1 trillion, 4th) ■ The export contract between HK inno.N and Dr. Reddy’s Laboratories takes effect in the following 7 countries: ▲India ▲Republic of South Africa ▲Russia ▲Kazakhstan ▲Uzbekistan ▲Ukraine ▲Belarus