HK inno.N's new drug for gastroesophageal reflux disease K-CAB, receives approval in Peru
Jul 24, 2023
HK inno.N's new drug for gastroesophageal reflux disease K-CAB, receives approval in Peru
K-CAB receives 2nd LATAM approval following successful Mexico launch in May
K-CAB to exploit KRW 72 trillion Latin American pharmaceutical market
HK inno.N has obtained product approval for its new drug 'K-CAB' for gastroesophageal reflux disease in Peru. The drug made its debut in the Latin American market by launching in Mexico in May, the second-largest pharmaceutical market in the LATAM region. With the approval in Peru, K-CAB will exploit the Latin American pharmaceutical market, which amounts to over KRW 72 trillion.
HK inno.N announced on the 24th that a new drug for gastroesophageal reflux disease, K-CAB (ingredient name: Tegoprazan), received product approval from the Peruvian General Directorate of Medicines, Supplies, and Drugs (DIGEMID), as of the 21st. In 2018, HK inno.N had already signed an export agreement for K-CAB(finished product) with 'Laboratorios Carnot,' a major pharmaceutical company in Latin America, targeting 17 countries, including Peru.
In Peru, the drug will be marketed under the name 'Ki-CAB' and is approved for four indications. It includes △treatment of erosive gastroesophageal reflux disease, △treatment of non-erosive gastroesophageal reflux disease, △treatment of gastric ulcers, △antibiotic combination therapy for the eradication of Helicobacter pylori in patients with peptic ulcers and chronic gastritis.
Through tech transfer or finished product exports, K-CAB has entered 35 countries, including the United States, China, India, and multiple countries in Latin America.
It is currently available in 18 Latin American countries, with a recent launch in Mexico, the second-largest market in the region. Following the approval in Peru, K-CAB is undergoing approval processes in other Latin American countries. It is expected to accelerate its presence in the Latin American pharmaceutical market, which exceeds KRW 72 trillion annually.
Dal Won Kwak, CEO of HK inno.N, stated, "Following last year, we have been continuously sharing news about K-CAB, including its launches in Mexico and Indonesia, as well as obtaining approval in Peru. Therefore, we have high expectations for its performance on the international stage. We will deploy various strategies to establish K-CAB as a leading P-CAB class product dominating the market in different countries."
K-CAB, the 30th new drug in South Korea, is a P-CAB class drug for gastroesophageal reflux disease. Its notable features include rapid onset of action within 30 minutes after administration and proven efficacy and safety even with long-term use for up to six months. K-CAB has recorded accumulated outpatient prescription sales of KRW 74.1 billion from January to June this year in Korea. Since its launch, it has maintained its position as the No.1 seller in the peptic ulcer drug market for three consecutive years. From 2019 to 2022, K-CAB accumulated a total of KRW 350.3 billion in prescription sales.
K-CAB has been launched in five out of 35 countries, including China, Mongolia, the Philippines, Mexico, and Indonesia. In Singapore and Peru, K-CAB is preparing for launch after obtaining approval, while going under phase 3 clinical trials in the United States. (End)
[Reference]
- P-CAB: Potassium Competitive Acid Blocker
- Presence of K-CAB in Latin America (Total of 18 countries): Brazil, Mexico, Argentina, Colombia, Peru, Chile, Ecuador, Uruguay, Paraguay, Bolivia, Venezuela, Dominican Republic, Guatemala, Honduras, Nicaragua, Costa Rica, Panama, El Salvador.
- Exchange rate: KRW 1,281.5/USD 1 (Jul. 21, 2023)
- Source of the outpatient prescription sales in South Korea: UBIST
- Pharmaceutical market size in Latin America: 56.2 billion dollars, IQVIA 2022 MAT
* Combined countries for the total market size: Brazil, Mexico, Argentina, Central America, Chile, Ecuador, Colombia, Peru, Venezuela, Dominican Republic, Uruguay (and others omitted).