Hanmi, get approval for four-drug combination, “Amosartan XQ”


For the first time in the world, Hanmi Pharm has received approval for its four-drug combination containing four ingredients for treating hypertension and dyslipidemia.

Hanmi Pharm (CEO Jong-soo Wu/Se-Chang Kwon) announced that it has received approval from the Korea Food and Drug Administration on November 10th for its four-drug combination, “Amosartan XQ’ mainly composed of amlodipine and losartan to treat hypertension, and rosuvastatin and ezetimibe to treat dyslipidemia.

Amosartan XQ, which is to be launched in February of next year, is the world’s first four-combination drug that combines “Amosartan”, a product belonging to the “Amosartan Family”, the flagship hypertension treatment brand of Hanmi Pharm, a company holding the largest share in the domestic hypertension treatment market, and Rosuzet, a dyslipidemia treatment recording annual sales of KRW 100 billion.

Now Hanmi Pharm offers all options for hypertension and dyslipidemia treatment, completing a product line of four products and 18 different dosages by adding Amosartan XQ to the Amosartan Family, composed of three product groups, including Amosartan, Amosartan Plus, and Amosartan Q.

In particular, Amosartan XQ is expected to help Hanmi Pharm solidify its leadership in the hypertension treatment market by improving the levels of medication compliance of high-risk cardiovascular patients requiring strong management of blood pressure and cholesterol and maximizing the treatment effect.

As developed through the exclusive and creative drug producing expertise of Hanmi Pharm, Amosartan XQ guarantees stability through minimization of the physical and chemical reactions between ingredients, maintaining their pharmacokinetic features, and adopting a tablet size similar to the ones applied to the existing products of the Amosartan Family.

Hanmi Pharm conducted the third-stage clinical trial of Amosartan XQ with 145 patients suffering from both hypertension and dyslipidemia in 13 medical institutions across the country. According to the results, Amosartan XQ reduced the average change in LDL-C by 59.2% compared to the results from the group receiving hypertension treatment (amlodipine and losartan), and an average change in SBP by approximately 11.1mmHg compared to the one receiving dyslipidemia treatment (losartan/rosuvastatin/ezetimibe).

Myung-hee Park, Senior Managing Director of Marketing Division of Hanmi Pharm stated, “Combination treatments for hypertension and dyslipidemia are growing the most in the hypertension treatment market.” The Senior Managing Director added, “We believe that Amosartan XQ would offer both doctors and patients the best option for treatment of hypertension and dyslipidemia through an improvement in the level of medication compliance.”

Hanmi Pharm plans to enhance its competitiveness in the field of combination drugs for treatment of hypertension and dyslipidemia both at home and abroad through the approval of Amosartan XQ. Three products of the Amosartan family exceeded the annual sales of KRW 100 billion in the previous year, and Amosartan and Rosuzet are exported to the major countries around the world through MSD, a US pharmaceutical company.

Mr. Woo, the CEO of Hanmi Pharm stated, “The approval for the four-combination drug of Hanmi Pharm, a company that ushered in the era of combination drugs in the country through the launch of Amosartan in 2009, is very meaningful in extending the product line of the Amosartan family; simultaneously it brings an opportunity to increase global awareness of Korea’s competitive drug production technology.” He added, “We will do our best to achieve ‘sustainable business management’, where successful development of combination drugs would lead to development of innovative new drugs.”

Source: Medical Newspaper