South Korea’s Hanmi Pharmaceutical Co. is set to launch its blockbuster high blood pressure drug Amosartan in China, the world’s largest hypertension treatment market.
Hanmi said on Thursday that it has secured approval for the medicine from China’s National Medical Products Administration. The pharmaceutical maker plans to release the drug in October through its Chinese unit Beijing Hanmi Pharm. Co. after preparing its marketing strategy.
“We will develop Amosartan sales networks through local internal medicine hospitals and clinics that we have been establishing,” said an official at the company’s headquarters in Seoul.
Hanmi expected Amosartan to draw strong demand in China as the efficacy of the 14-year old drug for Asians has been proved with cumulative sales of the medicine’s lineup topping 1 trillion won ($811.4 million) in South Korea. Hypertension patients in China jumped to 380 million in 2019 from 267 million in 2012, according to the National Health Commission of the People's Republic of China.
The drugmaker plans to apply for marketing approval to the Chinese authorities for Rosuzet, a dyslipidemia drug.
Last year, Hanmi generated sales of 125.5 billion won from Amosartan and 123.2 billion won from Rosuzet.
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Amosartan is South Korea’s first incrementally modified drug (IMD) that combines the Calcium Channel Blockers-based Amlodipine camsylate and the Angiotensin II Receptor Blocker ARB-based Losartan potassium. IMDs refer to medicines that have similar compounds to original drugs but have changed formulation or salt to increase safety and efficacy with greater convenience for patients. Hanmi's R&D center staff Hanmi spent earnings from the blockbuster medicine for new drug research and development, securing 30 new drug candidates, the most in the country.
The company said the European Medicines Agency (EMA) has granted an orphan drug designation (ODD) for LAPSTriple Agonist (HM15211) that is being developed for the treatment of primary biliary cholangitis. As a result, Hanmi’s number of ODDs increased to six candidates, 10 indications and 19 cases including nine by the US Food and Drug Administration, seven by the EMA and three by South Korea’s Ministry of Food and Drug Safety.
Hanmi also expected to win marketing approval by FDA for neutropenia drug Rolontis and lung cancer medicine Poziotinib within this year, according to a company source.
“We have been investing money earned from IMDs such as Amosartan in the development of breakthrough therapies for more than a decade. Such investment started bearing fruit,” said the company source. “Long-term investment was possible because we established a virtuous cycle structure of covering R&D costs with our own income.”
Hanmi spent 154.5 billion won, or 12.8% of its sales of 1.2 trillion won in 2021. It is unusual to see South Korean drugmakers make such a big investment in future growth engines.
Despite the investment, Hanmi logged an operating profit of 125.4 billion won, raising its cash and cashable assets by 43.2% to 209.2 billion won.
Write to Sang-Hun Oh at ohyeah@hankyung.com Jongwoo Cheon edited this article.
