Competition is heating up among Korean pharmaceutical companies, including GC Biopharma and Jeil Pharmaceutical, as they successively released four-drug combination treatments for high blood pressure-hyperlipidemia.
In the domestic hypertension-hyperlipidemia treatment market, a series of authorized generic products of Yuhan Corp.’s four-drug combo hypertension-hyperlipidemia therapy, Duowell Plus (telmisartan/ezetimibe/rosuvastatin), has been released recently.
For example, GC Biopharma released Rozetelpine last Friday, and Jeil Pharm launched TelmicanQ on Wednesday. Both products are the combination drugs of hypertension treatment compounds – telmisartan and amlodipine -- and hyperlipidemia treatment compounds – rosuvastatin and ezetimibe.
Yuhan obtained Duowell Plus’s approval from the Ministry of Food and Drug Safety in May. However, instead of releasing the product directly, the company adopted the contract manufacturing organization (CMO method of twin drugs. Therefore, GC and Jeil manufacture Rozetelpine and TelmicanQ at Yuhan’s Plant No. 1.
According to the Korean Society of Hypertension, about 12.07 million Korean adults 20 or older had high blood pressure in 2020. About 63 percent received treatment, and 35 percent of them also received hyperlipidemia treatment.
GC and Jeil expect to improve patient compliance by launching a four-drug combo treatment. Officials at these companies explain that patients with various diseases, such as high blood pressure and hyperlipidemia, effectively manage their conditions by taking a four-drug complex instead of many drugs.
A Jeil official also emphasized that telmisartan, one of the key substances of TelmicanQ, has no tetrazole ring in its chemical structure. Thus it is free from the issue of nitrosamine and azido impurities that can be caused in the manufacturing process of angiotensin receptor blocker (ARB)-family hypertension treatments.
Competition with Hanmi Pharmaceutical, which has preempted the domestic market for four-drug hypertension-hyperlipidemia treatments, is also a key point to watch, the sources said.
Hanmi released the four-drug combo treatment, Amosartan XQ, for the first time worldwide last year. It has characteristics of four compounds – losartan and amlodipine for hypertension and rosuvastatin and ezetimibe for hyperlipidemia. Amozaltan XQ reportedly marked the subscription amount of 2.5 billion won ($1.37 million) in the first half of this year.
Besides, Chong Kun Dang, Daewoong Pharmaceutical, and Ildong Pharmaceutical are also preparing to jump into the four-drug combo treatment market. Chong Kun Dang received approval from the Ministry of Food and Drug Industry for its four-drug combo treatment, Nuvorozet. In addition, Daewoong and Ildong have completed phase 3 clinical trials for their respective candidate substances, DWJ1451 and ID14009.
The domestic drugmakers’ zeal to develop combo treatments will likely continue.
“In the case of chronic disease treatment, patients need to take more than four to five pills regularly. As this is not easy, the enthusiasm for developing complex drugs to increase patient convenience will likely continue for the time being,” an industry executive said. “If drugmakers are already selling two- or three-drug combo treatments, they can also use the existing sales network.”
The official also hinted at the intention of pharmaceutical companies to develop combination therapies.
“From the standpoint of drugmakers, combining existing ingredients can save their time and money rather than developing new drugs,” the executive said. “In the case of developing biopharmaceutical products, the domestic pharma could aim for a ‘noble target.’ However, synthetic drug-based pharmaceutical companies with established manufacturing facilities have no choice but to turn to combination treatments.”