Novel drugs drive growth at Korean pharmaceutical companies

Daewoong Pharmaceutical Co.’s Fexuclue, a novel drug for gastroesophageal reflux disease. [Courtesy of Daewoong Pharmaceutical]

Novel drugs that were introduced by South Korean pharmaceutical companies in 2021 are performing beyond expectations, emerging as the cash cow and future growth engine of the firms.

According to Daewoong Pharmaceutical Co. on Thursday, Fexuclue, a novel drug for gastroesophageal reflux disease, recorded sales of 12.5 billion won ($9.62 million) in the second quarter of this year.

Fexuclue was approved as the country’s 34th novel drug at the end of 2021. In less than a year since its launch in July last year, it has become a flagship product of Daewoong Pharmaceutical, accounting for 4 percent of the company’s total sales.

For a year until the first half of this year, the company targeted big hospitals such as upper-class general hospitals. Prescriptions increased rapidly in the second half and the company is on track to achieve annual sales of 100 billion won next year.

Daewoong Pharmaceutical is also making advances into overseas markets, with an aim to achieve 550 billion won in global sales in 2025.

Fexuclue has been approved in Ecuador and Chile. The company plans to enter markets in 100 countries by 2027, starting with the Philippines this month. In June, it also applied for approval in China, the world’s No. 1 antiulcer drug market, with plans to enter the market next year.

Enblo, Korea’s 36th novel drug, also exceeded 1 billion won in sales within two months of its launch in May.

Enblo is a diabetes treatment in the SGLT-2 inhibitor class that Daewoong Pharmaceutical has successfully localized for the first time as a Korean drug company.

The company plans to expand the treatment’s indications to include obesity, heart, and kidney diseases to accelerate Enblo’s global expansion.

Hanmi Pharmaceutical Co.’s neutropenia treatment Rolontis. [Courtesy of Hanmi Pharmaceutical]

Hanmi Pharmaceutical Co.’s neutropenia treatment Rolontis, also known as Rolvedon in the U.S., was approved by the U.S. Food and Drug Administration (FDA) in September last year and began sales in the country in October. Sales in the first quarter reached $15.6 million.

Hanmi Pharmaceutical exports the drug substance (DS) at a royalty rate of 5 percent from Spectrum Pharmaceuticals Inc., its U.S. sales partner for Rolontis.

Rolontis is expected to generate $100 million in sales in the U.S. this year.

Leclaza, a treatment for non-small cell lung cancer, which is Korea’s No. 31 novel drug, has also become the flagship drug of Yuhan Corp. It generated 16.1 billion won in sales last year as a second-line treatment for lung cancer and is expected to contribute more to sales by expanding its indication to first-line treatment.

Some observers believe that Leclaza’s annual sales will soar up to 100 billion won if it enters the health insurance market as first-line treatment. Yuhan estimates the number of target patients for first-line treatment at 3,000 in Korea.

The success of Fexuclue, Enblo, Rolontis, and Leklaza is considered a rare success story in the history of domestic drugs.

New drugs developed by domestic pharmaceutical companies have often remained obscure or voluntarily withdrawn licenses without actual prescription results.

Earlier this year, the first domestic novel drug, Sunpla Injection, had its license expired, bringing the total number of revoked licenses to nine out of 36 domestic new drugs.

The production of Sunpla Injection had remained in approval but with production suspended since 2009, and more than five domestic new drugs are practically unmarketable.