Rising Expectations for Successful 'K-New Drugs' in the Second Half of the Year

K-CAB Expands Global Market
Reclaza Reaches 10 Billion KRW in Cumulative Sales
Rollontis Nears FDA Approval
Pexuclu Reflected in Q3 Sales

HK Inno.N K-CAB.

[Asia Economy Reporter Lee Gwan-ju] Domestic pharmaceutical and bio companies' newly developed drugs showed strong performance in the first half of this year, and a vigorous pace is expected to continue in the second half. As domestically developed new drugs actively enter the market, their achievements are anticipated to influence future new drug development in the pharmaceutical industry.

Rapid Sales Growth of K-CAB and Lekraza

According to the pharmaceutical industry on the 7th, both K-CAB, a treatment for gastroesophageal reflux disease by HK Inno.N, and Lekraza, a non-small cell lung cancer treatment by Yuhan Corporation, showed favorable results in the first half of this year. K-CAB, the 30th domestic new drug, recorded sales of 49.8 billion KRW in the first half, approaching 50 billion KRW. Since this is already about two-thirds of last year's sales (78.4 billion KRW), further sales growth is expected. K-CAB is a potassium-competitive acid blocker (P-CAB) drug, which, unlike conventional proton pump inhibitors (PPIs), can be taken regardless of meal times and also improves nighttime heartburn.

Since its approval in 2018, HK Inno.N has been accelerating the expansion of K-CAB into overseas markets. This year, it began full-scale sales in China and Mongolia and obtained product approval in the Philippines. Additionally, it signed finished product export contracts with seven countries including India, South Africa, and five Eastern European countries, increasing the total number of countries where K-CAB has entered to 34. An HK Inno.N official stated, "This year marks the first year of K-CAB's global expansion. Starting with China, where local sales have recently begun, global sales are expected to expand significantly," adding, "Our goal is to export to 100 countries, including Europe, by 2028."

Yuhan Corporation Lekraza.

Lekraza, the 31st domestic new drug, surpassed cumulative sales of 10 billion KRW within one year after being listed for health insurance reimbursement in July last year. According to IQVIA, Lekraza's sales in the first half of this year were 6.9 billion KRW. This is nearly a 70% increase compared to the 4.1 billion KRW sales in the second half of last year, when it officially entered the market after reimbursement listing. Quarterly sales have steadily increased, with 1.5 billion KRW in Q3 last year, 2.6 billion KRW in Q4, 3.2 billion KRW in Q1 this year, and 3.7 billion KRW in Q2, which is encouraging. The industry evaluates that despite the difficulty of market entry for domestically developed anticancer drugs, Lekraza's initial performance is very good.

Rollontis and Pexuclu Set for Full Launch

More domestic new drugs are set to be introduced in the second half. Rollontis, Hanmi Pharmaceutical's treatment for neutropenia and the 33rd domestic new drug, is on the verge of approval by the U.S. Food and Drug Administration (FDA). If Rollontis is approved this time, it will be the sixth domestic new drug to receive FDA approval, and the first in three years since SK Biopharm's Xcopri in November 2019.

Hanmi Pharm Rolontis.

Hanmi Pharmaceutical has finalized the U.S. product name (Rolvedon) and completed preparations for sales, including hiring marketing personnel in the U.S. Rollontis is the first product to receive marketing approval applying Hanmi Pharmaceutical's proprietary platform technology 'Lapscovery,' which enhances the efficacy of biopharmaceuticals. It is used for the treatment or prevention of severe neutropenia occurring in cancer patients undergoing chemotherapy. The FDA's decision on Rollontis' approval is scheduled for the 9th (local time). A Hanmi Pharmaceutical official said, "We will focus our capabilities to achieve tangible results in the neutropenia treatment market, which forms a market worth about 3 trillion KRW in the U.S. alone."

Pexuclu, Daewoong Pharmaceutical's treatment for gastroesophageal reflux disease and the 34th domestic new drug, was officially launched in July and is expected to be reflected in third-quarter sales. Pexuclu is also a P-CAB drug like K-CAB and is expected to be a direct competitor. Recently, Pexuclu became the first P-CAB drug in Korea to receive approval for the indication of 'improvement of gastric mucosal lesions in acute and chronic gastritis,' enhancing its competitiveness. A Daewoong Pharmaceutical official explained, "We plan to focus on strengthening product competitiveness through additional indications for Pexuclu and the development of various formulations."

Daewoong Pharmaceutical Fexuclue.

With all recently developed domestic new drugs performing well, trust in the domestic pharmaceutical industry's new drug development technology, which had been undervalued, is also rising. However, the industry also voices the need for various supports to ensure the success of domestic new drug development. In the 2023 budget recently announced by the government, the budget for the National New Drug Development Project is 41.2 billion KRW, slightly down from 42 billion KRW the previous year.

This content was produced with the assistance of AI translation services.