HK Innoen 'K-CAB'·Daewoong Pharmaceutical 'Pexuclu'
Only 4 Globally Commercialized P-CAB Therapeutics
Market Share Rising Daily... Jeil and Ildong Also Accelerating Development
As the number of patients suffering from gastroesophageal reflux disease (GERD) complaining of 'heartburn' rapidly increases, a new P-CAB formulation drug that improves both ease of administration and efficacy compared to existing medications is gaining popularity. In particular, domestically developed new drugs with competitive advantages are being released one after another, raising expectations for their growth into global blockbusters.
According to the industry on the 16th, there are currently only four P-CAB formulations commercialized worldwide. Among them, two are domestic new drugs. HK Innoen's K-CAB was the first domestic P-CAB drug, launched in 2019, followed by Daewoong Pharmaceutical's Pexuclu in 2022. Other than these, there are Takeda Pharmaceutical's Takecab from Japan and Gabipeng Pharmaceutical's Beiwen from China. Additionally, Jeil Pharmaceutical has applied for approval from the Korean Ministry of Food and Drug Safety last June for Zastaprazan, developed through its subsidiary Onconic Therapeutics, and if launched, domestic new drugs are expected to account for the majority of all commercialized P-CAB products. Ildong Pharmaceutical has also received approval for Phase 2 clinical trials of its own P-CAB new drug candidate.
P-CAB formulations are rapidly expanding their market share by emphasizing higher convenience and efficacy compared to the PPI formulations that have traditionally dominated the gastrointestinal drug market. Existing PPI formulations, although acid secretion inhibitors, ironically require the presence of stomach acid for their main ingredients to be effective. Because of this, they must be taken before meals and have the drawback of delayed onset of action. In contrast, P-CABs block acid secretion regardless of stomach acid presence and can be taken at any time. They also have the advantage of rapid and prolonged efficacy, which is helping them quickly increase their market share.
According to pharmaceutical market research firm Ubist, as of last month, P-CAB's market share in the domestic peptic ulcer drug market soared to 20%. This is a rapid growth compared to the approximately 4% share when K-CAB was first launched in 2019. In particular, K-CAB maintains the number one market share among all gastrointestinal drugs with 14%. After forming an alliance with Chong Kun Dang following its launch, it began joint sales with Boryung at the end of last year, continuing its growth through cooperation with strong domestic pharmaceutical marketing players.
Daewoong Pharmaceutical's gastroesophageal reflux disease treatment Pexuclu Photo by Daewoong Pharmaceutical
Building on their domestic success, P-CAB formulations are also accelerating their entry into the global market. K-CAB has received approval in eight countries across Asia and South America outside Korea, and Pexuclu is rapidly expanding its market by gaining approval in the Philippines and three South American countries.
The next target is the United States, the world's largest pharmaceutical market. The competing drug Takecab, which was launched earlier, has been prescribed over 10,000 times within three months of its release, fueling high expectations. HK Innoen plans to complete its ongoing Phase 3 clinical trials in the U.S. within this year, obtain approval from the U.S. Food and Drug Administration (FDA), and launch the drug next year.
Daewoong Pharmaceutical is actively seeking a new partner for Pexuclu after the termination of its license last year due to financial difficulties faced by its U.S. partner, which caused setbacks in U.S. clinical trials. A Daewoong Pharmaceutical official said, "We understand that several global pharmaceutical companies have shown interest," adding, "We are looking for a partner who can cover not only the U.S. but also Europe."
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
