[Edaily Reporter Kim Seung-kwon ] ILDONG PHARM(249420)has proven the value of Padoprazan on the global stage and has entered a race to accelerate its commercialization. This comes as partnership discussions in the U.S. are in full swing. The company is in talks with global Big Pharma companies and biotech firms specializing in metabolic diseases.

Padoprazan is the fourth domestically developed P-CAB (potassium-competitive acid blocker) new drug currently being jointly developed by ILDONG PHARM and DaewonPharmaceutical. Since the compound was developed by ILDONG PHARM, domestic rights are shared with DaewonPharmaceutical, while ILDONG PHARM holds the global rights. ILDONG PHARM is currently seeking a partner capable of handling both U.S. and global sales of Padoprazan. PharmDaily analyzed the market situation and the competitiveness of ILDONG PHARM’s Padoprazan.

Aiming for a “Single Global Mega-Deal” Instead of Regional Splits… Focused on Maximizing Value

According to the pharmaceutical and biotech industry on the 1st, ILDONG PHARM recently received term sheets—the preliminary stage of a contract—from multiple global pharmaceutical companies at BioUSA in the U.S. It is reported that Big Pharma companies were among them.

ILDONG PHARM’s strategy is to first seek a single global contract partner capable of covering major markets, including the U.S., in one go. This is because such an approach results in a larger upfront payment compared to split deals and allows the company to effectively communicate the global value of its candidate compounds to the market. The goal is to finalize a partnership structure around the time of next year’s JPMorgan Healthcare Conference (JPM).

An official from ILDONG PHARM emphasized, “At this year’s Bio USA, we held partnering meetings with numerous companies to discuss collaborations related to our key new drug pipelines, such as GLP-1RA and P-CAB,” adding, “While pursuing global commercialization strategies such as licensing out and open innovation, we are also planning follow-up development work in Korea, including the launch of new drugs under our own brand.”

Looking at the Korean market, the P-CAB sector is already witnessing a fierce three-way competition. HK inno.N Corporation’s “K-Cap” (Domestic New Drug No. 30), DAEWOONGPHARMACEUTICAL’s “Pexuclu” (Domestic New Drug No. 34), and Onconic Therapeutics Inc. and JEIL PHARM’s “Zacubo” (Domestic New Drug No. 37) are vying for market share. This market, which is projected to far exceed 300 billion won in size this year in South Korea alone, is currently taking the form of a “sales war” driven by superior drug efficacy.

So, what differentiation strategy is ILDONG PHARM using to catch up with its competitors? The most striking difference between ILDONG PHARM and competitors such as DAEWOONGPHARMACEUTICAL and Onconic Therapeutics Inc. in the marketing of Padofrazan lies in its “approach to global commercialization.”

Typically, when expanding globally with new drugs, domestic pharmaceutical companies have preferred a “segmented contract” approach—selecting local pharmaceutical partners in specific countries or regions, such as China, Central and South America, and Southeast Asia, to conduct separate technology exports (license-outs) in order to diversify risk and generate cash quickly. In fact, both DAEWOONGPHARMACEUTICAL’s Pexuclu and Onconic Therapeutics Inc.’s Jacubo are adopting a strategy of expanding into multiple countries through this regional segmentation approach to increase their cumulative export revenue.

In contrast, ILDONG PHARM is prioritizing a “single global master agreement” with a big pharma company that can manage major markets, including the U.S., all at once, rather than dispersing the global rights to Padoprazan.

Having already held meetings with numerous top-tier global companies at Bio USA 2026 and secured a large number of term sheets, the company is well-positioned to sign country-specific agreements immediately. Nevertheless, analysts suggest that ILDONG PHARM is prioritizing a single global master agreement to “preserve the value” of its pipeline.

ILDONG PHARM spokesperson stated, “Although we have already secured several term sheets for Padofrazan, we will prioritize discussions with partners capable of covering the global market, including the U.S.” This decision stems from the assessment that while splitting contracts by region might increase the number of upfront payments, the scale of each regional contract would be relatively small, raising concerns that the blockbuster-level potential value of the entire pipeline could ultimately be undervalued by the market.

Clash with Pecsuklu and Jacubo... Partnering with DaewonPharmaceutical to Aim for the “Top Tier in One Fell Swoop”

Market entry is also anticipated in South Korea. ILDONG PHARM, a partner of DaewonPharmaceutical, has been conducting Phase 3 clinical trials since last October for DW4421 (active ingredient: padoprazan), a P-CAB-class new drug candidate for gastroesophageal reflux disease, under approval from the Ministry of Food and Drug Safety. There are also projections that approval could be granted around next year.

Padoprazan’s strongest asset is its ability to sustain gastric pH levels, as confirmed by clinical data. According to Phase 2 clinical data, padoprazan maintained a gastric pH of 4 or higher for 24 hours in approximately 90% of cases and a pH of 6 or higher in about 60% of cases. These figures demonstrate that it offers superior duration of action compared to competing compounds in the same class.

Tegoprazan, the active ingredient in K-Cap, is reported to maintain a pH of 4 or higher at a rate of approximately 70–80%. Analysts suggest that, based on a simple comparison of drug efficacy duration alone, there is room to interpret that Padoprazan holds an advantage. DAEWOONGPHARMACEUTICAL’s Pexuclu also has a half-life of 9 hours, giving it a strong advantage in nighttime gastric acid suppression; however, no data has yet been released directly comparing it with padoprazan in terms of pH persistence.

An official from ILDONG PHARM explained, “We believe our drug is sufficiently competitive,” adding, “We hold a substance patent valid through 2041, which puts us in a favorable position to pursue global business initiatives, including licensing out.”

Intellectual property protection is also in place. Padoprazan has already been patented in major countries such as South Korea, the United States, Japan, and Australia. Despite being a latecomer, the groundwork has been laid to commercialize the drug in the global market without patent disputes. While K-Cap, Pecsuklu, and Jacubo are already locked in fierce competition in Asian markets such as China and India, Padoprazan has adopted a strategy of targeting premium markets—including North America and Europe—in collaboration with global partners.

However, in terms of indications, it still lags behind its competitors. K-Cap has already secured five indications, and Pexuclu has secured four or more. Padoprazan is currently undergoing Phase 3 clinical trials for erosive gastroesophageal reflux disease (GERD) and non-erosive reflux disease (NERD). This is because it will take considerable time to secure additional indications, such as Helicobacter pylori eradication and gastric ulcers. It is understood that the narrower the scope of prescribing, the less incentive doctors have to choose a new drug. This is why K-Cap, with its broad range of indications, is preferred for elderly patients with multiple symptoms.

An official from ILDONG PHARM went on to emphasize, “Since this ultimately comes down to a race against time, our goal is to establish domestic and global partnership frameworks around the time of next year’s JP Morgan Healthcare Conference (JPM).”