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Other Disclosures4579RaQualia Pharma Inc.Pharmaceuticals

Notice Regarding the Presentation of Phase III Clinical Trial Data for the Gastric Acid Secretion Inhibitor Tegoprazan at the International Conference DDW 2026

The licensee and sublicensee presented detailed positive data, including healing and maintenance of healing, from the US Phase 3 trial of tegoprazan at DDW 2026. Superiority over the comparator drug lansoprazole was reported for healing rates and the 24-week maintenance-of-healing rate.

Worth reading
68In focus
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Improvement
Direction inferred from the company’s description.
Scale
1245
Number of patients enrolled in the trial (example)
Wording
Conditional
How definitive the wording is.

Announced details

tegoprazanK-CAB®
Applicable field (uses covered by this announcement)
Healing of erosive gastroesophageal reflux disease (EE)Maintenance of healing following healing of EERelief of heartburn associated with non-erosive gastroesophageal reflux disease (NERD)Treatment of GERD in adults
Launch dateLaunched in South Korea in 2019 (actual). US approval expected in January 2027.
Contract DateSeptember 2010, November 2019, December 2021
What the company reported numerically
Quantitative Effects

Complete healing rate at 8 weeks: tegoprazan 84.6% vs. lansoprazole 78.0%; difference: 6.6 percentage points

Complete healing rate at 2 weeks: 76.4% vs. 67.0%; difference: 9.4 percentage points

Two-week healing rate for severe EE: 74.1% vs. 54.5%; difference: 19.6 percentage points

Eight-week healing rate for severe EE: 83.2% vs. 68.0%; difference: 15.2 percentage points

24-week maintenance-of-complete-healing rate across all LA grades: tegoprazan 100 mg, 69.4%; 50 mg, 61.4%; lansoprazole 15 mg, 50.6%

24-week maintenance-of-complete-healing rate for severe EE: tegoprazan 100 mg 76.4% vs. lansoprazole 44.3%; difference: 32.1 percentage points

Usage history

Cumulative domestic sales in South Korea (outpatient prescription sales): KRW 923.3 billion through 2025. Sold in 20 countries. Business activities, including development, manufacturing and sales, conducted in 57 countries worldwide. Marketing approval obtained in 23 countries worldwide (according to Sebela materials).

Relationship between the counterparty and the company
RaQualia Pharma Inc.4579
Relationship with the Company

In September 2010, the Company entered into an exclusive license agreement for tegoprazan in East Asia with CJ HealthCare Corporation (now HK inno.N Corporation). In November 2019, the partnership was expanded to North America and Europe. In December 2021, HK inno.N Corporation entered into an agreement with Braintree covering the exclusive development, manufacturing and marketing rights in the United States and Canada. The Company is entitled to receive a portion of the revenue that HK inno.N Corporation receives from its partner.

CounterpartyHK inno.N Corporation (HK inno.N)Sebela Pharmaceuticals Inc. (Sebela)Braintree Laboratories, Inc.

HK Inno.N: headquartered in Osong, South Korea. Sebela: headquartered in Georgia, United States. Sebela focuses on gastrointestinal products and also operates in women's health. Braintree is a division of Sebela that has pursued the research and development, manufacturing and commercialization of gastrointestinal products for more than 40 years. Its locations are in Roswell, Georgia, United States; Braintree, Massachusetts, United States; and Dublin, Ireland.

Registration number and expiry date

TRIUMpH-EE:NCT05587309、TRIUMpH-NERD:NCT05587322

Location (as indicated in this announcement)

HK Inno.N Corporation: Osong, South Korea. Sebela: Georgia, United States. Sebela locations: Roswell, Georgia, United States; Braintree, Massachusetts, United States; and Dublin, Ireland.

Impact on Business Performance

The Company will receive no upfront payment in connection with this matter. The Company explained that the matter will contribute to increased value over the medium to long term.

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

Digestive Disease Week® 2026

Sebela Pharmaceuticals press release dated 5 May 2026

American Association for the Study of Liver Diseases(AASLD)

American Gastroenterological Association(AGA)

American Society for Gastrointestinal Endoscopy(ASGE)

Society for Surgery of the Alimentary Tract(SSAT)

Announced details
ItemDetails
Names of Products / Services Coveredtegoprazan, K-CAB®
CounterpartyHK inno.N Corporation (HK inno.N), Sebela Pharmaceuticals Inc. (Sebela), Braintree Laboratories, Inc.
Counterparty overviewHK Inno.N: headquartered in Osong, South Korea. Sebela: headquartered in Georgia, United States. Sebela focuses on gastrointestinal products and also operates in women's health. Braintree is a division of Sebela that has pursued the research and development, manufacturing and commercialization of gastrointestinal products for more than 40 years. Its locations are in Roswell, Georgia, United States; Braintree, Massachusetts, United States; and Dublin, Ireland.
Relationship with the CompanyIn September 2010, the Company entered into an exclusive license agreement for tegoprazan in East Asia with CJ HealthCare Corporation (now HK inno.N Corporation). In November 2019, the partnership was expanded to North America and Europe. In December 2021, HK inno.N Corporation entered into an agreement with Braintree covering the exclusive development, manufacturing and marketing rights in the United States and Canada. The Company is entitled to receive a portion of the revenue that HK inno.N Corporation receives from its partner.
Contract DateSeptember 2010, November 2019, December 2021
Launch dateLaunched in South Korea in 2019 (actual). US approval expected in January 2027.
Applicable areaHealing of erosive gastroesophageal reflux disease (EE), Maintenance of healing following healing of EE, Relief of heartburn associated with non-erosive gastroesophageal reflux disease (NERD), Treatment of GERD in adults
Registration number and expiry dateTRIUMpH-EE:NCT05587309、TRIUMpH-NERD:NCT05587322
LocationHK Inno.N Corporation: Osong, South Korea. Sebela: Georgia, United States. Sebela locations: Roswell, Georgia, United States; Braintree, Massachusetts, United States; and Dublin, Ireland.
Quantitative EffectsComplete healing rate at 8 weeks: tegoprazan 84.6% vs. lansoprazole 78.0%; difference: 6.6 percentage points, Complete healing rate at 2 weeks: 76.4% vs. 67.0%; difference: 9.4 percentage points, Two-week healing rate for severe EE: 74.1% vs. 54.5%; difference: 19.6 percentage points, Eight-week healing rate for severe EE: 83.2% vs. 68.0%; difference: 15.2 percentage points, 24-week maintenance-of-complete-healing rate across all LA grades: tegoprazan 100 mg, 69.4%; 50 mg, 61.4%; lansoprazole 15 mg, 50.6%, 24-week maintenance-of-complete-healing rate for severe EE: tegoprazan 100 mg 76.4% vs. lansoprazole 44.3%; difference: 32.1 percentage points
Usage historyCumulative domestic sales in South Korea (outpatient prescription sales): KRW 923.3 billion through 2025. Sold in 20 countries. Business activities, including development, manufacturing and sales, conducted in 57 countries worldwide. Marketing approval obtained in 23 countries worldwide (according to Sebela materials).
Impact on Business PerformanceThe Company will receive no upfront payment in connection with this matter. The Company explained that the matter will contribute to increased value over the medium to long term.
SourceDigestive Disease Week® 2026, Sebela Pharmaceuticals press release dated 5 May 2026, American Association for the Study of Liver Diseases(AASLD), American Gastroenterological Association(AGA), American Society for Gastrointestinal Endoscopy(ASGE), Society for Surgery of the Alimentary Tract(SSAT)
Items this document does not state (5)
Contract ValueOffering priceAward/certification nameAwarding / certifying bodyLocation scale

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

Because Phase 3 trial data were presented orally at DDW 2026. The Company explained that this represents important progress in the development of tegoprazan's business in the United States and will contribute to increased value over the medium to long term.

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Notice Regarding the Presentation of Phase III Clinical Trial Data for the Gastric Acid Secretion Inhibitor Tegoprazan at the International Conference DDW 2026 | RaQualia Pharma Inc. (4579) timely disclosure | Komori