Horien Biotech’s Global Expansion Gains Renewed Attention: Three Class 4 Approvals from the Thai FDA and U.S. Patent Achievements Featured in International Media

HORIEN Biochemical Technology Co., Ltd. (TPEx: 7814) continues to advance its international market expansion. The Company has recently achieved significant progress in both the Thai medical device market and its international intellectual property strategy. Related news was distributed through the PR Newswire global news release network and subsequently published or syndicated by international and Asian media platforms, including Yahoo Finance and Kosmo Digital. This further enhances the international visibility of the HORIEN brand and Taiwan’s biomedical materials technology.

Three Collagen-Based Medical Devices Receive Thai FDA Class 4 Approvals

One of the key developments highlighted by international media is the formal approval of three collagen-based medical devices developed by HORIEN Biochemical Technology under the Thai Food and Drug Administration (Thai FDA) Class 4 classification:

The three products cover a range of medical applications, including dentistry, surgery, and tissue care. Completion of the approval process for these high-risk medical devices in Thailand marks an important milestone in HORIEN’s expansion into Southeast Asia. It also establishes a foundation for the Company to develop distribution partnerships, professional education programs, and local market support services in Thailand.

HORIEN is currently engaging with Thai medical device partners that possess experience in dental, surgical, and regenerative medicine distribution channels. Through localized market strategies and professional support, the Company aims to gradually establish long-term and stable partnerships.

Biodegradable Ureteral Stent Receives U.S. Patent

In addition to expanding into Southeast Asian markets, HORIEN’s independently developed Biodegradable Ureteral Stent has received a U.S. invention patent, demonstrating the Company’s continued efforts to extend its biomedical materials technologies into additional medical fields.

From its existing dental and collagen-based biomedical materials products to technologies related to urological medical devices, HORIEN continues to invest in materials science, manufacturing processes, and medical device product development. Through patents, regulatory approvals, and international market partnerships, the Company is gradually building a more comprehensive biomedical materials technology platform.

International Media Exposure Enhances HORIEN Brand Visibility

Following the official release of the international news on September 8, 2026, the announcement was published across multiple international and Asian media outlets and financial information platforms, including:

In addition to the platforms listed above, the announcement continues to be distributed through international news networks across different regional markets, enabling more healthcare industry professionals, distribution partners, and international audiences to follow the development of Taiwan’s biomedical materials industry.

From Taiwan to the Global Market: Deepening Southeast Asian Expansion

Thailand is one of the key markets in HORIEN’s Southeast Asian expansion strategy. The approval of three products under the Thai FDA Class 4 classification not only represents an important regulatory foundation for entering the Thai market, but also enables the Company to further develop local distribution partnerships and market opportunities.

HORIEN General Manager Hsin-Yu Ho stated that Thailand is an important part of HORIEN’s Southeast Asian market development strategy. In the next phase, the Company will focus on identifying partners with established clinical distribution networks and a strong commitment to professional medical education, with the goal of building long-term partnerships with substantial market depth.

Looking ahead, HORIEN will continue to focus on independent research and development, biomedical materials technology, international regulatory strategy, and local market partnerships. The Company will deepen its presence in Thailand and Southeast Asia while actively pursuing additional international certifications and patent opportunities for its products, bringing biomedical materials technologies from Taiwan to more markets around the world.

HORIEN Biochemical Technology — From Taiwan to the Global Healthcare Market.