TSH Biopharm (TW-8432) announced a strategic partnership with Tenacia Biotechnology to secure the Taiwan market rights for ZTALMY®, an innovative treatment for CDKL5 Deficiency Disorder (CDD). This milestone strengthens TSH Biopharm’s presence in the central nervous system (CNS) disease segment and enhances its competitiveness in the rare disease market.

CDD is a rare neurodevelopmental disorder that typically manifests in infancy, characterized by severe epileptic seizures and developmental delays. Recognized by the World Health Organization (WHO) as a rare disease since 2020, CDD has not yet been officially classified as such in Taiwan. Existing antiepileptic medications offer limited efficacy for CDD, leaving a significant unmet clinical need. ZTALMY® is the first therapy specifically developed for CDD. Clinical trials have demonstrated its ability to significantly reduce major motor seizure frequency and it has been approved by both the U.S. FDA and European authorities.

In 2022, the global rare disease treatment market was valued at USD 98.61 billion and is projected to grow at a compound annual growth rate (CAGR) of 10.42% through 2028. With growing international focus on rare diseases, TSH Biopharm is actively engaging in global collaborations to fill market gaps and bring innovative therapies to Taiwan, offering new hope for patients.

Sze Yuan (Grace) Yang, General Manager of TSH Biopharm, stated:
“The introduction of ZTALMY® demonstrates our ongoing commitment to improving patients’ quality of life and further reinforces our strategic role as a regional partner for innovative biotech development in Asia. Through this collaboration with Tenacia Biotechnology, we aim to bring cutting-edge treatments to Taiwan and provide more comprehensive medical support for CDD patients, enhancing access to innovative care.”

Chih-Hsiang Chen, CEO of Tenacia Biotechnology, added:
“ZTALMY® has already proven its clinical value in global markets. We believe that, through our partnership with TSH Biopharm, we can accelerate its launch in Taiwan, benefiting more CDD patients and advancing the field of rare disease treatment.”

This collaboration marks a major step forward for TSH Biopharm in the treatment of CDD, accelerating the clinical adoption of ZTALMY® and bringing hope to patients with CDKL5 Deficiency Disorder. Recognized among the top 5% in corporate governance among Taiwan's OTC-listed companies, TSH Biopharm continues to demonstrate robust governance and execution capabilities.

Looking ahead, TSH Biopharm will continue to deepen its focus in CNS and rare disease areas, actively expanding international partnerships, broadening its product portfolio, and enhancing access to innovative therapies. The company remains committed to delivering patient-centric solutions and driving healthcare innovation forward.