First-ever approved treatment for CDD in China now set for commercial launch through dedicated rare disease platform
Tenacia Biopharmaceuticals (Shanghai) Co., Ltd. ("Tenacia") and GOLDEN AGE HEALTH (SHANGHAI) CO., LTD., a subsidiary of Golden Age Health Pte. Ltd. (collectively, "GAH") today announced a Commercialization Agreement granting GAH exclusive rights to commercialize ZTALMY® (泽元安), the first and as of now only approved treatment for CDKL5 deficiency disorder (CDD) in Mainland China.
ZTALMY® (ganaxolone oral suspension) was developed by Marinus and Tenacia obtains exclusive rights to develop and commercialize it in Greater China. In July 2024, the drug was approved by the National Medical Products Administration for treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.
Tenacia has partnered with GAH to leverage its comprehensive patient-focused commercialization platform—encompassing disease awareness, diagnosis support, market access, and patient affordability programs—to ensure this therapy reaches the families affected by this devastating rare epilepsy.
"Bringing the first approved therapy for CDKL5 deficiency disorder to patients in China represents exactly the type of mission-critical work Golden Age Health was built for," said Chao (Brook) Wu, Chief Executive Officer of Golden Age Health (Shanghai). "We are honored to partner with Tenacia to ensure that children and families affected by CDD can access this breakthrough treatment as quickly as possible."
Dr. Xiaoxiang Chen, Founder and CEO of Tenacia Biopharmaceuticals (Shanghai), said: "GAH's proven expertise in rare disease commercialization and their commitment to patient access make them the ideal partner to bring ZTALMY® to the patients who need it most in China. Together, we will work to maximize the impact of this important therapy."
About CDKL5 Deficiency Disorder
CDKL5 deficiency disorder (CDD) is a rare developmental epileptic encephalopathy caused by mutations in the CDKL5 gene. Patients typically experience early-onset, treatment-resistant seizures, profound developmental delays, and motor impairments. CDD is included in China's National Rare Disease Catalog, reflecting the urgent need for effective treatments for affected patients and their families.
About ZTALMY® (ganaxolone oral suspension)
ZTALMY® (ganaxolone oral suspension) is a neuroactive steroid GABAA receptor positive allosteric modulator. The oral suspension formulation (110ml: 5.5g) is approved by China's NMPA for the treatment of seizures associated with CDKL5 deficiency disorder in patients 2 years of age and older. It represents the first therapy specially approved for this indication in China.
About Golden Age Health
Golden Age Health is a specialty pharmaceutical company dedicated to redefining patient access to medicine across China, Asia-Pacific and MEA. Headquartered in Singapore, GAH pairs data-driven market-access expertise with deep medical-affairs and RWE capabilities to bring high-impact therapies to underserved populations.
About Tenacia Biopharmaceuticals
Founded in 2022 by Bain Capital, Tenacia is a commercial-stage biopharmaceutical company dedicated to developing innovative therapeutics for patients with underserved neurological disorders. Tenacia's seasoned management team brings decades of drug development experience from both MNCs and biotechs. Their deep understanding of complex disease biology and insights into unmet patient needs enable Tenacia to create a highly efficient neuroscience R&D platform with a proven track record of advancing novel therapies. Empowered by its founder and strategic investor, Bain Capital – through significant initial investment, long-term commitment and extensive life science network – Tenacia is poised to become a leading neuroscience company in China and deliver substantial value to shareholders while upholding an unwavering commitment to the patients.
Forward-Looking Statements
This release contains forward-looking statements, including expectations regarding clinical development, regulatory matters and commercial launches. These statements involve risks and uncertainties that may cause actual outcomes to differ materially.