Tenacia Biopharmaceuticals Partners with Golden Age Health to Launch First CDKL5 Deficiency Disorder Treatment in China
核心洞察
Tenacia Biopharmaceuticals and Golden Age Health (搜索) announced a commercialization agreement for ZTALMY®, the first and only approved treatment for CDKL5 (搜索) deficiency disorder in mainland China.
ZTALMY® (ganaxolone oral suspension) received approval from China's National Medical Products Administration in July 2024 for treating seizures in CDD patients aged 2 years and older.
The partnership leverages Golden Age Health (搜索)'s rare disease commercialization platform to ensure patient access through disease awareness, diagnosis support, and affordability programs.
Tenacia Biopharmaceuticals (Shanghai) Co., Ltd. and Golden Age Health (搜索) (Shanghai) Co., Ltd. announced a commercialization agreement granting Golden Age Health exclusive rights to commercialize ZTALMY® (ganaxolone oral suspension) in mainland China. The drug represents the first and only approved treatment for CDKL5 (搜索) deficiency disorder (CDD) in the country, marking a significant milestone for patients with this rare neurological condition.
Regulatory Approval and Development Background
ZTALMY® received approval from China's National Medical Products Administration in July 2024 for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5 (搜索)) deficiency disorder in patients 2 years of age and older. The drug was originally developed by Marinus (搜索), with Tenacia obtaining exclusive rights to develop and commercialize it in Greater China.
The oral suspension formulation (110ml: 5.5g) functions as a neuroactive steroid GABAA receptor positive allosteric modulator, representing the first therapy specifically approved for this indication in China.
Strategic Partnership for Rare Disease Access
The collaboration aims to leverage Golden Age Health (搜索)'s comprehensive patient-focused commercialization platform, which encompasses disease awareness, diagnosis support, market access, and patient affordability programs. This approach is designed to ensure the therapy reaches families affected by this devastating rare epilepsy.
"Bringing the first approved therapy for CDKL5 (搜索) deficiency disorder to patients in China represents exactly the type of mission-critical work Golden Age Health (搜索) 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), emphasized the strategic value of the partnership: "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."
Understanding CDKL5 Deficiency Disorder
CDKL5 (搜索) deficiency disorder 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. The condition is included in China's National Rare Disease Catalog, reflecting the urgent need for effective treatments for affected patients and their families.
Company Profiles
Golden Age Health (搜索) operates as a specialty pharmaceutical company dedicated to redefining patient access to medicine across China, Asia-Pacific, and the Middle East and Africa. Headquartered in Singapore, the company combines data-driven market-access expertise with medical affairs and real-world evidence capabilities to bring high-impact therapies to underserved populations.
Tenacia Biopharmaceuticals, founded in 2022 by Bain Capital (搜索), functions as a commercial-stage biopharmaceutical company focused on developing innovative therapeutics for patients with underserved neurological disorders. The company's management team brings decades of drug development experience from multinational corporations and biotechnology companies, with expertise in complex disease biology and insights into unmet patient needs.