Tenacia Biopharmaceuticals (Shanghai), a commercial-stage biopharma company, has entered into an exclusive commercialisation agreement with Golden Age Health (Shanghai), a subsidiary of Golden Age Health (GAH), for Ztalmy in Mainland China.

Under the agreement, GAH will hold exclusive rights to commercialise Ztalmy (ganaxolone oral suspension), currently the first and only approved treatment in China for seizures associated with CDKL5 Deficiency Disorder (CDD). The therapy was originally developed by Marinus Pharmaceuticals, with Tenacia holding exclusive rights to develop and commercialise it in Greater China.

In July 2024, China’s National Medical Products Administration (NMPA) approved Ztalmy for the treatment of seizures linked to CDD in patients aged two years and older. CDD is a rare genetic developmental epileptic encephalopathy caused by mutations in the CDKL5 gene and is characterised by early-onset, drug-resistant seizures, severe developmental delays and motor impairments. The condition is listed in China’s National Rare Disease Catalog, underscoring the urgent need for targeted therapies.

Through the partnership, Tenacia aims to leverage GAH’s patient-centric commercialisation platform, which includes disease awareness initiatives, diagnostic support, market access strategies and patient affordability programmes. The collaboration is designed to accelerate access to Ztalmy for families affected by this rare and debilitating disorder.

Chao (Brook) Wu, Chief Executive Officer of Golden Age Health (Shanghai), said the partnership aligns with the company’s mission to expand access to critical therapies for underserved patient populations. He added that GAH is committed to ensuring timely availability of the breakthrough treatment to children and families living with CDD.

Dr. Xiaoxiang Chen, Founder and CEO of Tenacia Biopharmaceuticals (Shanghai), stated that GAH’s expertise in rare disease commercialisation and patient access makes it a strategic partner to maximise the therapy’s reach and impact in China.

Ztalmy is a neuroactive steroid that acts as a positive allosteric modulator of GABAA receptors. The approved oral suspension formulation marks a milestone as the first therapy specifically indicated for CDD in China.

Golden Age Health, headquartered in Singapore, focuses on expanding patient access to innovative medicines across China, Asia-Pacific and the Middle East and Africa, combining data-driven market access strategies with strong medical affairs and real-world evidence capabilities.

Founded in 2022 by Bain Capital, Tenacia Biopharmaceuticals is dedicated to developing innovative therapies for underserved neurological disorders, supported by a leadership team with extensive experience across multinational pharmaceutical companies and biotech firms.