AdAlta Partner to Provide Adapted CAR-T Mesothelioma Therapy in China under Special Access Scheme

AdAlta (ASX: 1AD) co-development partner Shanghai Cell Therapy Group has received approval to provide BZDS1901 first-in-class, armored CAR-T cell therapy to eligible patients with advanced mesothelioma.

The approval, which falls under a special access scheme in China’s Hainan Boao Lecheng international medical tourism pilot zone, was granted after Hainan’s provincial health and medicines authorities independently assessed BZDS1901’s safety and efficacy evidence.

The therapy will be available at Ruijin Hospital to qualifying patients with mesothelin-positive advanced malignant mesothelioma, who currently face a median survival of up to 10 months on recurrence of the disease.

BZDS1901 is China’s version of AdAlta’s EW‑001 lead CAR-T cell therapy, which contains the same engineered features but employs a faster, lower-cost third generation manufacturing process in Australia for Western markets.

Early Access to New Medicines

Located within China’s Hainan free trade port, Boao Lecheng is a special zone created to give patients earlier access to promising new medicines and technologies that are ethically sound and have been shown to be safe and potentially effective.

New products used in the zone are independently approved by Hainan’s provincial health and medicines authorities under the zone’s own rules, rather than being centrally approved by China’s National Medical Products Administration.

BZDS1901 qualified on the strength of investigator-initiated trials into advanced mesothelioma in China and follows the regulator’s approval for the therapy to enter formal Phase I/II clinical trials.

It means eligible patients with advanced mesothelioma can apply to be treated with BZDS1901 at Ruijin Hospital outside of a clinical trial, under the zone’s “clinical translation and application” pathway.

Shanghai Cell Therapy Group will continue to receive information from the treating hospital on the number of patients treated, any side effects they experience, and how well they respond.

Few Treatment Options

AdAlta chief executive officer Dr Tim Oldham said BZDS1901 would bring new hope to patients who have very few treatment options.

“An independent group of regulators has examined the BZDS1901/EW-001 safety and efficacy data and concluded that this therapy can be offered to patients outside of a clinical trial,” he said.

“That is a meaningful external endorsement of a product we have believed in from the outset.”

“Now every patient treated at Ruijin Hospital will have real hope, and every one of them adds to the body of evidence providing confidence and momentum behind the development of EW-001.”

“That is exactly what our East to West strategy is designed to convert into value for shareholders.”