AdAlta’s partner, Shanghai Cell Therapy Group (SHcell), has been approved to provide BZDS1901 CAR-T therapy (AdAlta product code EW-001) to advanced mesothelioma patients under a special access scheme in China

This is further endorsement of the potential for EW-001 to transform outcomes in advanced mesothelioma and other solid cancers, and will provide an additional source of data to inform planned future clinical studies in Australia.

Approval follows an independent assessment of safety and possible efficacy, brings new hope to patients with very few options, and gives AdAlta a growing source of real-world data on its lead product

• SHcell has received official approval to provide BZDS1901 to eligible advanced mesothelioma patients in China’s Hainan Boao Lecheng special access zone.

• Patients will receive BZDS1901 manufactured using SHcell’s first generation manufacturing process; AdAlta’s EW-001 contains the same engineered armoured CAR-T features but will use a faster, lower cost third generation manufacturing process in Australia for Western markets.

• Approval followed an independent assessment of BZDS1901’s safety and possible efficacy by Hainan’s health and medicines regulators.

• Treatment will be provided at Ruijin Hospital, Hainan, a top tier (Grade A tertiary) hospital in the zone.

• SHcell and AdAlta will continue to receive data on the number of patients treated and their safety and treatment outcomes, providing real-world evidence supporting BZDS1901/EW-001 development in China and around the world.