AdAlta (ASX: 1AD) Wins China Special Access for CAR-T Therapy

AdAlta’s Chinese partner has secured approval to provide BZDS1901 to eligible advanced mesothelioma patients through a special access pathway in Hainan.

Shanghai Cell Therapy Group, known as SHcell, will supply the therapy at Ruijin Hospital, Hainan. The hospital is a Grade A tertiary institution within the Boao Lecheng special access zone.

Approval followed an independent review by Hainan’s provincial health and medicines authorities. Regulators assessed evidence covering the therapy’s safety and possible efficacy.

Access Outside Clinical Trials

Eligible patients can apply for treatment outside a clinical trial under Boao Lecheng’s clinical translation and application pathway. Hospitals may charge patients at prices registered with Hainan authorities.

The decision was supported by completed investigator-initiated trials in advanced mesothelioma. BZDS1901 has also received Chinese regulatory clearance to enter formal Phase I/II clinical trials.

However, the Hainan decision is not national marketing approval from China’s National Medical Products Administration. It applies only to selected patients within the designated zone.

AdAlta will receive no revenue from patients treated under the scheme. Greater China remains SHcell’s territory under the companies’ development and collaboration agreement.

Building the Evidence Base

The treating hospital will provide information covering patient numbers, side effects and treatment outcomes. That creates an expanding source of real-world evidence for BZDS1901 and AdAlta’s related EW-001 program.

AdAlta cautioned that this evidence will not carry the rigour of a controlled clinical study. It will be supportive, rather than directly predictive, of results from AdAlta’s planned trials.

Still, the data may support a future Chinese registration. AdAlta also expects to present the evidence to the US FDA and prospective commercial partners at no cost to the company.

Same Therapy, Different Manufacturing

BZDS1901 is the Chinese version of EW-001, AdAlta’s lead CAR-T cell therapy. Both contain the same active CAR and engineered armouring technology.

Patients in Hainan will receive product made through SHcell’s first-generation manufacturing process. AdAlta is transferring a faster, lower-cost third-generation process to Cell Therapies in Australia.

The first Australian manufacturing runs remain scheduled for the second half of calendar 2026. A pre-IND meeting with the US FDA is anticipated during the same period.

Those activities are intended to prepare EW-001 for an Australian Phase 1 study. Separate regulatory approvals will still be required in Australia, the United States and Europe.

Mesothelioma Treatment Context

Mesothelioma is a rare, aggressive cancer commonly associated with asbestos exposure. Options become especially limited after patients relapse following initial chemotherapy or immunotherapy.

The announcement said median survival after relapse is often only eight to 10 months. Complete tumour clearance is almost never recorded in second-line patients using current treatments.

Early Chinese studies of EW-001 in relapsed or advanced disease reported overall response rates of up to 50%. Complete responses reached up to 20%, while median overall survival has not yet been reached in the current cohort.

An earlier generation achieved median survival exceeding 25 months. These findings remain early-stage clinical evidence and do not replace AdAlta’s planned Western clinical program.