Key Highlights

  • AdAlta's partner SHcell has received official approval to provide BZDS1901 to eligible advanced mesothelioma patients in China's Hainan Boao Lecheng special access zone.
  • Approval followed an independent assessment of BZDS1901's safety and possible efficacy by Hainan's provincial health and medicines authorities, with treatment provided at Ruijin Hospital, Hainan.
  • Patients will receive BZDS1901 made using SHcell's first generation Manufacturing process, while AdAlta's EW-001 will use a faster, lower cost third generation process for Western markets.
  • AdAlta does not receive Revenue from patients treated in Hainan, but SHcell will continue supplying real-world safety and outcome data supporting EW-001's global development program.

AdAlta Limited (ASX:1AD) has announced that its co-development partner, Shanghai Cell Therapy Group Co Ltd (SHcell), has received official approval to provide BZDS1901 to eligible patients with advanced mesothelioma under a special access scheme in China's Hainan Boao Lecheng International Medical Tourism Pilot Zone. Shares in AdAlta were trading at A$0.0030, unchanged (0.00%) as at 10:01am GMT+10 on 2 September 2026.

BZDS1901 is the China version of EW-001, AdAlta's lead CAR-T cell therapy, containing the same engineered features. Treatment will be provided at Ruijin Hospital, Hainan, a Grade A tertiary hospital affiliated with Shanghai Jiao Tong University School of Medicine, following an independent assessment of the therapy's safety and possible efficacy by Hainan's provincial health and medicines authorities.

What the Approval Permits

Boao Lecheng is a special zone within China's Hainan Free Trade Port, created to give patients earlier access to promising new medicines and medical technologies that are ethically sound and have been shown to be safe and potentially effective. New biomedical technologies used in the zone are independently approved by Hainan's provincial authorities under the zone's own rules, rather than centrally by China's National Medical Products Administration (NMPA).

BZDS1901 qualified on the strength of completed investigator-initiated trials in advanced mesothelioma in China and the NMPA's approval for BZDS1901 to enter formal Phase I/II clinical trials. The approval means eligible patients can apply to be treated with BZDS1901 at Ruijin Hospital, Hainan, outside a clinical trial and under the zone's clinical translation and application pathway, with the hospital permitted to charge patients at prices registered with and published by the Hainan authorities.

Scope and Limitations of the Approval

The company was explicit about what the approval does not change. It permits BZDS1901 to be provided to selected patients within one zone in one Chinese province and is expressly distinct from full NMPA Marketing approval. Patients in Hainan will receive BZDS1901 made with SHcell's first generation manufacturing process, while AdAlta is separately establishing SHcell's faster, lower cost third generation process in Australia for EW-001. The approval also does not replace the regulatory approvals AdAlta needs in the United States, Europe or Australia, which will continue to require AdAlta's own clinical trial program.

AdAlta confirmed it does not receive revenue from patients treated in Hainan, as Greater China is SHcell's territory under the parties' Development and Collaboration Agreement, and AdAlta's rights to develop and commercialise EW-001 in markets outside Greater China are unaffected.

Real-World Data Supporting Global Development

SHcell will continue to receive information from the treating hospital on the number of patients treated, any side effects experienced, and treatment responses. The company noted that this real-world experience will not carry the rigour of a controlled study but is drawn from the same disease and patient population AdAlta intends to study, and will be supportive of, rather than directly predictive of, AdAlta's own results.

AdAlta said this data strengthens the global evidence base for EW-001, may be submitted in support of a future Chinese registration, and reduces uncertainty for AdAlta, regulators and prospective commercial partners.

Company Program and Next Steps

AdAlta's own program continues on plan, with transfer of manufacturing to Cell Therapies Pty Ltd progressing and first Australian manufacturing runs expected in the second half of calendar 2026. A pre-IND meeting with the US FDA is anticipated in the same period, steps the company said pave the way for its Australian Phase 1 study.

AdAlta CEO and Managing Director Dr Tim Oldham said an independent group of regulators had examined the BZDS1901/EW-001 safety and efficacy data and concluded the therapy could be offered to patients outside a clinical trial, describing this as a meaningful external endorsement. He added that patients with advanced mesothelioma have almost nothing else available to them, and that every patient treated at Ruijin Hospital adds to the body of evidence supporting the development of EW-001.

Conclusion

AdAlta's China partner has secured approval to treat advanced mesothelioma patients with BZDS1901 outside a formal clinical trial, marking an independent regulatory endorsement of the therapy's safety and possible efficacy within one designated Chinese pilot zone. The approval does not generate revenue for AdAlta and does not substitute for the separate regulatory pathways the company must still pursue in the United States, Europe and Australia for its own EW-001 product, which uses a different, third-generation manufacturing process. Its principal near-term value to AdAlta lies in the flow of real-world safety and outcome data the arrangement is expected to generate, supporting the company's parallel Australian manufacturing transfer and planned FDA engagement later in 2026.