Chinese regulators clear AdAlta partner to treat mesothelioma patients with CAR-T therapy
AdAlta Limited (ASX:1AD) has confirmed that its co-development partner, Shanghai Cell Therapy Group Co Ltd (SHcell), has received official approval to provide BZDS1901, the China version of AdAlta’s lead CAR-T therapy EW-001, to eligible patients with advanced mesothelioma under a special access scheme in China. Treatment will be offered at Ruijin Hospital, Hainan, a Grade A tertiary (top tier) hospital within the Hainan Boao Lecheng International Medical Tourism Pilot Zone.
For investors, the development carries two-fold significance: an independent regulatory assessment of the therapy’s safety and possible efficacy, and a growing flow of real-world data at no cost to AdAlta. BZDS1901 contains the same engineered features as EW-001, but this clearance is a special access approval, not NMPA marketing approval.
Importantly, AdAlta does not receive revenue from patients treated in Hainan. Greater China is SHcell’s territory under the parties’ Development and Collaboration Agreement, meaning the direct financial impact on AdAlta is limited to its value as validation and evidence.
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What the approval actually covers
Boao Lecheng is a special zone within China’s Hainan Free Trade Port, created to give patients earlier access to promising new medicines that are ethically sound and have been shown to be safe and potentially effective. Approval followed an independent assessment by Hainan’s provincial health and medicines authorities, not China’s national NMPA.
BZDS1901 qualified on the strength of completed investigator-initiated trials (IITs) in advanced mesothelioma in China, together with the NMPA’s approval for BZDS1901 to enter formal Phase I/II clinical trials.
In practical terms, the approval means that:
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Eligible advanced mesothelioma patients can apply to be treated with BZDS1901 at Ruijin Hospital, Hainan.
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Treatment is provided outside a clinical trial, under the zone’s “clinical translation and application” pathway.
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Hospitals in the zone may charge patients for approved technologies at prices registered with, and published by, the Hainan authorities.
What it does not change
Equally important is what this clearance does not do. The table below separates what the approval delivers from what it does not.
| Element | What the approval does | What it does NOT do |
|---|---|---|
| Scope | Permits BZDS1901 to be provided to selected patients within one zone in one Chinese province | Is NOT full NMPA marketing approval |
| Product | Patients receive BZDS1901 made with SHcell’s first generation manufacturing process | AdAlta is separately establishing the faster, lower cost third generation process in Australia for EW-001 |
| Regulatory path | Adds real-world evidence supporting EW-001 development | Does NOT replace the approvals AdAlta needs in the US, Europe or Australia |
Dr Tim Oldham, CEO & Managing Director, AdAlta
“First, an independent group of regulators has examined the BZDS1901/EW-001 safety and efficacy data and concluded that the therapy can be offered to patients outside a clinical trial. That is a meaningful external endorsement of a product we have believed in from the outset. Second, patients with advanced mesothelioma have almost nothing available to them. Every patient treated at Ruijin Hospital, Hainan, is a patient who now has real hope – and every one of them adds to the body of evidence providing confidence and momentum behind development of EW-001, and that is exactly what our East to West strategy is designed to convert into value for shareholders.”
Understanding CAR-T therapy and why mesothelioma matters
CAR-T (chimeric antigen receptor-T cell) therapy is a living drug manufactured from a patient’s own immune cells. These cells are engineered in a laboratory to incorporate a receptor that can bind to a molecule found on the surface of a cancer, enabling the immune cells to find and kill the cancer. As a living drug, a single dose has the potential for durable effects and to be potentially curative.
Mesothelioma is a rare but rapidly fatal cancer usually linked to asbestos exposure. Once the disease returns, second-line patients face a median survival of only eight to ten months, leaving them with very limited options.
The durability signal behind EW-001 extends well beyond response rates, with one complete responder now passing a two-year cancer-free milestone following a single infusion, an outcome that has no documented precedent in second-line mesothelioma treatment.
For investors, this represents a severely underserved market. Solid tumours account for 90% of cancers yet remain underserved by current cellular immunotherapies. The cellular immunotherapy market is projected to grow at a compound annual growth rate of 34% to reach US$20.3 billion by 2028.
How EW-001 compares to current treatments
Current second-line treatment outcomes for mesothelioma remain poor. Against this backdrop, early EW-001 studies in China have reported encouraging figures, though these are early results rather than controlled trial data.
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Current second-line treatments: tumour shrinkage (Overall Response) in only 11-29% of patients; complete tumour clearance almost never; median survival of 8-10 months.
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EW-001 China studies (second line and later): up to 50% Overall Response rate; up to 20% Complete Response rate; median overall survival not yet reached in the current cohort, though an earlier generation achieved more than 25 months median survival.
According to AdAlta, these early results suggest EW-001 may offer a potential new treatment option for patients with few alternatives.
The investment case: validation, data and momentum
The approval sits within AdAlta’s “East to West” strategy, which integrates Asia’s prowess in T-cell therapy development with the efficiency and quality of Australia’s clinical and manufacturing ecosystem to connect Eastern innovation with Western regulated markets.
For shareholders, the significance of the announcement lies in three things:
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Validation. An independent regulatory authority has assessed EW-001’s safety and possible efficacy and found it suitable to offer to patients.
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Data. The safety and outcome data from these additional patients adds to the evidence AdAlta will present to the US FDA and to prospective partners, at no cost to AdAlta.
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Momentum. Clinician and patient demand in China is a real-world signal of the need EW-001 is designed to meet.
AdAlta has noted that this real-world experience will not have the rigour of a controlled study. It will be supportive of, rather than directly predictive of, AdAlta’s own results, but it strengthens the global evidence base for EW-001 and may be submitted in support of a future Chinese registration.
What comes next for AdAlta
AdAlta’s own program continues on plan. Transfer of manufacturing to Cell Therapies Pty Ltd is progressing, with 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. Together, these steps are designed to pave the way for AdAlta’s Australian Phase 1 study.
Ahead of that meeting, AdAlta secured FDA-submission-ready safety data and CAR-T cell persistence records from five additional patients treated in China following its final milestone payment to SHcell, materially strengthening the regulatory package it will bring to the pre-IND discussion.
Each patient treated in Hainan adds to the body of evidence behind EW-001 at no cost to AdAlta. By connecting Asian innovation in cellular immunotherapy with Western regulated markets, the strategy is designed to convert this validation, data and momentum into value for shareholders.
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