AdAlta’s partner SHcell has gained regulatory approval to provide the BZDS1901 CAR-T therapy to advanced mesothelioma patients in China’s Hainan Boao Lecheng special access zone, marking a key milestone in real-world data collection and treatment availability.
- SHcell approved to treat advanced mesothelioma in Boao Lecheng
- Therapy uses first-generation manufacturing; faster process planned for Australia
- Approval based on independent safety and efficacy assessment
- Treatment at Ruijin Hospital, a top-tier facility in Hainan
- Real-world patient data to support global EW-001 development
Regulatory Green Light for CAR-T Therapy in China’s Special Access Zone
AdAlta’s partner, Shanghai Cell Therapy Group (SHcell), has secured official approval to provide BZDS1901, a CAR-T cell therapy, to eligible advanced mesothelioma patients under China’s Hainan Boao Lecheng International Medical Tourism Pilot Zone special access scheme. This regulatory nod follows an independent evaluation by Hainan’s provincial health and medicines authorities, who assessed the therapy’s safety and potential efficacy, allowing treatment outside of clinical trials at Ruijin Hospital, a Grade A tertiary hospital affiliated with Shanghai Jiao Tong University.
A New Treatment Avenue for a Tough Cancer
Mesothelioma patients with mesothelin-positive advanced disease face bleak prospects, with median survival typically just eight to ten months after relapse. BZDS1901, essentially the Chinese version of AdAlta’s lead CAR-T therapy EW-001, offers a novel option. While BZDS1901 uses SHcell’s first-generation manufacturing process, EW-001 will employ a more advanced and cost-efficient third-generation process in Australia to serve Western markets. This approval provides not only a treatment pathway for Chinese patients but also a valuable stream of real-world data to bolster ongoing development efforts globally.
Scope and Limitations of the Approval
The special access approval is geographically limited to the Boao Lecheng zone in Hainan province and does not equate to full marketing authorisation by China’s National Medical Products Administration. Patients treated will receive the first-generation manufactured BZDS1901, distinct from the faster manufacturing process AdAlta is establishing for EW-001 in Australia. Importantly, this pathway does not replace the need for regulatory approvals in Australia, the US, or Europe, where AdAlta’s clinical trials and regulatory submissions continue on schedule.
Real-World Data to Support Global Development
SHcell will collect ongoing data on patient numbers, safety, and treatment outcomes from Ruijin Hospital, providing real-world evidence that complements AdAlta’s clinical trial data. While this data lacks the rigour of controlled studies, it aligns with the same patient population and disease setting targeted by AdAlta’s EW-001 program. This growing evidence base may support future regulatory filings in China and reduce uncertainties with regulators and potential commercial partners.
AdAlta’s Progress in Manufacturing and Clinical Plans
AdAlta is advancing its own manufacturing transfer to Cell Therapies Pty Ltd in Australia, expecting initial production runs in the second half of 2026. A pre-IND meeting with the US FDA is also anticipated during this period, paving the way for an Australian Phase 1 clinical trial. This regulatory and manufacturing momentum complements the Chinese approval, reinforcing AdAlta’s ‘East to West’ strategy that bridges Asian innovation with Western regulatory frameworks and markets.
Clinical Promise of EW-001 in Mesothelioma
Early clinical studies of EW-001 in China have reported up to a 50% overall response rate and 20% complete response rate in relapsed or advanced mesothelioma patients, with median overall survival not yet reached. These results contrast sharply with current standard treatments, where complete tumour clearance is rare and median survival after relapse is under a year. The therapy’s engineered CAR-T features and armouring technology aim to provide durable cancer control from a single dose.
Strategic Implications for Shareholders
AdAlta CEO Dr Tim Oldham highlighted the dual significance of this approval: external regulatory validation of the therapy’s safety and efficacy, and the creation of a real-world patient treatment pathway that generates valuable data at no cost to AdAlta. This development underscores the unmet medical need in mesothelioma and the potential of AdAlta’s approach to cellular immunotherapy. It also exemplifies the company’s strategy to leverage Asian clinical progress to accelerate development and commercialisation in Western markets.
Bottom Line?
While limited to a special access zone, this approval marks a tangible step in validating and expanding AdAlta’s CAR-T therapy reach, with real-world data poised to underpin upcoming regulatory and commercial milestones.
Questions in the middle?
- How will real-world data from Boao Lecheng influence upcoming US FDA and Australian regulatory decisions?
- What is the timeline for transitioning EW-001 manufacturing to the third-generation process in Australia?
- Could the special access approval in China pave the way for broader regulatory acceptance or partnerships in Greater China?