Boron neutron capture therapy (BNCT) has captured another significant milestone, bringing new hope to patients worldwide.
The overseas BNCT treatment system NeuCure, developed in collaboration with CH BIOTECH SER (ASX: 08037), received formal approval from overseas regulators on October 28 to add "recurrent meningioma" as a new indication.
This official approval marks the expansion of BNCT's clinical application boundary from existing head and neck tumors into the intracranial tumor field, offering a novel precision treatment option for clinically challenging recurrent meningioma cases, and opening a clear incremental patient space for Pengbo (Hainan) Boron Neutron Hospital under CH BIOTECH SER.
Recurrent Meningioma Presents Major Clinical Challenges, BNCT Fills Precision Treatment Gap
Meningioma is a commonly occurring primary intracranial tumor. Most meningiomas follow a benign course, but some cases—due to deep-seated locations, proximity to critical brain functional areas, or high-grade subtypes—still face recurrence challenges after standard treatments such as surgery and radiotherapy. Following recurrence, reoperation carries high risks, cumulative radiotherapy doses are limited, and evidence for systemic drug therapy remains weak. These have long been clinical pain points in the neuro-oncology field, with a large number of recurrent cases having pressing unmet treatment needs.
BNCT is a cutting-edge precision radiotherapy technology that relies on targeted boron drugs selectively accumulating in tumor cells, combined with neutron irradiation to trigger capture reactions that directionally release tumor-killing effects, with controllable damage to surrounding normal brain tissue. It is highly suited to the stringent precision and safety requirements of intracranial tumors. The formal approval of the BNCT treatment system NeuCure for the new indication of recurrent meningioma means that BNCT's clinical value in the intracranial tumor direction has received formal recognition from overseas pharmaceutical regulatory authorities, representing a significant breakthrough in the industrialization process of BNCT technology.
Clinical Data Supports Indication Expansion, Disease Control Duration Significantly Extended
This indication expansion is built on clinical data. A Phase II randomized controlled study targeting recurrent high-grade meningioma after radiotherapy showed that the BNCT group achieved a median progression-free survival of 14.4 months, compared to 1.4 months in the control group; the BNCT group had a 1-year survival rate of 100% and a 2-year survival rate of 90.9%. In recurrent high-grade meningioma where traditional options are limited, BNCT has demonstrated the potential to significantly extend disease control duration. For patients who have experienced multiple recurrences, cannot undergo surgery again, or have progressed after radiotherapy, this formal approval means an additional precision treatment option backed by clinical data.
CH BIOTECH SER Broadens Boundaries, "Drug-Device-Medicine Integration" Advantage Amplified
As one of the earlier platforms in China to commercialize BNCT clinical services, CH BIOTECH SER has stably carried out BNCT clinical treatment services relying on its mature equipment platform, clinical expert team, and standardized diagnosis and treatment system. Its Pengbo Hainan Hospital officially began receiving patients in March 2026, equipped with China's first BNCT treatment system approved for clinical application; as of September 2026, it has completed dozens of BNCT clinical treatments. At an overseas industry conference, the first 10 head and neck cancer patients shared showed a total response rate of 80% at three months after treatment.
On the operational level, leveraging the policy advantages of the Boao Lecheng pilot program, Pengbo (Hainan) Boron Neutron Hospital has formally partnered with Fudan University Affiliated Huashan Hospital to co-build a BNCT Innovation Research Center: both parties will focus on real-world research, jointly build a standardized BNCT academic research system, technical evaluation standards, and talent training system, explore clinical innovation pathways for neutron radiotherapy technology, and conduct international medical academic collaboration and medical model research. It has also established a cross-border service model of "overseas assessment, domestic treatment, overseas follow-up" with international medical institution member Tianma Medical, with the national green channel and academic cooperation network continuously improving.
With the formal implementation of the recurrent meningioma indication, Pengbo Hainan Hospital's service boundary will significantly broaden: in addition to existing head and neck tumor patients, the hospital can now accept recurrent meningioma patients, revitalizing existing equipment capacity, enriching clinical scenarios, and continuously amplifying the advantages of the "drug-device-medicine integration" layout. For clinical physicians in neurosurgery and radiotherapy departments, this will enrich multidisciplinary MDT treatment options for intracranial tumors; for recurrent meningioma patients and their families trapped in treatment dilemmas, it means an additional hope of regaining treatment opportunities.
BNCT Business Growth Momentum Continues to Materialize, Second Growth Engine Gradually Opens
From an operational fundamentals perspective, the group's BNCT business growth momentum has been continuously materializing. According to CH BIOTECH SER's 2026 interim results announcement, for the six months ended June 30, 2026, the group's continuing operations revenue grew 49.7% year-on-year; among this, BNCT treatment service revenue contributed a prominent share, becoming the group's core growth curve. As the recurrent meningioma indication is formally approved and gradually implemented in clinical practice, clinical evidence continues to accumulate, and the national academic cooperation network continuously improves, the BNCT business is expected to welcome a second growth engine on top of the head and neck tumor base.
It is believed that the company will leverage its advantages to continuously follow up on the entire clinical implementation process of this indication, simultaneously advance multi-center clinical research, academic promotion, and patient service system construction, and continuously solidify the BNCT technology platform. In the future, it will continue to explore BNCT's clinical potential in more solid tumor fields, using Pengbo (Hainan) Boron Neutron Hospital as a bridgehead, continuously introducing newly approved indications, enhancing the accessibility of boron neutron capture radiotherapy technology, and while benefiting tumor patients, promoting the group's BNCT business toward long-term steady growth.