BNCT indication for recurrent meningioma officially approved overseas: Pengbo Hainan Hospital under CH BIOTECH SER (08037) opens new space for intracranial tumor treatment
The overseas BNCT treatment system NeuCure, in collaboration with CH BIOTECH SER Holdings Limited, received official approval from an overseas regulatory authority on October 28 to add the "recurrent meningioma" indication.
BNCT (boron neutron capture therapy) has scored another victory, bringing good news to patients worldwide. The overseas BNCT treatment system NeuCure, partnered with CH BIOTECH SER Holdings Limited (08037), received formal approval from an overseas regulatory authority on October 28 to add the "recurrent meningioma" indication. This formal approval marks the expansion of BNCT's clinical application boundary from existing head and neck tumors to the intracranial tumor track, providing a brand-new precision treatment option for the clinically challenging recurrent meningioma and opening up clear incremental patient space for Pengbo (Hainan) Boron Neutron Hospital under CH BIOTECH SER.
Recurrent meningioma has prominent clinical pain points, and BNCT fills the precision treatment gap
Meningioma is a clinically common primary intracranial tumor. Most meningiomas follow a benign course, but some casesdue to deep-seated locations, proximity to important functional brain areas, or high-grade subtypesstill face recurrence after standard treatments such as surgery and radiotherapy. After recurrence, reoperation carries high risk, cumulative radiotherapy dose is limited, and evidence for systemic drug therapy is weak; this has long been a clinical pain point in neuro-oncology, with a large number of recurrent cases having urgent unmet treatment needs.
BNCT is a cutting-edge precision radiotherapy technology that relies on targeted boron drugs to selectively accumulate in tumor cells, combined with neutron irradiation to trigger a capture reaction that directionally releases tumor-killing effects, with controllable damage to surrounding normal brain tissuemaking it highly suited to the stringent precision and safety requirements of intracranial tumors. The formal approval of the BNCT treatment system NeuCure for the new recurrent meningioma indication means that BNCT's clinical value in the intracranial tumor direction has been formally recognized by an overseas pharmaceutical regulatory authority, representing a significant breakthrough in the industrialization of BNCT technology.
Clinical data support indication expansion, with significantly prolonged disease control time
This indication expansion is built on clinical data. A Phase II randomized controlled study of recurrent high-grade meningioma after radiotherapy showed that the BNCT group achieved a median progression-free survival of 14.4 months, versus 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 prolong disease control time. For patients who have recurred multiple times, 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's boundary widens, amplifying its "drugdevicemedical integration" advantage
As one of the earlier platforms in China to implement commercial BNCT clinical services, CH BIOTECH SER, relying on a mature equipment platform, a clinical expert team, and a standardized diagnosis and treatment system, has been steadily providing BNCT clinical treatment services. Its Pengbo Hainan Hospital officially began receiving patients in March 2026 and is equipped with the first BNCT treatment system in China approved for clinical application; as of September 2026, it had completed dozens of BNCT clinical treatments, and at an overseas industry conference, it shared that the first 10 head and neck cancer patients achieved an overall response rate of 80% three months after treatment. At the operational level, leveraging the Boao Lecheng pilot policy advantage, Pengbo (Hainan) Boron Neutron Hospital has formally partnered with Huashan Hospital affiliated with Fudan University to jointly build a BNCT innovation research center: the two parties will focus on real-world research, jointly build a standardized BNCT academic research system, technology evaluation standards, and talent training system, explore clinical innovation pathways for neutron radiotherapy technology, and conduct Xi'An International Medical Investment 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, and the national green channel and academic cooperation network continue to improve.
With the formal implementation of the recurrent meningioma indication, Pengbo Hainan Hospital's service boundary will be significantly widened: in addition to existing head and neck tumor patients, the hospital can accept recurrent meningioma patients, revitalizing existing equipment capacity, enriching clinical scenarios, and continuously amplifying the advantages of its "drugdevicemedical integration" layout. For clinical physicians in neurosurgery and radiotherapy, this will enrich multidisciplinary MDT treatment options for intracranial tumors; for recurrent meningioma patients and their families trapped in treatment dilemmas, it means one more hope of regaining a treatment opportunity.
BNCT business growth momentum continues to materialize, with a second growth engine gradually opening up
From the perspective of operating fundamentals, the Group's BNCT business growth momentum has continued to materialize. According to CH BIOTECH SER's 2026 interim results announcement, for the six months ended June 30, 2026, the Group's continuing operations revenue increased by 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 clinically, clinical evidence continues to accumulate, and the national academic cooperation network continues to improve, the BNCT business is expected to welcome a second growth engine on top of its head and neck tumor base.
The Company is believed to leverage its advantages to continuously follow through on the full clinical implementation process of this indication, simultaneously advance multicenter clinical research, academic promotion, and patient service system development, and continuously consolidate its 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 long-term steady growth in its BNCT business.
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