China Approves First Commercially Available Brain-Computer Interface

China has taken a significant step forward in neurotechnology, granting commercial approval for the country’s first brain-computer interface (BCI) device. Developed by Shanghai-based Neuracle Medical Technology, the device is designed to help individuals with paralysis regain hand movement . This approval marks a global first, allowing the BCI to be used outside of clinical trials .

Restoring Movement for Paralysis Patients

The Neuracle device is intended for individuals aged 18 to 60 who have paralysis affecting all limbs due to spinal cord injuries in the neck area . The system utilizes implanted electrodes to record electrical activity in the brain. These signals are then transmitted and decoded by a computer, which controls a robotic glove enabling grasping movements .

A Milestone for BCI Research

Experts in the field have hailed the approval as a major milestone. Chen Liang, a neurosurgeon at Huashan Hospital at Fudan University in Shanghai, who participated in the clinical trials of the device (named NEO), emphasized the importance of BCI technology given the limited treatment options available for spinal cord injuries . Zhengwu Liu, an electrical engineer at the University of Hong Kong who collaborated with the NEO team, noted the significance of the 18 months of long-term data demonstrating the system’s effectiveness, which contributed to the approval .

Growing Interest in Brain-Computer Interfaces

The approval comes as interest in BCI technology continues to grow globally. Other companies are likewise pursuing BCI development, including Paradromics in the United States, which received approval to trial a BCI restoring speech, and Neuralink, founded by Elon Musk, which has enrolled 21 participants in its device trials . The Chinese government views the BCI sector as a strategic industry and is providing support to foster its growth, including streamlining regulatory processes and reimbursement pathways .

Other Developments in China’s Biopharma Sector

Beyond the BCI approval, several other developments are shaping China’s biopharmaceutical landscape:

• AstraZeneca is investing in establishing cell therapy manufacturing and R&D centers in Shanghai, aiming for end-to-end capabilities in China .
• Astellas has terminated a T-cell engager collaboration with CytomX Therapeutics after six years .
• Sandoz is expanding its biosimilar partnership with Samsung Bioepis, including a focus on a biosimilar version of Takeda’s Entyvio .
• Syneos Health has acquired Chinese CRO Bestudy to strengthen its position in the growing Chinese biopharma market .
• Novo Nordisk’s semaglutide is expected to face generic competition in both India and China, with numerous firms preparing to launch products .