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News - China Grants Priority Review to Subcutaneous LEQEMBI Application for Early Alzheimer’s Disease

Image Credit: Biogen
February 2026 | Katie Ogden, Portfolio Manager – Pharma, SAE Media Group

On Feb. 8, 2026, Eisai and Biogen said China’s National Medical Products Administration has granted Priority Review status to the biologics license application for a subcutaneous formulation of LEQEMBI, an anti-amyloid beta protofibril antibody for the treatment of early Alzheimer’s disease.

The application, which was accepted in January, covers a subcutaneous autoinjector formulation of lecanemab. Priority Review is intended to accelerate the evaluation of medicines that are considered to have significant clinical value, potentially shortening the regulatory review timeline.

If approved, the subcutaneous autoinjector would allow patients to receive a once-weekly 500 mg dose administered as two injections at home from the start of treatment. This would provide an alternative to the currently available intravenous formulation, which is administered every two weeks in a hospital or clinic setting. Each injection is designed to take approximately 15 seconds to deliver.

According to the companies, a subcutaneous option could broaden treatment settings for patients and caregivers by enabling home administration. The formulation may also reduce the use of healthcare resources associated with intravenous infusions, such as infusion preparation and on-site monitoring by nursing staff, while simplifying the overall care pathway for people living with Alzheimer’s disease.

Eisai estimates that about 17 million people in China were living with mild cognitive impairment or mild dementia due to Alzheimer’s disease in 2024, a figure expected to rise as the population ages. The company said expanded treatment options could become increasingly relevant as demand for care grows.

LEQEMBI was launched in China in June 2024 and has been available through the private market. In addition, the treatment has been included in China’s newly introduced Commercial Insurance Innovative Drug List, which took effect in January 2026. Under recent government policies aimed at improving access to innovative therapies, commercial insurers are expected to develop insurance products that include coverage for LEQEMBI.

Globally, Eisai leads the development and regulatory submission activities for LEQEMBI, while Eisai and Biogen jointly commercialize and promote the therapy. Eisai holds final decision-making authority. In China, Eisai is responsible for product distribution and for providing information through specialized medical representatives.

LEQEMBI targets amyloid beta protofibrils, which are believed to play a role in the development and progression of Alzheimer’s disease. The companies said the Priority Review designation reflects the potential clinical value of offering a more flexible route of administration for patients in the early stages of the disease.

The NMPA’s Priority Review and Approval Procedure was established to support the faster development and introduction of medicines that address unmet medical needs, particularly for serious and chronic conditions.
 

Editor’s Corner



WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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