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AstraZeneca wins approval in China for Soliris in myasthenia gravis

ALN

AstraZeneca PLC on Tuesday announced another approval in China for Soliris to treat a rare neuromuscular disease.

The Cambridge, England-based pharmaceutical company said Soliris has been approved in China for adults with refractory generalised myasthenia gravis, gMG, who are anti-acetylcholine receptor, AChR, antibody-positive.

‘gMG is a rare, debilitating, chronic, autoimmune neuromuscular disease that leads to a loss of muscle function and severe weakness,’ Astra explained.

It is caused by a defect in the action of acetylcholine at neuromuscular junctions.

Soliris, generically known as eculizumab, is a monoclonal antibody that targets protein C5 in the terminal complement cascade. The complement cascade is a part of the body’s immune system.

‘When activated in an uncontrolled manner, the terminal complement cascade over-responds, leading the body to attack its own healthy cells,’ the firm explained.

Soliris is now the first and only complement inhibitor approved to treat gMG in China.

Soliris is already available in China for the treatment of paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome in adults and children. It has various other approvals elsewhere.

Astra established a rare disease business unit in China in September 2021.

‘In the future, [AstraZeneca] aims to continue introducing more innovative medicines in China, targeting the complement system and beyond, [and] for the treatment of rare diseases,’ the company said.

Shares in AstraZeneca were down 1.4% to 11,664.00 pence each in London on Tuesday morning.

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