AstraZeneca gets China drug regulator's review for expanded use of Soliris
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China's National Medicine Products Administration (NMPA) accepted AstraZeneca's (NASDAQ:AZN) application seeking expanded approval of Soliris to treat adults with refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AchR) antibody positive.
GMG is an autoimmune neuromuscular disorder mainly characterized by muscle weakness and muscle fatigue.

AstraZeneca on Friday said that the NMPA also granted the company approval to start ongoing, global trials in China of medicines being evaluated to treat lupus nephritis (LN), immunoglobulin A nephropathy (IgAN) and light chain (AL) amyloidosis.
In addition, the British pharma giant said Soliris (eculizumab) was now available in China to treat paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome ((aHUS)) in adults and children.
PNH is rare disorder in which red blood cells break apart prematurely.
AstraZeneca added that this marks the first rare disease therapy from its unit Alexion in China.
The company noted that it established a rare disease business unit in China in September 2021 and in the future, aims to introduce more innovative medicines in China.
AZN -2.49% to $63.47 premarket Nov. 11