Company: ZLAB
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0001628280-25-008409
Chunk: 106

Company: Zai Lab Ltd
Filing Date: 2025-02-27
Form: 10-K
Item: Item 1
Chunk 106
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 additional indications for efgartigimod SC and the pre-filled syringe, including for the treatment of thyroid eye disease, myositis, seronegative gMG, ocular MG, and lupus nephritis. 

•TED: We are participating in the Greater China portion of the global registrational Phase III UplighTED study of efgartigimod for the treatment of TED. We estimate that there are around 1 million patients with moderate to severe TED in China.

•Myositis: We are participating in the Greater China portion of the global registrational Phase II/III ALKIVIA study of efgartigimod for the treatment of idiopathic inflammatory myopathies, or myositis. We estimate that there are around 170,000 myositis patients diagnosed in China. 

•sn-gMG: We are currently supporting enrollment in Greater China for the global registrational Phase III ADAPT-SERON study of efgartigimod for the treatment of sn-gMG. We estimate that there are around 25,000 patients diagnosed with sn-gMG in China.

•Ocular MG: We are currently supporting enrollment in Greater China for the global registrational Phase III ADAPT-OCULUS study of efgartigimod for the treatment of ocular MG. We estimate that there are around 44,000 patients diagnosed with ocular MG in China.

•LN: We are currently conducting a Phase II POC study of efgartigimod for the treatment of LN in China. We estimate that there are around 320,000 patients diagnosed with LN in China.

KarXT (Xanomeline and Trospium Chloride)

KarXT is a combination of an oral M1/M4-preferring muscarinic acetylcholine receptor agonist and a peripheral acting antimuscarinic agent, which is in development for the treatment of psychiatric and neurological conditions, including schizophrenia and psychosis associated with Alzheimer’s Disease. KarXT preferentially stimulates muscarinic receptors implicated in these conditions, as opposed to current antipsychotic medicines, which mostly target dopamine or serotonin receptors. KarXT has the potential to represent a new class of treatment for schizophrenia and ADP based on its differentiated mechanism of action. We have an exclusive license from Karuna (a company later acquired by BMS) to develop, manufacture, and commercialize xanomeline and trospium chloride in Greater China.  

We are evaluating KarXT for the