Company: ZLAB
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0001628280-25-008409
Chunk: 96

Company: Zai Lab Ltd
Filing Date: 2025-02-27
Form: 10-K
Item: Item 1
Chunk 96
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 in January 2024, this product was added to the NRDL for this indication. In July 2024, the NMPA approved the BLA for the subcutaneous formulation of efgartigimod, under the brand name VYVGART Hytrulo, as an add on to standard therapy for the treatment of adult patients with gMG who are AChR antibody positive, and we launched VYVGART Hytrulo for this indication in the fourth quarter of 2024. 

In November 2024, the NMPA approved the sBLA for VYVGART Hytrulo for the treatment of adult patients with CIDP, and we launched VYVGART Hytrulo for this indication in the fourth quarter of 2024. There are approximately 50,000 patients diagnosed with CIDP in mainland China.

NUZYRA (Omadacycline)

NUZYRA, a novel tetracycline-class antibacterial with both oral and IV formulations, is a broad-spectrum antibiotic. We have an exclusive license from Paratek (subsequently acquired by Gurnet Point Capital and Novo Holdings) to develop, manufacture, and commercialize NUZYRA in Greater China. 

Our primary market for NUZYRA is patients with CABP or ABSSSI in mainland China. CABP is the most common type of pneumonia that is acquired outside of the hospital. It is one of the most common infectious diseases and is a significant cause of mortality and morbidity worldwide. ABSSSI are bacterial infections of skin and associated soft tissues, such as loose connective tissue and mucous membranes. ABSSSI are common and encompass a variety of disease presentations and degrees of severity. The World Health Organization has identified the worldwide development of resistance to currently available antibacterial agents as one of the greatest threats to human health. In 2020, the estimated 

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incidence of CABP in mainland China was approximately 10 million patients, and in 2015, the estimated incidence of ABSSSI in mainland China was 2.8 million patients. We launched the oral and IV formulations of NUZYRA in mainland China in 2021 for the treatment of adults with CABP and/or ABSSSI. NUZYRA was included in the NRDL for the treatment of adult patients with CABP and/or ABSSSI in January 2023 for its IV formulation and in January 2024 for its oral formulation. The NRDL listing for the IV formulation of