SHANGHAI & CAMBRIDGE, Mass. — Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced today that three of its key medicines have been renewed for inclusion in China’s 2025 National Reimbursement Drug List (NRDL) by the National Healthcare Security Administration (NHSA).
- VYVGART® (efgartigimod alfa injection) – renewed for adult patients with generalized myasthenia gravis (gMG) who test positive for anti‑acetylcholine receptor (AChR) antibodies.
- NUZYRA® (omadacycline) – oral formulation renewed for the treatment of community‑acquired bacterial pneumonia (CABP) and acute bacterial skin and skin‑structure infections (ABSSSI) in adults.
- ZEJULA® (niraparib) – renewed for maintenance therapy in adult patients with platinum‑sensitive, first‑line and recurrent ovarian cancer.
“The renewal of VYVGART®, NUZYRA® and ZEJULA® underscores the strong clinical value these products deliver to patients and the health‑care system,” said Andrew Zhu, Chief Commercial Officer of Zai Lab for Greater China. “Having six products on the NRDL dramatically expands patient access, reduces out‑of‑pocket costs, and positions Zai Lab to capture meaningful market share across oncology, immunology and infectious disease.”
Myasthenia Gravis in China
Generalized myasthenia gravis (gMG) affects roughly 170,000 patients in China, with an estimated 85% positive for AChR antibodies. The disease is characterized by fluctuating muscle weakness that can involve ocular function, speech, swallowing and, in severe cases, respiration. Existing therapies—acetylcholinesterase inhibitors, steroids, immunosuppressants and intravenous immunoglobulin—often provide only partial symptom control, leaving a substantial unmet medical need.
VYVGART® (efgartigimod alfa)
VYVGART is an FcRn‑targeted antibody fragment that accelerates the degradation of pathogenic IgG antibodies. By blocking the neonatal Fc receptor (FcRn), the drug reduces circulating autoantibodies, directly addressing the pathogenic mechanism of gMG. The National Medical Products Administration (NMPA) approved VYVGART in June 2023 as an add‑on to standard therapy, making it the first FcRn inhibitor available in China. Zai Lab launched the product in September 2023 under an exclusive license from argenx.
Community‑Acquired Bacterial Pneumonia and ABSSSI in China
Both CABP and ABSSSI remain major drivers of antibiotic use, with an estimated 10 million CABP cases and 2.8 million ABSSSI cases annually in mainland China. Growing antimicrobial resistance and safety concerns around older agents heighten the demand for novel, broad‑spectrum antibiotics with favorable tolerability.
NUZYRA® (omadacycline)
NUZYRA is a next‑generation tetracycline that offers both oral and intravenous dosing. Its spectrum covers Gram‑positive, Gram‑negative, atypical and many resistant organisms, positioning it as a versatile option for CABP and ABSSSI. The NMPA designated NUZYRA as a Category 1 innovative drug, and Zai Lab secured market entry in December 2021. The oral formulation entered the NRDL in January 2024, expanding its reimbursement footprint.
Ovarian Cancer Landscape in China
Ovarian cancer accounts for over 55,000 new diagnoses and 37,000 deaths each year in China. While platinum‑based chemotherapy achieves high initial response rates, most patients ultimately experience disease recurrence. Maintenance therapies that extend progression‑free survival are critical to improving long‑term outcomes, especially for platinum‑sensitive disease.
ZEJULA® (niraparib)
ZEJULA is an oral PARP 1/2 inhibitor that exploits synthetic lethality in tumors deficient in homologous recombination, such as those harboring BRCA mutations. Approved by the NMPA in September 2020 for maintenance after response to platinum‑based chemotherapy, ZEJULA entered the NRDL in December 2021. Its inclusion supports a growing market for precision oncology agents in China, where PARP inhibitors are projected to achieve double‑digit annual growth.
Strategic Implications and Market Outlook
The NRDL renewal of these three products strengthens Zai Lab’s revenue pipeline across three high‑growth therapeutic areas:
- Immunology: VYVGART’s FcRn‑blocking technology is differentiated from conventional immunosuppressants, potentially capturing a share of the estimated $1.2 billion Chinese gMG market.
- Infectious Disease: NUZYRA’s oral formulation aligns with China’s strategic push for outpatient antimicrobial therapy, providing a competitive edge against older macrolides and fluoroquinolones.
- Oncology: ZEJULA benefits from the expanding PARP inhibitor market in China, driven by increasing genetic testing and reimbursement reforms that favor targeted maintenance therapies.
Inclusion on the NRDL not only guarantees reimbursable pricing but also signals regulatory confidence, which can catalyze uptake by hospitals and physicians. For Zai Lab, the renewed listings are expected to translate into a multi‑year revenue uplift, with analysts projecting a compound annual growth rate (CAGR) of 18‑22% for the company’s China operations through 2028.
About Zai Lab
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is a research‑driven, commercial‑stage biopharmaceutical company headquartered in China and the United States. The company focuses on developing and commercializing innovative therapies that address unmet medical needs in oncology, immunology, neuroscience and infectious disease.
Forward‑Looking Statements
This release contains forward‑looking statements regarding Zai Lab’s expectations for VYVGART®, NUZYRA®, ZEJULA®, and their respective markets in Greater China. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially, including the ability to commercialize products, regulatory outcomes, funding availability, and market acceptance. The company does not undertake any duty to update these statements, except as required by law.
Original article, Author: Jam. If you wish to reprint this article, please indicate the source:https://aicnbc.com/14160.html
