SHANGHAI - Zai Lab (NASDAQ:ZLAB) Limited (NASDAQ: ZLAB; HKEX: 9688), a biopharmaceutical company, announced today that the China National Medical Products Administration (NMPA) has accepted for review a supplemental Biologics License Application (sBLA) for efgartigimod SC, a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP).
The Center for Drug Evaluation (CDE) granted the application priority review status on May 11, 2024, indicating a potential acceleration of the drug's approval process.
CIDP is an autoimmune disease that affects the peripheral nerves and currently has no approved therapies in China. The sBLA submission is supported by results from the ADHERE trial, which included a subgroup analysis of Chinese participants. The data showed a 69% reduction in relapse rates and a 78% rate of clinical improvement among these patients, with a safety profile consistent with the global study population.
The ADHERE trial, sponsored by argenx, was a double-blind, placebo-controlled study that enrolled 322 adult patients across multiple centers, including Greater China. The primary endpoint of the trial was the time to first adjusted INCAT deterioration, which is a measure of disease relapse.
In related developments, Zai Lab launched VYVGART® (efgartigimod alfa injection) for generalized myasthenia gravis (gMG) in mainland China in September 2023, marking the first approved FcRn antagonist for gMG patients in the region.
Zai Lab, which specializes in oncology, autoimmune disorders, infectious disease, and neuroscience, has an exclusive license agreement with argenx to develop and commercialize efgartigimod in Greater China for various autoimmune indications. This recent sBLA acceptance underscores Zai Lab's commitment to addressing unmet medical needs in China.
The information in this article is based on a press release statement from Zai Lab Limited.
InvestingPro Insights
Zai Lab Limited's recent sBLA acceptance by the NMPA for efgartigimod SC could signify a pivotal moment for the company, as CIDP remains an area with significant unmet medical needs in China. As investors consider the potential impact of this development on Zai Lab's financial performance, several metrics and tips from InvestingPro are noteworthy.
With a market capitalization of $2.14 billion, Zai Lab is a key player in the biopharmaceutical industry. The company's revenue has grown by 25.94% over the last twelve months as of Q1 2024, showcasing a strong upward trend. Moreover, the revenue growth for Q1 2024 alone was an impressive 38.78%, reflecting the company's expanding market presence.
InvestingPro Tips highlight that Zai Lab holds more cash than debt on its balance sheet, which provides a level of financial stability and flexibility for the company. In addition, analysts have revised their earnings upwards for the upcoming period, indicating positive sentiment regarding the company's future performance. These factors may be particularly relevant for investors considering the potential costs and revenue associated with the launch and commercialization of efgartigimod SC, should it gain approval.
However, it is important to note that Zai Lab's P/E ratio stands at -5.74, with an adjusted P/E ratio for the last twelve months as of Q1 2024 at -6.03, suggesting that investors are expecting future growth to justify the current share price. Moreover, the company has experienced significant returns over the last week and month, with price total returns of 29.43% and 45.58% respectively, reflecting heightened market activity that could be associated with the recent sBLA news.
For those interested in a deeper analysis, InvestingPro offers additional tips on Zai Lab, which can be accessed through InvestingPro's platform. To further enhance your investment research, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. With these insights, investors can make more informed decisions regarding Zai Lab's potential in the dynamic biopharmaceutical industry.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.