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GSK plc (LSE/NYSE: GSK), a prominent pharmaceutical company with a market capitalization of $71.31 billion and an impressive gross profit margin of 72.39%, has announced that its new drug applications for depemokimab have been accepted for review by the China National Medical (TASE:PMCN) Products Administration and submitted to the Japanese Ministry of Health, Labour and Welfare.
According to InvestingPro analysis, GSK maintains a "GREAT" financial health score, positioning it well for continued pharmaceutical innovation. If approved, depemokimab would be the first ultra-long-acting biologic with a six-month dosing interval for the treatment of asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP).
The submissions are supported by data from the SWIFT and ANCHOR trials. SWIFT-1 and -2 demonstrated that depemokimab reduced exacerbation and hospitalization rates in patients with asthma, while ANCHOR-1 and -2 showed the drug reduced nasal polyp size and obstruction compared to placebo. With revenue growth of 5.59% in the last twelve months, GSK continues to strengthen its pharmaceutical portfolio. For deeper insights into GSK's financial performance and growth prospects, investors can access the comprehensive Pro Research Report available on InvestingPro.
Kaivan Khavandi, SVP at GSK, stated, "Simultaneous regulatory submissions for two indications highlight our confidence in depemokimab to help reduce the burden of both asthma and CRSwNP for patients and health systems."
Depemokimab is a monoclonal antibody targeting interleukin-5 (IL-5), which plays a crucial role in type 2 inflammation, commonly found in patients with difficult-to-treat asthma and up to 80% of people with CRSwNP. The drug's extended half-life, high-binding affinity, and potency allow for a dosing schedule of just two injections per year.
In China, asthma affects an estimated 46 million adults, with around 15.5% experiencing exacerbations requiring hospital visits in the last year. CRSwNP affects up to 4% of the general population, with approximately 40% having uncontrolled disease. In Japan, about 200,000 people with chronic sinusitis are subject to surgery due to nasal polyps.
Depemokimab is not yet approved in any country but is being evaluated in phase III trials for other IL-5 mediated diseases, including eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES). With GSK's next earnings report scheduled for February 5, 2025, investors are closely monitoring the company's pipeline developments. InvestingPro's analysis suggests GSK is currently undervalued, presenting a potential opportunity for investors interested in the pharmaceutical sector.
This news is based on a press release statement from GSK plc.
In other recent news, GSK has made significant strides in its pharmaceutical endeavors. The European Medicines Agency (EMA) has accepted the Marketing Authorisation Application for the company's innovative biologic therapy, depemokimab, for asthma and chronic rhinosinusitis with nasal polyps. GSK's Jemperli has also received expanded approval from the European Commission for certain endometrial cancer cases. In acquisition news, GSK plans to acquire Boston-based biopharmaceutical firm IDRx, a move that aligns with its strategy to strengthen its portfolio in the field of gastrointestinal cancers.
The FDA has directed that GSK's vaccine Arexvy must include warnings about a rare neurological side effect, Guillain-Barré syndrome. Meanwhile, the company's investigational drug, GSK'227, has been granted Breakthrough Therapy Designation by the FDA for the treatment of relapsed or refractory osteosarcoma in adults.
Despite these recent developments, financial analysts from Jefferies and Guggenheim have downgraded GSK's stock due to expectations of subdued growth in 2025. These are the recent developments for GSK, a company that has demonstrated solid revenue growth of 5.59% over the last twelve months.
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