GSK plc (LSE/NYSE: GSK) experienced a modest share price increase of approximately 1% in early trading following the announcement that China’s National Medical Products Administration (NMPA) has approved Exdensur (depemokimab) for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients. The approval marks a significant milestone for GSK, expanding the market reach of its novel biologic therapy.
Exdensur is now the first and only ultra-long-acting biologic available in China for CRSwNP, offering a new treatment option for patients who have not achieved adequate disease control with existing therapies like systemic corticosteroids and/or surgery. This approval follows the recent green light for Exdensur as a maintenance treatment for severe asthma in China, further solidifying its position in the respiratory disease market.
The NMPA’s decision was based on data from the ANCHOR-1 and ANCHOR-2 phase III trials. These trials demonstrated clinically meaningful and statistically significant improvements in nasal polyp size and nasal obstruction among patients treated with Exdensur. Specifically, the trials showed a notable reduction from baseline in nasal polyp score at 52 weeks (ANCHOR-1 p<0.001 and ANCHOR-2 p=0.004) and in nasal obstruction over weeks 49-52 (ANCHOR-1 p=0.047 and ANCHOR-2 p=0.025).
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The positive clinical trial results and subsequent approval address a significant unmet need in the CRSwNP treatment landscape. Almost half of all patients with CRSwNP remain uncontrolled, and a substantial proportion exhibit underlying type 2 inflammation, which is associated with more severe disease. Exdensur’s ultra-long-acting mechanism, requiring only two doses per year, could provide sustained suppression of type 2 inflammation, offering considerable relief to patients facing debilitating daily symptoms.
Kaivan Khavandi, SVP, R&D Head Respiratory, Immunology & Inflammation (RI&I), and Head of Translational & Development Sciences, GSK, said: “Given the continued unmet need amongst patients with CRSwNP, today’s approval of Exdensur could redefine care by protecting from the debilitating symptoms of this disease in just two doses a year. This builds on Exdensur’s recent approval in severe asthma, which means more patients in China could have access to this first and only ultra-long-acting biologic.”
Analyst Summary: Bull and Bear Cases
Bull Case:
- First-Mover Advantage: Exdensur is the first and only ultra-long-acting biologic approved in China for CRSwNP.
- Clinical Efficacy: The ANCHOR trials demonstrated significant improvements in key disease parameters.
- Convenient Dosing: Twice-yearly dosing offers a significant advantage over more frequent treatment regimens.
Bear Case:
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