GSK's New Drug Application Accepted by China's NMPA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
0mins
Should l Buy GSK?
GSK announced that the China National Medical Products Administration, NMPA, has accepted for review a new drug application, NDA, for bepirovirsen, an investigational antisense oligonucleotide, for the treatment of adults with chronic hepatitis B. The regulatory submission is supported by positive results from the B-Well 1 and B-Well 2 Phase III trials, where bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. Functional cure rates were significantly higher with bepirovirsen plus standard of care compared with standard of care alone across all ranked endpoints, including in patients with lower baseline HBsAg levels where an even greater effect was observed. Bepirovirsen demonstrated an acceptable safety and tolerability profile consistent with previous studies. These data will be presented at a congress and submitted for scientific peer-reviewed publication in 2026.
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Analyst Views on GSK
Wall Street analysts forecast GSK stock price to fall
6 Analyst Rating
1 Buy
2 Hold
3 Sell
Moderate Sell
Current: 54.230
Low
20.15
Averages
38.72
High
55.60
Current: 54.230
Low
20.15
Averages
38.72
High
55.60
About GSK
GSK plc is a biopharma company. The Company’s segments include Commercial Operations and Research and Development. Its portfolio and pipeline are focused on developing medicines and vaccines in four core therapeutic areas, which are the areas of human health it focuses on to prevent and treat disease: respiratory, immunology and inflammation; oncology; human immunodeficiency virus (HIV), and infectious diseases. Its specialty medicines prevent and treat diseases, from HIV to respiratory diseases, immune-mediated conditions like lupus, and cancer. General medicines include inhaled medicines for asthma and COPD with antibiotics. Its portfolio also includes Efimosfermin, a fibroblast growth factor 21 (FGF21) analog therapeutic in clinical development. The Company also engaged in ozureprubart, a long-acting anti-immunoglobulin E (IgE) monoclonal antibody. It is in phase IIb clinical development for prophylactic protection against food allergens.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Clinical Trial Support: The approval is based on data from the SWIFT-1 and SWIFT-2 phase III trials, demonstrating Exdensur's efficacy in improving patient symptoms, providing a robust scientific foundation for GSK's innovations in asthma treatment.
- Market Strategy: GSK's SVP, Global Head of Respiratory, Immunology & Inflammation R&D, Kaivan Khavandi, stated that with Exdensur approved in several major markets, the company aims to transform the treatment paradigm for severe asthma, further solidifying its market leadership.
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See More
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- Recent Transaction Activity: Prior to the Excellergy deal, Novartis announced the acquisition of Pikavation Therapeutics for up to $3 billion to secure rights to an experimental breast cancer drug, highlighting its strategic focus on oncology.
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- Clinical Trial Results: The application is based on positive outcomes from the B-Well 1 and B-Well 2 Phase III trials, indicating the drug's potential efficacy and safety in treating chronic hepatitis B, which could address a significant unmet medical need.
- Collaborative Development: GSK licensed bepirovirsen from Ionis Pharmaceuticals and collaborated on its development, showcasing the company's strategic partnerships in advancing innovative therapeutics.
- Market Potential Assessment: Although the drug is not yet approved anywhere globally, successful market entry could open new opportunities for GSK in the chronic hepatitis B treatment space, enhancing its competitive position in the biopharmaceutical industry.
See More
