丨Compiled by the PharmaHunter Club Research Team
On January 9 local time, GSK CEO Emma Walmsley spoke at the 42nd Annual J.P. Morgan Healthcare Conference, stating that the company...Achieve the goal of total revenue CAGR exceeding 5% from 2021 to 2026, among which vaccines, specialty medicines, and general medicines achieved CAGR in the high single digits, double, and stable growth respectively. To achieve such performance targets, GSK focuses on its four core therapeutic areas.Infection, HIV, Respiratory and Immunology, OncologyWhat kind of product planning and strategic deployment has been carried out?
Infectious Disease Field: Holding Several Heavyweight Products, Striving to Be the Global Leader in Infectious Diseases
Across GSK's global R&D pipeline (67 products), the company has the largest number of products in the infectious disease field, with 37 products, seven of which are in Phase III clinical trials or beyond.GSK's Achievements in the Field of Infectious Diseases in 2023Achievements and Future Plans：- Shingrix: In China, an exclusive agency agreement for the recombinant shingles vaccine was signed with Zhifei Biological Products. The product's sales reached 2.538 billion pounds in the first three quarters of 2023, a year-on-year increase of 15%. GSK estimates that the product’s maximum annual sales could exceed 4 billion pounds.
- Arexvy: It has been approved in multiple regions including the US, EU, JP, and UK. A regulatory decision regarding high-risk populations aged 50-59 is expected by 2024. As the world’s first RSV vaccine, Arexvy achieved sales of 709 million pounds in its first quarter (Q3 2023) after being approved for marketing in May 2023. GSK estimates that the peak annual sales of this product could exceed 3 billion pounds.
GSK has product reserves in the fields of hepatitis B, influenza, meningococcal disease, pneumococcal disease, and herpes simplex virus, and it is expected that in the future:--Hepatitis B: Potential blockbuster productBepirovirsenData from the Phase III clinical study B-WELL will be available in 2025; GSK has obtained the exclusive licensing rights to JNJ-3989 from Johnson & Johnson, with plans to initiate a Phase II sequential treatment trial in combination with Bepirovirsen starting in 2024, further strengthening GSK's late-stage specialty drug pipeline. GSK estimates that the product’s peak annual sales could exceed £2 billion.--Influenza: GSK estimates that the annual sales of such products could exceed £3 billion. Trials of multivalent mRNA candidate vaccines are underway, with Phase II data to be released in the first half of 2024.Fluarix/FluLaval Vaccine Generated Total Revenue of £409 Million in the First Three Quarters of 2023, Down 7% Year-on-Year Due to Competition in the U.S.--Meningitis：GSK estimates that the peak annual sales of products in this field will be between £1 billion and £2 billion. The application for the U.S. market approval of the pentavalent meningococcal vaccine MenABCWY will be submitted in the first half of 2024.GSK's revenue in the meningitis field reached 987 million pounds in the first three quarters of 2023, mainly driven by the Bexsero vaccine, which achieved revenue of 678 million pounds during this period, representing a year-on-year increase of 12%. Another product, the Menveo vaccine, generated revenue of 293 million pounds during the same period.MenABCWYIs a meningitis candidate vaccine that achieved 11 primary endpoints in Phase III clinical trials and demonstrated safety data consistent with Bexsero and Menveo. The vaccine combines antigens from Bexsero (MenB) and Menveo (MenACWY) and targets five serotypes: A, B, C, W, and Y. These five serotypes cover nearly all invasive meningococcal disease cases, and so far, no vaccine has been able to provide protection against all five serotypes simultaneously.--Infectious Diseases: GSK estimates the peak annual sales in this field to be approximately $2 billion. Plans for the future include submitting a new drug application for Gepotidacin and initiating Phase III clinical trials for Tebipenem.GepotidacinGepotidacin is a first-in-class novel oral antibiotic intended for the treatment of uncomplicated urinary tract infections. The product selectively binds to and inhibits both DNA gyrase and DNA topoisomerase IV, inducing single-strand breaks in DNA during replication and thereby killing the pathogen. Both pivotal Phase III clinical studies of the drug met their primary endpoints, with a significantly higher proportion of patients in the Gepotidacin treatment group achieving clinical and microbiological composite resolution.If Gepotidacin is successfully approved, it could become the first innovative oral antibiotic for the treatment of uncomplicated urinary tract infections in over 20 years.
HIV Field: Ultra/Long-Acting Products Are Key Plans in Recent Years
GSK has more than 7 HIV products on the market, and achieved revenue of 4.671 billion pounds in the HIV field in the first three quarters of 2023, increasing by 14% year-on-year. Currently, GSK owns 6 R&D pipelines.GSK hopes to achieve full-year revenue of approximately £7 billion from its HIV products by 2026.GSK's Outlook in the HIV Field：1. Continuous innovation in HIV treatment and prevention;2. The CAGR of sales from 2021 to 2026 is 6%~8%;3. Increased sales of products Dovato and Cabotegravir;4. Cabotegravir replaces Dolutegravir as the foundational drug for HIV treatment.GSK Emphasizes Plans for Ultra/Long-Acting HIV Products by 2026:1. Long-acting product administered once every four months;2. Achieve by 2030Once every six months ultra-long-acting administrationProducts. GSK has proposed three ultra-long-acting target products, with plans to gradually submit marketing applications starting from 2026;3. GSK to Provide Long-Acting HIV Treatment Products in More Channels.
Respiratory Field: Three Key Products
GSK highlighted three products in this field:1. The peak sales of this product are expected to be between £500 million and £1 billion.2. The MATINEE data from the Phase III clinical study for COPD is expected to be read out in the second half of 2024.3. The world's first monoclonal antibody targeting IL-5 for the treatment of COPD.On January 10, 2024, Mepolizumab Injection (Nucala) was approved in China for the treatment of severe eosinophilic asthma.Is China's first anti-interleukin-5 (IL-5) targeted biologic for the treatment of severe eosinophilic asthma.In 2021, China approved mepolizumab injection for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), and it was included in the National Medical Insurance Drug Catalog in January 2023. This time, China has approved the expansion of its therapeutic scope for maintenance treatment of severe eosinophilic asthma (SEA) in adults and adolescents aged 12 years and above.In the United States and Europe, the drug became the first approved treatment for four inflammatory diseases caused by eosinophilia: Severe Eosinophilic Asthma (SEA), Eosinophilic Granulomatosis with Polyangiitis (EGPA), Hypereosinophilic Syndrome (HES), and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). To date, the injectable form of mepolizumab has been approved in the U.S., EU, and more than 25 other markets as a maintenance treatment for patients with severe eosinophilic asthma.Mepolizumab generated global revenue of £1.184 billion (£11.84 billion) (approximately $1.511 billion USD) in the first three quarters of 2023, representing a 26% year-over-year increase.1. Future peak sales exceeding £3 billion;2. The SWIFT data from the Phase III clinical study is expected to be read in the first half of 2024.Depemokimab is a long-acting IL-5 monoclonal antibody. Currently, the product's clinical progress in China and the U.S. is consistent, both in phase III clinical trials.1. GSK expects the peak sales of this product to exceed 2.5 billion pounds;2. The CALM data from the Phase III clinical study is expected to be released in the second half of 2025.Camlipixant is a small molecule P2X3 receptor antagonist acquired by GSK for a total amount of approximately $2 billion through the acquisition of Bellus Health. One of its competitors is Merck's Gefapixant, whose 2023 marketing application for the treatment of chronic cough was rejected by the FDA.This gives GSK the opportunity to catch up and take the lead.。
Oncology Field: Three Key Products
GSK has 11 products in the oncology field, of which 4 have been launched, 1 is in Phase II clinical trials, and 5 are in Phase I clinical trials.Marketed Oncology ProductsRevenue in the first three quarters of 2023 was £4.87 billion, a year-on-year increase of 9%.
1. GSK regards it as a backbone product in the field of oncology;2. Data from the combination therapy of TIM3-targeting drug Cobolimab with NSCLC1 is expected to be available in 2024.3. Data for the treatment of rectal cancer is expected to be available in 2027.1. The first and only treatment available for anemia in MF2 patients;2. Expected to obtain EU marketing authorization in early 2024;3. Due to its different MOA, it has the potential to become a backbone therapy for myelofibrosis;4. Combination drug regimens and new indications are under evaluation.1. Combination therapy for endometrial cancer has yielded positive results;2. As a combination therapy for the treatment of ovarian cancer, data is expected to be available in 2024;3. Maintenance Treatment for Ovarian Cancer, Data Expected in 20244. Maintenance treatment for NSCLC, with data expected in 2024.1. In the treatment of second-line RRMM,BlenrepThe DREAMM-7 study has preliminarily achieved positive results, and the data from the DREAMM-8 study will be announced in the second half of 2024.2. Explore novel combinations targeting all major points on the CD226 axis.
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