Novartis Unveils Strategic Refocus on Four Core Therapeutic Areas Following 2024 Transformation

China Finance Network January 5th, by reporter Du Ding — In 2023, Novartis officially spun off its generic drug business Sandoz. From then on, Novartis became a company fully focused on innovative drugs.

In 2024, the "renewed" Novartis will focus on four core therapeutic areas—cardiovascular, renal and metabolic; oncology; immunology; and neuroscience.

In the field of autoimmune treatment, Novartis mainly focuses on two major disease areas: dermatology and rheumatology. The indications approved for currently marketed products include psoriasis, ankylosing spondylitis, chronic spontaneous urticaria, psoriatic arthritis, and hidradenitis suppurativa, among others. More indications are expected to be approved or are currently under pipeline research, including inducible urticaria, Sjögren's syndrome, systemic lupus erythematosus, lupus nephritis, and food allergies.

A Novartis representative stated that, for a long time, Novartis has primarily focused on four key growth markets—the United States, China, Germany, and Japan. As one of the key markets for Novartis’ strategic development, China’s autoimmune drug market shows vast potential.

Data show that autoimmune diseases are a class of inflammatory immune diseases characterized by local or systemic abnormal inflammatory immune responses, including rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, ankylosing spondylitis, psoriasis, Crohn's disease, autoimmune liver disease, atopic dermatitis, and other diseases.

The number of people suffering from autoimmune diseases worldwide is expected to exceed 500 million, with nearly 40 million patients in China. However, there are few innovative drugs for autoimmune diseases, and their penetration rate is relatively low. Patients need long-term medication, so the unmet clinical needs are substantial, and the development potential is considerable.

Currently, several drugs have "stood out" in this market, including Novartis' "Secukinumab" and "Omalizumab." Secukinumab (brand name: Cosentyx) is used to treat adult psoriasis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. It is the only fully human IL-17A inhibitor approved for marketing. Recently, a new indication for secukinumab has been approved by the FDA for treating adult patients with moderate to severe hidradenitis suppurativa. Additionally, omalizumab (brand name: Xolair) is the world's first innovative targeted drug for asthma treatment and the only biologic approved in China for treating chronic spontaneous urticaria. As secukinumab and omalizumab have successively entered the medical insurance system, their prices have significantly decreased compared to before, greatly improving the accessibility of these drugs.

Tian Yu, Vice President of Novartis China and Head of the Immunotherapy Field, stated that in the future, Novartis will carry out a series of drug introductions and development efforts in various disease areas such as axial spondyloarthritis, Sjögren's syndrome, lupus, lupus nephritis, food allergies, and knee osteoarthritis, bringing world-leading treatments to tens of millions of patients with various autoimmune diseases.

According to reports, Novartis will next focus on Remibrutinib (a selective Bruton's Tyrosine Kinase (BTK) inhibitor), Ianalumab (VAY736 Ilyumab), and the T-Charge cell production platform development.

In November 2023, according to Novartis' analysis, Remibrutinib showed rapid and clinically significant improvement in urticaria symptoms compared to placebo. It plans to collect the final clinical trial data after 52 weeks, with regulatory submission expected to be completed in 2024. In the future, if approved by regulatory authorities for marketing, it may become the first new treatment for chronic spontaneous urticaria in nearly a decade.

Ianalumab has achieved positive results in Phase II clinical trials for the treatment of Sjögren's syndrome and systemic lupus erythematosus (SLE) and is currently being tested in Phase III clinical trials.

In terms of cell therapy, Novartis' T-Charge technology platform is a second-generation rapid CAR-T cell production platform. Novartis is currently preparing to conduct Phase 2b/III clinical trials to treat patients with severe refractory SLE and lupus nephritis.