World Lupus Day 2024: Biologics Emerge as a Promising Frontier in SLE Treatment, with Nearly Ten Chinese Pharma Companies Accelerating R&D

　　【Pharmaceutical Network Industry DynamicsMay 10, 2024, marks the 21st "World Lupus Day." Systemic lupus erythematosus is a chronic autoimmune connective tissue disease that can lead to damage in multiple organs and tissues, including the kidneys, cardiovascular system, lungs, digestive system, blood system, and eyes, posing a threat to patients' safety. According to the "Chinese Guidelines for the Diagnosis and Treatment of Lupus Nephritis," the incidence rate of systemic lupus erythematosus in China is 30.13~70.41 per 100,000 people, corresponding to a patient population of 422,000 to 986,000.
 

The market demand for therapeutic drugs behind hundreds of thousands of patients is enormous. According to Frost & Sullivan data, the global market size for systemic lupus erythematosus (SLE) treatment drugs reached 1.6 billion USD in 2020 and is expected to reach 6.5 billion USD by 2025. In 2021, the market size for SLE drugs in China had increased to 400 million USD and is projected to reach 3.4 billion USD by 2030.
 

Currently, systemic lupus erythematosus (SLE) cannot be completely cured, and patients face unmet treatment needs. In an April research report, Southwest Securities pointed out that commonly used treatments for SLE include hormones, non-steroidal anti-inflammatory drugs, immunosuppressants, antimalarials, and biologics. However, traditional therapies have shortcomings such as toxic side effects, bone marrow suppression, and increased risk of infection. For patients with SLE who respond poorly to conventional treatments or experience recurrent symptoms, the use of biologics can significantly improve the remission rate.
 

Biological agents are emerging as a new direction for lupus erythematosus drugs, attracting efforts from pharmaceutical companies both domestically and internationally. In China, nearly ten local listed pharmaceutical companies have already positioned themselves in this track.
 

Among them, the biologics approved for systemic lupus erythematosus in China mainly include belimumab from GlaxoSmithKline (GSK) and telitacicept from RemeGen.
 

In addition, nearly ten listed companies, including Hengrui Pharma, Kang Nuoya Biomedical Technology (Chengdu) Co., Ltd., CSPC Pharmaceutical Group Limited, GENRIX BIO, Ascentage Pharma, InnoCare, and Zelgen, have made arrangements in systemic lupus erythematosus, but they are still in the early research stage.
 

Besides biologics, the CAR-T therapy, which costs millions per injection, is also considered promising for treating systemic lupus erythematosus, attracting a group of pharmaceutical companies to actively invest in its development.
 

For example, in April 2023, JW Therapeutics announced that the clinical trial application for Brexucabtagene Autoleucel Injection for the treatment of moderate to severe refractory systemic lupus erythematosus (SLE) had received tacit approval in China. In its 2023 annual report, JW Therapeutics mentioned that the company had initiated a clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of the drug in Chinese patients with moderate or severe active SLE. To further investigate the drug's efficacy and the recommended Phase II dose for SLE, several rounds of dose exploration have been completed, and promising preliminary safety and efficacy data have been observed in the first group of enrolled patients. The company plans to continue patient enrollment and expects to release initial trial data in the first half of 2024.
 

By the end of 2023, Gracell also announced that the IND application for its FasTCAR-T autologous CAR-T candidate therapy GC012F, intended for the treatment of refractory systemic lupus erythematosus (rSLE), has been approved in China, with plans to initiate a Phase 1/2 clinical trial in China. Previously, Gracell also announced that it would conduct a Phase 1/2 clinical trial targeting the same indication in the United States.
 

As major pharmaceutical companies actively lay out the treatment of refractory systemic lupus erythematosus, there may come a day when we hear good news about the disease being conquered.
 

Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to any person.