Hengrui Medicine’s “New Type 1 Psoriasis Drug” Receives Clinical Approval

Today (March 29), according to the CDE official website, the clinical trial application of Guangdong Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as “Hengrui Pharmaceutical”) Class 1 new drug SHR-1139 injection has received implicit permission, and the indication is psoriasis. sick.

Image source: CDE official website

1. Category 1 biological drugs
Psoriasis

Psoriasis is a chronic inflammatory skin disease stimulated by environmental factors, controlled by polygenes, and immune-mediated. According to relevant statistics, there are more than 7 million psoriasis patients in my country. Frost & Sullivan predicts that my country’s psoriasis market will grow to US$9.5 billion in 2030, with a compound annual growth rate of 27.1%. Globally, the number of psoriasis cases is on the rise. At present, biological drugs have gradually become one of the mainstream treatments for psoriasis in my country, and related drugs mainly focus on targets such as TNF-α and IL family.

Hengrui Medicine has also deployed psoriasis treatment drugs, among which funakizumab injection (SHR-1314) targets the IL-17A target. After the marketing application for plaque psoriasis indications was accepted by CDE in 2023, the marketing application for SHR-1314 for the treatment of ankylosing spondylitis was also accepted in February this year.

SHR-1139 is another psoriasis drug from Hengrui Pharmaceuticals. It belongs to Class 1 therapeutic biological products. The target has not yet been disclosed. Its clinical trial application was accepted in January this year.

Image source: CDE official website

After the clinical trial application of SHR-1139 for the treatment of psoriasis is approved, Hengrui Medicine’s immune sector is expected to add another potentially blockbuster drug.

2、IL、HOW…
Immunity section is under development

Hengrui Medicine’s R&D pipeline covers a wide range of areas. Among them, the immunology segment has deployed a wealth of innovative drugs targeting IL-17A, URAT1, JAK1 and other targets, including the IL-17A monoclonal antibody SHR-1314 mentioned above.

Image source: Hengrui Medicine

SHR0302

SHR0302 is a JAK1 inhibitor developed by Hengrui Pharmaceuticals and is intended to be used to treat psoriatic arthritis, alopecia areata and other diseases. In 2023, the marketing applications for two indications of SHR0302 were accepted by CDE, namely rheumatoid arthritis and ankylosing spondylitis. It is understood that Hengrui Medicine is currently developing multiple dosage forms of SHR0302, including tablets and sustained-release tablets, topical ointment, and oral solution. The clinical trial of its topical ointment dosage form for atopic dermatitis has entered Phase III.

SHR4640

SHR4640 is the first domestically produced URAT1 inhibitor to enter Phase III clinical trials and was independently developed by Hengrui Medicine. Currently, SHR4640 is undergoing phase III clinical trials as a single drug for the treatment of primary gout with hyperuricemia, and is also undergoing phase II clinical trials in combination with febuxostat for the treatment of hyperuricemia in patients with gout. According to clinical studies, compared with benzbromarone, the SHR4640 high-dose group showed better uric acid-lowering effect.

SHR-1703

SHR-1703 is an IL-5 monoclonal antibody independently developed by Hengrui Medicine. It is currently undergoing clinical trials for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) and eosinophilic asthma. According to Hengrui Medicine, SHR-1703 inhibits the proliferation and activation of eosinophils mainly by inhibiting binding to IL-5R, thereby reducing eosinophil-mediated inflammation and injury.

In addition, Hengrui Medicine also owns TSLP monoclonal antibody SHR-1905, new lgA nephropathy drug SHR-2010, RORγ inhibitor RS1805 and systemic lupus erythematosus drug SHR-2001, etc., which are currently in the early clinical research stage.

3. Conclusion

In addition to the immunology segment, Hengrui Medicine also has plans in anti-tumor, cardiovascular and metabolic, pain, infection, ophthalmology and other fields, with a focus on the anti-tumor segment. Since the beginning of this year, three products of Hengrui Medicine have obtained fast-track qualifications from the US FDA.

By accelerating the clinical progress of pipelines under development, Hengrui Medicine is expected to reap more innovative fruits in 2024.