April 2, 2024 Source: drugdu 92
Today (March 29), according to the official website of CDE, Guangdong Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as "Hengrui Pharmaceutical") class 1 new drug SHR-1139 injection indicated for psoriasis application obtained approval.
Psoriasis is a chronic inflammatory skin disease that is stimulated by environmental factors, genetic control, and immune media. According to relevant data, there are more than 7 million psoriasis patients in China. Fhstrilin predicts that China’s psoriasis market will increase to US $ 9.5 billion in 2030, with a compound annual growth rate of 27.1%. Globally, the number of patients with psoriasis is on the rise. At present, biopharmaceuticals have gradually become one of the mainstream therapies of psoriasis in China. Related drugs are mainly focused on targets such as TNF-α and IL families.
Hengrui Pharmaceutical also deployed psoriasis therapy drugs, of which Fu Niqizumab (SHR-1314) targets IL-17A targets. Following the CDE acceptance of the listing of plaques in 2023, the SHR-1314 application for the treatment of ankylosing spondylitis was also accepted in February this year.
The SHR-1139 is another psoriasis drug developed by Hengrui Pharmaceutical. It belongs to Class I biological products for treatment and its target has not be published in public. Its clinical trial application was accepted in January this year.
Hengrui Pharmaceutical's R & D pipeline has covered widely. Among them, the immunization sector has deployed rich innovative drugs for targets such as IL-17A, URAT1, and Jak1, including the IL-17A monoclonal SHR-1314 mentioned earlier.
SHR0302 is an JAK1 inhibitor developed by Hengrui Pharmaceutical, which is intended to treat psoriasis arthritis and alopecia areata and other diseases. In 2023, the listing application of the two indications of SHR0302 obtained CDE acceptance, which were rheumatoid arthritis and ankylosing spondylitis, respectively. Hengrui Pharmaceutical is currently developing SHR0302 multiple dosage forms, including tablets and slow -release tablets, external ointments, and oral solutions. The clinical trials of specialty ointment for specialty dermatitis have entered Phase III.
The SHR4640 is the first domestic URAT1 inhibitor to enter the phase III clinical study, which is independently developed by Hengrui Pharmaceutical. At present, the SHR4640 is carried out phase III clinical trial of primary gout with hyperuricemia, while conducting phase II clinical study of hyperuricemia in patients with gout patients with non -Tiss. According to clinical studies, the SHR4640 high -dose group shows a better uric acid effect compared to the benzinemaron.
The SHR-1703 is the IL-5 monoclonal antibody independently developed by Hengrui Pharmaceutical. The clinical trial for treating eosinophilic granulitis (EGPA) and eosinophilocytes is conducted right now. According to Hengrui Pharmaceuticals, the SHR-1703 mainly inhibits the proliferation and activation of eosinophilic granulocytes by inhibiting the combination of IL-5R, thereby reducing inflammation and injury of eosinophilic granulocytes.
In addition, Hengrui also has TSLP monoclonal SHR-1905, LGA nephrotic drug SHR-2010, ROR γ inhibitors RS1805, and systemic lupus erythematosus SHR-2001, which are currently in the early clinical research stage.
In addition to the immune sector, Hengrui Pharmaceuticals also lay out in the fields of anti -tumor, cardiovascular and metabolism, pain, infection, and ophthalmology, which focuses on the anti -tumor plate. Since the beginning of this year, Hengrui Pharmaceutical has obtained the FDA fast channel qualification recognition.
By accelerating the clinical progress of the research pipeline, Hengrui Pharmaceutical is expected to pick more innovative fruits in 2024.
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