For hives!

According to the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration, the QGE031 injection submitted by Novartis has obtained the implied license for clinical trials, and the indication is chronic induced urticaria

Screenshot source: CDE official website

According to the "Guidelines for the Diagnosis and Treatment of Urticaria in China" (2018 edition), urticaria is a localized edema reaction due to dilation and increased permeability of small blood vessels in the skin and mucous membranes

According to Novartis' official website, ligelizumab is a new-generation monoclonal anti-immunoglobulin E (IgE) antibody that is thought to work by blocking the IgE/FcεRI pathway

In a phase 2b dose-finding trial, more patients experienced complete resolution of symptoms with ligelizumab compared with a previous-generation IgE antibody; In a phase 2b dose-finding trial in patients with chronic spontaneous urticaria (CSU), no safety concerns were identified with ligelizumab compared with previous-generation IgE antibodies or placebo

According to the ClinicalTrials.

We look forward to the smooth progress of clinical research of Novartis' new generation of IgE antibody therapy in China and bring more treatment options to patients as soon as possible

References:

[1] The official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China.

[3] clinicaltrials.

[4] Urticaria Research Center, Dermatology and Venereology Branch of Chinese Medical Association.