The application for the listing of a new adaptation of Fuhong Han-Han-Lytoxi mono-anti-biosynthic drug was accepted

On December 17, Fu Hong hanxuan announced that China's State Drug Administration (NMPA) had officially accepted the application for the listing of the Lytoxidan anti-biosynthic drug HLX01 for the new adaptive rheumatoid arthritis (RA).
, HLX01 was approved by the NMPA in February 2019 and is currently available for non-Hodgkin's lymphoma and leukemia adaptation treatment.
litoxi monoantigen is a monoclonal antibody that binds to CD20 antigens on the surface of B lymphocytes, mediates the cytotoxic effect (CDC) and antibody-dependent cell-mediated cytotoxic action (ADCC), mediates normal and malignant B cell dissolution in the body, and achieves anti-tumor treatment effect.
February 2019, HLX01, a lysoxi monobial-like drug developed by Fuhong Hanxuan, was approved for sale in China, making it the first biosychic drug approved in China.
application for the listing of HLX01 New Adaptations is based on key research data from a Phase 1 clinical trial HLX01-RA01 and Phase 3 clinical trial HLX01-RA03.
, the results of the HLX01-RA01 study show that HLX01 is highly similar in pharmacodynamics/pharmacological dynamics and safety to the lytoxides sold in the European Union and can effectively support the follow-up clinical Phase 3 trials (HLX01-RA03).
HLX01-RA03 is a randomized, double-blind, placebo-controlled Phase 3 clinical study that assessed the effectiveness and safety of HLX01 combined methotrexate (MTX) treatment in subjects with moderate to severe active rheumatoid arthritis (MTX-IR) treatment, with the lead researcher being Professor Zeng Xiaofeng of the Rheumatology Immunology Department at Beijing Concord Hospital.
, the study has reached the primary endpoint of "the proportion of subjects who reached the American Rheumatology Society's 20% mitigation standard (ACR20) in week 24" and the results show that HLX01 combined MTX is safe and effective in moderate-severe active RA subjects in MTX-IR.
rheumatoid arthritis is a class of chronic systemic autoimmune diseases dominated by joint lesions, with patients accounting for about 0.5%-1.0% of the global population.
women are more than twice as likely as men to develop the disease at any age, with the highest risk of developing the disease around the age of 50. The common clinical manifestations of class
rheumatoid arthritis are symmetrical, persistent joint swelling and pain, often accompanied by morning stiffness, light to joint cartilage and bone damage, heavy to joint malformation and loss of function, and even affect the normal life of patients.
because the disease is not completely curable and can only be alleviated through treatment, it requires lifelong treatment.
HLX01's application for registration for RA's new adaptation marks the product's promise to realize its clinical potential in the field of rheumatoid immunology more fully.
According to the press release, HLX01's benefits, including low frequency of administration and long duration of drug effectiveness, are expected to significantly improve patient compliance, thereby improving patient quality of life, reducing the medical burden on patients, and benefiting more patients who have not yet met their medical needs.
Reference: .1 Heavy! NMPA officially accepts the listing application for HLX01 (Lytoxi single anti) rheumatoid arthritis new adaptive disorder. Retrieved Dec 17, 2020, from Source: Medical Mission Hills