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On March 2, 2022, InnoCare (Hong Kong Stock Exchange: 09969), a high-tech biopharmaceutical company, recently announced that the company's Bruton's tyrosine kinase (BTK) inhibitor orelabrutinib is used for the treatment of optic nerve cord Neuromyelitis Optica Spectrum Disorder (NMOSD) has passed the New Drug (IND) review of the National Medical Products Administration (NMPA) of China and was approved to conduct Phase II clinical studies in China
.
This is a randomized, double-blind, placebo-controlled Phase II clinical study evaluating the efficacy and safety of orelabrutinib in patients with neuromyelitis optica spectrum disorders
.
Neuromyelitis optica spectrum disorders (NMOSD) are a group of inflammatory demyelinating autoimmune diseases of the central nervous system mainly involving the optic nerve and spinal cord, mediated by antigen-antibody mainly involved in humoral immunity
.
Clinically, it is characterized by severe optic neuritis and longitudinally extending long-segment transverse myelitis
.
The latest epidemiological study based on hospitalized patients in China showed that the peak incidence of the disease was 45-65 years old, the incidence rate was 0.
445/100,000 person-years, and the ratio of female to male patients was 4.
71:1
.
NMOSD is a highly relapsing, highly disabling disease, with more than 90% of patients having a relapsing course; about 60% of patients relapse within 1 year, 90% within 3 years, and most patients have severe visual impairment (blindness) , limb dysfunction (paraplegia), and urination and defecation disorders
.
Studies have shown that there is a clear correlation between functional disability and relapse in patients, so it is necessary to seek new treatments to reduce relapse in patients
.
The etiology and pathogenesis of NMOSD are not fully understood
.
It is currently thought to be related to a specific aquaporin 4 antibody (AQP4-IgG) produced by mature B cells, and up to 80% of patients are serologically AQP4-IgG positive
.
BTK is a key kinase in the B cell receptor signaling pathway responsible for regulating B cell proliferation, differentiation, maturation and cytokine expression
.
Abnormal activation of BTK-related signaling pathways can lead to autoantibody production and autoimmune diseases, so it can be used as a new therapeutic target for autoimmune diseases, including NMOSD, multiple sclerosis, systemic lupus erythematosus,
etc.
Dr.
Jisong Cui, co-founder, chairman and CEO of Nuocheng Jianhua, said: "Finding efficient treatments for NMOSD remains a challenge, and there is still a large unmet medical need in reducing recurrence and improving prognosis
.
Combining the pathogenesis of NMOSD and the mechanism of action of orelabrutinib, it is believed that orelabrutinib will bring new treatment options
for NMOSD.
" About Orbrutinib Orelabrutinib is a class 1 innovative drug independently developed by Nuocheng Jianhua.
It is a highly selective novel BTK inhibitor for the treatment of lymphoma and autoimmune diseases
.
On December 25, 2020, orelabrutinib was approved by the China National Medical Products Administration (NMPA) for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and relapsed/refractory Two indications for refractory mantle cell lymphoma (MCL)
.
By the end of 2021, orbrutinib will be included in the national medical insurance, which will benefit more lymphoma patients
.
In addition to the approved indications, orelabrutinib is undergoing multi-center, multi-indication clinical trials in China and the United States to study its efficacy and safety as a single drug and a combination drug
.
About Nuochengjianhua Nuochengjianhua (Hong Kong Stock Exchange Code: 09969) is a high-tech biopharmaceutical company in the commercialization stage, focusing on the development of a class of new drugs for the treatment of malignant tumors and autoimmune diseases, suitable for the treatment of Lymphomas, solid tumors and autoimmune diseases
.
A number of new drug products are currently in the commercialization, clinical and preclinical development stages
.
The company has branches in Beijing, Nanjing, Shanghai, Guangzhou, New Jersey and Boston
.
.
This is a randomized, double-blind, placebo-controlled Phase II clinical study evaluating the efficacy and safety of orelabrutinib in patients with neuromyelitis optica spectrum disorders
.
Neuromyelitis optica spectrum disorders (NMOSD) are a group of inflammatory demyelinating autoimmune diseases of the central nervous system mainly involving the optic nerve and spinal cord, mediated by antigen-antibody mainly involved in humoral immunity
.
Clinically, it is characterized by severe optic neuritis and longitudinally extending long-segment transverse myelitis
.
The latest epidemiological study based on hospitalized patients in China showed that the peak incidence of the disease was 45-65 years old, the incidence rate was 0.
445/100,000 person-years, and the ratio of female to male patients was 4.
71:1
.
NMOSD is a highly relapsing, highly disabling disease, with more than 90% of patients having a relapsing course; about 60% of patients relapse within 1 year, 90% within 3 years, and most patients have severe visual impairment (blindness) , limb dysfunction (paraplegia), and urination and defecation disorders
.
Studies have shown that there is a clear correlation between functional disability and relapse in patients, so it is necessary to seek new treatments to reduce relapse in patients
.
The etiology and pathogenesis of NMOSD are not fully understood
.
It is currently thought to be related to a specific aquaporin 4 antibody (AQP4-IgG) produced by mature B cells, and up to 80% of patients are serologically AQP4-IgG positive
.
BTK is a key kinase in the B cell receptor signaling pathway responsible for regulating B cell proliferation, differentiation, maturation and cytokine expression
.
Abnormal activation of BTK-related signaling pathways can lead to autoantibody production and autoimmune diseases, so it can be used as a new therapeutic target for autoimmune diseases, including NMOSD, multiple sclerosis, systemic lupus erythematosus,
etc.
Dr.
Jisong Cui, co-founder, chairman and CEO of Nuocheng Jianhua, said: "Finding efficient treatments for NMOSD remains a challenge, and there is still a large unmet medical need in reducing recurrence and improving prognosis
.
Combining the pathogenesis of NMOSD and the mechanism of action of orelabrutinib, it is believed that orelabrutinib will bring new treatment options
for NMOSD.
" About Orbrutinib Orelabrutinib is a class 1 innovative drug independently developed by Nuocheng Jianhua.
It is a highly selective novel BTK inhibitor for the treatment of lymphoma and autoimmune diseases
.
On December 25, 2020, orelabrutinib was approved by the China National Medical Products Administration (NMPA) for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and relapsed/refractory Two indications for refractory mantle cell lymphoma (MCL)
.
By the end of 2021, orbrutinib will be included in the national medical insurance, which will benefit more lymphoma patients
.
In addition to the approved indications, orelabrutinib is undergoing multi-center, multi-indication clinical trials in China and the United States to study its efficacy and safety as a single drug and a combination drug
.
About Nuochengjianhua Nuochengjianhua (Hong Kong Stock Exchange Code: 09969) is a high-tech biopharmaceutical company in the commercialization stage, focusing on the development of a class of new drugs for the treatment of malignant tumors and autoimmune diseases, suitable for the treatment of Lymphomas, solid tumors and autoimmune diseases
.
A number of new drug products are currently in the commercialization, clinical and preclinical development stages
.
The company has branches in Beijing, Nanjing, Shanghai, Guangzhou, New Jersey and Boston
.
