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Beijing October 20, 2021-Beihai Kangcheng Pharmaceutical Co.
, Ltd.
(hereinafter referred to as "Beihai Kangcheng") is a leading rare disease biopharmaceutical company based in China and has been committed to the research, development and commercialization of innovative therapies
.
The company announced today that the CAN103 New Drug Clinical Trial Application (IND) has been approved by the National Medical Products Administration (NMPA) of China
Dr.
Xue Qun, Founder, Chairman and CEO of Beihai Kangcheng, said: “The rapid approval of the CAN103 clinical trial application is a major development for Gaucher patients in China
.
We are actively doing various activities to initiate the clinical trial.
Gaucher disease is one of the most common lysosomal storage diseases.
It is inherited in an autosomal recessive manner.
The mutation of the glucocerebrosidase gene located on the long arm of chromosome 1 causes the lack of this enzyme in the body.
Intracellular glucocerebroside molecules cannot be metabolized normally and accumulate in lysosomes.
The clinical manifestations include splenomegaly, hepatomegaly, anemia, thrombocytopenia, bone pain, and nervous system symptoms
.
In the past 30 years, clinical trials and real-world supporting data have shown that Gaucher's disease is treated with glucocerebrosidase replacement therapy (ERT), and its main non-neurological symptoms and health-related patients' quality of life have been significantly improved
Beihai Kangcheng Pharmaceutical Co.
, Ltd.
is a global rare disease biopharmaceutical company based in China, dedicated to the research, development and commercialization of innovative therapies
.
Beihai Kangcheng currently has a comprehensive and differentiated pipeline consisting of 13 pharmaceutical assets with huge market potential, targeting some of the most common rare diseases and rare tumor indications
.
These include treatments for Hunter syndrome (MPS II) and other lysosomal storage diseases (LSD), complement-mediated diseases, hemophilia A, metabolic disorders, and rare cholestatic liver diseases, including Alagille syndrome ( ALGS), progressive familial intrahepatic disease (PFIC) and biliary atresia (BA), and glioblastoma (GBM)
Beihai Kangcheng strategically combines global cooperation and internal research to establish a diversified drug portfolio, while investing in the next generation of gene therapy technology for rare disease treatment
.
Beihai Kangcheng’s global partners include Apogenix, GC Pharma, Mirum, WuXi Biologics, Privus, University of Massachusetts Medical School (UMass) and LogicBio
