North Sea Kangcheng Ado sulfate enzyme beta injection has been approved for sale in China.

On September 9, 2020, Beihai Kangcheng announced that its long-term enzyme replacement drug Hunterase® (Adolfate Enzyme Beta Injection) for the treatment of mucosal polysaccharide storing disorder TYPE II., also known as MPSII., also known as Hunter syndrome, has been approved by China's State Drug Administration.
As the first rare disease drug successfully commercialized in China by Beihai Kangcheng, Haixuan is the first and only new generation of enzyme replacement therapy (Enzyme replace therapy, ERT) in China, with FDA orphan drug qualification and priority review qualification from the State Drug Administration for the diagnosis of mucosal polysaccharide storage syndrome II.
to fill the unseeded demand for drug treatment in China, and ushered in a new era of treatment of MPSII.
has been used in 11 countries around the world and has been proven to be effective and safe Chinese a wide range of populations and groups.
As a new generation of enzyme replacement therapy in the world, hyalurologically reduces uGAGs levels in MPSII. patients and significantly improves the 6-minute walking test distance (6-MWT) 1, as well as in children under 6 years of age.
the production process of sea otters has been reformed, its enzyme activity is high, and no serum culture base will avoid the risk of exogenetic contamination.
drug can be used for long-term treatment, safe and stable, good infusion tolerance.
to fill the clinical blank of China's MPSII. Enzyme replacement therapy MPSII. is a rare progressive disability, fatal X chain recessive genetic disease.
because of the absence or deficiency of Adolfalic acid-2-sulphatease (IDS), glycamine polysaccharides (GAG) stored in the patient's body can affect multiple organ systems.
, mucosal polysaccharies (MPS) has been included in the national "first list of rare diseases", ranked No. 73.
National Health Care Commission rare disease diagnosis and treatment and protection expert committee member, Shanghai Children's Rare Disease Diagnosis and Treatment Center Director, Shanghai Xuanda Medical College affiliated Xinhua Hospital Professor Gu Xuefan introduced: "MPSII. The middle age of patients is mostly before the age of 5 years old, the main clinical manifestations are stunted, rough face, bone deformity, liver swelling and so on."
mPSII. Patients died of heart or respiratory diseases when they were under 15 years of age.
is urgently needed for this seriously life-threatening genetic disease.
" According to the 2020 release of the "Analysis of the survival status of patients with rare diseases in China from mucosal polysaccharide accumulation" report, due to the lack of effective enzyme replacement therapy drugs in China, 41% of patients with mucosal polysaccharide storage disease after diagnosis did not receive any treatment, 47% of patients can only treat the disease, and even 8.95% of patients in order to receive effective drug treatment and go overseas.
enzyme replacement therapy (ERT) is unanimously recommended as the standard treatment for MPSII.
Professor Luo Xiaoping, Vice Chairman of the Science Branch of the Chinese Medical Association, said: "MPSII. The damage to the organ system is almost irreversible, if timely treatment can be given in the early stages of the disease, so that patients receive long-term standardized enzyme replacement therapy, can prevent and delay the progression of the disease, but also can avoid the emergence of serious complications, improve the multi-organ system tired, improve growth and development, to give patients hope for life."
the approval of Haixuan Siwei will change china's MPSII. Patients have no cure for the dilemma.
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