CAN106 injection completed the first patient with PNH in Phase Ib/I I clinical trial in China

Beihai Kangcheng Pharmaceutical Co.
, Ltd.
(hereinafter referred to as "Beihai Kangcheng", stock code 1228.
HK) is a biopharmaceutical company based in China.
As a global company in the field of rare diseases, Beihai Kangcheng is committed to the research, development and commercialization of innovative therapies.

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The company recently announced that CAN106 injection has completed the first patient dosing in the Phase Ib/I I clinical trial in China
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This study is a multicenter, open-label, continuous-dose Phase Ib/I I clinical trial evaluating CAN106 injection in subjects with paroxysmal nocturnal hemoglobinuria (PNH) who have not received complement inhibitor therapy previously.
Tolerability, Efficacy and Safety, Pharmacokinetic and Pharmacodynamic Characteristics
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Professor Han Bing, chief physician and doctoral supervisor of the Department of Hematology, Peking Union Medical College Hospital, is the chief researcher of the study
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Prior to this, CAN106 injection has carried out a clinical trial on healthy subjects in Singapore, the results show that CAN106 injection is safe, well tolerated, and has good dose-dependent and pharmacokinetic properties, free C5 and CH50 can be effectively inhibited
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Based on the results of the Singapore trial, a phase Ib/I I clinical trial protocol for PNH patients was designed, and the study was started within a relatively short period of time after CDE approval.
The first PNH patient has been administered so far, allowing patients to benefit as soon as possible
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"The first human data validate CAN106 as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) and other complement-mediated disorders
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We are pleased to see that the CAN106 PNH clinical trial was initiated shortly after the above data were published.
The first patient was administered
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” said Dr.
Xue Qun, founder, chairman and CEO of Beihai Kangcheng, “Peking Union Medical College Hospital is one of the leading research institutions in China, and we are looking forward to the cooperation between the two parties
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Previously, Beihai Kangcheng and Beijing Union Medical College Hospital has also reached a cooperation intention on rare disease research
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We hope to bring this new treatment method to China to change the current situation of limited anti-C5 treatment routes and lack of treatment options for domestic patients
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About CAN106 CAN106 is an innovative long-acting recombinant humanized monoclonal antibody that binds and neutralizes C5, a complement system protein, thereby preventing the formation of the membrane attack complex (MAC), which causes cell lysis (destruction) and other symptoms associated with PNH.

When C5 protein is cleaved into C5a and C5b, MAC is activated, and the specific binding of CAN106 to C5 can block this process
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CAN106 shows good PK/PD properties, safety This suggests that it has the potential to effectively inhibit certain complement-mediated diseases
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About Paroxysmal Nocturnal Hemoglobinuria (PNH) Paroxysmal nocturnal hemoglobinuria (PNH) is a fatal and rare Complement system diseases
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The complement system is a part of the immune system.
It removes microorganisms and damaged cells by attacking cell membranes, but its imbalance in regulation can lead to the production of some diseases.

PNH is a typical complement-related disease, which can cause Severe anemia, thromboembolism, gastrointestinal pain and dysfunction, fatigue, pulmonary hypertension, renal impairment, and ultimately death
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It is estimated that in Western countries, 1 to 2 people per million people suffer from PNH each year
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According to the "Guidelines for the diagnosis and treatment of rare diseases (2019 edition)", in Asia, about 10 people per million people suffer from PNH every year
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However, the treatment options for this disease are currently only allogeneic bone marrow transplantation and anti-C5 monoclonal antibody (Eculizumab).
Monoclonal antibody and relizumab), while only eculizumab has been approved in China, but it is still out of reach for Chinese PNH patients due to its high treatment cost
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About Beihai Kangcheng Pharmaceutical Co.
, Ltd.
Beihai Kangcheng Pharmaceutical Co.
, Ltd.
(hereinafter referred to as "Beihai Kangcheng", stock code 1228.
HK) 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 of 13 drug assets with significant market potential, targeting some of the most prevalent rare disease and rare tumor indications
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These include treatments for Hunter syndrome (MPS II) and other lysosomal storage disorders (LSDs), complement-mediated disorders, hemophilia A, metabolic disorders, and rare cholestatic liver diseases, including Alagille syndrome ( ALGS), progressive familial intrahepatic cholestasis (PFIC) and biliary atresia (BA), and glioblastoma (GBM)
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Beihai Kangcheng strategically combines global collaboration with in-house research to build a diverse drug portfolio, while investing in next-generation gene therapy technologies for rare disease treatment
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Beihai Kangcheng's global partners include but are not limited to Apogenix, GC Pharma, Mirum, WuXi Biologics, Privus, UMass, LogicBio, University of Washington School of Medicine and scriptr Global
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