Beihai Kangcheng CAN108 Maralixibat Oral Liquid was approved for "first trial" in Boao Lecheng International Medical Tourism Pilot Zone

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Maralixibat oral solution was approved by the U.
S.
Food and Drug Administration (FDA) on September 29, 2021, for the treatment of cholestatic pruritus in patients with Alajeri syndrome one year old and older, for which there is no other indication in China With approved therapeutic drugs, there is a large unmet need for patient care
.

The "pioneering and piloting" of the Boao Lecheng International Medical Tourism Pilot Zone allows Chinese patients to enjoy disease treatment programs that are synchronized with the world, and improves the quality of life of patients, especially children

Beihai Kangcheng has an exclusive license to develop and commercialize CAN108 in Greater China for three rare liver disease indications: Alajeri syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC) and biliary atresia ( BA)
.

The National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for CAN108 in China for the treatment of Alajeri syndrome (ALGS) and is in the priority review stage

Dr.
Xue Qun, founder, chairman and chief executive officer of Beihai Kangcheng, said: "After the approval of Maralixibat oral solution in the United States, we quickly made this promising experimental therapy available to Chinese patients
.

This is our practice.

About Alajeri Syndrome (ALGS)

Alagille Syndrome (ALGS) is an autosomal dominant multisystem disorder that can lead to end-stage liver disease and death
.

Its incidence is between 1/30,000 and 1/50,000 ^[1] , and it has been registered in the NRDRS (China National Rare Disease Registry System)

About Maralixibat Oral Solution

Maralixibat oral solution is a barely absorbed ileal bile acid transporter (IBAT) inhibitor that blocks the enterohepatic circulation of bile acids, reduces intrahepatic and serum bile acid levels, and reduces mediated liver damage, Relieves itching
.

Maralixibat oral solution is currently the first and only drug approved by the FDA for the treatment of cholestatic pruritus in patients 1 year and older with Alajeri syndrome

In addition to ALGS, the development of Maralixibat oral solution for other cholestatic liver disease indications has also entered the late stage of clinical development, including progressive familial intrahepatic cholestasis (PFIC) and biliary atresia (BA), both of which have been granted breakthroughs by the FDA Identification of innovative drugs for sex therapy and rare diseases
.

Beihai Kangcheng has obtained the exclusive authorization for the development and commercialization of Maralixibat oral liquid in Greater China for the three indications of ALGS, PFIC and BA.
The National Medical Products Administration (NMPA) has officially accepted and included in the priority review
.

1.
Kamath et al, JPGN 2018; 67: 148-156
2.

Turnpenny PD, Ellard S.

About Beihai Kangcheng Pharmaceutical Co.
, Ltd.

Beihai Kangcheng Pharmaceutical Co.
, Ltd.
("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
.

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)

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
.

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
.

For more information about Beihai Kangcheng Pharmaceutical Co.
, Ltd.
, please visit: .

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