- SB12 (also referred to as AMT904) is an eculizumab biosimilar candidate for the treatment of paroxysmal nocturnal hemoglobinuria
- The only biosimilar candidate referencing Soliris® (eculizumab)1 to be granted IND approval in China
Incheon, South Korea and Shanghai, China (GLOBE NEWSWIRE) - Samsung Bioepis Co., Ltd. and AffaMed Therapeutics today announced that the China National Medical Products Administration (NMPA) has approved the Clinical Trial Application (CTA) for SB12, also referred to as AMT904 in China – a biosimilar candidate referencing Soliris® (eculizumab). The CTA approval grants start of Phase 3 clinical study at Chinese sites.
SB12 is developed by Samsung Bioepis for the treatment of paroxysmal nocturnal hemoglobinuria and has responsibility for its global clinical trials conducted across 10 countries. AffaMed is responsible for SB12 (AMT904)’s China NDA approval based on the ongoing global Phase 3 trial conducted by Samsung Bioepis and received exclusive rights to commercialize the treatment in China and Singapore. To date, SB12 (AMT904) is the only biosimilar candidate referencing Soliris® (eculizumab) to be granted IND approval in China.
“We are very pleased to announce the CTA approval of SB12 in China as it allows us to expand our global Phase 3 clinical trial to include Asian market,” said Il Sun Hong, Vice President of Clinical Operation team at Samsung Bioepis. “The clinical collaboration with AffaMed furthers Samsung Bioepis’ goal to innovate access to life-changing medicines for patients in need.”
“We are delighted for this CTA approval as it further validates AffaMed’s position as a clinical-stage biopharmaceutical company,” said Dr. Nathan Pang, CEO of AffaMed Therapeutics. “This is AffaMed’s second biosimilar candidate to receive CTA approval within one-year of founding, accelerating its goal of providing innovative medicines to Chinese patients improving accessibility.”
The approved clinical trial is part of Samsung Bioepis’ ongoing global Phase 3 trial, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB12 and the reference product in subjects with paroxysmal nocturnal hemoglobinuria. The trial started in August 2019 and expected to enroll 50 subjects globally. The clinical study preparation in China is on track and first Chinese patient visit is scheduled in Q1 2020.
In addition to the SB12 (AMT904), Samsung Bioepis and AffaMed are collaborating across a number of biosimilar candidates in China, including biosimilars referencing Lucentis® (ranibizumab)2 and Eylea® (aflibercept).
1 Soliris ® is a registered trademark of Alexion
2 Lucentis® is a registered trademark of Genentech
3 Eylea® is a registered trademark of Regeneron Pharmaceuticals
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.
About AffaMed Therapeutics
AffaMed Therapeutics is a biopharmaceutical company focused on identifying and licensing late-stage candidates for commercialization in emerging Asia Pacific markets and globally. AffaMed was founded and funded by CBC Group, a healthcare private equity firm focused on the development and late-stage investment opportunities in 2019.
About CBC Group
CBC Group is a healthcare dedicated private equity firm, focused on growth and late-stage investment opportunities across the healthcare industry. CBC Group is committed to supporting the commercialization of cutting-edge technologies and companies that fulfill unmet medical needs, thus continuously improving the standard and quality of care for patients.
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