Phase 3 Trial Enrollment Approved in China for Samsung Bioepsis' Biosimilar Eculizumab

January 11, 2020

The biosimilar candidate treats paroxysmal nocturnal hemoglobinuria, a rare blood condition that features destruction of red blood cells, thrombosis, and impaired bone marrow function.

A phase 3 trial for SB12, a biosimilar eculizumab referencing Soliris, will begin in China, following clearance by the country’s National Medical Products Administration Friday. Samsung Bioepsis, which is developing the therapy, and AffaMed Therapeutics announced the milestone.

SB12, also called AMT904 in China, treats paroxysmal nocturnal hemoglobinuria (PNH), a rare blood condition that features destruction of red blood cells, thrombosis, and impaired bone marrow function. The Samsung Bioepsis biosimilar candidate is the only one that China has cleared for investigational new drug approval. The pharmaceutical company has clinical trials in 10 countries, with partner AffaMed managing the process 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, clinical operations, Samsung Bioepis, in a statement. “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 [clinical trial application] approval as it further validates AffaMed’s position as a clinical-stage biopharmaceutical company” said Nathan Pang, MBBS, chief executive officer, 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 first Chinese patient is expected to enroll in the first quarter of 2020 as part of broader trial that will eventually enroll 50 people worldwide to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB12 and reference eculizumab.

Soliris is a C5 complement inhibitor made by rare disease specialist Alexion.