China Clears Phase 3 Trial for SB12, Samsung Bioepis' Biosimilar Eculizumab

Samsung Bioepis and AffaMed Therapeutics said Friday that the China National Medical Products Administration (NMPA) cleared a phase 3 trial to begin for SB12, a biosimilar eculizumab referencing Soliris.

Also referred to as AMT904 in China, the eculizumab biosimilar treats paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening disease of the blood characterized by destruction of red blood cells, presence of blood clots, and impaired bone marrow function.

It is the only biosimilar candidate referencing Soliris to be granted investigational new drug approval in China.

SB12 is developed by Samsung Bioepis, which has responsibility for its global clinical trials in 10 countries.

AffaMed is responsible for the approval of SB12/AMT904 in China, based on the ongoing global phase 3 trial conducted by Samsung Bioepis; it also has received exclusive rights to commercialize the treatment in China and Singapore.

“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 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 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 reference eculizumab.. The trial, which started in August 2019, is expected to enroll 50 subjects globally. The first Chinese patient visit is scheduled in the first quarter of 2020.

In addition to eculizumab, the 2 companies are collaborating across a number of biosimilar candidates in China, including biosimilar ranibizumab and aflibercept.

In the United States, the reference eculizumab is approved by the FDA to treat atypical hemolytic uremic syndrome (a rare disease that causes abnormal blood clots to form in the small blood vessels in the kidneys), generalized myasthenia gravis (a rare, autoimmune, neuromuscular junction disorder), and, PNH, and, most recently, neuromyelitis optica spectrum disorder (NMOSD, a rare disorder of the central nervous system).

Soliris, a C5 complement inhibitor, is made by rare disease drug maker Alexion. Another possible competitor to Soliris is Amgen’s ABP 959.