The Center for Drug Evaluation (CDE) website indicates that China-based Beijing Mabworks Biotech Co., Ltd’s MIL162 and US firm Amgen’s AMG 890 are on track to receive breakthrough therapy designation (BTD) awards in China. MIL162 is under development as a treatment for primary membranous nephropathy (pMN), while AMG 890 targets patients with atherosclerosis cardiovascular disease, aiming to reduce the risk of coronary heart disease death, myocardial infarction, and emergency coronary revascularization.
MIL162’s Potential in Primary Membranous Nephropathy
Mabworks’ official website does not list MIL162 in its pipeline; however, it is speculated that the product is essentially MIL62, the third-generation CD20 monoclonal antibody (mAb) and Mabworks’ lead pipeline candidate. This drug, billed as China’s first and only home-grown third-generation anti-CD20 antibody to reach the Phase III stage, is being developed to treat multiple hematological tumors and autoimmune diseases. Mabworks secured Phase III clinical approval for the drug to treat refractory follicular lymphoma in China in April 2021. The BTD designation would be a significant boost for Mabworks following Jiangsu Hengrui Medicine’s decision to cancel a license deal focused on MIL62, citing an overly competitive market landscape.
Competition in the CD20-Targeted Antibody Market
Other CD20-targeted antibodies available on the Chinese market include Roche’s Gazyva (obinutuzumab), Novartis’s Kesimpta (ofatumumab), Sinocelltech’s ripertamab, and Zhejiang BioRay Bio’s Anruixi (zuberitamab), with Gazyva and Kesimpta already included on the National Reimbursement Drug List (NRDL).
AMG 890’s Role in Atherosclerosis Cardiovascular Disease
AMG 890 (olpasiran), meanwhile, is an Lp(a)-targeted small interfering RNA (siRNA) originally developed by Arrowhead and licensed by Amgen in September 2016. It is under development to treat atherosclerosis cardiovascular disease (ASCVD) and reduce the risk of cardiovascular events. Lp(a) is determined by genes and is considered an independent risk factor for cardiovascular disease (CVD), with approximately 20% of adults having Lp(a) greater than 125 nmol/L (or approximately 50 mg/dL). Currently, there are no drugs approved that can continuously achieve significant or sustained reductions in Lp(a) concentration, and olpasiran is expected to provide a promising treatment method.-Fineline Info & Tech
