Junshi's lipid lowering drug hits phase 3 goals, teeing up challenge to Amgen, Sanofi in growth market

Junshi Biosciences has delivered the data to challenge Amgen and Sanofi for a cardiovascular disease opportunity, with the results of two phase 3 anti-PCSK9 antibody trials advancing the Chinese biotech toward approval in its home market.

Shanghai-based Junshi is well behind the front-runners. The FDA approved Amgen’s Repatha and Sanofi and Regeneron’s Praluent in 2015. Neither drug took off commercially as analysts expected, with slow revenue ramps making a mockery of peak sales forecasts that topped $3 billion. But, while revenues remain far below the preapproval hype, both drugs gained momentum last year, with Repatha sales up 16% to $1.3 billion and Sanofi’s Praluent sales jumping (PDF) 73% to $376 million.

Amgen and Sanofi both cited the inclusion of their medicines on China’s National Reimbursement Drug List at the start of 2022 as a driver of the fast growth seen last year. Now, Junshi is threatening to throttle the growth by launching China’s first home-grown anti-PCSK9 monoclonal antibody, ongericimab.

Two pivotal clinical trials of the drug candidate in patients with primary hypercholesterolemia and mixed dyslipidemia, conditions associated with high cholesterol, met their primary endpoints. Junshi is yet to share the data, but Yaling Han, from the General Hospital of Northern Theatre Command, said the results are “very encouraging” and “show comparable efficacy and safety” to PCSK9 inhibitors from overseas.

Junshi’s phase 3 studies tested two subcutaneous formulations of ongericimab, prefilled syringes and prefilled automatic syringes. A phase 3 study registered on ClinicalTrials.gov is testing the effects of giving ongericimab every two weeks and every four weeks. 

Repatha is given every two weeks using an autoinjector or every four weeks via an on-body infusor with a prefilled cartridge. Patients administer Praluent every two or four weeks using a prefilled pen.