Junshi Biosciences (SHA: 688180) is reportedly taking steps to challenge a key patent held by Alynlam Pharmaceutical related to the development of PCSK9-targeted small-interfering RNA (siRNA) therapies, such as the lipid-lowering drug Leqvio (inclisiran), which is now marketed globally by Novartis.
CNIPA Oral Proceedings and Patent Dispute
According to a notification on oral proceedings recently issued by the China National Intellectual Property Administration (CNIPA), Junshi is seeking to invalidate an invention patent originally filed by US-based Alnylam Pharmaceutical (patent no. 2013800639305) named “PCSK9 iRNA composition and its use method”. The invalidation declaration was filed by an individual named Li Caihui, identified as an IP executive at Junshi.
Details of the Contested Patent
The patent in question involves RNAi agents targeting the PCSK9 gene, including double-stranded RNAi agents, as well as methods for using such RNAi agents to inhibit PCSK9 expression and methods for treating subjects with lipid disorders, such as hyperlipidemia. The application for this invention patent was made on December 5, 2013.
PCSK9-targeted Therapies and Market Landscape in China
The PCSK9 target is a popular focus in the field of lipid-lowering drugs. Currently, there are two imported anti-PCSK9 monoclonal antibodies approved for sale in China: Amgen’s Repatha (evolocumab) and Sanofi’s Praluent (alirocumab). No domestic anti-PCSK9 drug has been approved yet.
Alnylam’sPCSK9-targeted siRNA Therapy and Novartis
Alnylam was responsible for discovering and developing the PCSK9-targeted siRNA inclisiran, which it licensed to The Medicines Company. Novartis later acquired the drug via its 2019 acquisition of The Medicines Co., for USD 9.7 billion. Inclisiran was first approved in Europe as a treatment for adult hypercholesterolemia and mixed dyslipidemia in December 2020 and gained US approval in 2021. The drug requires only two injections each year to achieve lipid-lowering effects, compared with the weekly subcutaneous injections of PCSK9-targeted competitors or daily use of statins. Novartis filed inclisiran for approval in China in November 2021 and expects a regulatory decision in the second half of 2023, as per the Swiss giant’s Q4 2022 financial report.
Junshi Biosciences’ PCSK9-targeted Pipeline
In terms of Junshi’s activity in the PCSK9 space, the firm’s annual report for 2022 shows that ongericimab (code JS002), a PCSK9-targeted monoclonal antibody, is set for a market approval filing later this year. Junshi also has a siRNA drug research and development platform, with one RNAi drug (code JS401) targeting angiopoietin-like protein 3 messenger RNA in the clinic.-Fineline Info & Tech
