The China National Intellectual Property Administration (CNIPA) has rejected a challenge filed by Junshi Biosciences (SHA: 688180) against a patent held by Alynlam Pharmaceutical (NASDAQ: ALNY), which is related to the development of PCSK9-targeted small-interfering RNA (siRNA) therapies. CNIPA’s decision to fully maintain Patent No. 561449, associated with application number “2013800639305” and titled “PCSK9 iRNA Composition and Its Use Method,” is a significant ruling in the field of RNAi therapy development.
Background of the Patent Dispute
The invalidation declaration was filed by Li Caihui, an individual identified as an IP executive at Junshi Biosciences, as reported by Fineline Info & Tech in early April. The invention patent in question, filed by US-based RNAi therapy specialist Alnylam on December 5, 2013, covers RNAi agents targeting the PCSK9 gene, including double-stranded RNAi agents, and methods for using these agents to inhibit PCSK9 expression and treat lipid disorders such as hyperlipidemia.
Market Landscape and Existing Treatments
Currently, two imported anti-PCSK9 monoclonal antibodies are approved for sale in China: Amgen’s Repatha (evolocumab) and Sanofi’s Praluent (alirocumab). There is no domestic anti-PCSK9 drug approved yet, highlighting the importance of patents like Alynlam’s in the development of new treatments.
Alnylam’s PCSK9-targeted siRNA and Novartis Acquisition
Alnylam was responsible for discovering and developing the PCSK9-targeted siRNA inclisiran, which it licensed to The Medicines Company. Novartis later acquired the drug as part of its 2019 acquisition of The Medicines Co. for USD 9.7 billion. Inclisiran was first approved in Europe for adult hypercholesterolemia and mixed dyslipidemia in December 2020 and gained US approval in 2021. The drug’s unique advantage is its requirement for only two injections per year, compared to the weekly injections of PCSK9-targeted competitors or daily statin use. Novartis filed inclisiran for approval in China in November 2021 and anticipates a regulatory decision in the second half of 2023, according to its Q4 2022 financial report.
Junshi Biosciences’ PCSK9 Developments
Junshi Biosciences has shown significant activity in the PCSK9 space, with its 2022 annual report indicating that ongericimab (code JS002), a PCSK9-targeted monoclonal antibody, is set for a market approval filing later this year. Additionally, Junshi has an siRNA drug research and development platform, with one RNAi drug (code JS401) targeting angiopoietin-like protein 3 messenger RNA filed for clinical trials.-Fineline Info & Tech
