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FDA Fast Track Designation granted for Varoglutamstat in Early Alzheimer’s disease

Release time:2021-12-23

Simcere Pharmaceutical Group Limited (HKEX: 2096) announced today that varoglutamstat (PQ912,SIM0408), an investigational oral small molecule medicine co-developed by Simcere and Vivoryon Therapeutics N.V. in Greater China for the potential treatment of early Alzheimer’s disease (AD) has obtained the U.S. Food and Drug Administration (FDA) Fast Track designation.

Varoglutamstat is novel candidate designed to block formation of N3pE amyloid, a particularly neurotoxic variant of the Abeta peptide, by inhibiting glutaminyl cyclase (QPCT) and its isoenzyme (QPCTL). Varoglutamstat is currently being investigated in two Phase 2 clinical trials in patients living with early and mild AD: the European Phase 2b VIVIAD study and the recently initiated Phase 2a/b VIVA-MIND study in the U.S.

In June 2021, Simcere and Vivoryon entered into a regional strategic licensing partnership to develop and commercialize varoglutamstat and another preclinical monoclonal N3pE-antibody PBD-C06 in greater China.

It is estimated that there are nearly 10 million AD Patients in China, 2020 and the figure will reach to 21 million in 2050. The unmet medical need of Alzheimer’s disease treatment and social & economics burdens are continuously increasing. Simcere has included these Alzheimer's disease drugs into its R&D pipeline and quickly submitted clinical trial application, hoping to make more effective drugs available to patients sooner.

Fast Track is a process designed to facilitate the development, and expedite the review of drugs with the potential to treat serious conditions and fill an unmet medical need, aiming to bring important new drugs to the patient earlier. With Fast Track designation, the development of varoglutamstat can benefit from more frequent engagement with the FDA to discuss varoglutamstat’s development plan and ensure collection of the appropriate data needed to successfully advance varoglutamstat through clinical development. A drug that receives Fast Track designation is also potentially eligible for Accelerated Approval and Priority Review, if relevant criteria are met.

Forward Looking Statements

Information set forth in this press release contains forward-looking statements, which involve a number of known and unknown risks, uncertainties and assumptions. The forward-looking statements contained herein reflect the current judgment and views of Simcere Pharmaceutical Group Limited as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, or may not materialize, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements, whether as a result of new information, future events or otherwise, to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.