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The Clinical Trial Application of Alzheimer's Disease Drug Varoglutamstat Accepted for Review by China CDE

Release time:2021-12-14

December 13, 2021 -- Simcere Pharmaceutical Group Limited (HKEX: 2096) announced that the clinical trial application for SIM0408 (Varoglutamstat), a drug for the treatment of Alzheimer's disease (AD) co-developed with Vivoryon Therapeutics N.V., has been accepted for review by China CDE.

In June of this year, Simcere and Vivoryon entered into a regional strategic licensing partnership to develop and commercialize medicines targeting the neurotoxic amyloid species N3pE (pGlu-Abeta) to treat Alzheimer's disease in Greater China and comprises Vivoryon's Phase 2b-stage N3pE amyloid-targeting oral small molecule glutaminyl cyclase (QPCT) inhibitor with disease-modifying potential for AD, as well as the Vivoryon's preclinical monoclonal N3pE-antibody PBD-C06.

About Varoglutamstat (PQ912)

Varoglutamstat is an orally administered small molecule inhibitor of glutaminyl cyclase (QPCT), which is a promising approach for AD drug development currently, as it can inhibit the production of neurotoxic N3pE amyloid, which plays a role in the early stages of AD. N3pE amyloid triggers a number of pathological processes in AD and by preventing formation of this toxic molecule, Varoglutamstat has the potential to prevent neuronal damage.

Its pharmacology, toxicology, main pharmacodynamics and other characteristics have been verified by pre-clinical research, and Varoglutamstat has already reached the stage of clinical Phase 2b development in Europe. The short-term treatment results of a completed Phase 2a study of Varoglutamstat (12 weeks of treatment + 4 weeks of follow-up) showed statistically significant improvements in working memory in the Varoglutamstat treatment group compared with the placebo group as measured by the Cogstate NTB (one back test). In addition, the results of the Varoglutamstat treatment group showed a statistically significant difference from those of the control group for other parameters such as: inhibition of QPCT enzyme in cerebrospinal fluid, neurogranin in cerebrospinal fluid, a biomarker representing synaptic toxicity, YKL-40 in cerebrospinal fluid, a biomarker representing neuroinflammation, and neural network function as measured by EEG.

It is estimated that there are be about 9 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.

About Simcere

Simcere Pharmaceutical Group limited (2096. HK) is rapidly transitioning to an innovation and R&D-driven pharmaceutical company, with the mission of "providing today's patients with the medicines of the future." With an established national key laboratory of translational medicine and innovative pharmaceuticals, Simcere focuses on the three main therapeutic areas of oncology, central nervous system diseases and autoimmune diseases. The company has developed a diversified product portfolio and industry-leading capabilities through its vigorous in-house R&D efforts and extensive R&D collaborations. In an effort to bring more global life science breakthroughs to China, Sincere continues strategically collaborate with world-leading pharmaceutical companies and biotechnology companies.

For more information, please visit: www.simcere.com

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.