Simulations Plus Enters Agreement with Distributor in China

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, today announced that it has entered into a distribution agreement with Mosim, one of China’s leading biopharmaceutical services companies, to distribute MonolixSuite™, the Lixoft division’s pharmacokinetic/pharmacodynamic (PK/PD) modeling platform, in China.

Founded in 2015, Mosim was the first clinical contract research organization (CRO) providing clinical pharmacology services in China. During the last 5 years, by expanding its clinical operation team with a focus on clinical pharmacology studies, Mosim has become a full service clinical CRO. With a staff of over 100 qualified scientists, Mosim will provide extensive connections throughout industry, academia, and regulatory agencies to increase awareness of MonolixSuite, including PKanalix, Monolix, and Simulx.

Jiansong Yang, chief executive officer of Mosim, said: “We are excited to be partnering with Lixoft, whose MonolixSuite is the most advanced and simple solution for non-linear mixed effects modeling (NLME) for pharmacometrics. In recent years, we’ve seen an increasing demand for model-informed drug development by China’s pharmaceutical industry as well as its regulatory agency, the National Medical Products Administration, or NMPA (formerly known as the China Food and Drug Administration). Working with Lixoft will allow us to provide China’s pharmaceutical scientists with a powerful tool for population PK/PD modeling. Also, as a leading provider of modeling and simulation in China, Mosim is committed to training young clinical pharmacologists and pharmacometricians, and MonolixSuite will contribute significantly to this important work.”

“China is one of the fastest growing markets in pharmaceutical research and development with the emergence of domestic companies for the development of new drugs,” added Jonathan Chauvin, president of Lixoft. “In 2019, we hosted MonolixSuite modeling and simulation workshops at Innovent Biologics and the International Symposium of Quantitative Pharmacology (ISQP) in China, and the response to our technology was very enthusiastic. There are now approximately one hundred users in China utilizing our products in their drug development efforts, so we are confident that this new partnership with Mosim is perfectly timed to serve the growing needs of China’s scientific community.”

The MonolixSuite is a unique solution for non-compartmental analysis (NCA), PK/PD and population modeling for Clinical Pharmacology and Pharmacometrics that supports the efforts of pharmacometricians to manage their projects from the first data exploration up to clinical trial simulations. With a powerful, unified, and user-friendly interface, the MonolixSuite consists of three applications: PKanalix for non-compartmental and compartmental analysis, Monolix for population modeling and diagnostics, and Simulx for clinical trial simulations. These integrated and interactive applications are based on the most state-of-the-art and rigorous statistical methods in order to deliver reliable and high-quality results on a timely basis.

This distribution agreement with Mosim for MonolixSuite will complement the existing arrangement between Simulations Plus and PharmoGo Co., Limited, the China-based distributor for the Company’s software products, including GastroPlus® and ADMET Predictor®, thereby expanding the Company’s reach across discovery, pre-clinical and clinical research and development within China’s pharmaceutical industry.

About Simulations Plus, Inc.

Simulations Plus, Inc., is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. With our subsidiaries, Cognigen, DILIsym Services, and Lixoft, we offer solutions which bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, chemical, consumer goods companies and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like “believe,” “expect” and “anticipate” mean that these are our best estimates as of this writing, but that there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports and filed with the U.S. Securities and Exchange Commission.

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