NMPA’s Center for Drug Evaluation Adds Licenses of GastroPlus®

Chinese government institute to apply software to research model-informed drug development approaches for clinical pharmacology

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 received an order from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China to add licenses to GastroPlus^®.

John DiBella, Simulations Plus division president, said: “The adoption of physiologically based biopharmaceutics (PBBM) / pharmacokinetic (PBPK) modeling to support various applications during the drug development process has exploded over the years, in large part driven by encouragement from global regulatory agencies. We have cultivated relationships with different affiliated institutions of NMPA to apply our technology to support the evaluation of drug product specifications and bioequivalence. Now, researchers at the CDE will add GastroPlus to serve as a key platform for model-informed drug development (MIDD) to aid regulatory reviews. This news is welcomed by over 20 (and growing) domestic Chinese pharmaceutical companies and research hospitals that have been employing our technologies and publishing case studies to validate novel MIDD approaches.”

“We anticipate that this will lead to increased confidence and more fruitful interactions with NMPA,” added Linda Lin, General Manager at PharmoGo Co., Ltd., the Simulations Plus division representative in China. “The ultimate goal will be to identify how the simulation results can potentially be applied to reduce time to market and get medicines to patients more cost effectively.”

Views expressed in this press release do not necessarily reflect the official policies of the National Medical Products Administration; nor does any mention of trade names, commercial practices, or organization imply endorsement by the Chinese Government.

About Simulations Plus, Inc.

Serving clients worldwide for 25 years, 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 that 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. Follow us on Twitter | Read our Environmental, Social, and Governance (ESG) Report.

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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