VivoSim Enters China with First Commercial Sales of NAMkind™ Toxicology Screening and Efficacy Testing Services

SAN DIEGO, July 21, 2026 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (NASDAQ:VIVS) (the "Company" or "VivoSim"), a provider of next-generation New Approach Methodologies (NAMs) for preclinical safety, today announced its first commercial sales in China, opening a significant new market for its NAMkind™ testing services. VivoSim delivers both toxicology and efficacy testing built on its 3D human tissue models of the liver and gastrointestinal (GI) tract. The two initial engagements, with a leading Shanghai-based oncology biotech and a large Chengdu-based pharmaceutical company, represent the Company’s first paid programs on the Chinese mainland and a milestone in VivoSim’s expansion across Asia-Pacific.

The two orders cover GI toxicology screening and NAMkind™ GI efficacy profiling for candidate molecules in oncology and other disease areas, and were secured through Tekon, VivoSim’s local distributor in China. Together, the engagements represent a meaningful share of the Company’s contracted revenue to date.

"China is now the world’s second-largest pharmaceutical market and among the fastest-moving sources of drug innovation globally, and these first two sales show there is real, paying demand for the human-relevant safety and efficacy data VivoSim is built to deliver," said Tony Lialin, Chief Commercial Officer of VivoSim. "Landing our first paid programs on the mainland validates our channel strategy and gives us a beachhead to scale a market we believe can become a meaningful contributor to Company revenue."

China’s drug regulator, the National Medical Products Administration (NMPA), approved a record 76 innovative drugs in 2025 — up from 48 in 2024 — and the country now accounts for a growing share of the world’s first-in-world drug launches, supported by regulatory reforms that have accelerated development timelines, including a 30-working-day fast-track review channel for eligible innovative-drug clinical trial applications. VivoSim’s internal analysis sizes the addressable China market for liver and gastrointestinal in vitro models and toxicology services at approximately $2 billion, growing at a 10% CAGR. As Chinese regulators and sponsors increasingly evaluate scientifically robust, non-animal evidence, the Company sees a durable tailwind for adoption of its models in the region.

VivoSim’s NAMkind™ platform combines 3D human organoid models of the liver and intestine — built from primary human donor cells — with proprietary AI trained on an extensive, real-world dataset. On the same models, VivoSim offers two service lines: toxicology testing, which flags safety liabilities in the liver and GI tract, and efficacy testing, which measures whether a candidate produces its intended biological effect in human-relevant tissue. In toxicology benchmarking against a clinical dataset of 92 small-molecule compounds, the NAMkind™ Liver model achieved 91% predictive accuracy, with 90% sensitivity and 95% specificity — materially outperforming the 50–65% sensitivity typical of animal models and traditional methods. Together, the two service lines help clients screen out toxicity liabilities and confirm efficacy before candidates reach expensive clinical trials, where a single late-stage failure can cost a sponsor years of development time and $50 million to $200 million.

"The science behind these wins is what makes them repeatable," said Amar Sethi, MD, PhD, Chief Scientific Officer of VivoSim. "Our multi-endpoint profiling gives development teams in China the same translational signatures we deliver to partners in the U.S. and Europe — the ability to move from detecting liabilities to predicting risk, long before a single patient is dosed."

The Company also anticipates accelerated global adoption of human tissue models following the U.S. Food and Drug Administration’s April 2025 plan to phase out the animal-testing requirement for monoclonal antibodies and other drugs — a requirement the agency said it will reduce, refine, or potentially replace using NAM approaches. The shift is increasingly mirrored by momentum toward human-relevant testing worldwide. NAMkind™ liver and GI toxicology and efficacy testing services are now available in the U.S., Europe, and — with these first APAC commercial sales — mainland China, as VivoSim continues to scale capacity to support expanding global demand.

About VivoSim Labs

VivoSim Labs, Inc. ("VivoSim" and the "Company") is a pharmaceutical and biotechnology services company focused on providing testing of drugs and drug candidates in three-dimensional ("3D") human tissue models of liver and intestine. The Company offers partners liver and intestinal toxicology insights using its new approach methodologies ("NAM") models. The Company anticipates accelerated adoption of human tissue models following the U.S. Food and Drug Administration ("FDA") announcement on April 10, 2025 to refine animal testing requirements in favor of these non-animal NAM methods. VivoSim Labs operates from San Diego, CA. Visit www.vivosim.ai.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Forward-looking statements include statements regarding China as a new or significant market for the Company’s NAMkind™ testing services; the demand for human-relevant safety and efficacy data; the validation of the Company’s channel strategy; the Company’s ability to scale the Chinese market; the Company’s belief that the Chinese market can become a meaningful contributor to the Company’s revenue; the Company’s internal analysis of the addressable China market for liver and gastrointestinal in vitro models and toxicology services and projected CAGR; the Company’s belief that its models will be adopted in China and that there is a durable tailwind for adoption of its models in the region; the Company’s services’ ability to help clients screen out toxicity liabilities and confirm efficacy before candidates reach expensive clinical trials; the Company’s belief that global adoption of human tissue models will accelerate; the Company’s ability to capture growing demand in the in vitro toxicology testing market; and the Company’s scaling capacity to support expanding global demand and development needs. Such forward-looking statements are not guarantees of performance and actual actions or events could differ materially from those contained in such statements. These risks and uncertainties and other factors are identified and described in more detail in the Company's filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on July 14, 2026. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events, or circumstances or to reflect the occurrence of unanticipated events.

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VivoSim Labs, Inc.