Press Releases April 7, 2026 08:00 PM

Longeveron Granted Chinese Patent for Potency Assay Methods for Assessing Human Mesenchymal Stem Cells (MSCs)

Longeveron secures Chinese patent for human mesenchymal stem cell potency assay methods, bolstering its global IP portfolio and advancing clinical programs.

By Derek Hwang LGVN
Longeveron Granted Chinese Patent for Potency Assay Methods for Assessing Human Mesenchymal Stem Cells (MSCs)
LGVN

Longeveron Inc. announced the granting of a Chinese patent covering potency assay methods for evaluating human mesenchymal stem cells (MSCs) derived from various tissues. This patent strengthens Longeveron's international portfolio, protecting its cell-based therapies, including its lead investigational product laromestrocel (Lomecel-B), which is in advanced clinical trials for conditions like hypoplastic left heart syndrome and Alzheimer's disease. The Chinese patent extends protection through 2041 and supports potential commercialization in the significant Chinese market.

Key Points

  • China granted Longeveron a patent for potency assays assessing human MSCs, valid through 2041, enhancing its intellectual property protection.
  • Longeveron's laromestrocel therapy is in pivotal Phase 2b trials for Hypoplastic Left Heart Syndrome (HLHS) with FDA designations including Orphan Drug and Fast Track.
  • The expanded patent portfolio (now totaling 52 patents worldwide) underpins Longeveron's strategy to commercialize MSC-based regenerative therapies addressing rare pediatric and aging-related diseases.
  • Sectors impacted include biotechnology, regenerative medicine, and healthcare, notably the cell therapy and rare disease treatment markets.
  • The patent relates to potency assay methods for assessing human mesenchymal stem cells (MSCs) derived from bone marrow, adipose tissue, peripheral blood, a lung, a heart, amniotic fluid, inner organs, an amniotic membrane, an umbilical cord or a placenta or differentiated from induced pluripotent stem cells (IPSCs)
  • Patent issuance contributes to Longeveron’s growing international portfolio of 52 patents protecting its clinical programs and products globally
  • Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation
PreviousThis patent issuance adds to our growing international portfolio of 52 patents protecting the novelty of our cell-based therapeutic products globally.
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MIAMI, April 08, 2026 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related conditions, today announced that the China National Intellectual Property Administration has granted a patent covering potency assay methods for assessing human mesenchymal stem cells (MSCs) derived from bone marrow, adipose tissue, peripheral blood, a lung, a heart, amniotic fluid, inner organs, an amniotic membrane, an umbilical cord or a placenta or differentiated from induced pluripotent stem cells (IPSCs). Potency assays are a crucial element for approved cell-based therapy products.

China Patent No. 2026031300230720, entitled “Potency Assay,” provides Longeveron with patent rights in China through 2041, assuming all annuity fees are paid.

“This patent issuance adds to our growing international portfolio of 52 patents protecting the novelty of our cell-based therapeutic products globally,” said Dr. Joshua M. Hare, Executive Chairman and Chief Science Officer of Longeveron. “We believe the breadth and strength of our global intellectual property portfolio is a strategic asset as Longeveron continues to advance its mission of advancing stem cell therapies for the benefit of patients and their families.”

Longeveron has previously conducted clinical trials with laromestrocel (Lomecel-BTM) in Alzheimer’s disease (Phase 1 & 2), Aging-related Frailty (Phase 1 & 2), and Hypoplastic Left Heart Syndrome (HLHS) (Phase 1), a rare pediatric and orphan-designated disease. Longeveron is currently conducting a potentially pivotal Phase 2b clinical trial evaluating laromestrocel in HLHS, with trial results anticipated in the third quarter of 2026. These data may allow Longeveron to proceed to a Biologics License Application (BLA) with the U.S. FDA for this indication, subject to the results of the study.

About laromestrocel (Lomecel-B®)
Laromestrocel is a living cell product made from specialized cells isolated from the bone marrow of young healthy adult donors. These specialized cells, known as mesenchymal stem cells (MSCs), are essential to our endogenous biological repair mechanism. MSCs have been shown to perform a number of complex functions in the body, including the formation of new tissue. They also have been shown to respond to sites of injury or disease and secrete bioactive factors that are immunomodulatory and regenerative. We believe that laromestrocel MSCs may have multiple potential mechanisms of action that may lead to anti-inflammatory, pro-vascular regenerative responses, and therefore may have broad application for a range of rare and aging related diseases.

About Longeveron Inc.

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, Pediatric Dilated Cardiomyopathy (DCM) and Aging-related Frailty. Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram.

Forward-Looking Statements
Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expects,” “intend,” “looks to,” “may,” “on condition,” “plan,” “potential,” “predict,” “preliminary,” “project,” “see,” “should,” “target,” “will,” “would,” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; the size of the market opportunity for certain of our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the product candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 17, 2026, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company’s management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Investor and Media Contact:
Derek Cole
Investor Relations Advisory Solutions
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f106bde7-972a-4687-a91e-03e924f409fc


Risks

  • Clinical trial results remain pending and uncertain; failure to demonstrate safety or efficacy could delay or prevent regulatory approval and commercialization.
  • Dependence on securing and maintaining intellectual property rights in multiple jurisdictions is critical; potential IP challenges could affect competitive positioning.
  • Capital requirements and financial sustainability pose risks, as additional funding may be needed to continue clinical programs and commercialization efforts, impacting company valuation and operations.

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