ElpasBio Completes Patient Enrollment in Phase III Pivotal Clinical Trial of AlloJoin®

• AlloJoin® is one of the few stem cell product candidates in late-stage clinical development worldwide
• ElpasBio is planning for data readout and NDA by next year
• ElpasBio partnered with Fosun Kairos to accelerate AlloJoin® commercialization in China

SHANGHAI, June 3, 2026 /PRNewswire/ -- ElpasBio Holdings ("ElpasBio"), a leading clinical-stage biotechnology company focused on regenerative medicine, today announced it completed patient enrollment in May in its China Phase III pivotal clinical trial of AlloJoin® (lotazadromcel), the allogeneic human adipose-derived mesenchymal stem cell (haMPC) therapy for the treatment of knee osteoarthritis (KOA).

AlloJoin® is ElpasBio's core investigational, off-the-shelf stem cell product, developed entirely in-house based on its proprietary haMPC technology platform and protected by independent intellectual property rights. The therapy is being explored for its potential to provide safe and durable symptom relief for KOA patients by suppressing inflammation and promoting the repair of damaged cartilage, with the goal of becoming the world's first regenerative medicine product with the potential to modify the progression of KOA.

ElpasBio plans to read out the data from the Phase III pivotal study in 2027 and submit a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China later the same year.

Tony (Bizuo) Liu, Chairman of ElpasBio, stated, "We sincerely thank the principal investigators, experts at all study sites, trial patients, and partners for their full support. We are proud of the execution of our team in efficiently completing the enrollment. The Phase III clinical trial of AlloJoin® is the world's first dual-primary-endpoint clinical trial designed for disease modification of KOA. The completion of efficient enrollment of over 500 patients reaffirmed the huge unmet medical need. As one of the first stem cell products with commercialization BD partnership, we will closely work with our partner Fosun Kairos to accelerate the commercialization of AlloJoin®."

On January 14, 2026, ElpasBio entered into a commercialization collaboration agreement with Fosun Kairos for AlloJoin® for the treatment of KOA in Mainland China, Hong Kong SAR and Macau SAR. ElpasBio will continue to be responsible for the development, regulatory registration, and manufacturing of AlloJoin® in Mainland China, Hong Kong SAR, and Macau SAR, and will retain all commercialization rights outside these territories.

About Knee Osteoarthritis
Knee Osteoarthritis (KOA) is an age-related degenerative joint disease characterized by joint pain, stiffness, and functional impairment, significantly impacting patients' quality of life. With China's rapidly aging population, the number of osteoarthritis patients in China is expected to reach approximately 160 million by 2025. Current common drug-based methods of management provide limited improvement, highlighting the importance of developing novel therapies to address significant unmet clinical needs.

About ElpasBio
ElpasBio Holdings is a leading clinical-stage biotechnology company focused on regenerative medicine. ElpasBio was spun off from AbelZeta Pharma, Inc. (previously known as CBMG Holdings) in 2023 and completed over $10 million seed round financing in 2025. ElpasBio brings proven experience and capabilities in developing world-class cell therapy products, with more than 15 years of expertise in the stem cell field and has developed and explored multiple stem cell products across autologous and allogeneic approaches and various cell sources. ElpasBio operates GMP-compliant manufacturing and R&D facilities in Wuxi and Shanghai, China. It's core product, AlloJoin®, is the first stem cell drug in China approved to enter into Phase III clinical trial for the treatment of knee osteoarthritis.

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Forward-Looking Statements
Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to numerous factors. Forward-looking statements are based on the current beliefs and management's expectations and are subject to significant risks and uncertainties outside of ElpasBio's control. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, ElpasBio does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

Company Contact:
Sarah Kelly
Director of Communications
ElpasBio Holdings
[email protected]
+86 21 5406 9990

SOURCE ElpasBio Holdings