Fosun Kite and ElpasBio Announce Completion of Enrollment in Pivotal Phase III Trial for AlloJoin®, China's First Stem Cell Therapy for Knee Osteoarthritis

Jun 04, 2026 16:59 CST Updated 16:59

Fosun Pharmaceutical

Healthcare Industry Group

Fosun Kairos

Developer of Tumor Immune Cell Therapy Technologies and Products

On June 3, 2026, Sibioman Biologics, a strategic partner of Fosun Kite, a subsidiary controlled by Fosun Pharmaceutical, announced that its core investigational pipeline product, lotazadromcel (brand name: AlloJoin), an allogeneic human adipose-derived mesenchymal stem cell injection,^®) The pivotal Phase III clinical trial in China for the indication of knee osteoarthritis successfully completed the enrollment of all 500-plus patients this May.

AlloJoin®Sibiman Biologics’ core investigational stem cell product, developed on its allogeneic mesenchymal stem cell technology platform and protected by independent intellectual property rights. The product aims to explore the potential of providing safe and long-lasting symptom relief for patients with osteoarthritis by suppressing inflammation and repairing damaged cartilage, striving to become the world’s first regenerative medicine product with the potential to modify the disease course of knee osteoarthritis. Sibiman Biologics plans to read out the data from this pivotal Phase III study in 2027 and submit a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration later that same year.

In January 2026, Fosun Kite Biotechnology Co., Ltd. entered into a strategic partnership with Sibiman Bio, obtaining AlloJoin®Exclusive commercialization rights in mainland China, Hong Kong, and Macau. As a leading enterprise in the field of cell therapy in China, Fosun Kite has accumulated mature experience and established a comprehensive network in the clinical promotion, market implementation, and patient access of cell therapy products. This time, AlloJoin®The successful completion of enrollment in the Phase III clinical trial also signifies that the collaboration between both parties has entered a new stage of advancement.

Zhang Wenjie

Co-President of Fosun Pharmaceutical, Chairman of Fosun Kite

AlloJoin^®The successful completion of full enrollment in the Phase III clinical trial is a highly encouraging milestone. We are confident about AlloJoin^®...remain firmly confident in its clinical value and commercialization prospects. Moving forward, Fosun Kite Biotechnology Co., Ltd. will spare no effort in preparing for commercialization, with the aim of bringing this innovative therapy to Chinese patients with knee osteoarthritis as soon as possible.

In the future, Fosun Kite will work closely with the R&D sector to proactively establish a commercialization readiness framework, ensuring that products are launched to the market immediately upon approval. This will accelerate the filling of the gap in regenerative therapy for knee osteoarthritis in China and meet the urgent needs of a large patient population.

About Osteoarthritis

Osteoarthritis (OA) is a degenerative joint disease closely associated with aging, primarily characterized by joint pain, stiffness, and functional limitation, which severely impacts patients' quality of life. With the pronounced trend of population aging in China, the number of OA patients in the country is projected to reach 160 million by 2025, with a disability rate of 53%. Currently, conventional therapeutic approaches yield unsatisfactory improvements in OA. Therefore, the development of novel treatment modalities to address unmet clinical needs is of significant importance.

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