Recently, SkyeThera Pharmaceuticals (Shanghai) Co., Ltd. (“SkyeThera” or the “Company”) announced the completion of a seed round financing totaling over 100 million yuan. The round was co-led by Hony Capital and PowerFong Health Fund, with participation from Su Venture Capital, Chenshu Investment, Yingxian Investment and Yida Capital. The proceeds will be mainly allocated to three core areas: the R&D of in vivo multi-target cell therapy candidates, the next-generation universal multi-target CAR-T products for the broad autoimmune disease field, and the development of multi-target CAR-T cell therapy products based on a new-generation rapid autologous manufacturing process.

SkyeThera’s founding was driven by keen insights into deep-seated pain points in the cell therapy industry. Although CAR-T therapies have demonstrated remarkable efficacy in hematologic malignancies, they still face three major challenges in real-world clinical practice: high production costs, long manufacturing cycles, and patient relapse due to antigen escape. As an innovative company focused on unmet clinical needs, SkyeThera was established in the Shanghai Free Trade Zone in March 2024 with a clear goal: to redefine the boundaries of efficacy and cost for cell therapies by leveraging the founding team’s extensive industrialization experience and self-developed core technology platform, and to develop next-generation, highly effective and accessible cellular immunotherapies.

The Company’s core competitiveness stems from its highly experienced founding team. Dr. Wang Wen, Founder, has more than 10 years of expertise in cell therapy R&D. He has held key R&D and management positions at several leading domestic cell therapy companies, and led the full lifecycle of R&D and commercialization of two CAR-T products approved in China. Supported by such proven industrialization experience, SkyeThera has built a solid technology foundation since inception, aiming to achieve comprehensive improvements in the safety, efficacy and accessibility of cell therapy products through continuous technological innovation.

Under a clear strategic roadmap, SkyeThera has adopted a three-stage pipeline strategy: autologous, allogeneic, and in vivo, with rapid progress across all programs.

For relapsed and refractory B-cell non-Hodgkin lymphoma, the Company has developed Skye-01, an autologous CAR-T product targeting CD19/20. It features multiple innovations: fourth-generation Armed CAR-T technology that enhances stemness and persistence via autocrine factors; novel protein structure design to improve expansion and cytotoxicity; and a 1–3 day rapid manufacturing process that significantly reduces costs while preserving the naive state of T cells. Core sequence screening and in vitro functional assays have been completed, and Skye-01 is expected to enter an Investigator-Initiated Trial (IIT) in mid-2026.

To address the large autoimmune disease market, SkyeThera has built the Skye-02 program. Traditional single-target CAR-T products only cover a subset of autoimmune diseases mediated by autoantibodies from B cells or plasma cells, leaving many other autoimmune conditions with no effective treatment. As a next-generation universal multi-target CAR-T candidate, Skye-02 aims to overcome this limitation. The project is scheduled to launch formal in vivo pharmacodynamic studies and mid-scale cell manufacturing tests in March 2026, and is expected to advance to IIT in the second half of the year, bringing new hope to more patients with autoimmune diseases.

In addition, in vivo CAR-T therapy, a future technology frontier, is another key focus for SkyeThera. The Skye-03 program is dedicated to in vivo multi-target CAR-T cell therapy candidates. The Company is using proprietary multi-targeting technology to construct in vivo delivery vectors, evaluating various target combinations, and actively engineering novel vectors to navigate existing patent barriers, aiming to gain a leading position in next-generation therapies.

Looking back at the evolution of the pharmaceutical industry, it took more than 30 years from the launch of the first monoclonal antibody to its widespread use. Since the first approval of cellular immunotherapy in 2017, despite being in the early stage of rapid growth, new technology routes, engineering strategies and combination regimens have continued to emerge. SkyeThera understands that translating laboratory discoveries to clinical applications and ultimately benefiting patients requires strong R&D capabilities and long-term commitment. Backed by capital and driven by its team, SkyeThera is moving steadily forward. By addressing the limitations of current therapies, the Company aims to advance cell therapy drugs toward greater accessibility, better patient experience, and broader indications, providing more effective treatment options for patients in China and worldwide.