With the rapid onset of an aging population, human health faces new challenges. A vast number of clinical needs remain unmet, while the long R&D cycle for innovative drugs leaves many patients without timely treatment.

After May 2026, State Council Decree No. 818 will officially take effect. By enabling the clinical research and translational application of innovative biomedical technologies, the decree establishes a brand-new top-level design and a “fast track” for the R&D and industrialization of innovative drugs, which is expected to systematically accelerate their approval and market access.

As an innovative biopharmaceutical enterprise focused on cell therapy and regenerative medicine, Cellgenes Biotechnology has long been dedicated to stem cell drug R&D, clinical translation, and industrialization capacity building. Addressing major unmet clinical needs in critical illnesses, degenerative diseases, neurological disorders, and beyond, the company continues to advance collaborative innovation across industry, clinical practice, and research.

At this special symposium, Cellgenes Biotechnology will bring together renowned domestic scholars, clinicians, and other distinguished guests to share the latest progress in stem cell research at home and abroad, and to explore the critical pathway from scientific discovery to approved stem cell drug innovation. The symposium will also unveil Cellgenes Biotechnology’s clinical research achievements in collaboration with several top-tier Chinese hospitals.

Through this symposium, we aim to build a professional dialogue platform among scientists, clinical experts, and innovative enterprises, helping stem cell drug development seize policy opportunities, accelerate the translation of innovation, and ultimately better serve patient needs and public health.

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About Cellgenes Biotechnology

As a benchmark for scientific translation in the stem cell field, Cellgenes Biotechnology has built over a decade of deep research foundation. Its founder and chief scientist, Professor Xiang Peng, serves as the director of the National & Local Joint Engineering Research Center for Stem Cell and Regenerative Medicine. In close collaboration with Sun Yat-sen University, the company has independently established three core technology platforms: a large-scale bone marrow mesenchymal stem cell expansion platform, a cell-targeted delivery platform, and a pluripotent stem cell differentiation platform. These form a complete closed-loop system of technology iteration – pipeline expansion – clinical validation.

According to the Insight Database, the company’s core pipeline R&D progress and clinical data are both outstanding:

Acute-on-chronic liver failure (ACLF) pipeline: Ranked first globally for the same indication. Clinical data demonstrate excellent safety and efficacy, positioning it to become the world’s first approved stem cell product for this indication.

Chronic ischemic stroke pipeline: Ranked among the top two in China for the same indication, having advanced to Phase II clinical trials. Clinical data have fully confirmed the product’s safety and efficacy.

Sarcopenia pipeline (geriatric sarcopenia): The world’s first stem cell drug approved to enter clinical trials for this indication.

Of particular note, Cellgenes Biotechnology has already established a significant first-mover advantage in commercialization. In the layout of pilot demonstration zones, its pipelines for ACLF, ischemic stroke, liver injury, and sarcopenia have been approved for implementation in pilot zones including Nansha. Relevant projects have already begun fee-based treatment and generated actual revenue, making Saijun one of the few companies to achieve commercialized clinical application of stem cell therapies. With respect to the new “Decree No. 818” policy, the company has formed deep collaborations with multiple top-tier hospitals and obtained approvals for several clinical research projects, laying a solid foundation for future applications for the translation of new medical technologies, and demonstrating a clear first-mover advantage under the new policy.

Looking ahead, Cellgenes Biotechnology will fully accelerate the clinical progress and commercial rollout of its core pipelines. Building on its deep research heritage and three core technology systems, the company will seize policy tailwinds and the industry’s window of opportunity, continuously strengthening its capabilities in technology iteration, pipeline expansion, and clinical translation. It aims to provide novel treatment options for major refractory diseases, support the high-quality development of China’s cell therapy industry, and lead Chinese stem cell innovation to the global forefront.

About TONACEA

TONACEA is a premier ecosystem platform in China's biomedical innovation sector. With over 20 years of deep engagement in China's innovative drug development, it has grown into a key organizational force driving China's pharmaceutical innovation and serves as a core hub connecting multinational pharmaceutical companies with local innovation.

TONACEA brings together multinational pharmaceutical companies, biotech firms, investment institutions, research institutes, and regulatory experts, establishing a high-end professional network and knowledge-sharing system that covers the entire R&D value chain. Its business encompasses industry summits, technical forums, customized corporate training, media communications, and strategic consulting. With multiple branches across China, TONACEA has built an operational network that extends nationwide. Its official WeChat account and video channel consistently deliver in-depth industry insights, with perspectives frequently cited by investors and media, earning recognition as a trusted authoritative source within the industry.