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09

2025-01

Stem Cell Drug Compliance Services | MSC One-Stop Comprehensive Solution

On January 2, 2025, the National Medical Products Administration granted conditional approval, via the priority review and approval pathway, for the launch of China’s first stem cell–based therapeutic product, amivastin injection, for the treatment of acute graft-versus-host disease (aGVHD) in patients aged 14 years and older whose condition is primarily characterized by gastrointestinal involvement and who have failed conventional corticosteroid therapy. Amivastin injection is the first mesenchymal stem cell (MSC)–based therapeutic product approved for marketing in China for the treatment of aGVHD refractory to corticosteroid therapy. To date, approximately ten MSC–based therapies have been approved globally, with variations in cell source and indications. The past year is poised to be a landmark chapter in the history of stem cell therapy in China, as the wheels of fate begin to turn.

2025-01-09

He Yousheng

29

2024-11

Only by Joining Hands Can We Go Far | We Cordially Invite You to Participate in the Distrimap Conference on Innovation and Development of Research Tools and Distribution Channels

The Distrimap Conference on Innovation in Research Tool Development and Distribution Channels, hosted by the Juyuan Platform and co-organized by Dingxiangtong, Aniu Youshuo, Kasma Platform, and Instrument Learning Network, will kick off on December 7. At this event, more than 40 industry leaders will deliver in-depth market analyses from their respective areas of expertise, providing a comprehensive overview of industry prospects, customer pain points, cutting-edge products, technological trends, service support, and investment attraction policies. Hycells has also been invited to attend the conference.

2024-11-29

He Yousheng

20

2024-11

Hycells New Product | Ultra-High-Density MSC Serum-Free Culture Medium

Mesenchymal stem cells (MSCs) are multipotent stem cells that possess all the hallmark properties of stem cells: self-renewal and the capacity for multi-lineage differentiation. MSCs were first identified in bone marrow, and subsequent studies have revealed their presence in numerous tissues throughout human development. Currently, MSCs can be isolated and cultured from a variety of sources, including bone marrow, adipose tissue, synovial membrane, bone, muscle, lung, liver, pancreas, as well as amniotic fluid and umbilical cord blood; among these, bone-marrow–derived MSCs are the most widely used.

2024-11-20

He Yousheng

01

2024-11

CDE Releases “Common Issues and Technical Requirements for Replicable Lentiviral Vector Testing”

On October 29, the Center for Drug Evaluation of the National Medical Products Administration released the “Common Issues and Technical Requirements for Replicable Lentiviral Vector Testing.” The issuance of these technical requirements aims to enhance the standardization of pharmaceutical R&D and regulatory submissions by biopharmaceutical companies, establish a scientifically sound and standardized review and approval system, and accelerate the high-quality development of cell and gene therapy products in China.

2024-11-01

He Yousheng

21

2024-10

Small “Life” Makes Sense (8) | Pre-Screening of Reconstructed Humanized Hu-PBMC Mouse Strains

As an advanced experimental animal model, humanized immune system mice have demonstrated tremendous potential and practical value in biomedical research and drug development in recent years. The generation of such mice typically relies on immunodeficient mouse models, in which human hematopoietic stem cells (HSCs), peripheral blood mononuclear cells (PBMCs), or other immune tissues are transplanted into these mice to reconstruct a human immune system, thereby mimicking human immune characteristics and pathological processes.

2024-10-21

He Yousheng

09

2024-10

Good News | Hycells Awarded the Filing Certificate for Class I Medical Device Production

Recently, Heyou Bio successfully obtained the “Registration Certificate for Class I Medical Device Manufacturing” issued by the Minhang District Administration for Market Regulation of Shanghai (Registration No.: Hu Min Yao Jian Xie Sheng Chan Bei 20243438), marking official recognition of Heyou Bio’s innovative achievements in the field of CAR positivity rate testing.

2024-10-09

He Yousheng
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