Who will become the leading “water supplier” during the “gold rush” of the cellular therapy industry?
2022 marks the 10th anniversary of Emily Whitehead, the world's first child with leukemia cured by CAR-T cell immunotherapy, achieving cancer-free survival.In 2012, Emily, who suffered from acute ...
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Bayer Advances Parkinson’s Stem Cell Therapy into Phase III Clinical Trial
On September 22, 2025, Reuters reported that Bayer’s subsidiary BlueRock Therapeutics has officially initiated a Phase III clinical trial of its experimental stem cell therapy for Parkinson’s diseas...
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The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Key Points for Inspection of Drug Product MAHs (Draft for Comments)”
In order to strengthen the supervision and management of drug marketing authorization holders (hereinafter referred to as holders), supervise the holders to fulfill the quality management responsibili...
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French Biotech Allogenica Secures €2.5M Grant to Advance Universal CAR-T Therapy Industrialization
Allogenica, a biotechnology company based in Lyon, has secured €2.5 million in funding from the French government’s France 2030 strategic investment program. The grant will accelerate the industrial...
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Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Evaluation of Immune-related Adverse Events in Antitumor Therapy” (No. 25, 2022)
Tumor immunotherapy is a hot topic in the current research and development of new anti-tumor drugs. How to improve the scientificity and robustness of the identification and judgment of immune-related...
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AstraZeneca and Algen Biotechnologies Forge $555 Million Gene Therapy Collaboration
October 6, 2025 — San Francisco, USA – AstraZeneca announced a strategic collaboration and licensing agreement with Algen Biotechnologies, a U.S.-based biotech company specializing in AI-driven gene...
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Hillgene Winning the Bid on the First Contract Manufacturing Order for Commercial CAR-T Cell Therapy in China
It is reported that Shanghai Xianbo Biotechnology Co., Ltd. and Jiangsu Puxin Biopharmaceutical Co., Ltd. have reached a strategic cooperation agreement, entrusting Puxin Bio to carry out the second p...
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Hillgene Takes Note of FDA New Guidelines: Interpreting the Latest Developments and Industry Opportunities in Cross-Border Genetic Data Research
The U.S. Food and Drug Administration (FDA) recently issued an important announcement stating it will pause new clinical trial applications led by U.S. institutions that involve sending cells from U.S...
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[GMP revised] Appendix for “Investigational Drugs (Interim)” issued and taking effect as of July 1!
In accordance with Article 310 of the Good Manufacturing Practice for Pharmaceuticals (Revised in 2010), the Appendix to the Drugs for Clinical Trial Use (Trial) is hereby issued as a supporting docum...
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