First-in-class! China's first original stem cell new drug IND with Yeedozencom registration service!
According to the information released by the Center for Drug Evaluation of CFDA, the autologous reinfusion preparation of REGEND001 cells under Jiangxi Xianhe Medical Technology Co., Ltd. (hereinafter referred to as Xianhe Medical) was approved by the CFDA on July 15, 2020 for the treatment of early and middle idiopathic pulmonary fibrosis (Approval Letter No.: CXSL1900019). The new stem cell drug developed by Xianhe Medical and its parent company Gemfibroon is the first lung stem cell product in the world to enter the clinic. It uses the unique lung tissue regeneration and repair mechanism to play a therapeutic role and is a First-in-class new drug in a real sense.
Idiopathic pulmonary fibrosis (IPF) is a rare disease that progresses rapidly and has a high mortality rate, with a mean survival of only 2.8 years after diagnosis and a higher mortality rate than most tumors. There are currently no effective agents to improve ventilatory dysfunction in patients with IPF.
Since the Center for Drug Evaluation opened the acceptance of new cell therapy products in 2018, a total of 10 stem cell products have passed the clinical trial with tacit approval in China. Except for REGEND001, the other 9 items are stem cell products. Compared with traditional stem cell products, lung stem cells as a functional cell population derived from the lung show natural advantages in the treatment of respiratory diseases. The core component of REGEND001 product is adult lung stem (progenitor) cells derived from the basal layer of bronchi, which have the function of regenerating lung tissue. By transplanting autologous lung stem cells into the lungs of patients, the pulmonary respiratory units (alveoli) can be effectively regenerated, the pulmonary blood-gas exchange function can be directly improved, and the proliferation of fibroblasts can be antagonized, so as to achieve the goal of fundamental treatment of IPF.
Yeedozencom provides high-quality registration technical services for this project and successfully helps China's first original (First-in-class) stem cell new drug IND. Biological drugs also provide a full set of drug registration technical services:
• Technical and regulatory advice during development
• Feasibility analysis
• GAP analysis
• Technical assessment
• Registration strategy development
• Collation of application dossiers
• Medical Writing
• Coordination of sample specification review
• Application for a generic name
• Interpretation of supplementary comments and preparation of supplementary materials
• Communication with regulatory agencies and project follow-up
• On-site verification
• Various conference services with CDE
• Whole-process technical services for other pharmaceutical R & D lifecycle
