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Maxinovel receives official acceptance of IPF clinical trial applications from CDE

DATA:2023/01/11

Idiopathic pulmonary fibrosis (IPF) is the most common type of idiopathic interstitial pneumonia in clinical practice. It is a chronic lung disease of unknown etiology, characterized by progressive and irreversible pulmonary parenchymal fibrosis, leading to progressive decline in lung function. The number of IPF patients is also increasing year by year, with a conservative estimate of at least 500000. As a chronic interstitial lung disease, IPF has a hidden onset and gradually worsens. The average survival time after diagnosis of IPF is only 2.8 years, and the mortality rate is higher than most tumors. IPF is known as a "tumor like disease".
At present, the main therapeutic drugs for IPF are Nintedanib and Pirfenidone.Nintedanib's global marketing in 2020 exceeded $2.5 billion, followed closely by pirfenidone, with global marketing exceeding $1.2 billion. In preclinical animal model studies, MAX-40279 was compared for head to head efficacy with Nintedanib and Pirfenidone, and all data were significantly better than Nintedanib and Pirfenidone.

Therefore, Maxinovel quickly submitted an IPF clinical trial application to the China National Medical Products Administration's CDE, hoping to contribute to the treatment of this high mortality and tumor like disease as soon as possible.


MAX-40279

MAX-40279 is a multi-target tyrosine kinase inhibitor primarily targeting FLT3/FGFR/HPK1. Multiple Phase I/II and Phase II clinical trials have been conducted on hematological tumors and solid tumors, demonstrating good safety, tolerability, and therapeutic efficacy.


The research strategy of Maxinovel is to actively carry out "one medicine for multiple uses", expand multiple clinical indications, reduce the company's research risks and costs, in order to achieve the goal of reducing patient medication expenses and increasing medication accessibility. This strategy has been adopted by international pharmaceutical companies, such as the development of JAK inhibitor drugs for clinical applications in multiple indications such as tumors, rheumatoid arthritis, alopecia areata, dermatitis, and psoriasis.

Dr. Wang, President of Maxinovel, stated:
The official acceptance of CDE for IPF clinical trials is the first important milestone at the beginning of 2023. Special thanks to the company's preclinical team, clinical application team, and clinical team for their joint efforts and cooperation. In the new year, Zhongji Medicine will achieve more important milestones.

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