On October 17, 2024, Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences, Stock Symbol: 688321.SH) submitted the company’s Investigational New Drug (IND) application for CS231295 tablets, a Class 1 innovative drug for the treatment of tumors. The application has been accepted by the Center for Drug Evaluation of National Medical Products Administration of China (Application Number: CXHL2401105、CXHL2401107、CXHL2401108).

Malignant tumors are one of the main causes leading to human death. Although clinical treatments have been significantly improved, most tumors are still incurable. The drug resistance, tumor recurrence and metastasis still are the biggest threat to long-term survival of patients. Particularly, Malignant brain tumors and brain metastasis  not only brings direct life hazards but also has a natural barrier for drug efficacy due to the blood-brain barrier. Therefore, developing new anti-tumor drugs with good brain permeability has become a hot and difficult topic in improving the current tumor therapy. 

CS231295 is a novel brain-penetrating small-molecule, multi-target protein kinase inhibitor independently developed by Chipscreen Biosciences, with proprietary intellectual property rights. This drug candidate exhibits significant synthetic lethal effects on tumors carrying particular genetic defects, providing a new treatment option for patients with such tumors. Additionally, it demonstrates potent anti-tumor angiogenesis activity, resulting in broad-spectrum anti-tumor efficacy. In the future, CS231295, either as a monotherapy or in combination with other anti-tumor drugs, is expected to offer differentiated and innovative treatment options for various types of cancer. Due to its excellent blood-brain barrier permeability, CS231295 possesses significant therapeutic advantages for Malignant brain tumors and metastatic brain tumors, with particularly strong potential for treating primary and metastatic brain tumors. In preclinical studies, CS231295 has shown significant pharmacodynamic activity, favorable pharmacokinetic properties, and a good safety profile. 

About Chipscreen:

Chipscreen Biosciences is an innovative drug company driven by core technologies with globally competitive pipelines. As a pioneer in drug innovation & development in China, adhering to the concept of "Constant Innovation for Life", we focus on developing revolutionary innovative drugs with new mechanisms of action, to address patients' pressing clinical needs. Our complete industry chain that covers early exploratory discovery through commercialization allows us to provide innovative Chinese drugs for patients worldwide.

With a global development strategy based on early-stage research in China, Chipscreen Biosciences has leveraged the top scientists and teams with extensive experience in related fields from the Shenzhen Small Molecule Early R&D Center and Chengdu Small Molecule Early R&D Center to create an integrated technology platform based on AI-driven design and chemical genomics, which spanned the whole process from basic science to clinical translation. We have successfully developed first-in-class and best-in-class innovative drugs. Currently, 2 drugs with 6 indications have been marketed worldwide. In addition, we have launched a number of R&D projects with differentiated advantages and global competitiveness in the five major areas, including malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and antivirals.

    
Chipscreen Biosciences has formed a global industrial layout consisting of Shenzhen Head Office/R&D Center/GMP production base, Chengdu Regional Head Office/R&D Center/GMP production base, Beijing Branch, Shanghai Branch, and Chipscreen Biosciences (USA) Co., Ltd. Meanwhile, as one of the first batches of national "innovative drug incubation bases" and national high-tech enterprises, Chipscreen Biosciences has independently undertaken many national "863" plans and national major science and technology projects, such as "10th five-year plan", "11th five-year plan", "12th five-year plan" and "13th five-year plan", and National Science and Technology primary Project for Innovative Drug Development. We have filed over 680 invention patents in China and worldwide, with over 200 granted.