Chipscreen Biosciences' CS231295 Anti-Tumor Drug IND Application Accepted

SHENZHEN, China, Oct. 17, 2024 — On October 17, 2024, Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences, Stock Symbol: 688321.SH) filed an Investigational New Drug (IND) application for CS231295 tablets, a Class 1 innovative drug aimed at treating tumors. This submission has been accepted by the Center for Drug Evaluation of the National Medical Products Administration of China (Application Numbers: CXHL2401105, CXHL2401107, CXHL2401108).

Malignant tumors remain one of the leading causes of death. While clinical treatments have seen notable advancements, many tumors are still beyond cure. Challenges such as drug resistance, tumor recurrence, and metastasis continue to impede long-term patient survival. Malignant brain tumors and brain metastases pose significant threats due to the blood-brain barrier, which restricts drug efficacy. Consequently, developing new anti-tumor drugs with good brain permeability is crucial in enhancing current tumor therapies.

CS231295 is a groundbreaking small-molecule, multi-target protein kinase inhibitor developed by Chipscreen Biosciences. It holds proprietary intellectual property rights and is designed to penetrate the brain. This drug candidate is notable for its synthetic lethal effects on tumors with specific genetic defects, offering a new treatment avenue for these patients. Furthermore, it exhibits strong anti-tumor angiogenesis properties, providing broad-spectrum efficacy against tumors. CS231295 is anticipated to be beneficial both as a standalone treatment and in combination with other anti-tumor drugs, potentially revolutionizing therapy for various cancer types. Its exceptional ability to cross the blood-brain barrier gives it a therapeutic edge in treating primary and metastatic brain tumors. Preclinical studies have highlighted CS231295's significant pharmacodynamic activity, favorable pharmacokinetic properties, and promising safety profile.

Chipscreen Biosciences is a pioneering drug development company driven by cutting-edge technologies and competitive pipelines. Committed to "Constant Innovation for Life," the company focuses on creating groundbreaking drugs with new mechanisms of action to meet urgent clinical needs. Their comprehensive industry chain spans from early exploratory discovery to commercialization, providing innovative Chinese drugs globally.

Adhering to a global development strategy based on early-stage research in China, Chipscreen Biosciences utilizes top scientists and experienced teams from the Shenzhen Small Molecule Early R&D Center and Chengdu Small Molecule Early R&D Center. They have developed an integrated technology platform based on AI-driven design and chemical genomics, covering the entire process from basic science to clinical translation. This approach has led to the successful development of first-in-class and best-in-class innovative drugs. Currently, two drugs with six indications have been marketed worldwide. Additionally, the company has initiated several R&D projects with unique advantages and global competitiveness in five major areas: malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and antivirals.

Chipscreen Biosciences has established a global industrial presence, including its 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. As a national "innovative drug incubation base" and high-tech enterprise, Chipscreen Biosciences has independently undertaken numerous national projects, including the "10th five-year plan," "11th five-year plan," "12th five-year plan," "13th five-year plan," and National Science and Technology primary Project for Innovative Drug Development. The company has filed over 680 invention patents in China and globally, with more than 200 granted.