/PRNewswire/ -- Shenzhen Chipscreen Biosciences Co., Ltd. ('Chipscreen Biosciences') announced that its wholly owned subsidiary, Chipscreen Biosciences (

/PRNewswire/ -- 深圳微芯生物科技股份有限公司（“微芯生物”）宣布其全资子公司微芯生物 (

) Ltd., has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for its innovative drug CS231295 tablet for the treatment of advanced solid tumors. This significant milestone marks a key step forward in the global development strategy for CS231295.

）有限公司已获得美国食品药品监督管理局（FDA）对其用于治疗晚期实体瘤的创新药物CS231295片剂的新药临床试验（IND）批准。这一重要里程碑标志着CS231295全球开发战略向前迈出了关键一步。

Malignant tumors remain one of the leading causes of death worldwide. Despite continuous advancements in clinical treatments and efficacy, most cancers remain incurable. Drug resistance, recurrence, and metastasis pose significant threats to long-term patient survival. In particular, due to the presence of the blood-brain barrier, primary brain tumors and brain metastases not only pose a severe danger to life but also serve as natural barriers to effective drug therapy.

恶性肿瘤仍然是全球主要的死亡原因之一。尽管临床治疗和疗效不断进步，但大多数癌症仍然无法治愈。耐药性、复发和转移对患者的长期生存构成了重大威胁。尤其是由于血脑屏障的存在，原发性脑肿瘤和脑转移不仅对生命构成严重威胁，也成为了有效药物治疗的天然屏障。

Thus, developing novel brain-penetrant anti-cancer drugs has become a pressing challenge and a key research focus..

因此，开发新型能穿透大脑的抗癌药物已成为一项紧迫的挑战和关键的研究重点。

CS231295 is a next-generation brain-penetrant Aurora B selective inhibitor discovered through years of mechanism-based research by Chipscreen Biosciences. On one hand, it precisely inhibits tumor-specifically overexpressed Aurora B kinase to induce synthetic lethality, directly targeting the genetic vulnerability of hard-to-treat cancers such as those with RB1 deletion.

CS231295是通过多年基于机制的研究，由 Chipscreen Biosciences 发现的新一代可穿透大脑的Aurora B选择性抑制剂。一方面，它通过精确抑制肿瘤特异性过表达的Aurora B激酶来诱导合成致死性，直接靶向难以治疗的癌症（如RB1缺失型癌症）的基因脆弱性。

On the other hand, due to its strong blood-brain barrier permeability, it shows significant therapeutic potential for both primary and metastatic brain tumors. Furthermore, this molecule also exhibits broad-spectrum anti-tumor activity, which improves the tumor microenvironment. It is expected to provide a novel solution for tumors with similar genetic defects and the global challenge of brain metastases.

另一方面，由于其较强的血脑屏障穿透性，对原发性和转移性脑肿瘤均显示出显著的治疗潜力。此外，该分子还表现出广谱的抗肿瘤活性，能够改善肿瘤微环境，有望为具有类似基因缺陷的肿瘤和全球性的脑转移难题提供全新的解决方案。

Currently, there is no similar compound with this design that has entered clinical trials globally.

目前，全球范围内尚无此类设计的化合物进入临床试验。

With its unique mechanism and chemical structure, CS231295 demonstrates synergistic effects when combined with chemotherapy, targeted therapy, and cancer immunotherapy. In preclinical studies, CS231295 has shown remarkable pharmacodynamic activity, ideal pharmacokinetic properties, and a favorable safety profile..

凭借其独特的机制和化学结构，CS231295在与化疗、靶向治疗和癌症免疫治疗联合使用时表现出协同效应。在临床前研究中，CS231295显示出显著的药效学活性、理想的药代动力学特性和良好的安全性。

Notably, CS231295 completed the first patient enrollment in its Phase I first-in-human clinical trial in

值得注意的是，CS231295 已经完成了其 I 期首次人体临床试验的首例患者入组。

China

中国

in

在

May 2025

2025年5月

, providing preliminary evidence to support the scientific rationale and feasibility of global multicenter clinical development. The FDA's IND approval will further accelerate the initiation and implementation of its clinical research in

，为支持其全球多中心临床开发的科学依据和可行性提供了初步证据。FDA对IND的批准将进一步加速其临床研究的启动和实施步伐，在

About Chipscreen Biosciences

关于微芯生物科技股份有限公司

Chipscreen Biosciences is an innovation-driven pharmaceutical company dedicated to developing globally competitive pipelines of first- and best-in-class original drugs. As a pioneer in

创胜集团是一家创新驱动的制药公司，致力于开发具有全球竞争力的首创和同类最优的原创药物管线。作为一家先锋企业，

China's

中国的

original drug innovation space, the company upholds the mission of 'Innovation, Safety, Efficacy, China-Origin'. It is committed to delivering urgently needed, revolutionary mechanism-based therapies to patients. Chipscreen has established a comprehensive industrial chain, spanning from early discovery to commercialization, and offers innovative drug solutions originating from .

原始药物创新空间，公司秉承“创新、安全、有效、中国起源”的使命，致力于为患者提供急需的、基于革命性机制的治疗方案。微芯生物建立了从早期发现到商业化的完整产业链，并提供源自中国的创新药物解决方案。

China

中国

to global patients.

给全球患者。

Anchored by a global development strategy based on early-stage research in

以早期研究为基础的全球发展战略为锚点

China

中国

, Chipscreen leverages its small-molecule R&D centers in

，微芯生物利用其小分子研发中⼼在

, where experienced scientific teams have built an integrated technology platform powered by AI-assisted design and chemical genomics. This enables a seamless translation from fundamental research to clinical development. The company has successfully developed multiple first-in-class and best-in-class novel drugs.

，经验丰富科学团队建立了由人工智能辅助设计和化学基因组学驱动的综合技术平台。这使得从基础研究到临床开发的无缝转化成为可能。该公司已成功开发出多种首创和最佳同类新药。

Two of its drugs covering six indications have been launched globally. The company maintains a diversified innovation pipeline across five major areas: oncology, metabolic diseases, autoimmune disorders, central nervous system diseases, and antivirals. As one of the first national 'Innovative Drug Incubation Bases' and a certified National High-Tech Enterprise, Chipscreen has independently undertaken numerous national-level projects, including the 'Major New Drug Innovation' initiative, and has filed over 700 patent applications globally, with more than 200 granted..

两款药物覆盖六大适应症已在全球上市。公司围绕肿瘤、代谢性疾病、自身免疫性疾病、中枢神经系统疾病和抗病毒等五大领域，保持多元化的创新研发管线。作为最早一批国家“创新药物孵化基地”，国家高新技术企业，微芯生物独立承担了包括“重大新药创制”专项在内的多项国家重大科技攻关项目，累计申请全球专利超700项，其中已获授权200多项。

About Chipscreen Biosciences (

关于 Chipscreen Biosciences (

) Ltd. is a wholly owned subsidiary of Chipscreen Biosciences. It is committed to advancing the clinical development of the company's innovative drugs globally. Upholding the motto 'Constant Innovation for Life,' the U.S. subsidiary has built a U.S.-based R&D platform to accelerate the clinical translation and global registration of drug candidates, including CS231295.

）有限公司是微芯生物的全资子公司，致力于推进公司创新药物在全球的临床开发。美国子公司秉承“持续创新为生命”的理念，建立了美国本土的研发平台，加速包括CS231295在内的药物候选物的临床转化和全球注册。

Leveraging its parent company's strong AI-assisted design and chemical genomics platforms, the U.S. team works closely with early R&D forces in .

利用其母公司强大的人工智能辅助设计和化学基因组学平台，美国团队与早期研发力量密切合作。

and international multicenter clinical networks, forming a globalized drug development system. The company will continue to drive the global advancement of CS231295 and aims to bring breakthrough therapies to patients with brain tumors and other unmet medical needs.

国际多中心临床研究网络，构建全球化的药物开发体系。公司将持续推进CS231295在全球的开发进展，致力于为脑肿瘤等存在未满足医疗需求的患者带来突破性疗法。