/PRNewswire/ -- D3 Bio, Inc, a clinical-stage oncology company focuses on discovery and development of precision oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation to D3S-001, the company's next generation KRAS G12C-selective inhibitor, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic .

/PRNewswire/ -- 临床阶段肿瘤学公司D3 Bio, Inc专注于发现和开发精准肿瘤治疗药物，今天宣布美国食品药品监督管理局（FDA）已授予其下一代KRAS G12C选择性抑制剂D3S-001突破性疗法认定，用于治疗携带KRAS G12C突变的局部晚期或转移性成年患者。

NSCLC who

非小细胞肺癌患者

have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor. Additionally, D3S-001 has been granted Orphan Drug Designation for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC.

曾接受过先前的化疗和免疫治疗，但未接受过KRAS G12C抑制剂治疗。此外，D3S-001已被授予用于治疗携带KRAS G12C突变的局部晚期或转移性结直肠癌成年患者的孤儿药资格。

The Breakthrough Therapy and Orphan Drug Designations are based on clinical data from an ongoing Phase 1/2 study (NCT05410145) evaluating D3S-001 in patients with advanced solid tumors harboring a KRAS G12C mutation. Results from this ongoing clinical trial demonstrated highly compelling and durable efficacy according to RECIST (Response Evaluation Criteria in Solid Tumors) with a favorable safety and tolerability profile..

突破性疗法和孤儿药资格的认定是基于一项正在进行的1/2期临床研究（NCT05410145）的数据，该研究评估了D3S-001在携带KRAS G12C突变的晚期实体瘤患者中的疗效。这项正在进行的临床试验结果显示，根据RECIST（实体瘤疗效评价标准），药物表现出极具说服力且持久的疗效，同时具备良好的安全性和耐受性特征。

We are very pleased to receive both Breakthrough Therapy and Orphan Drug Designations from the FDA for D3S-001, which highlights D3S-001's promising potential to

我们非常高兴D3S-001获得了FDA的突破性疗法和孤儿药双重认定，这突显了D3S-001在治疗潜力上的广阔前景。

address critical unmet needs in patients with KRAS G12C-mutated cancers,' said

满足KRAS G12C突变癌症患者的关键未满足需求，”表示

George Chen

乔治·陈

, Founder and CEO of D3 Bio. 'These designations also recognize D3S-001's novel profile as a next-generation KRAS G12C inhibitor. We look forward to bringing this exciting new treatment to patients with support and collaboration from health authorities.'

D3 Bio的创始人兼首席执行官表示：“这些认定也认可了D3S-001作为下一代KRAS G12C抑制剂的新颖特性。我们期待在卫生当局的支持和合作下，将这一令人兴奋的新疗法带给患者。”

KRAS mutations are among the most common oncogenic drivers in human cancers, found in approximately 25 to 30% of all tumors. The KRAS G12C mutation occurs in approximately 12% of NSCLC cases and 3 to 4% of CRC. Patients with KRAS G12C-mutated cancers often have more aggressive disease and limited responses to standard therapies, such as immunotherapy and/or chemotherapy..

KRAS突变是人类癌症中最常见的致癌驱动因素之一，存在于大约25%至30%的所有肿瘤中。KRAS G12C突变发生在约12%的非小细胞肺癌（NSCLC）病例和3%至4%的结直肠癌（CRC）中。携带KRAS G12C突变的癌症患者通常病情更具侵袭性，并且对标准治疗（如免疫疗法和/或化疗）的反应有限。

About D3S-001

关于 D3S-001

D3S-001 is a next-generation KRAS G12C inhibitor designed to achieve rapid and complete KRAS G12C target engagement. D3S-001 potently, selectively, and covalently binds to the oncogenic RAS (Off) form of the RAS G12C variant, functionally abolishing the nucleotide cycling between RAS (Off) and RAS (On) forms of the G12C mutant protein.

D3S-001 是一种下一代 KRAS G12C 抑制剂，旨在实现快速且完全的 KRAS G12C 靶点结合。D3S-001 能够强效、选择性且共价地结合到 RAS G12C 变体的致癌 RAS（关闭）形式，功能性地消除 G12C 突变蛋白的 RAS（关闭）和 RAS（开启）形式之间的核苷酸循环。

In preclinical investigations, D3S-001 demonstrated high covalent potency, complete engagement of KRAS G12C at clinically relevant doses and CNS penetration properties. D3S-001 is currently under evaluation as monotherapy and in combination regimens in a Phase II global clinical trial in patients with advanced solid tumors harboring KRAS G12C mutations, including NSCLC, CRC, and other tumor types.

在临床前研究中，D3S-001 展现了高共价效力、在临床相关剂量下完全结合 KRAS G12C 的能力以及中枢神经系统渗透特性。D3S-001 目前正在一项二期全球临床试验中作为单药疗法及联合治疗方案进行评估，用于治疗携带 KRAS G12C 突变的晚期实体瘤患者，包括非小细胞肺癌、结直肠癌及其他肿瘤类型。

D3S-001, a KRAS G12C Inhibitor with Rapid Target Engagement Kinetics, Overcomes Nucleotide Cycling, and Demonstrates Robust Preclinical and Clinical Activities. Cancer Discov. (2024)14 (9):1675–1698.

D3S-001，一种具有快速靶标结合动力学的KRAS G12C抑制剂，克服了核苷酸循环，并在临床前和临床研究中显示出强大的活性。《癌症发现》（2024）14（9）：1675–1698。

D3S-001 in advanced solid tumors with KRASG12C mutations: a phase 1 trial. Nat Med. 2025 Aug;31(8):2768-2777.

D3S-001在携带KRASG12C突变的晚期实体瘤中的应用：一项1期试验。《自然医学》，2025年8月；31(8):2768-2777。

About D3 Bio

关于D3 Bio

D3 Bio is a global biotechnology company focused on the discovery, development, and registration of new medicines in oncology and immunology. The company's discovery and development platforms leverage proprietary clinical insight and biomarker strategies to create novel and clinically meaningful therapies for patients in need..

D3 Bio是一家全球生物技术公司，专注于在肿瘤学和免疫学领域发现、开发和注册新药。该公司利用其专有的临床洞察和生物标志物策略，通过发现和开发平台为有需要的患者创造新颖且具有临床意义的治疗方法。

D3 Bio's oncology programs target driver mutations or critical immune pathways and are designed to have first-in-class or best-in-class potential. D3 Bio owns global rights for all of its programs. For more information, please visit

D3 Bio的肿瘤学项目针对驱动突变或关键免疫通路，并旨在具有首创或最佳潜力。D3 Bio拥有其所有项目的全球权利。欲了解更多信息，请访问