Bayer announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has granted Breakthrough Therapy designation for BAY 2927088, a potential new targeted therapy for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC), whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy.

拜耳宣布，中国国家医药产品管理局（NMPA）药物评估中心（CDE）已授予BAY 2927088突破性治疗指定，BAY 2927088是一种潜在的新靶向治疗方法，适用于无法切除或转移的非小细胞肺癌（NSCLC）成年患者，其肿瘤具有激活HER2（ERBB2）突变，并且之前接受过全身治疗。

The CDE's designation for BAY 2927088 follows the Breakthrough Therapy designation granted by the U.S. Food and Drug Administration (FDA) in February 2024 for the same patient population. .

CDE对BAY 2927088的指定遵循美国食品和药物管理局（FDA）于2024年2月为同一患者群体授予的突破性治疗指定。。。

'The Breakthrough Therapy designations granted for BAY 2927088 by China's CDE and the U.S. FDA underscore the potential of this targeted therapy to transform the lives of patients with HER2-mutant NSCLC, a type of lung cancer with limited treatment options and often poor prognosis,' said Christian Rommel, Ph.D., Head of Research and Development at Bayer's Pharmaceuticals Division.

拜耳制药部研发主管克里斯蒂安·隆美尔（ChristianRommel）博士说：“中国CDE和美国食品和药物管理局（FDA）授予BAY 2927088突破性治疗方案，突显了这种靶向治疗改变HER2突变型非小细胞肺癌患者生活的潜力，这种肺癌的治疗选择有限，预后往往较差。”。

'This recognition, backed by promising clinical evidence, strengthens our commitment to addressing critical unmet needs in cancer care. It reinforces our mission to be a leader in oncology by accelerating the development of targeted therapies, one of our key focus areas.' .

“这一认识得到了有希望的临床证据的支持，加强了我们对解决癌症护理中未满足的关键需求的承诺。它加强了我们成为肿瘤学领导者的使命，加速了靶向治疗的发展，这是我们的关键重点领域之一。”。。

This Breakthrough Therapy designation is supported by preliminary clinical evidence from the Phase I/II, open-label, multicenter first-in-human study (NCT05099172) evaluating the safety, pharmacokinetics and preliminary efficacy of BAY 2927088 in adult patients with advanced NSCLC harboring HER2 or EGFR.

这一突破性治疗指定得到了I/II期，开放标签，多中心首次人体研究（NCT05099172）的初步临床证据的支持，该研究评估了BAY 2927088在携带HER2或EGFR的晚期NSCLC成年患者中的安全性，药代动力学和初步疗效。

The Breakthrough Therapy designation is a process designed to expedite the development and review of novel medicines that are intended for the prevention or treatment of serious, life-threatening diseases or conditions that severely impact the quality of life for which there is no existing treatment, or where sufficient evidence indicates advantages of the novel drug over available treatment options. .

突破性治疗指定是一个旨在加速开发和审查新药的过程，这些新药旨在预防或治疗严重威胁生命的疾病或严重影响生活质量的疾病，而目前尚无治疗方法，或者有足够的证据表明新药优于现有治疗方案。。。

About BAY 2927088

关于BAY 2927088

BAY 2927088 is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential new targeted treatment option for patients with NSCLC harboring HER2 activating mutations. BAY 2927088 is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant human epidermal growth factor receptors 2 (HER2), including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR.(1,2) .

BAY 2927088是一种研究药物，尚未获得任何卫生当局的批准，可用于任何国家的任何适应症。目前正在评估它作为携带HER2激活突变的NSCLC患者的潜在新靶向治疗选择。BAY 2927088是一种口服可逆酪氨酸激酶抑制剂（TKI），可有效抑制突变型人表皮生长因子受体2（HER2），包括HER2外显子20插入和HER2点突变，以及表皮生长因子受体（EGFR），对突变型和野生型EGFR具有高选择性。（1,2）。。

About Non-Small Cell Lung Cancer (NSCLC)

关于非小细胞肺癌（NSCLC）

Lung cancer is the leading cause of cancer-related deaths worldwide.(3) NSCLC is the most common type of lung cancer, accounting for more than 85% of cases.(4) Activating HER2 mutations are found in 2% to 4% of advanced NSCLC.(5) 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat.(6) Currently there are no available therapies that have received full approval for patients with NSCLC harboring HER2 activating mutations. .

肺癌是全球癌症相关死亡的主要原因。（3） NSCLC是最常见的肺癌类型，占病例的85%以上。（4） 在2%至4%的晚期NSCLC中发现激活HER2突变。（5） 80%被诊断患有非小细胞肺癌的人已经进展到晚期，这使得治疗更加困难。（6） 。。。

About Oncology at Bayer

拜耳肿瘤学简介

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes several marketed products across diverse indications and multiple compounds in different stages of clinical development.

拜耳致力于通过推进一系列创新疗法，为更好的生活提供科学。该公司有激情和决心开发新药，帮助改善和延长癌症患者的寿命。拜耳的肿瘤学特许经营权包括多种适应症的上市产品和临床开发不同阶段的多种化合物。

We have a wealth of expertise in areas including: Tumor Intrinsic Pathways, Targeted Radionuclide Therapies, and Next-Generation Immuno-Oncology. We are advancing prostate cancer treatment from early to metastatic stage, with the goal of extending survival while limiting side effects. Part of Bayer's focus on innovative precision oncology treatments, includes an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread. .

我们在以下领域拥有丰富的专业知识：肿瘤内在途径，靶向放射性核素治疗和下一代免疫肿瘤学。我们正在将前列腺癌治疗从早期推进到转移阶段，目的是延长生存期，同时限制副作用。拜耳专注于创新的精确肿瘤治疗的一部分，包括一种经批准的TRK抑制剂，专门用于治疗具有NTRK基因融合的肿瘤，NTRK基因融合是肿瘤生长和扩散的致癌驱动因素。。。

About Bayer

拜耳简介

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 'Health for all, Hunger for none,' the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

拜耳是一家全球性企业，在医疗保健和营养等生命科学领域拥有核心竞争力。该公司的产品和服务旨在帮助人们和地球繁荣，支持人们努力应对全球人口不断增长和老龄化带来的重大挑战，这与“人人健康，无人饥饿”的使命相一致。

Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros.

拜耳致力于推动可持续发展，并对其业务产生积极影响。与此同时，该集团旨在通过创新和增长来提高其盈利能力和创造价值。拜耳品牌代表着全世界的信任、可靠性和质量。2023财年，该集团雇佣了约10万人，销售额476亿欧元。

R&D expenses before special items amounted to 5.8 billion euros..

特殊项目前的研发费用为58亿欧元。。

1. Siegel F, Karsli-Uzunbas G, Kotynkova K, et al, Preclinical activity of BAY 2927088 in HER2 mutant non-small cell lung cancer. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 4035. .

1.Siegel F，Karsli Uzunbas G，Kotynkova K等，BAY 2927088在HER2突变型非小细胞肺癌中的临床前活性。。在：2023年美国癌症研究协会年会论文集；第1部分（定期和邀请摘要）；2023年4月14日至19日；佛罗里达州奥兰多。费城（PA）：AACR；癌症研究2023；83（7\u Suppl）：摘要编号4035。。。

2. Siegel F, Siegel S, Graham K, et al. BAY 2927088: The first non-covalent, potent, and selective tyrosine kinase inhibitor targeting EGFR exon 20 insertions and C797S resistance mutations in NSCLC. European Journal of Cancer. 2022;174:S9-S10.

2.Siegel F，Siegel S，Graham K等人，BAY 2927088：第一个针对NSCLC中EGFR外显子20插入和C797S耐药突变的非共价，有效和选择性酪氨酸激酶抑制剂。欧洲癌症杂志。2022年；174:S9-S10。

3. Sung, H. et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin. 71, 209-249 (2021).

3.Sung，H.等人，《2020年全球癌症统计：GLOBOCAN对185个国家36种癌症的全球发病率和死亡率的估计》。CA Cancer J.Clin。71209-249（2021）。

4. Leiter, A., Veluswamy, R.R. & Wisnivesky, J.P. The global burden of lung cancer: current status and future trends. Nat Rev Clin Oncol 20, 624-639 (2023).

4.Leiter，A.，Veluswamy，R.R。和Wisnivesky，J.P。肺癌的全球负担：现状和未来趋势。Nat Rev Clin Oncol 20624-639（2023）。

5. Stephens P, Hunter C, Bignell G, et al. Lung cancer: intragenic ERBB2 kinase mutations in tumours. Nature 2004;431:525-526.

Stephens P，Hunter C，Bignell G等。肺癌：肿瘤中的基因内ERBB2激酶突变。自然2004；431:525-526。

6. Yale Medicine Factsheet - Non-Small Cell Lung Cancer. Available at: https://www.yalemedicine.org/conditions/non-small-cell-lung-cancer Accessed April 2024.

耶鲁医学概况-非小细胞肺癌。网址：https://www.yalemedicine.org/conditions/non-small-cell-lung-cancer2024年4月访问。