– Bayer and Suzhou Puhe BioPharma Co.,Ltd., a clinical-stage biotechnology company, today announced that they have entered into a global license agreement for Puhe BioPharma’s oral, small molecule PRMT5 inhibitor that selectively targets MTAP-deleted tumors. Under the agreement, Bayer obtains an exclusive worldwide license to develop, manufacture and commercialize the MTA-cooperative PRMT5 inhibitor.

– 拜耳和苏州普禾生物医药公司（一家临床阶段的生物技术公司）今天宣布，双方已就普禾生物医药的一款口服小分子PRMT5抑制剂达成全球许可协议，该抑制剂可选择性靶向MTAP缺失的肿瘤。根据协议，拜耳获得了开发、生产和商业化这种MTA协同PRMT5抑制剂的全球独家许可。

Bayer has enrolled the first participant in a Phase I first-in-human dose escalation study investigating MTA-cooperative PRMT5 inhibitor under the development name BAY 3713372 for the treatment of MTAP-deleted solid tumors..

拜耳已经注册了第一位参与者，参与一项 Phase I 人体首次剂量递增研究，该研究正在调查名为 BAY 3713372 的 MTA 协同 PRMT5 抑制剂，用于治疗 MTAP 缺失的实体瘤。

“We are looking forward to explore the potential of the PRMT5 inhibitor, which could improve outcomes for patients with MTAP-deleted tumors who often have a poor prognosis,” said Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer’s Pharmaceuticals Division. “The highly selective targeting of cancer cells while sparing healthy cells, based on the innovative mechanism of action is very promising.

“我们期待探索PRMT5抑制剂的潜力，这可能会改善MTAP缺失肿瘤患者的治疗效果，这类患者通常预后较差，”拜耳制药部门业务发展与授权负责人尤尔根·艾克哈特医学博士说道。“基于创新的作用机制，这种高度选择性地靶向癌细胞同时保护健康细胞的策略非常有前景。”

This will support our mission to build one of the most transformative and differentiated precision oncology pipelines in the industry.”.

这将支持我们建立行业内最具变革性和差异化的精准肿瘤学管线之一的使命。”

“We see great potential in MTA-cooperative PRMT5 inhibitors in treating MTAP-deleted tumors. Our MTA-cooperative PRMT5 inhibitor, PH020, now named BAY 3713372, has demonstrated competitive selectivity for PRMT5 bound to MTA and activity in preclinical studies, as well as brain penetration capabilities,” said Yongqi Guo, CEO of Puhe BioPharma.

“我们看到MTA协同PRMT5抑制剂在治疗MTAP缺失肿瘤方面具有巨大潜力。我们的MTA协同PRMT5抑制剂PH020，现名为BAY 3713372，在临床前研究中显示出对与MTA结合的PRMT5的竞争性选择性及活性，还表现出血脑屏障渗透能力，”普和生物医药公司首席执行官郭永琪表示。

“We are excited to partner with Bayer, a global leader in the field of life sciences, to advance our PRMT5 inhibitor into the clinic. Together with Bayer, we look forward to bringing this therapeutic option to patients worldwide.”.

“我们很高兴与生命科学领域的全球领导者拜耳合作，将我们的PRMT5抑制剂推进到临床。与拜耳一起，我们期待将这种治疗选择带给全球患者。”

PRMT5 (protein arginine methyltransferase 5) and a specific gene called MTAP (metabolic enzyme 5’-deoxy-5'-methylthioadenosine phosphorylase) play important roles in cell metabolism and are critical for cell survival. MTAP deletions, which occur in approximately 10 to 30 percent of all cancers

PRMT5（蛋白质精氨酸甲基转移酶5）和一种名为MTAP（代谢酶5'-脱氧-5'-甲硫腺苷磷酸化酶）的特定基因在细胞代谢中发挥重要作用，对细胞存活至关重要。MTAP缺失发生在大约10%到30%的所有癌症中。

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, lead to elevated levels of MTA in tumor cells and BAY 3713372 is designed to bind the PRMT5-MTA complex thus specifically exploiting tumor vulnerability.

，导致肿瘤细胞中MTA水平升高，而BAY 3713372旨在结合PRMT5-MTA复合物，从而特异性地利用肿瘤脆弱性。

“Loss of the MTAP gene occurs in a variety of tumor types, including those with few treatment options and poor prognosis, such as pancreatic cancer and glioblastoma,” said Dominik Ruettinger, M.D., Ph.D., Global Head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division.

“MTAP基因的丢失发生在多种肿瘤类型中，包括那些治疗选择少且预后较差的癌症，例如胰腺癌和胶质母细胞瘤，”拜耳制药部门肿瘤学全球研究与早期开发主管Dominik Ruettinger博士说道。

“We look forward to advancing this program as we are driven by our ambition to develop innovative medicines that improve and extend the lives of cancer patients we serve, focusing on areas of high unmet medical need.”.

“我们期待推进这一项目，因为我们致力于开发创新药物，以改善和延长我们所服务的癌症患者的生命，重点关注那些未满足医疗需求的领域。”

Financial terms are not disclosed.

财务条款未披露。

About BAY 3713372 (MTA-cooperative PRMT5 inhibitor)

关于BAY 3713372（MTA协同PRMT5抑制剂）

BAY 3713372 is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is an oral, potent selective MTA-cooperative PRMT5 inhibitor being evaluated as a potential new targeted treatment option for patients with MTAP-deleted solid tumors.

BAY 3713372 是一种研究性药物，尚未获得任何卫生部门批准在任何国家用于任何适应症。它是一种口服、强效的选择性MTA协同PRMT5抑制剂，正被评估作为MTAP缺失实体瘤患者的潜在新型靶向治疗选择。

BAY 3713372 has unique characteristics including brain penetrance, which allows targeting of central nervous system (CNS) metastases and primary brain tumors..

BAY 3713372 具有独特的特性，包括能够穿透大脑，从而可以靶向中枢神经系统 (CNS) 转移瘤和原发性脑肿瘤。

Protein arginine N-methyltransferase 5 (PRMT5) plays a crucial role in modifying proteins that control the cell cycle. The metabolic enzyme 5’-deoxy-5'-methylthioadenosine phosphorylase (MTAP) is involved in the methionine salvage pathway which recycles methionine from methylthioadenosine (MTA).This targeted approach takes advantage of the unique relationship between MTA and PRMT5, creating a specific vulnerability that can be exploited to effectively treat MTAP deficient cancer cells..

蛋白质精氨酸N-甲基转移酶5（PRMT5）在修饰控制细胞周期的蛋白质方面发挥关键作用。代谢酶5'-脱氧-5'-甲硫腺苷磷酸化酶（MTAP）参与了甲硫氨酸补救途径，该途径从甲硫腺苷（MTA）中回收甲硫氨酸。这种靶向方法利用了MTA与PRMT5之间的独特关系，创造了一种特定的脆弱性，可以被用来有效治疗MTAP缺陷的癌细胞。

About the clinical phase I study

关于临床一期研究

BAY 3713372 is investigated in

BAY 3713372 正在被研究中

a global Phase I first-in-human dose escalation study in patients with MTAP-deleted solid tumors. The clinical program aims to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and preliminary clinical activity of BAY 3713372, a novel cancer cell specific PRMT5 inhibitor.

一项全球I期首次人体剂量递增研究，针对MTAP缺失的实体瘤患者。该临床项目旨在评估BAY 3713372（一种新型癌细胞特异性PRMT5抑制剂）的安全性、耐受性、药代动力学、药效学及初步临床活性。

About Puhe BioPharma

关于普禾生物医药

Suzhou Puhe BioPharma Co., Ltd. is a biotechnology company dedicated to the research and development of innovative small-molecule precision therapeutics. Adhering to a strategy that addresses differentiated clinical needs, the company focuses on high-incidence, high-mortality cancers and other chronic diseases.

苏州浦合生物医药科技有限公司是一家致力于创新小分子精准治疗药物研发的生物技术公司。公司以满足差异化临床需求为策略，专注于高发、高致死率的癌症及其他慢性疾病。

By leveraging scientific and industrial insights, Puhe combines various advanced technologies such as next-generation kinase inhibitors, synthetic lethality, and molecular glue approaches to address complex medical challenges. For more information, go to .

通过利用科学和工业洞察力，普禾结合了多种先进技术，如下一代激酶抑制剂、合成致死性和分子胶方法，以应对复杂的医学挑战。欲了解更多信息，请访问 。

www.puhebiopharma.com

普赫生物制药公司官网

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About Bayer

关于拜耳

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.

拜耳是一家在医疗保健和营养等生命科学领域具有核心竞争力的全球性企业。秉承“人人健康，无饥饿”的使命，公司通过支持应对不断增长和老龄化的全球人口所带来的重大挑战，设计其产品和服务以帮助人类和地球繁荣发展。

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 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros.

拜耳致力于通过其业务推动可持续发展并产生积极影响。同时，集团旨在通过创新和增长提高盈利能力并创造价值。拜耳品牌在全球范围内代表信任、可靠性和质量。在2024财年，集团拥有约93,000名员工，销售额达466亿欧元。