Bispecific Antibody Candidate PM8002 demonstrated encouraging data at this year's ASCO Annual Meeting (abstract #2536 & #e13091) and ESMO Congress (abstract #1992P)

双特异性抗体候选物PM8002在今年的ASCO年会（摘要＃2536和＃e13091）和ESMO大会（摘要＃1992P）上展示了令人鼓舞的数据

BioNTech will hold exclusive licenses to develop and commercialize PM8002 globally excluding Greater China

BioNTech将持有开发和商业化PM8002的独家许可证，不包括大中国

ZHUHAI, China, Nov. 6, 2023 /PRNewswire/ -- Biotheus Inc. ('Biotheus'), a clinical-stage biotech company dedicated to the discovery and development of biologics for oncology and inflammatory diseases, today announced that the company has entered into an exclusive global license and collaboration agreement under which BioNTech will be developing, manufacturing and commercializing PM8002 globally ex-Greater China, whereas Biotheus retains the rights to exploit PM8002 in Greater China.

中国珠海，2023年11月6日/PRNewswire/-Biotheus Inc.（'Biotheus'），一家致力于发现和开发肿瘤和炎症性疾病生物制剂的临床阶段生物技术公司，今天宣布该公司已经签署BioNTech将在其下开发的独家全球许可和合作协议，在全球范围内制造和商业化PM8002前大中国，而Biotheus保留在大中国开发PM8002的权利。

PM8002 is currently being tested in Phase 2 studies in China to evaluate the efficacy and safety of the candidate as a monotherapy or in combination with chemotherapy in patients with advanced solid tumors..

PM8002目前正在中国进行2期研究，以评估该候选药物作为单一疗法或联合化疗治疗晚期实体瘤患者的疗效和安全性。。

Under the terms of the agreement, Biotheus will receive an upfront payment of $55 million, and is eligible to receive additional development, regulatory and sales milestone payments potentially totalling over $1 billion as well as tiered royalties on potential future product sales. The transaction is expected to close in Q4 2023, subject to customary closing conditions, including clearance under the Hart-Scott-Rodino ('HSR') Antitrust Improvements Act, and regulatory clearances..

根据协议条款，Biotheus将获得5500万美元的预付款，并有资格获得额外的开发，监管和销售里程碑付款，可能总计超过10亿美元，以及潜在的未来产品销售的分层版税。根据习惯性关闭条件，包括根据Hart-Scott Rodino（'HSR'）反托拉斯改进法案进行的许可以及监管许可，预计该交易将于2023年第四季度结束。。

PM8002 is a bispecific antibody candidate with humanized anti-PD-L1 single heavy-chain variable (VHH) domains fused to an anti-VEGF-A IgG1 antibody containing Fc-silencing mutations. PM8002 has demonstrated a positive safety profile and encouraging antitumor activity presumably through reduced systemic toxicity by enriching anti-VEGF activity into the tumor microenvironment at this year's ASCO Annual Meeting and ESMO Congress 2023..

PM8002是具有与含有Fc沉默突变的抗VEGF-a IgG1抗体融合的人源化抗PD-L1单重链可变（VHH）结构域的双特异性抗体候选物。在今年的ASCO年会和ESMO 2023大会上，PM8002通过在肿瘤微环境中富集抗VEGF活性，证明了积极的安全性并通过降低全身毒性来鼓励抗肿瘤活性。。

'Biotheus' innovative platform has the capability to expedite preclinical research, bolstering our impressive innovative pipeline of products with encouraging efficacy and safety including PM8002. Collaborating with industry trailblazer BioNTech, we hope to advance PM8002 through multi-regional clinical trials with the aim to be able to provide it to patients worldwide,' stated Xiaolin Liu, Co-founder, Chairman, and CEO of Biotheus..

'Biotheus'创新平台具有加速临床前研究的能力，为我们令人印象深刻的创新产品管道提供支持，具有令人鼓舞的功效和安全性，包括PM8002。Biotheus联合创始人兼首席执行官刘晓林表示，我们希望通过多区域临床试验推进PM8002，以便能够将其提供给全球患者。。

About Biotheus

关于Biotheus

Biotheus Inc. is a clinical-stage biotech company dedicated to the discovery, development, and delivery of novel antibodies and cell therapies to address the unmet medical needs of patients with oncology and inflammatory diseases worldwide. Since its inception, Biotheus has established several innovative platforms for antibody discovery and a proprietary cell therapy that delivers T cell engagers into the tumor microenvironment to eradicate tumor cells.

Biotheus Inc.是一家临床阶段生物技术公司，致力于发现，开发和提供新型抗体和细胞疗法，以解决全球肿瘤学和炎症性疾病患者未满足的医疗需求。自成立以来，Biotheus已经为抗体发现和专有的细胞疗法建立了几个创新平台，将T细胞参与者提供到肿瘤微环境中以根除肿瘤细胞。

With an experienced development team, Biotheus has built a robust pipeline of ten programs at various stages of clinical development..

凭借经验丰富的开发团队，Biotheus在临床开发的各个阶段建立了一个由10个项目组成的强大管道。。

For more information about Biotheus, please visit www.biotheus.com.

有关Biotheus的更多信息，请访问www.Biotheus.com。

About BioNTech

关于BioNTech

Biopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals.

生物制药新技术（BioNTech）是下一代免疫治疗公司，开创癌症和其他严重疾病的新疗法。该公司利用各种计算发现和治疗药物平台来快速开发新型生物制药。

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules.

其广泛的肿瘤产品候选组合包括个性化和现成的基于mRNA的疗法，创新的嵌合抗原受体（CAR）T细胞，几种基于蛋白质的疗法，包括双特异性免疫检查点调节剂，靶向癌症抗体和抗体-药物偶联物（ADC）疗法，以及小分子。

Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, OncoC4, Regeneron, Sanofi, and Pfizer..

BioNTech及其合作者基于其在mRNA疫苗开发和内部制造能力方面的丰富专业知识，正在开发多种mRNA疫苗候选物，用于各种传染病以及其多样化的肿瘤学管道。BioNTech与多个全球制药合作者建立了广泛的关系，包括Duplicative Biologics，Fosun Pharma，Genentech，罗氏集团成员，Genevant，Genmab，OncoC4，Regeneron，赛诺菲和辉瑞。。

For more information, please visit www.BioNTech.com

欲了解更多信息，请访问www.BioNTech.com

Biotheus Inc.Jun Bao[email protected]

Biotheus Inc.Jun Bao[电子邮件保护]

Goby Global LLCBob Ai[email protected]

虾虎鱼全球LLCBob Ai[电子邮件保护]

SOURCE Biotheus

SOURCE Biotheus