Porton Advanced proudly announces its CDMO support for TASLY PHARMACEUTICAL CO.,LTD’s Innovative Dual-Targeting CAR-T Therapy, “P134 Cell Injection,” which has received Investigational New Drug (IND) approval from China’s National Medical Products Administration (NMPA) (Approval No.: 2025LP01030). This breakthrough CAR-T therapy is indicated for recurrent glioblastoma (GBM)..

保诺科技自豪地宣布其为天士力制药集团股份有限公司创新的双靶向CAR-T疗法“P134细胞注射液”提供CDMO支持，该疗法已获得中国国家药品监督管理局（NMPA）的临床试验新药（IND）批准（批准文号：2025LP01030）。这项突破性的CAR-T疗法适用于复发性胶质母细胞瘤（GBM）。

As the exclusive CDMO partner for this program, Porton Advanced provided comprehensive process development and manufacturing services, including plasmid, lentiviral vectors and final CAR-T cell products. We successfully manufactured dozens of batches of clinical-grade investigational products for Investigator-Initiated Trials (IITs), with all batches passing quality control on the first attempt..

作为该计划的独家CDMO合作伙伴，Porton Advanced提供了包括质粒、慢病毒载体和最终CAR-T细胞产品在内的全面工艺开发和生产服务。我们成功为研究者发起的试验（IITs）生产了数十批次的临床级研究产品，所有批次均一次性通过质量控制。

About GMB and Tasly ‘s Dual-Targeting CAR-T Therapy

关于GMB和天士力的双靶向CAR-T疗法

Glioblastoma (GBM) is the most common primary malignant tumor of the central nervous system, characterized by high invasiveness, frequent recurrence, and poor prognosis. P134 Cell Injection is an autologous CAR-T product targeting CD44 and/or CD133. Its mechanism of action involves specifically recognizing and binding to antigen targets that are highly and mutually exclusively expressed in primary and recurrent GBM, thereby effectively activating and prolonging T-cell lifespan to eliminate tumor cells..

胶质母细胞瘤（GBM）是中枢神经系统最常见的原发恶性肿瘤，具有高侵袭性、频繁复发和预后差的特点。P134 细胞注射是一种自体 CAR-T 产品，靶向 CD44 和/或 CD133。其作用机制涉及特异性识别并与在原发性和复发性 GBM 中高度且互斥表达的抗原靶点结合，从而有效激活并延长 T 细胞寿命以消除肿瘤细胞。

Porton Advanced: Accelerating Progress of Advanced Therapies

凯莱英：加速先进疗法的进展

Our team’s expertise in cell therapy development and cGMP production ensured high-quality, on-time delivery, contributing to Tasly ‘s continued effort in bringing innovative oncology treatments to patients worldwide. Notably, the regulatory submission achieved zero deficiencies during the CDE review, demonstrating the high compliance of our quality system and production stability..

我们的团队在细胞治疗开发和cGMP生产方面的专业知识确保了高质量、按时交付，助力天士力持续为全球患者带来创新的肿瘤治疗方案。值得注意的是，监管提交在CDE审评中实现了零缺陷，展示了我们质量体系的高度合规性和生产的稳定性。

Plasmid Production: A robust two-step chromatography process enabled rapid delivery of engineering run and GMP batches, significantly shortening timelines and reducing costs.

质粒生产：一个强大的两步层析工艺实现了工程批次和GMP批次的快速交付，大幅缩短了时间并降低了成本。

Lentivirus Production: Utilizing our proprietary LV-SMART® lentiviral suspension platform, we achieved high batch-to batch consistency, high yield, high infectious, low residual impurities as well as 30% reduced material cost with animal components free.

慢病毒生产：利用我们专有的LV-SMART®慢病毒悬浮平台，我们实现了高批次一致性、高产量、高感染性、低残留杂质，并且在无动物成分的情况下降低了30%的材料成本。

CAR-T Production: Porton Advanced produced high-transfection-efficiency CAR-T cells meeting with all release standards, delivered over 10 IIT samples with consistent quality, which contributes to observable clinical efficacy in IIT study.

CAR-T生产：博腾生物制备出高转染效率的CAR-T细胞，符合所有放行标准，交付了10多个IIT样品，质量稳定，为IIT研究中的临床疗效提供了可观的支持。

Leveraging our end-to-end CDMO platform, Porton Advanced has established a deep collaboration with Tasly. We sincerely wish Tasly success in the clinical development of CAR-T pipeline and hope it will soon bring new treatment options to patients with recurrent glioblastoma. We look forward to further strengthening our partnership to accelerate the delivery of transformative therapies to patients worldwide..

利用我们端到端的CDMO平台，Porton Advanced与天士力建立了深度合作。我们衷心祝愿天士力在CAR-T管线的临床开发中取得成功，并希望它能尽快为复发性胶质母细胞瘤患者带来新的治疗选择。我们期待进一步加强合作伙伴关系，加速将变革性疗法带给全球患者。

About Tasly Pharma

关于天士力制药

As an international modern Chinese medicine enterprise, Tasly Pharma. (Stock code: 600535) is committed to developing into a leading solution provider of medicine and health services with global influence in China. With “people-oriented and precise innovation”, Tasly Pharma. constantly promotes the progress of medicine and health to make every human-being can enjoy the beauty and hope of life..

作为一家国际化现代中药企业，天士力医药（股票代码：600535）致力于发展成为中国具有全球影响力的医药健康解决方案领先提供商。秉承“以人为本，精准创新”的理念，天士力医药不断推动医药健康进步，让每个人都能享受生命的美好与希望。

Headquartered in Tianjin, China, the company has more than 20 research centers worldwide and 11 production bases throughout the country. We are committed to cracking the digital code of life medicine. Adhering to the concept of “patient-centered”, we pay close attention to the evolution of disease spectrum, and make precise innovations in major therapeutic fields such as cardio-cerebrovascular, digestion and metabolism, tumor immunity, and neuroscience, which sustain the healthy life experience of human beings..

总部位于中国天津，公司全球拥有20余个研发中心，国内拥有11个生产基地。我们致力于破译生命医药的数字密码，秉承“以患者为中心”的理念，密切关注疾病谱变化，在心脑血管、消化代谢、肿瘤免疫、神经科学等重大治疗领域进行精准创新，助力人类健康生活。

With a rich drug combination including modern Chinese medicine, chemical medicine and biological innovation medicine, regenerative medicine and the 4-D integrated health management solutions, we can provide service of the whole health journey including health examination, early warning, prevention, diagnosis, treatment and rehabilitation and a personalized and integrated medical solutions covering the whole disease course for each patient and family so as to meet the diverse needs of the individual life, optimize life experience and improve life quality..

通过包含现代中药、化学药、生物创新药、再生医学以及四位一体健康管理方案的丰富药品组合，我们可以提供包括健康检查、预警、预防、诊断、治疗和康复在内的全健康旅程服务，为每位患者及其家庭提供覆盖疾病全过程的个性化、一体化医疗解决方案，从而满足个体生命的多样化需求，优化生命体验，提高生命质量。

About Porton Advanced

关于Porton Advanced

Porton Advanced Solutions is a subsidiary of the leading CDMO, Porton Pharma Solutions. Porton Advanced has headquarters in Cranbury, New Jersey, and two GMP sites in Suzhou, China, providing end-to-end CDMO solutions for ATMPs. We offer services from cell banking, process, and analytical method development, cGMP production to fill & finish, covering different stages of drug development from early research, IITs, Investigational New Drug (IND) applications, clinical trials, New Drug Applications (NDA), to commercialization..

Porton Advanced Solutions是领先CDMO公司Porton Pharma Solutions的子公司。Porton Advanced总部位于新泽西州克兰伯里，在中国苏州拥有两个GMP基地，为ATMP提供端到端的CDMO解决方案。我们提供的服务涵盖细胞库构建、工艺与分析方法开发、cGMP生产到灌装与包装，覆盖药物开发的各个阶段，包括早期研究、IIT、研究性新药（IND）申请、临床试验、新药申请（NDA）以及商业化。

Porton Advanced has developed specialized CRO and CDMO platforms focusing on plasmids, viral vectors (lentiviral vector, adenoviral vector, AAV,etc), cell therapy CMC services including CAR-T, TCR-T, CAR-NK, HSC, exosome, etc) and nucleic acid therapies. Our state-of-the-art, GMP-compliant facilities span an impressive 215,000 sq ft, equipped with 10 viral vector production lines, 12 GMP-compliant cell therapy production suites (including 2 suites for infectious donors), and a multitude of clean rooms.

Porton Advanced 开发了专门的 CRO 和 CDMO 平台，专注于质粒、病毒载体（慢病毒载体、腺病毒载体、AAV 等）、细胞治疗 CMC 服务（包括 CAR-T、TCR-T、CAR-NK、HSC、外泌体等）以及核酸疗法。我们拥有先进的、符合 GMP 标准的设施，占地达 215,000 平方英尺，配备了 10 条病毒载体生产线、12 个符合 GMP 标准的细胞治疗生产套间（包括 2 个用于感染供体的套间）以及众多洁净室。

As of now, we have successfully supported our clients to secure 18 global IND approvals from NMPA, FDA, and Medsafe, with 5 ongoing Phase I/II ATMP projects. Additionally, Porton Advanced has supported the successful transition of several overseas clinical-stage pipelines into China..

截至目前，我们已经成功支持客户获得来自NMPA、FDA和Medsafe的18项全球IND批准，并有5个正在进行的I/II期ATMP项目。此外，Porton Advanced还成功支持了多个海外临床阶段管线转入中国。

Porton Advanced is committed to a customer-centric approach, offering excellent global, end-to-end CDMO services to our clients, enabling effective drugs to benefit the public sooner.

保诺科技致力于以客户为中心，为客户提供优质的全球端到端CDMO服务，助力有效药物早日惠及公众。

Source: portonadvanced.com

来源：portonadvanced.com