Porton Advanced's End-to-End CDMO Solutions Accelerates IND Approval of Tasly's Innovative Dual-Targeting CAR-T Therapy

SUZHOU, China, April 16, 2025 /PRNewswire/ -- April 12, 2025, 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).

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.

About GMB and Tasly's Dual-Targeting CAR-T Therapy

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.

Porton Advanced: Accelerating Progress of Advanced Therapies

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.

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

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.

About Tasly Pharma

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.

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.

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.

About 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 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. 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.

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.

SOURCE Porton Advanced Solutions