Porton Advanced Supports LianLi Zhongda’s LM101 Injection in Securing IND Clearance, Marking Another Milestone in End-to-End CDMO Track Record

Recently, Beijing Arion Cancer Center announced that LM101 Injection, independently filed by its cell therapy R&D platform, Beijing LianLi Zhongda Medical Technology Co., Ltd., has received IND clearance from China's National Medical Products Administration (NMPA) (Acceptance No. CXSL2600608). The product is a CD19-targeted CAR-T therapy indicated for patients with CD19-positive relapsed/refractory (r/r) B-cell lymphoma in patients who have received at least two prior lines of systemic therapy. Porton Advanced extends its warmest congratulations on this achievement.

Porton Advanced provided end-to-end CDMO services for this program, including plasmids, lentiviral vectors, and CAR-T cells. These services covered the entire workflow from process development, analytical method development, and GMP manufacturing to CMC regulatory support. All manufacturing batches were successfully completed on the first production run, and the program achieved IND clearance with a “zero-deficiency” record.

About LM101 Injection

LM101 Injection was independently developed by Beijing Arion Cancer Center. Built on the classic CD19-CAR core structure, the product features an innovative chimeric receptor designed to relieve immunosuppression within the tumor microenvironment. This dual-structure design precisely addresses the challenges of immune escape and immune suppression in the tumor microenvironment, aiming to enhance tumor cell clearance and achieve deeper and more durable responses.

End-to-End CDMO Services Across Full CGT Modalities

Porton Advanced provides CDMO services for a full range of CGT products, including plasmids, lentiviral vectors, cell therapies (CAR-T, TCR-T, UCAR-T, NK, CAR-NK, MSC, TIL, iPSC, etc.), mRNA-LNP/tLNP, bacterial vectors, and exosomes. These services cover the entire product lifecycle from IND filing and clinical research through commercial manufacturing.

To date, the company has served over 200 global clients and supported 27 IND approvals globally. Among these are multiple first-in-class products, including:

• China's first in vivo CAR-T therapy to receive clinical trial approval
• The world's first mRNA-encoded TCR-T product targeting HBV
• The world's first CAR-T product targeting EpCAM to obtain IND approvals in both China and the US
• China’s first CAR-NK product targeting BCMA to receive clinical trial approval
• China’s first non-genetically modified allogeneic peripheral blood NK product approved by the FDA

Regulatory-Ready Quality System and Commercial Manufacturing Capabilities

Porton Advanced has established a full-lifecycle quality management system aligned with NMPA, FDA, and EMA standards, ensuring compliant and high-quality project delivery. In July 2026, Porton Advanced officially obtained the Class C Drug Manufacturing License, signifying its qualification for commercial contract manufacturing of CGT products. This milestone extends its capabilities from process development and clinical-stage manufacturing through commercial production.

The IND clearance of LianLi Zhongda’s LM101 injection, supported by Porton Advanced, further demonstrates the strength of the company’s end-to-end CDMO services. Moving forward, Porton Advanced will continue to provide global clients with integrated support from early-stage development through commercial manufacturing, helping more innovative therapies reach patients faster.

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, Investigator-initiated Clinical Trial Services (IITs), and Investigational New Drug (IND) applications to clinical trials, New Drug Applications (NDA), and 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., bacterial vector and nucleic acid therapies. Our state-of-the-art, GMP-compliant facilities span an impressive 215,000 sq ft, equipped with 10 viral vector GMP-compliant production lines, 12 cell therapy GMP-compliant production suites (2 for commercial products). As of now, we have successfully supported our clients to secure 26 global IND approvals from NMPA, FDA, and Medsafe, with 12 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 earlier access to good medicines.