Porton Advanced’s End-to-End Cell Therapy CDMO Service Accelerates NMPA Approval of Gene MiNK Biotechnology’s Innovative NK Therapy

December 11, 2025 – Porton Advanced proudly announces that its client, Gene MiNK Biotechnology, has received IND clearance from China’s NMPA for its QM101 Cell Injection, indicated for advanced solid tumors. This marks the second NMPA IND approval that Gene MiNK Biotechnology has secured for its cell therapy products this year. Just one week earlier, the company’s QM103 Cell Injection—a BCMA-targeted CAR-NK therapy—was approved by the NMPA for the treatment of relapsed/refractory multiple myeloma.

These milestones underscore Gene MiNK Biotechnology’s differentiated pipeline strategy and robust R&D capabilities in the cell therapy arena.

Key Features of QM101

QM101: A feeder-free, serum-free, autologous NK cell product for treating solid tumors, featuring high purity (>99%) and potent cytotoxicity, is dedicated to addressing limitations of existing therapies.
QM101 and QM 103 both leverage Gene MiNK Biotechnology’s proprietary NK cell platform, reflecting the company’s deep expertise in innovation.

Breakthrough CDMO Support from Porton Advanced

As Gene MiNK Biotechnology’s exclusive CDMO partner, Porton Advanced delivered full-integrated, GMP-compliant CMC services for QM101, spanning process development, GMP manufacturing, QC analytics and regulatory documentation preparation.

Porton Advanced’s feeder-dependent/feeder-free NK expansion platform has supported multiple client projects, including Gene MiNK Biotechnology’s pipelines. Leveraging its feeder-free expansion platform, Porton Advanced overcame technical hurdles to achieve large-scale, serum-free production of highly pure NK cells:

• Process Development: Achieved large-scale, serum-free NK cell production with 99% purity via optimized PBMC-derived NK cell expansion process.
• GMP Manufacturing: Scaled up NK cell amplification to meet clinical and commercial demands.
• Gryopreservation: Developed a stable freeze-thaw protocol preserving post-revival viability and cytotoxic activity.

QM101 demonstrates Gene MiNK Biotechnology’s fully integrated innovation—from early discovery to final product—and represents a major advance in solid tumor immunotherapy. Backed by Porton Advanced’s end-to-end CDMO services, this therapy is poised to enter clinical trials, bringing new hope to patients with advanced solid tumors and accelerating global access to cutting-edge cell therapies.

About Gene MiNK Biotechnology

Beijing Gene MiNK Biotechnology Co., Ltd. is an innovative biopharmaceutical company focused on the research and development of immune cell-based therapies. Founded in December 2021, the company has secured Seed, Angel, and Series A funding. The pipeline currently comprises six novel NK and CAR-NK cell-based therapeutic candidates. Notably, two candidates have received IND clearances from both China's National Medical Products Administration (NMPA/CDE) and the US Food and Drug Administration (FDA). These therapies are being developed for multiple high-need indications, including: Advanced-stage cancers: Leukemia, Lung Cancer, Ovarian Cancer, Breast Cancer, and Autoimmune diseases.

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 GMP-compliant production lines, 12 cell therapy GMP-compliant production suites and a multitude of clean rooms. As of now, we have successfully supported our clients to secure 23 global IND approvals from NMPA, FDA, and Medsafe, with 9 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.