Gene MiNK Biotechnology’s Innovative BCMA-targeted CAR-NK Therapy Secures NMPA IND Approval, Accelerated by Porton Advanced’s Comprehensive End-to-End Cell Therapy CDMO Service

December 2, 2025 –Porton Advanced is delighted to congratulate its client, Gene MiNK Biotechnology, has received IND clearance from China’s NMPA for its QM103 Cell Injection—the first BCMA-targeted CAR-NK therapy in China approved for clinical studies, indicated for relapsed/refractory multiple myeloma (RRMM).

RRMM—one of the three most lethal hematological malignancies—offers patients few options after multiple lines of therapy. QM103’s IND clearance not only pioneers a novel therapeutic approach but also establishes Gene MiNK Biotechnology as a global leader in universal cell therapy.

Gene MiNK Biotechnology's Groundbreaking CAR-NK Platform Shatters Industry Barriers

To date, the global market has yet to witness the official approval of any CAR-NK product, with the majority of candidates languishing in the preclinical phase. This stagnation is largely attributable to three formidable challenges: the inadequate expansion of NK cells, their suboptimal purity, and the inefficient transduction processes. Against this backdrop, Gene MiNK Biotechnology has emerged as a trailblazer, leveraging its proprietary platform to surmount these seemingly insurmountable obstacles:

• Cell Expansion: Our unparalleled serum- and feeder-free cell cultivation platform propels NK cell expansion by an astounding factor of 10,000, all the while preserving a remarkable purity exceeding 98%. This represents a quantum leap in the field, setting a new gold standard for NK cell expansion.
• Transduction: Our proprietary pseudoviral vector has revolutionized the industry by achieving CAR positivity rates that soar above 90%. This unprecedented benchmark, unmatched in any published literature, underscores our platform's unparalleled efficiency. With multiple patents filed and trademarks registered, we stand as a beacon of innovation, unencumbered by intellectual property constraints and fully empowered to forge ahead.

QM103, the inaugural therapeutic candidate birthed from this integrated platform, has recently secured its IND clearance. This milestone not only marks a significant validation of Gene MiNK Biotechnology's trailblazing capabilities but also heralds a new era of promise in the treatment of multiple myeloma.

Porton Advanced Accelerates Gene MiNK Biotechnology’s IND CMC Development 

As Gene MiNK Biotechnology’s CDMO partner, Porton Advanced provided end-to-end support—from plasmids and lentiviral vectors to CAR-NK manufacturing—completing all deliveries in just 10 months. All batches successfully delivered on the first attempt and regulatory documentation passed CDE review without any requests for supplementary information, maintaining Porton's zero-deficiency record. This further demonstrates the robust capabilities of Porton Advanced’s integrated cell therapy CDMO platform.

• Plasmids: Delivered the plasmid within one month, starting from the clone screening and microbial banking.
• Lentiviral vectors: Delivered GMP batches using our LV-SMART lentiviral suspension platform, completed in under 2 months with yields exceeding 3.5 × 10^11 TU.
• CAR-NK cells: Optimized project management and seamless teamwork enabled overlapping GMP batch manufacturing and delivered —5 GMP batches in 2 months, which maintains high CAR positivity and strong cytotoxicity with reduced time-related cost by 46%.

We take great pride in our team's exceptional collaboration and execution excellence—this achievement stands as further validation of Porton Advanced's industry-leading cell therapy CDMO platform.

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 22 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.