On March 5th, Nanolattix Group announced that its T320-ADC drug received clinical trial approvals from China’s NMPA, the US FDA, and Australia’s TGA, marking its entry into global development. Medicilon as the partner of Nanolattix Group provided preclinical services, including efficacy, pharmacokinetics, and safety evaluation, supporting this milestone in ADC drug development.
A Novel, Highly Differentiated ADC Drug
T320 Targets Malignant Solid Tumors
T320, as a novel and highly differentiated ADC drug, is designed to treat pancreatic, cervical, lung, and colorectal cancers. Preclinical data shows:
- High Efficacy: 92.3% tumor suppression in pancreatic cancer models, outperforming existing drugs.
- Safety Validation: Demonstrated potent anti-tumor activity with favorable safety.
- Global Recognition: Received FDA Orphan Drug Designation for pancreatic cancer in May 2024.
Medicilon’s ADC Drug Development Platform
Empowering 28+ ADC Drugs to Clinical Approval
The approval of Nanolattix Group’s T320 in China, the US, and Australia not only highlights Nanolattix Group’s capabilities in the ADC field but also underscores the successful collaboration between Nanolattix Group and Medicilon.
Medicilon’s expertise in ADC R&D includes:
- One-Stop Preclinical Development: Offering services including ADC Payloads synthesis, ADC conjugation, pharmacodynamic evaluation, pharmacokinetic assessment, and safety evaluation, enabling the journey from molecular design to IND submission.
- 440+ Tumor Models: Including 118+ PDX models, syngeneic tumor models, xenograft tumor models, and humanized tumor models.
- 28+ ADC Projects Supported: By the end of 2024, Medicilon has successfully supported about 28 ADC drugs in obtaining clinical approval, with over 20 ADC projects in development.
- Global Regulatory Support: Medicilon’s 29,000㎡ GLP laboratory complies with the standards of the US FDA, Australian TGA, and EU EMEA, having supported about 520 IND approvals for clinical trials.
Medicilon congratulates Nanolattix Group on this achievement, Medicilon will continue to deepen its expertise in novel drug R&D and fully support global partners in exploring and breaking new ground in the field of novel drug development.