A new nanodrug development company - MegaPro Biomedical Co., Ltd. (hereinafter referred to as "MegaPro", Taiwan OTC Stock Code: 6827) announced today that the company's independently developed new drug MPB-2043, an MRI contrast agent for lymph node staging in patients with head and neck squamous cell carcinoma, has completed the admission of the first domestic patient at National Taiwan University Hospital and is currently undergoing an Investigator-Intiated Trial (IIT).  It is expected that clinical admissions of the IIT can be completed within the first six months of next year.

MegaPro's nanoparticle technology platform has developed MPB-2043, a new imaging agent.  This new application is mainly based on the fact that MPB-2043 can be differentially phagocytosed by immune cells, producing high-contrast MRI images for doctors to determine lymph nodes and whether it is metastasized by tumor cells, thereby assisting doctors to more accurately stage cancer cases and formulate correct treatment strategies for patients.  This IIT trial is expected to obtain the effectiveness and safety of lymph node staging in patients with head and neck cancer.  Since MPB-2043 is also part of a nanoparticle technology platform, relevant clinical phase 1 data can be shared with it, and IIT data will be used to apply for clinical phase II trials to regulatory authorities.

Assessing whether lymph nodes have been metastasized by malignant tumors has been an important unmet medical need.  According to statistics from The Global Cancer Observatory (GCO) in 2022, it is currently highly required to determine whether lymph nodes have metastasized for cancers such as breast cancer, lung cancer, prostate cancer, gastric cancer, colorectal cancer and head/neck cancer to formulate medical strategies.  Currently, the number of new cases of the aforementioned cancers is about 9 million per year, and the number of 5-year survivors exceeds 23 million.  The total number of people who would need to use this drug worldwide would exceed 32 million annually.

Global regulations have regarded imaging agents as new drugs and are required to conform to the process of new drug development.  In the past, MegaPro has used its nanoparticle technology platform to develop the MPB-1523 MRI Imaging Agent - Hepatocellular Carcinoma.  This product is currently preparing for questions raised by the US FDA, and it is expected that a phase 3 clinical trial application will be submitted after completion. In addition, the MPB-2043 MRI Imaging Agent - Lymph Node belongs to the nanoparticle technology platform as well.  In the future, the development experience and certain data of the MPB-1523 will be used to accelerate clinical trials and drug license applications.