Trinomab just announced that the Guangdong Provincial Drug Administration has issued the drug manufacturing license (A certificate) for its production facility after inspection of manufacturing process of pharmaceutical products on site. The pharmaceutical production license A certificate represents the holder of a drug marketing license for the manufactured pharmaceutical product(s).
A pharmaceutical manufacturing license is a necessary pre-condition for submitting new drug application (NDA). The license for Trinomab’s GMP drug substance (DS) and drug product (DP) production facility for manufacturing the scope of the drug products marks that a major milestone and a solid step toward the commercialization of the company's first global innovative drug, anti-tetanus toxin monoclonal antibody. It will enhance the company‘s capability and competitiveness in China as well as global markets in the research and development of innovative drugs, and accelerate the timeline of the company’s anti-tetanus toxin monoclonal antibody drug reaching to the clinics.
Trinomab has already built about 23,000㎡ GMP antibody production facility in the Zhuhai International Health Harbor with the capacity to meet the needs for pre-clinical and clinical- development as well as the commercial production of antibody products currently in the pipeline for next few years.
The production facility integrates new generation information technology and advanced intelligent manufacturing technology following vigorously the international quality management system in line with the specifications of NMPA in China, FDA in the United States and EMA in the European Union for manufacturing safe and high-quality new monoclonal antibody drugs.
Mr. Li Gang, General Manager of Production, said:
Obtaining the pharmaceutical production license is a key link in the commercial layout of Trinomab monoclonal antibody products, and is the pre-requirement for submitting NDA of the company's core product, the world's first anti-tetanus toxin monoclonal antibody (TNM002 injection). We will take this as a new starting point, promote and maintain the high standard compliance with the GMP guideline for each batch of the pharmaceutical products that has been manufactured, prepare the manufacturing registration materials for NDA of TNM002 injection, and strive to move the product to the market as quickly as possible in benefiting the patients in need.
Trinomab Biotech Co., Ltd. is a clinical stage biopharmaceutical company with a global expansion perspective. The company is mainly engaged in R&D of novel fully native human mAb drugs. The core technology of the company is known as the fourth-generation antibody technology HitmAb®, a proprietary technology platform featuring differentiated advantages and high efficiency for the discovery of fully native human mAbs.
With the mission of “Creating Clinical Value”, Trinomab has two products currently in clinical development phases. TNM001 injection (anti-RSV long half-life monoclonal antibody) is currently been in Phase I/IIb clinical trials and will soon enter the confirmatory phase II/III clinical trials this fall. TNM002 injection (anti-tetanus toxin monoclonal antibody) is in phase III clinical trials that has completed the enrollment of more than 600 subjects in April. NDA of TNM002 is expected to be filled in this fall. TNM005 Injection (anti-VZV monoclonal antibody) received IND approval from FDA. IND of TNM006 injection (anti-hCMV monoclonal antibody) and TNM009 injection (anti-NGF monoclonal antibody as a pain killer) has recently been approved for clinical trials in China by the National Medical Products Administration (NMPA) in April. Phase I trial of TNM009 will roll out in coming months. In addition, several more products are in preparation of IND filling with additional more antibody projects on the horizon.