On March 2nd, it was announced on the website of State Drug Administration Drug Evaluation Center that the polymer prefillable syringe components evaluated by Shandong Ujoin Medical Technology Co., Ltd. and Qidu Pharmaceutical Co., Ltd. was successfully approved as "Active". This is the first time that similar products in China have passed the related review.
Prefillable syringe is called the third generation syringe. As a new medicine and equipment integrated product, it integrates the two functions of drug storage and clinical use. It is an important packaging form and carrier for vaccines, biological agents and high-end pharmaceutical products. It has been adopted by more and more pharmaceutical enterprises, and shows a trend of gradually replacing ordinary syringes.
The world's first prefillable syringe was born in BD Company of America in 1984. In 2019, the global market for prefillable syringes reached 4.6 billion US dollars, with the fastest growth among all kinds of pharmaceutical packaging containers. At present, the prefillable syringes in the market are made of glass and polymer materials, and the prefillable syringes made of polymer materials have the advantages of high biological safety, good drug compatibility, strong sealing performance, accurate dose, high transparency, less protein adsorption, etc.
Ujoin Technology actively conforms to the new situation of "accelerating the upgrading of packaging system products in the field of packaging materials" in the national "Thirteenth Five-Year Plan". Since 2017, it has started the research and development of new polymer material prefillable syringes, and jointly established a research and development team of prefillable project with Qidu Pharmaceutical Research Institute. After four years of hard work, the R&D team solicited experts' opinions, deeply studied the Requirements for Consistency Evaluation of Quality and Efficacy of Generic Drugs for Chemical Injections and other related policies, demonstrated and designed the product structure, equipment mold and raw material formula, and conducted in-depth and systematic research on intellectual property rights, quality standards, process verification, compatibility and stability inspection, and successfully broke through technical barriers such as body tightness, syringe residue, sliding property, silicone oil content and uniformity. The performance is equal to or better than that of similar products in the international market, replacing imports and filling domestic gaps. It is listed as a key support project for the central government to guide the transfer and transformation of scientific and technological achievements of local scientific and technological development funds.
Polymer prefillable syringes of Ujoin Technology are the first in China to pass the related approval, which indicates that the research on material formula, process parameters and quality standards, stability and safety, and related policy research and application of the company's polymer prefillable syringes have reached the advanced level in the same industry in China. At present, Ujoin Technology has introduced international advanced equipment and digital control system, built production workshops with high standards, and already has the conditions for large-scale industrial production. Ujoin Technology will seize the important market opportunity of upgrading packaging materials driven by the consistency evaluation of injections and the surge in the use of prefillable syringes by COVID-19 vaccines, accelerate the realization of the goal of "large-scale, export-oriented and high-quality development", and accelerate the construction of an international research and production base for new medical packaging materials.