Congratulations to Avatar's partner Livzon Pharmaceuticals for its approval of the emergency authorization for marketing use

Recently, Livzon Pharmaceutical Group (Livzon) announced that its holding subsidiary, Zhuhai Livzonumab Biotechnology Co.
, Ltd.
, in cooperation with the Institute of Biophysics of the Chinese Academy of Sciences, developed a recombinant coronavirus fusion protein vaccine (V-01) that has been included in the virus epidemic prevention sequence for emergency use
by the Food and Drug Administration.
V-01 is an innovative vaccine with independent intellectual property rights independently developed by Zhuhai Livzon Bund Biotechnology Co.
, Ltd.
, a holding subsidiary of Livzon Pharmaceutical Group, and the Institute of Biophysics of the Chinese Academy of Sciences, and belongs to the recombinant protein vaccine route among the five technical routes
of national vaccines.
The V-01 R&D project was launched in July 2020, approved clinically in January 2021, completed Phase I and Phase II clinical research reports in June 2021, and completed Phase III clinical summary reports and submitted conditional listing declarations
in February 2022.
It is worth noting that as a supplier of pharmaceutical excipients, Aiweituo (Shanghai) Pharmaceutical Technology Co.
, Ltd.
has continued to supply the required injection-grade pharmaceutical excipients as a partner in the research and development and production process of Lizumab V-01 vaccine
.
Biologics have stricter quality requirements for the quality of pharmaceutical excipients
.
Protein preparations such as recombinant protein vaccines, for example, are particularly sensitive to conductive impurities such as metal ions in excipients, because metal ions can form insoluble salts with free carboxyl groups in proteins, resulting in protein denaturation
.
For mRNA vaccines and other nucleic acid preparations, the RNA enzyme / DNA enzyme residue of pharmaceutical excipients is an indicator that needs to be paid attention to, if the excipients used do not strictly control and detect the relevant indicators, it is very easy to lead to the degradation of mRNA and other nucleic acid active ingredients, which in turn affects the stability and safety
of the final preparation.
In addition, for all injectable preparations, their exogenous impurities and microorganisms are safety indicators
that require strict supervision.
As a company that has been focusing on pharmaceutical excipients for 15 years, from the research and development of V-01 vaccine to clinical trials to the final conditional listing, ARVITUO continues to provide its partner Livzon Group with domestic injection-grade pharmaceutical excipients that meet mainstream pharmacopoeia standards such as USP, EP and ChP, and have perfect regulatory support (with CDE registration number and DMF number), while actively cooperating with relevant audits and reviews, and cooperating with the completion of overseas clinical application required information supplementation and other actions at the first time.
Ensure the progress of
customer projects.
In addition, in the field of vaccines, ARVTTO nucleic acid delivery product line (phospholipids, sugars, buffer salts) also has many partners, especially at present, it has supported 8 mRNA vaccine projects to enter the clinical stage at home or abroad, issued more than 100 copies of authorization for the use of nucleic acid delivery related excipients, and established good cooperative relations
with 98% of industry-related enterprises.
Aviton will continue to provide pharmaceutical excipients with international standards for the majority of biomedical enterprises, and give full play to the advantages of high cost performance, fast supply speed and safe and stable supply chain, and contribute to the
development of China's biologics field 。 Avitor long-term and stable supply of injectable grade trehalose, sucrose, TRIS/TRIS-HCl, HEPES and other bioprotective agents and buffer salts, GMP condition production, Sino-US double report, for injection, ultra-low endotoxin, DNase & RNase free, in line with international mainstream pharmacopoeia standards, to help recombinant protein vaccines, mRNA vaccines, adenovirus vector vaccines, liposomes, single and double antibodies, antibody conjugated drugs and other biological agents production and foreign declaration!