Editor's note:
Labor writes the chapter of the times, and strives to create a better future.
On the occasion of the annual "May Day" International Labor Day, another group of workers in Hebei Province won the National May Day Labor Award and Medal, the National Worker Pioneer, Hebei Province Model Worker, Advanced Worker and Advanced Collective and other honors.
From now on, Hebei Daily will launch a series of reports on "Song of Workers" to tell the stories of their struggle and dreams, so as to inspire more workers, especially the young generation, to take the road of becoming skilled and serving the country with skills.
Accelerate the production line of innovative drugs
-- National Worker Pioneer, Shijiazhuang Research Institute of CSPC Pharmaceutical Group Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd
On April 25, in the high-performance liquid chromatography laboratory, R&D personnel conducted business discussions. Photo by Hebei Daily reporter Ma Yanming
The Shijiazhuang Research Institute of CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. is a R&D team composed of graduates from well-known universities, with an average age of 34 years old and more than 70% of the team members having master's and doctoral degrees. The projects they undertake have won the National Science and Technology Progress Award, the China Patent Gold Award, the China Industry Award and other awards. This year, the team was named the National Worker Pioneer.
Zhongqi Pharmaceutical Shijiazhuang Research Institute has been continuously advancing with innovation as a signpost, and has promoted the industrialization of a large number of innovative technologies and drugs. Thanks to their efforts, more innovative drugs are moving from the laboratory to the production line.
Strengthen biomedical innovation and R&D, and put a nano "coat" on drug molecules
When a person is sick, common treatment methods include taking medicine, injections and infusions, and external application. However, after the drug enters the human body, the effective drug molecule must reach the accurate therapeutic target at the right time, in the right way, and stay for the right time to better exert the efficacy, and it is not smooth sailing to achieve this.
Drug delivery technology is a technical system that comprehensively regulates the distribution of drugs in living organisms in terms of space, time and dose. At present, in addition to classic small molecules, drug forms also include peptides, proteins, polysaccharides, nucleic acids and other forms, and the development of drugs continues to pose new challenges to drug delivery technology. For this reason, drug delivery technology is considered the "last mile" of drug development.
"One of the core tasks of our R&D team is to develop nano preparation technology for drug loading, drug release and large-scale preparation, to solve the problem that such preparations cannot be scaled up, and to promote the continuous marketing of such drugs. Recently, Liang Min, president of Zhongqi Pharmaceutical Shijiazhuang Research Institute, said.
In 2004, CSPC Pharmaceutical Group officially entered the field of nano-preparation technology, including liposomes, and began to build a nano-preparation technology platform. According to Liang Min, liposomes are lipid molecules or lipid self-assemblies, which are generally composed of one or several lipid bilayers and are between 20 and 1000 nanometers in size. In modern pharmaceutical technology, liposomes become a versatile drug delivery material that can deliver small molecules, proteins, and nucleic acids. "It is equivalent to putting on a nano 'coat' for drug molecules, so that they can reach the correct position and complete the release as expected, increase the utilization efficiency of drug molecules, improve the efficacy, and reduce toxic side effects. ”
From the initial 4 R&D personnel to more than 100 now, the R&D team of nano preparations of Shijiazhuang Research Institute of Zhongqi Pharmaceutical has been growing. The nano preparation R&D team currently has more than 30 varieties under development, and 6 products are the first to be listed or passed the review in China. Among them, the mitoxantrone hydrochloride liposome injection, which was approved for marketing in 2022, is the world's first marketed mitoxantrone liposome, breaking the situation that no innovative drugs have been launched in the field of liposomal drug research and development in mainland China for many years.
In recent years, the application and development of liposome technology has entered the fast lane, which has greatly improved the research and development efficiency of innovative drugs. The "14th Five-Year Plan for the Development of the Pharmaceutical Industry" jointly issued by the Ministry of Industry and Information Technology and other nine departments proposes that in terms of biopharmaceutical technology, new delivery methods and new delivery technologies for biological drugs should be developed to better meet the health needs of the public.
Liposomal preparations are difficult to produce and have a long R&D cycle, and European and American pharmaceutical companies initially took the lead in this field. With the efforts of Shijiazhuang Research Institute of Zhongqi Pharmaceutical, CSPC Pharmaceutical Group's liposomal formulation technology has been in a leading position in the world, and has realized the licensing of liposomal formulation technology to European and American pharmaceutical companies for the first time in mainland China. "In recent years, our 4 products, including doxorubicin hydrochloride liposome injection, have been licensed to European and American pharmaceutical companies for 5 times. Liang Min said proudly.
Crossing the "valley of death" to promote the industrialization of innovative technologies and drugs
In recent years, the development of innovative drugs by many pharmaceutical companies in mainland China has the phenomenon of "hot R&D, difficult transformation, and slow industrialization". In reality, a large number of innovative achievements are either submerged in the first "valley of death" from basic research to commercialization, or in the second "valley of death" from productization to scale, and the road to industrialization is long and obstructive.
Wang Yajuan, vice president of Zhongqi Pharmaceutical Shijiazhuang Research Institute, said that industrialization is difficult, not only due to factors such as the disconnection between basic research and clinical practice, the mismatch between scientific research results and market demand, but also the weak links in the industrial chain and the lack of relevant supporting equipment. "From small-scale laboratory to large-scale commercial production, there is too much work to be done step by step. Wang Yajuan introduced that while strengthening the research and development of innovative drugs, Zhongqi Pharmaceutical Shijiazhuang Research Institute pays attention to technical research on the weak links of the industrial chain, and jointly carries out joint innovation of supporting equipment with equipment manufacturers, which promotes the industrialization of innovative achievements.
In 2021, as an important part of CSPC's new crown mRNA vaccine team, Zhongqi Pharmaceutical Shijiazhuang Research Institute carried out the process development and manufacturing of lipid nanoparticles. Through the unremitting efforts of the R&D team, CSPC Pharmaceutical Group has established a new nucleic acid lipid nanoparticle drug delivery technology platform for the first time, and built a series of production lines from R&D to commercialization. "By cooperating with the manufacturing team, we completed the process exploration from pilot test to large-scale preparation in half a month, expanded the batch by 15 times, and subsequently completed the process verification of the commercial batch. Wang Yajuan said that this will provide technical and equipment support for the development of a variety of human mRNA vaccines and veterinary mRNA vaccines such as respiratory syncytial virus vaccine by CSPC Pharmaceutical Group in the future.
In the process of promoting the industrialization of innovative drugs, high-end excipients often become a "bottleneck" problem. For some high-end accessories, the price of 1 gram has reached 100,000 yuan, and foreign suppliers cannot guarantee the supply.
In view of the weak links of high-end excipients in the industrial chain, Zhongqi Pharmaceutical Shijiazhuang Research Institute continues to carry out technical research, and currently has nearly 20 high-end excipient projects under research, of which 10 are the first and exclusively developed in China, which solves the problem of "stuck neck" of high-end excipients, greatly reduces costs, and improves the accessibility of drugs.
The industrialization of R&D results means benefits for enterprises and more choices for patients. After the liposome injection of doxorubicin hydrochloride developed by Shijiazhuang Research Institute of Zhongqi Pharmaceutical was launched, the price was reduced by half compared with that of foreign imported products.
In addition to innovative drugs, Zhongqi Pharmaceutical Shijiazhuang Research Institute has also strengthened innovative research and development in the field of high-end generic drugs with unique clinical advantages and high technical barriers, applied new preparation technologies, and promoted drug industrialization. Wang Yue, vice president of the research institute, said that the production of high-quality generic drugs is no less than the production of an innovative drug, and pharmaceutical companies need to meet high standards in R&D, production and other links.
According to Wang Yue, Zhongqi Pharmaceutical Shijiazhuang Research Institute focuses on new preparation technologies such as osmotic pump controlled-release system and peptide oral delivery, and has obtained 89 production approvals, of which 12 varieties are the first in China to pass the consistency evaluation, 13 are new preparation technologies such as sustained and controlled release, and 33 varieties have entered the national centralized procurement, ranking among the top in the country. (Hebei Daily reporter Ma Yanming)
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