On January 23, the medical network itself, the special nature of bio-therapeutic drugs, coupled with the continuous development of the national innovative pharmaceutical industry policy, has gradually made bio-therapeutic products a hotspot for enterprise innovation and product development.
For example, the new and recent open source major asset restructuring plan, the proposed price of 1.7 billion yuan to purchase shares of new open source organisms 83.74% equity to achieve wholly-owned holdings. The main asset of the new open source bio is the 100% stake in BioVision USA. The new open source plan will introduce BioVision's biotherapeutic technology.
Biotherapy innovation speeds up
Academician Wei Yuquan, director of the Center for Clinical Oncology and Biotherapeutics of West China Hospital, recently held the "2017 China Translational Medicine Summit Forum and Guangdong Translational Medicine Annual Meeting". It is expected that there will be more anti-tumor drugs such as CAR-T and ADC drugs in recent years. Biotherapeutic products are approved for marketing and annual sales are expected to exceed many tumor antibody drugs. “At present, there are more than 900 new drugs in the United States at different stages of research and development, of which about 1/4 are biological products, indicating that bio-therapy is still a research and development hot spot; research and development of bio-therapeutic products is also the focus of innovation for Chinese pharmaceutical companies , national policy and supervision. Give strong support."
Biotherapeutic product development and technological innovation is a typical translational medical research model through disease genome, proteome, knockout mice, Zebrafish, signaling pathways, synthetic biology, structural biology, development and genetics, major diseases Frontier biotechnology and basic research, such as molecular mechanism research and immunology, are transformed into biotherapeutic programs or preparations such as vaccines, antibodies, recombinant proteins, stem cells and tissue engineering, nanobiotechnology and targeted therapy technologies.
In fact, the door to the development and transformation of biotherapeutic products has been opened, and the “Guidelines for the Examination and Approval of the Registration of Biological Products for Treatment (Trial)â€, which the parties are looking forward to, will be officially issued on December 1, 2017, followed by the CAR submitted by Nanjing Legend Bio. The clinical application of the -T therapy was quickly accepted by the CFDA Drug Evaluation Center, which caused widespread concern.
Wei Yuquan said frankly that CAR-T cell therapy is a key focus area for biotherapy, and the new policy requires that CAR-T cell therapy must be promoted in accordance with the development model of a class of innovative drugs. "Before doing a CAR-T for two or three years, now the various technology platforms are mature, and one can be made in two or three months. Domestic targets for CD19, EpCAM, VEGFR-1, Frα, CD30, CD33, MUC, etc. CAR-T technology is in the process of transformation at different stages, and the new policy will bring capital and industry cooperation closer together."
In this regard, Academician Zhong Nanshan, director of the National Center for Clinical Medical Research of Respiratory Diseases, called for the innovation and transformation of China's pharmaceutical industry to meet the needs of the times, to build a platform for rapid transformation between basic and clinical applications, to connect upstream and downstream industries, and to create a complete investment in biomedical industry. The value chain realizes the integration and sharing of resources and comprehensively promotes the transformation of medical achievements and industrialization.
Biotherapeutics has obvious basic and clinical integration, interdisciplinary, cutting-edge and major needs. Whether it is cell products or genetic technology, the basis of innovative bio-therapy transformation must be designed through genetic sequencing, in the process of implementing accurate medical solutions. In large, it requires a large number of cell and molecular level detection; at the same time, drug development requires more knowledge from various disciplines, especially at the molecular level, to find new targets and develop new ideas.
　　 Accurate clinical value of "drug + diagnosis"
With the development of genome sequencing technology and the cross-application of bioinformatics and big data science, new medical concepts and medical models are developed through large-sample populations and specific disease types through genomics, proteomics and other omics technologies and cutting-edge technologies. The analysis, identification, validation and application of biomarkers to pinpoint the cause of disease and therapeutic targets.
Genomics brings new opportunities for tumor immunotherapy, cell therapy and gene therapy. For example, high-throughput second-generation sequencing is used to analyze the mutation sites of tumor cells by whole exon sequencing, and candidate mutant polypeptides or cells can be applied to individualized treatment of tumors.
Yan Guangmei, a professor at Sun Yat-Sen University School of Medicine, used the oncolytic virus as an example. Early anti-tumor therapy research was subject to genetic testing and transformation techniques. The oncolytic virus was found to be highly pathogenic and limited in effectiveness. "The genetic modification of human herpesvirus (HSV) was first achieved in 1988; in 1991, researchers used genetic engineering to remove the thymidine kinase gene, so that HSV with reduced neurotoxicity can be used to effectively inhibit ID gel in nude mice. Tumor production; in October 2015, the US FDA approved the listing of T-VEC."
It can be seen that the content of the molecular diagnostic test must be clearly related to the clinical value of the drug, in order to truly play the role of precision treatment. As an important branch of precision medicine, Companion Diagnostics (CDx) is critical for predicting a patient's response to a particular drug.
Concomitant diagnosis guides the development of a treatment plan by detecting the efficacy and safety of a particular drug in a specific patient. The ideal "drug + diagnosis" co-development program should be to jointly develop a companion diagnosis in the early stages of drug development and to be marketed at the same time. Currently, most of the companion diagnostic products are developed using a model developed in conjunction with drugs.
In addition, it is necessary to actively collaborate based on two product R&D project teams, including even close cooperation and communication between all relevant departments of the regulatory system. In the case of a drug/biological product from preclinical studies to NDA/BLA (new drug marketing approval/bioproduct licensing application), the corresponding in vitro diagnostic tests also need to be performed simultaneously, for pre-clinical studies (Pre-IND) The accompanying diagnostic products developed at the end of Phase I clinical trial (EOP1) and Phase II clinical trial (EOP2) should also be submitted for clinical trial reporting (IDE).
Hongxing Factory
Dongying Hongxing is located at Dongying City, Shandong Province China since 1995.
We have 30 categories of products, including Covid-19 products, frock, protection shoes, safety belt, Special gloves.
Our main customer in China is Sinopec, Petro China, Energy company, steel company and Tabacco Company in other countires. Our factory have 500workers and 22 technical employees and invest thirty eight million dollars .
FAQ
1. What are your main products ?- Safety shoes
- Protective helmet
- Work clothes
- Safety cloves
- Protective equipment and masks
2. Can you offer OEM ?
Our company accep OEM service , if you need, please inform us of your specific requirements
3. What's your mode of transportation ?
By sea, By air, By train, By truck, as your request. We also do a good job to deliver goods to your destination.
4. What's your payment terms ?
T/T, L/C, Paypal..... If you need to pay via other ways, please negotiate with us.
5. Can you offer sample ?
Yes, we can offer samples to help you check type and quality.
6. Are you manufacturer or trader ?
We have own factory in Donying city, Shandong province, welcom to visit our factory !
Fire Suit,Oil Field Coverall,Petroleum Workwear Clothing,Acid And Alkali Resistant Suit
Dongying Hong Xing Labor Protection Products Co.,Ltd. , https://www.hongxinglabor.com