New drug development involves high investment, long cycle, low success rate and strict supervision. The competitiveness of CRO enterprises is to help pharmaceutical companies make hard things simple in this process, and meet a series of demands such as reducing R&D costs, shortening R&D time, improving R&D quality and lowering R&D risks.

 

Shinesta Medicine (Chengdu) Co., Ltd. is conducting two categories of business. The first category is clinical R&D consulting service. It has provided professional consulting for multiple pharmaceutical enterprises. The other category is clinical R&D operation management service. At present, an injection dose exploration and consistency evaluation project has been completed and the project has successfully passed the clinical field verification. Besides, some new cooperation projects are under negotiation.

 

 

       As a start-up clinical CRO enterprise headquartered in Chengdu, Sichuan Province, Shinesta Medicine currently focuses on providing operation management services on innovative drug R&D strategy formulation, medical design, China-US double application, innovative drug FIH/phase I clinical trial and generic drug consistency evaluation.

 

       Zhu Xi, the person in charge of clinical operation of Shinesta Medicine, introduced that clinical CRO, as a technical service-oriented enterprise, not only provides human services, but also lays its emphasis on the technical services closely interacting with sponsors. It can be said that clinical CRO is a pharmaceutical service sub-industry with relatively high threshold. For a clinical CRO enterprise, the occupational experience, knowledge reserve and project focus of its CRO team in the field of clinical R&D are all core competencies. Especially in the early clinical development stage of innovative drugs, the scientific basis and the fineness degree of implementation of R&D strategy and medical design play a vital role in the final results.

 

       Nowadays, with the long-term development of domestic CRO industry, the services provided by CRO companies are becoming more and more elaborate. Zhu Xi said that as far as clinical CRO is concerned, the division of work among CRO enterprises has become more and more specified from the strategy formulation and medical design at the top level, to the clinical trial operation, research center cooperation, data management and statistical analysis at the implementation level, as well as the registration and application associated with policies and regulations. As you see, the services in CRO segments are becoming more and more professional, and after the segmentation of complex processes, the difficulty in advancing the whole clinical trials is reduced, and the efficiency of clinical R&D is further improved.

 

 

      At present, CRO participation can be seen in the clinical R&D of most drugs, but there are differences in the satisfaction of CRO services from sponsors. Clinical CROs with strong professional ability and high service awareness will be more favored by sponsors.

 

       Zhu Xi said that Shinesta Medicine received its first phase I clinical trial project entrusted by the sponsor in early 2020. With the close cooperation between Shinesta Medicine and the sponsor plus the high support and cooperation of the research center, the project took only 9 months from the initial bidding to the final results transfer, and moreover, successfully passed the clinical on-site verification arranged by NMPA.

 

       Zhu Xi said with emotion that, no matter in the early-stage strategy formulation and implementation or in the later-stage clinical on-site verification, Shinesta Medicine's team did their best to coordinate and support the work, and finally the topic was successfully concluded. The success of the first project was fully in line with the expectations.

 

       In addition, although Shinesta Medicine is headquartered in Chengdu, when selecting the research center, it will not be limited by the geographical location of hospitals. In addition to the abundant research center resources of Shinesta Medicine itself, more importantly, it gives appropriate suggestions and opinions from the perspective and needs of sponsors and implements as per the optimal scheme.

 

 

       As the most challenging part of the drug R&D process, clinical R&D strategy formulation directly determines the general direction of the whole R&D process. Therefore, it is very important for a CRO team to have domestic and even global senior experts.

 

       In 2019, Shinesta Medicine was founded by Wu Yonggang and Liu Heyi at the invitation and support of the Management Committee of Chengdu High-tech Zone.

 

 

       Dr. Wu Yonggang, a Grade-77 student graduated from West China University of Medical Sciences majoring in clinical medicine, has worked as a clinician in China, then completed his postdoctoral research in the Indiana University School of Medicine and his master's degree in applied statistics of Purdue University. Before returning China, Dr. Wu Yonggang engaged in medical statistics related work in several CRO enterprises in the United States. After returning home, he has successively served as medical director and statistical director in leading enterprises such as Tigermed Consulting Ltd and Hengrui Pharma.

 

 

       Another founder, Ms. Liu Heyi, also graduated from the School of Pharmacy, West China University of Medical Sciences, with a master's degree in pharmacology and toxicology from the University of British Columbia (UBC), Canada. She has successively engaged in drug analysis and research, pharmacokinetics in vivo drug analysis in West China, Canadian Lilly, American Squibb and Amgen China. She is an expert in CMC and GMP.

 

       All the milestone achievements made by Shinesta Medicine so far are inseparable from the steering of the two senior experts in the industry.

 

       Before joining Shinesta Medicine, Zhu Xi had been engaged in clinical operation and management in Hengrui Pharma for more than 10 years. He said that Hengrui Pharma is the leader of domestic innovative drug R&D in China, and he is very lucky to learn and grow on such a platform and accumulate rich experience in the whole process of drug clinical R&D.

 

 

       For the moment, as a small and sophisticated team of Shinesta Medicine, it has high requirements for personnel quality and ability. It is composed of professionals with rich professional experience, covering several links of promoting step-by-step clinical trials.

 

       So far, the team of Shinesta Medicine has successfully passed the running-in period and has successfully completed the complete the complete process of phase I clinical research project.

 

       In the future, Shinesta Medicine, as a CRO enterprise, aims to build a seamless link platform for clinical R&D to provide professional and efficient services according to customer needs.

 

        However, for the present stage, Shinesta Medicine will continue to give full play to its own characteristics and advantages, go ahead steadily in the subdivision fields, and deeply integrate as soon as possible into the key links in the drug development and innovation chain.

 

 

       Firstly, the vigorous development of Chengdu's pharmaceutical industry has attracted Shinesta Medicine to settle here. Before the establishment of Shinesta Medicine, Tianfu Life Science Park had reserved office space for it in the park, and the establishment of the company was also supported by the government and the park in policies. Zhu Xi expressed his great gratitude and said that clinical CRO enterprises are all full of confidence in the rapid development in Chengdu.

 

 

       In recent years, a number of large-scale pharmaceutical enterprises have developed rapidly inside and outside the park, and many innovative biomedical R&D teams have emerged. The pace of industrial development is getting faster and faster. The reason why Shinesta Medicine is incubating here is that it sees the explosive growth demand for clinical R&D in the future. It hopes to be based in Chengdu, match these needs as much as possible, and help further improve the biomedical industry ecosystem in Chengdu.

 

       Secondly, for the development of the enterprise itself, Chengdu is rich in medical education resources. In addition to West China University of Medical Sciences, Chengdu University of TCM, Chengdu Medical College, etc. all continuously supply potential talents for the team construction of CRO enterprises, and provide guarantee for the reserve of professional personnel.

 

       Finally, the livable living environment in Chengdu also attracts more and more coastal and overseas talents to gather here for innovation and entrepreneurship, which promotes the high-end development of Chengdu's biomedical industry and accelerates the pace of Chengdu's internationalization.

 

       In the future, Shinesta Medicine will further expand the CRO services in China-US double application and phase II-IV clinical trials. As an important part of Chengdu's new drug R&D industry chain and innovation chain, Shinesta Medicine will provide customers with the best solutions, provide different types of new drug R&D customers with high-quality pre-clinical - clinical - registration application "one-stop" services, and give full play to the function of industrial supporting services.

 

 

       Shinesta Medicine (Chengdu) Co., Ltd. was established in Chengdu in June 2019 at the invitation and with the strong support of the Management Committee of Chengdu High-tech Zone. Its founders are all domestic authorities and experts in the field of innovative drug R&D. The company is positioned to provide CRO services on innovative drug R&D strategy formulation, China-US double application, innovative drug FIH/phase I trials, phase II-IV clinical trials.

 

       The development goal of the company is to keep a foothold in Chengdu & face the world, and become an international leader in clinical CRO.