China’s innovative pharmaceutical industry ushered in a golden age thanks to the sustained and aggressive growth of the globe drug industry, as well as opportunities created by reforming the review and approval system, centralized drug procurement in “4+7 Cities”, joining the ICH, releasing new Drug Administration Law and various other key factors. All companies within the industry; from pharma companies, R&D and production institutions or clinical trial institutions, are all faced with challenges associated with developing new drugs to meet medical needs, realizing market value, and launching them worldwide.
What can we do in the face of opportunities and challenges?
With the support of the Tianjin municipal government, Asymchem initiated the establishment of the Tianjin Technology Innovation Center for Clinical Research (TICCR) in 2019. TICCR was established to integrate industry resources designed to accelerate the marketing of new drugs. Asymchem is always seeking strategic collaboration to accelerate China’s medical innovation.
Innovative and complementary cooperation is imperative to embrace advances in the healthcare industry. In response to this, Asymchem Laboratories Co., Ltd. (SHE 002821. SZ; “Asymchem”) and TEDA International Cardiovascular Hospital (“TICH”) jointly established the TICCR Binhai Center. Through successful combination of market-oriented operation and the research strength of the public hospital, the collaboration not only provides a large advantage in clinical research for Tianjin and China, but also helps bring additional new drugs to market benefiting more patients. This is not only a breakthrough in the field of clinical research in China, but also a milestone in the history of Chinese medical innovation.
Co-founding of TICCR Binhai Center to embrace huge opportunities in healthcare industry
China’s 13th Five-Year Plan for Social and Economic Development upgrades the “Health China” as a national strategy. According to the Report of Industry Strategic Planning and Enterprises Strategic Planning on China Major Health Industry, the healthcare industry could be worth 10 trillion in 2020, and become a major force to boost economic and social development. As the coronavirus epidemic worsens worldwide, the medical and healthcare system reform is underway, which in turn encourages rapid enhancements in the industry to accommodate more challenges and opportunities.
Asymchem and the TICH cofound a joint venture of Asym-TICH Clinical Research Co., Ltd. (“Asym-TICH”) responsible for the comprehensive operation of TICCR Binhai Center. This is a valuable step in promoting Tianjin’s pharmaceutical development in response to Tianjin government’s instruction of “encouraging independent innovation in enterprises, continuously improving research and development efficiency, giving full play to the industry platforms, and attracting a group of related enterprises”.
Innovative collaboration for identifying needs and solving challenges
In the 16 years from 2002 to 2018, China had 21 new drugs launched, while the United States had 59 new drugs launched in 2018 alone. This demonstrates a significant gap between China and developed countries in new drug development efficiency and conversion rate. China has considerable advantages in clinical resources such as large patient base and disease varieties, but has not yet made full use due to unmet clinical resources. Only 742 clinical trial sites in China meet the GCP requirements, of which less than 1/5 conducts new drug Phase I and multi-center research. As a series of medical policies are released, China ushered in unprecedented golden period for the development of domestic innovative drugs and clinical research.
The TICCR emerged to solve several of these challenges presented in clinical research. Challenges such as low enrollment rate (2% on average) caused by lack of reliable clinical trial information channels and high standards. Other challenges include insufficient capacity for clinical research design caused by mismatch of clinical research conducted and actual clinical needs, inadequate attention to cooperation with multidisciplinary experts and low efficiency of clinical data collection caused by data islands in medical institutions. The TICCR speeds up R&D and the launch of new drugs by improving the clinical trial process and quality standards to significantly improve the quality of clinical trials in each phase, while using integrated resources and cutting-edge technologies to make breakthroughs in clinical research. The collaboration with the TICH will help realize complementary progress and improve the conversion rate of domestic drugs.
Integration of hospital and industry seeks economic benefits
The TICCR aims to accelerate the market of new drugs and provide one suite of services for clinical research by applying innovative technology and integrated industry resources. The TICH is one of top public cardiovascular hospitals and cardiovascular research institutes included in the management system of the Chinese Academy of Medical Sciences & Peking Union Medical College. Approved by the National Medical Products Administration and certified by the GCP, the TICH is a registered medical device clinical trial institute. It is also certified by Tianjin Science and Technology Bureau as “Technology Center for Phase I Clinical Research”. The joint efforts between the two institutions will help achieve a mutual success.
With an area of 2,500m2, the TICCR Binhai Center contains Phase I wards to carry out early phase clinical trials in compliance with international standards. Through market-driven operation, the TICCR Binhai Center will continue to introduce clinical research talent, build on clinical research team, bring in clinical research projects, and attract more high-quality projects to Tianjin. In addition, with the technical support of the TICCR, the Center will effectively improve the quality and speed of clinical research meeting the demands for clinical trial design and advance China’s clinical research through preparatory work, smooth connection, multi-dimensional technology and accurate coordination.
It is TICCR’s objective to integrate resources and accelerate the marketing of new drugs. The establishment of the TICCR Binhai Center marks a milestone in advancing the clinical research industry within China and meeting unmet clinical demands for the benefit of more patients.