Innovation through our advantages in TCM together with chemical drugs
Ruihe is guided by unmet clinical needs and follows the "differentiation" strategy to build our R&D platform, so as to initiate multi-level, wide-ranging research projects. Through the process of R&D, planning and transformation, we design our unique pipelines and product portfolio.
Independent R&D
Collaborative Development
License-in
In-depth Incubation
Our Unique Pipeline
For innovative TCMs: Ensuring our leading position in the market regarding liver disease treatment by leveraging our production and marketing edges and conducting R&D on formulations for the hepatology. Expanding Ruihe’s TCM pipeline by targeting at therapeutic areas where TCM has advantages and developing new drugs based on human use experiences and through cooperating with external R&D resources. Promoting result transformation by initiating new R&D projects according to the National Major Scientific and Technological Special Project for Significant New Drugs Development, and seeking cooperation opportunities with universities and research institutes to co-develop new TCM formulations.
For classical TCM compound prescriptions: Following up national R&D trends on prescriptions of this kind with a focus on digestion, gynecology, pediatrics, respiratory and chronic diseases.
For a whole industrial chain of TCM: Looking for R&D projects that cover the whole chain (including herbal planting, herbal processing and herbal formula particles) based on Ruihe's development needs and industry trends.
For complex generic drugs: Initiating R&D projects based on the strategy of "low production costs, efficient and effective R&D, and high technical barriers", prescriptions listed by the government, and the policy of priority review & approval of pediatric drug. Seizing opportunities for quick initiation of projects related to chronic diseases such as hypertension, hyperlipidemia, and diabetes.
For modified new drugs: Focusing on developing modified new drugs with high technological barriers through joint development with CRO companies or by establishing a platform for unique categories. Conducting in-depth research on prodrug design, extended-release formulations, long-acting injectables, nanoemulsion, targeted microspheres and transdermal drug delivery system (TTDS) to create the 1+X pipeline.
Post-Marketing Surveillance
Pursuant to requirements of safety re-evaluation of TCM injections released by the Chinese government in 2009, Ruihe established a team for the safety re-evaluation of Shuganning injection. According to the regulations such as the Work Plan for Safety Re-evaluation of Traditional Chinese Medicine Injection, the Technical Principles for Quality Control Evaluation of Safety Re-evaluation of Traditional Chinese Medicine Injection, and the Basic Technical Requirements for Traditional Chinese Medicine and Natural Medicine Injection, we have cooperated with more than 10 universities and research institutes, including Peking University School of Pharmaceutical Sciences, Tianjin University of Traditional Chinese Medicine, Xi'an Jiaotong University, Guizhou Medical University and China Association of Chinese Medicine, to conduct a comprehensively evaluation on the product in terms of its herbal origin, chemical composition, substances, QA, stability, in vivo process, mechanism of action, non-clinical and clinical safety and efficacy. The ongoing post-marketing evaluation work is expected to incur about RMB 100 million in research expenses.