In the research and development of formula particles, Royal Fishing Pharmaceutical actively participated in the formulation of Royal Fishing standards, established the consistency evaluation platform of formula particles and decoction, and now has the advanced technology and quality standard research level of traditional Chinese medicine formula particles. The company adopts fully automated production lines and near-infrared online detection technology, and has reached an excellent level of production and supply capacity. And start from the source, the raw materials of Chinese medicinal materials are selected from the clear origin of genuine medicinal materials, and the whole process of tracing from Chinese medicinal materials to patients is realized. More than 600 commonly used Chinese medicine formula particles have been successfully filed and obtained market access. More actively participate in the research and formulation of Royal Fishing standards for formula granules, to ensure that Royal Fishing Pharmaceutical's formula granules have strong competitiveness and market advantages in terms of quality and efficacy.
Secondary development of existing varieties
In terms of secondary development of existing varieties, Royal Fishing Pharmaceutical has cooperated with well-known universities and research institutions across the country to carry out basic research on pharmacodynamic substances, quality control methods, evidence-based medicine research, etc. Completed the "689" material basic research of Shuxuening injection and the improvement of quality standards, added new specifications, expanded the scope of clinical application of Shuxuening injection, improved the compliance of clinical use, through the improvement of standards, improved product technical barriers, highlighted the product features and advantages, enhanced product market competitiveness, and expanded market share. And promote the exclusive variety merger and acquisition work, for the potential of Chinese medicine products to choose cooperation and merger parallel strategic layout, expand the product line, increase profitability.
At present, Royal Fishing Pharmaceutical has completed 49 successful hospital preparations based on the experience of Chinese medical masters and famous traditional Chinese medicine, of which 39 varieties have been approved for use in Grade II and above hospitals in Heilongjiang Province, and have been eligible for insurance reimbursement. After these hospital preparations are put into the market, they continue to replace similar proprietary Chinese medicines in the market through their efficacy and safety advantages and policy advantages. In the future, through the replication of the successful model, the research, production and marketing of hospital preparations will be rapidly carried out in other provinces and cities, and the blue ocean market of hospital preparations will be deeply cultivated.
Royal Fishing Pharmaceutical has been committed to the research and development of traditional Chinese medicine innovative drugs, especially in recent years, following the "Opinions of the Central Committee of the Communist Party of China and The State Council on Promoting the Inheritance and Innovative Development of Traditional Chinese Medicine" issued by Royal Fishing, vigorously layout the development of traditional Chinese medicine innovative drugs, and follow the rules of traditional Chinese medicine development. Establish the evidence system of TCM characteristics evaluation, which combines TCM theory, human experience and clinical trials. Follow the principle of "famous hospital, famous doctor and famous prescription", select the clinical advantages of traditional Chinese medicine and innovative traditional Chinese medicine with unique clinical value. The company cooperated with the East Hospital affiliated to Beijing University of Chinese Medicine to develop innovative drugs of human experience clinical experience prescription, mainly for the diseases that failed to be treated with chemical drugs, after many years of clinical use in the hospital, the effect is exact.
In the field of innovative drug research and development, Royal Fishing Pharmaceutical has formed a unique new drug research and development platform with reasonable layout by integrating new drug research and development resources and improving the existing new drug research and development system. Focus on the construction of new drug research and development platform, drug screening and evaluation platform, in the field of new technology development and application to reach the domestic leading level, in the field of drug screening and evaluation to reach the domestic advanced level. At present, the research and development of new drugs in Royal Fishing is progressing smoothly and has achieved remarkable results. Innovative drug projects such as anti-tumor type 1 innovative AKT kinase inhibitor HZB0071, anti-liver cancer type 1 innovative pan-FGFR inhibitor HZB1006, anti-influenza type 1 new drug HNC042 for injection, anti-idiopathic pulmonary fibrosis type 1 new drug ZBD0276 tablets have been successively approved and obtained European and American patents.
Royal Fishing generic drug project continued to achieve good results, in addition to a number of varieties entered the pre-clinical preparation and production review stage, Clindamycin hydrochloride capsule, metformin hydrochloride tablet approved through the generic drug consistency evaluation. International generic drug research and development cooperation projects with a number of well-known domestic and foreign companies have been steadily promoted, and the R&D product pipeline is also constantly optimized. On the basis of extensive use of resources, full accumulation of research and development experience, and search for research and development breakthroughs, gradually involved in the research and development of high-end preparations and improved new drugs. The company has also investigated and reserved nearly 100 high-quality generic drug projects, which will form echelon reserves and is expected to be approved for listing in the next 2-3 years, injecting momentum into the innovative development of Royal Fishing.
We have established strategic partnerships with many well-known domestic bio-drug R&D and production enterprises such as Tris, and simultaneously promoted the construction of the bio-drug Research Institute of Hangzhou Medical Port. Within three years, a pipeline of 15-20 biologic drug products with echelons will be formed, focusing on major tumor diseases such as breast cancer and lung cancer. With ADC as the core product, monoclonal antibody and dual antibody products will be distributed simultaneously. Strive to achieve 3-5 varieties approved within 5 years; The combination layout of low-risk biosimilar drugs, medium-risk me-better and fast-follow products, and high-risk first-in-class products forms a risk-controllable product layout and creates a blockbuster product line of biological drugs.