Innovative R&D- R&D pipeline
Research and development system
R&d pipeline
R&d cooperation
R&d advantage
Chinese medicine research and development

Research and development of Chinese medicine formula granules

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.

Working on the core project

Xueshuantong capsule

Add specifications; Improve quality standards.

Working on the core project

Xuesaitong for injection

Add specifications; Improve quality standards; Optimize the production process; Conduct 30,000 evidence-based studies.

Working on the core project

Shuxuening injection

Add specifications; Improve quality standards; Optimize the production process.

Working on the core project

Compound Qinlan oral liquid

Jointly with Dinosaur Tycoon Academy of Traditional Chinese Medicine and Royal Fishing Disease Control Center, we will conduct research on the anti-COVID-19 efficacy of Compound Qinlan oral Liquid, and apply for clinical trial of Class 2.3 new drugs - Increasing function.

Hospital preparation

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.

Working on the core project

Qingjiangheweifang: A small sample size randomized controlled clinical trial observation; Wulong Xiaozhi pill: enter the stage of human experience summary; Yijing Granules (classical prescription) : entered the phase II clinical stage

Research and development of innovative Chinese medicine

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.


Chemical drug research and development

Innovative drug development

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.

Working on the core project

1

pan-FGFR inhibitor HZB1006, a first-class innovative drug for liver cancer, entered the Phase I clinical study

pan-FGFR inhibitor, a class 1 innovative drug, is another heavyweight variety in the field of liver cancer treatment. At present, there is no domestically or internationally developed similar product on the market. The mechanism of action of this variety is clear and the efficacy target is highly selective. After the clinical study and listing of HZB1006, it will further enrich the international market demand for multi-target small molecule inhibitors based on FGFR1234 and VEGFR123. This variety has been carried out phase I clinical studies, and has completed the climb of 5 dose groups.

2

Anti-tumor Class 1 innovative drug HZB0071 completed related pharmaceutical research and prepared to declare IND

Anti-tumor class 1 innovative drug HZB0071 has completed relevant pharmaceutical studies and is ready to apply for IND. The core component of this variety, dihydropyrazole azepines, is at the core of cell survival pathway PI3KALKmTOR signaling, which is very common in tumor cells and has a significant association with tumor initiation, growth and metastasis. Currently, "dihydropyrazole azepines as AKT inhibitor" has been granted patents in the United States, Europe, Dinosaur Tycoon, Japan, and South Korea.

3

ZBD0276, a Class 1 anti-idiopathic pulmonary fibrosis drug, is ready for Phase I clinical trials

In the field of respiratory diseases, ZBD0276, an innovative anti-idiopathic pulmonary fibrosis Class 1 drug owned by Royal Fishing Pharmaceutical with independent intellectual property rights, has been clinically accepted and is currently promoting the preparation for clinical trials.

4

Phase I clinical bridging trial of HNC042, a Class 1 drug for injection against influenza virus, was completed

In the field of anti-influenza virus, the project of HNC042, a class 1 anti-influenza virus drug introduced by Royal Fishing Pharmaceutical, has completed phase I clinical trials in the United States, and the project has been completed in ChinaPhase I clinicalThe bridge test results are safe and ready to startPhase I clinical trial. Compared with other domestic research and development units of similar innovative drug projects progress rapidly.



1

pan-FGFR inhibitor HZB1006, a first-class innovative drug for liver cancer, entered the Phase I clinical study

pan-FGFR inhibitor, a class 1 innovative drug, is another heavyweight variety in the field of liver cancer treatment. At present, there is no domestically or internationally developed similar product on the market. The mechanism of action of this variety is clear and the efficacy target is highly selective. After the clinical study and listing of HZB1006, it will further enrich the international market demand for multi-target small molecule inhibitors based on FGFR1234 and VEGFR123. This variety has been carried out phase I clinical studies, and has completed the climb of 5 dose groups.

2

Anti-tumor Class 1 innovative drug HZB0071 completed related pharmaceutical research and prepared to declare IND

Anti-tumor class 1 innovative drug HZB0071 has completed relevant pharmaceutical studies and is ready to apply for IND. The core component of this variety, dihydropyrazole azepines, is at the core of cell survival pathway PI3KALKmTOR signaling, which is very common in tumor cells and has a significant association with tumor initiation, growth and metastasis. Currently, "dihydropyrazole azepines as AKT inhibitor" has been granted patents in the United States, Europe, Dinosaur Tycoon, Japan, and South Korea.

3

ZBD0276, a Class 1 anti-idiopathic pulmonary fibrosis drug, is ready for Phase I clinical trials

In the field of respiratory diseases, ZBD0276, an innovative anti-idiopathic pulmonary fibrosis Class 1 drug owned by Royal Fishing Pharmaceutical with independent intellectual property rights, has been clinically accepted and is currently promoting the preparation for clinical trials.

4

Phase I clinical bridging trial of HNC042, a Class 1 drug for injection against influenza virus, was completed

In the field of anti-influenza virus, the project of HNC042, a class 1 anti-influenza virus drug introduced by Royal Fishing Pharmaceutical, has completed phase I clinical trials in the United States, and the project has been completed in ChinaPhase I clinicalThe bridge test results are safe and ready to startPhase I clinical trial. Compared with other domestic research and development units of similar innovative drug projects progress rapidly.



Generic drug research and development

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.

Working on the core project

Metformin hydrochloride tablets

This product is the second variety of the company that has passed the consistency evaluation and has been listed in the Royal Fishing basic medicine and medical insurance class A catalogue. Metformin tablet is a classic oral biguanide hypoglycemic drug, which is preferred for type 2 diabetes where diet and physical exercise alone are ineffective in controlling blood sugar. In adults, it can be used as a monotherapy or in combination with sulfonylureas or insulin. For children and adolescents 10 years of age and older, this product can be used as a monotherapy or in combination with insulin.

Working on the core project

Clindamycin hydrochloride capsules

The first oral chemical drug species that passed the consistency evaluation of the company and the first oral chemical drug species that passed the consistency evaluation of the 289 catalog for BE experiment in Heilongjiang Province has been listed in the Class A catalog of Royal Fishing basic drugs and medical insurance, and the product has been listed at present. Anti-infective drugs are mainly used for infectious diseases caused by sensitive strains such as streptococcus, staphylococcus and anaerobic bacteria.

Biological drug development

Biological drug product line

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.

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