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R&D

Business

R&D

R&D is one of the key factors for the Company to maintain its strong competitiveness and success in the long run, and that is why we have always been putting ever-increasing efforts in R&D programs. In 2020, our total R&D expenditure was approximately HK$ 1,497.9 million. 

Oriented towards national policies, industry technology development trends and market demands, we enhance our core competitiveness by combining generic drugs with innovative drugs. Our R&D efforts focus on the cardiovascular system, the respiratory system, anti-tumor products, digestive tracts, metabolism, the central nervous system, the immune system, anti-infection products, the blood system, the genitourinary system, and so on. 

As of the end of 2020, three engineering technology research centers and three enterprise technology centers of CR Pharmaceutical had won national certifications, and 17 research centers of the Company had won provincial certifications. Besides, we have set up post-doctoral research workstations which hire 1,200 R&D staff in total. 

As of December 31, 2020, there were 199 new variety projects under research, including 68 innovative drug projects, which mainly cover tumor therapies, immunity, metabolism, the endocrine system, the respiratory system, the blood system, the cardiovascular system, classic Chinese medicine prescriptions, and so on. In 2020, the Company was granted 86 patents, submitted the applications for 99 new patents, and submitted production registration applications for 14 products, including linezolid tablets, apixaban tablets, dienogest tablets, etc. to the National Medical Products Administration (NMPA). In addition, the six products of CR Pharmaceutical, namely caffeine citrate injection, amlodipine besylate tablets (2.5 mg), pregabalin capsules, cefpiroxil sodium for injection, vildagliptin tablets, and oral rehydration salts (III) obtained the production approval issued by NMPA, further enriching the product portfolio of the Company’s pharmaceutical business. Among them, cefpiroxil sodium for injection is the first fifth-generation cephalosporin approved in China. 

In February 2020, CR Pharmaceutical’s class I innovative drug NIP292 obtained the Orphan Drug Designation (ODD) issued by the Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF). The Company sets various incentives for the clinical development of rare disease drugs, including tax credits related to the costs of clinical trials in the United States, FDA fee reductions, and a seven-year market monopoly period for newly launched drugs in the treatment of identified indications. 

In December 2020, CR Pharmaceutical’s class I innovative drug NIP046 received the Drug Clinical Trial Approval Notice issued by NMPA and the Company was approved to carry out clinical trials for rheumatoid arthritis indications. The self-developed class I small-molecule innovative drug NIP046 has a clear work mechanism. Being highly selectable, NIP046 shows excellent efficacy in the treatment of a variety of autoimmune diseases of animal models involved in pre-clinical studies, and has a good safety performance. In addition to rheumatoid arthritis, NIP046 also has the potential to treat other autoimmune diseases, such as systemic lupus erythematosus, multiple sclerosis, allergic dermatitis, and corpus sores. 

 
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