The investment in R&D of new drugs is relatively large. The success or failure of the project is crucial to the development of the company. There are some problems in the selection of new drug varieties by domestic companies. Therefore, it is necessary to actively improve the following aspects in order to earnestly do a good job in R&D of new drug companies: Innovative Ideas The development of new drugs is a systematic project. Enterprises should establish correct innovative ideas based on reality. First, the development of an innovative drug requires high investment and great uncertainty. Although the cost of developing new drugs in our country is relatively low, the characteristics of large capital requirements have not changed. Enterprises should make necessary preparations. Second, do not insist on obtaining completely innovative new drugs. The technical requirements for the development of innovative drugs are extremely high and extremely comprehensive, including fine chemicals, synthesis, purification, preparations, pharmacology and toxicology techniques, clinical organization and market planning. Enterprises should actively cooperate with powerful domestic units according to their own strengths, and select innovative projects suitable for the development of enterprises for development. Third, do pre-clinical and preclinical studies. With the increase in the number of innovative drug development projects, there is no existing data that can be used for reference. The corresponding late-stage failure rate will increase and the risk will be extremely high. Therefore, only the pre- and pre-clinical studies of a comprehensive system of drug candidates can eliminate bad drug candidates as soon as possible to minimize risk. Fourth, don't rush for success. In actual work, we must arrange work according to the law of R&D of new drugs, and we cannot ask for a leap from active substances to drug candidates. - Ingenious use of patents In the future, China will mainly protect new drugs through patent protection measures and allow new drugs to gain market exclusivity over a period of time in order to obtain investment returns. When applying for a patent, you should pay attention to: First, you must choose the right time to apply for a patent. Because the patent protection period is 20 years, if patents are filed early, R&D time will take more than 10 years, and after the listing, there will be less than 10 years of market exclusivity, which will affect the return on investment. In addition, after discovery of new compounds or new activity of the compounds, basic researches such as the necessary structure-activity relationship are required. If the patent is reported late, it may be the case that others are preemptively applied or the key technology is leaked. Second, consider the validity of the patent application, whether the claims are comprehensive, whether a structure type with good drug-like properties has been included, and whether the examples in the specification support claims or the like. Third, consider the necessity, scope and priority of applying for foreign patents. Because the annual fee is required to be paid each year after applying for a foreign patent, if the payment is not made on time, the patent protection will fail prematurely. In addition, when the new drug project is transferred, it must pay attention to the validity of the patent. Only patent protection or application acceptance is not enough. It also depends on whether the patent protection is effective. —— Pay attention to the pre-research During the new drug development stage, the development failure due to the drug metabolism and toxicity of the compound accounts for 40%-60%. Therefore, the safety of the compound to be developed should be obtained at a more appropriate cost in the previous study as much as possible. Information on the availability, availability, and pharmacokinetic properties of the compound to determine whether the compound or active substance has been developed and classified according to its value. Preclinical pharmacodynamic tests should pay attention to the following rules: the efficacy of new drugs must be characterized and higher than or not lower than existing drugs; the effectiveness of the application of recognized pharmaceutical efficacy standards is good or bad; if the existing drug efficacy is significant, The standards for the efficacy of new drugs will be relatively high. —— Pay attention to market prospects New drugs are drugs that are not marketed in China. In fact, not all new drugs are worth investing. Whether the new drug has development value depends on whether it has higher market demand and stronger competitiveness, whether it has advantages in efficacy and supporting effect, toxicity, medication compliance, production cost and process, etc. Doctors have a say in these areas. Therefore, when introducing or developing new varieties, it is best to listen to the opinions of the relevant professional clinicians to understand the advantages and disadvantages of the existing varieties and whether the market has new needs, not just to determine the value of product development from the technical point of view. When pharmaceutical companies develop new drugs, they are willing to develop varieties with high market demand, such as anti-hypertension drugs, hypolipidemic drugs, anti-diabetic drugs, antibiotics and antiviral drugs. This is understandable, but in fact, domestic companies have developed the above categories. There are not many innovative drugs. In contrast, the market for anti-tumor drugs is huge. At present, there are no specific drugs and the efficacy standards are relatively low. Therefore, many companies in China have actively developed anti-tumor drugs. In fact, the key to the development of anti-tumor drugs lies in "creativity." If there is significant and substantial improvement and improvement in efficacy and toxicity compared to existing varieties, there is hope for success. Developing new drugs is also relatively easy in emerging markets, such as improving quality of life drugs. In addition, with the advancement of new drug R&D technology, new drug development should take into account market segmentation and population segmentation, and effective drugs developed for specific markets and groups can also be successful. —— Concerned about the progress of foreign countries With the increase of foreign exchanges, domestic companies are paying more and more attention to the development progress of similar new drugs abroad, especially in the United States. When pharmaceutical companies choose product development, if there are similar products in foreign countries undergoing clinical trials, we must pay attention to the progress of clinical trials and the final results, because many candidate drugs were eliminated after the phase III clinical trials. Krebs, chairman of the International Federation of Pharmaceutical Manufacturers (IFPMA), said that currently there are 2/3 human diseases that have no treatment and the pharmaceutical industry is the most promising industry in the future. If domestic pharmaceutical companies can consider the long-term development of the company, increase investment, make full use of their own resource advantages, and rely on high-level pharmaceutical research institutions within the United Nations, attach importance to drug screening and pre-research, and eventually be able to develop excellent drugs for the benefit of people. .
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