It can only turn to a less effective synthetic cryptoalgin c-52. In the United States and Europe, c-52 has also conducted six clinical phase II trials, which are used in the end-stage patients with colon cancer, prostate cancer, breast cancer, non-small cell lung cancer (phase II) and ovarian cancer.
Although the tumors of these patients have developed a high degree of drug resistance, and the best existing anticancer drugs have failed to work for them, but there are still positive reactions among the patients treated with c-52 (for example, the effective rate of the patients with advanced ovarian cancer who failed in platinum treatment is 12%, and there are also other advanced patients whose condition is stable and no longer worsens, and the overall disease is alleviated and improved).
What's more, these two-stage clinical trials have proved that cryptoalgae is safe to human beings, and there is no irreversible clinical side effect or side effect damaging human organs, which greatly reduces the maximum risk in the development of new drugs. Among the hundreds of cryptoalgin derivatives covered by the patent, the one with the lowest production cost and the best anti-cancer activity is cryptoalgin C-8. All the in vivo tests conducted for different tumors have proved that the anti-tumor activity of C-8 is much better than that of c-52.
C-8 is a natural series of cryptoalgae, which is a derivative of C-1 through a simple chemical reaction. The mice inoculated with MX-1 breast cancer, TSU prostate cancer, LNCaP prostate cancer and colon-38 rectal cancer completely disappeared two weeks after administration, and even after discontinuation of the drug, the tumor did not recur, reaching the curative effect of complete cure.
Because Merck has not applied for the substance patent of natural series of cryptoalgae in China, this project plans to use natural cryptoalgae to conduct preclinical test in China, including redoing part of pharmacodynamics and toxicology research of natural cryptoalgae, so as to enter the clinical research as soon as possible.
With unique efficacy, high safety, simple preparation, low dosage, simple production process and quality control, the natural cryptoalgin series is expected to become a new class of bioengineering drugs with great market value and strict protection of intellectual property rights. Due to China's accession to the WTO, under the circumstances that the imitation of foreign new drugs is limited at present, and the innovation ability of Chinese new drugs is impossible to achieve a breakthrough in the near future, it is of great significance to legally introduce such special projects as cryptoalgae, which have been abandoned by large foreign pharmaceutical enterprises due to patent rights disputes.
This mode can obtain the exclusive production and marketing right of the drug in China at a low cost, and greatly speed up the research and development time of new drugs. More importantly, through close international cooperation, it can make full use of foreign knowledge and experience, reduce detours, enhance the ability of technological innovation and product innovation, and gradually form China's advantageous technology and product innovation in the field of medicine Superior products.
With the increasing attention and investment of Chinese government and enterprises in the development of new drugs, cryptoalgae, a special project with great demonstration significance, will be strongly supported by governments and enterprises at all levels.
The cryptoalgal research group of the University of Hawaii has a complete set of laboratories and corresponding research teams. It has been engaged in the preparation of cryptoalgal by biosynthesis, semi synthesis and total synthesis for a long time, and has studied the relationship between the chemical structure and physiological activity of cryptoalgal in detail.
The research and development work of the University of Hawaii in the early stage has used more than $3 million. The cryptoalgin research group now has $200000 for related research and development work. The University of Hawaii will invest another $70000 in July this year, and another $50000 special fund will be put in place in July this year.
Due to the maximum use of foreign funds and resources, the amount of investment needed to seek domestic has been reduced a lot. The investment company is required to invest 5 million yuan in one time for preclinical (and early clinical) trials in China. It is estimated that it will obtain the approval of clinical trials issued by the State Food and Drug Administration (SFDA) within 1-2 years.
It is planned to complete the clinical trial by applying for funding from governments at all levels and various foundations in China and the United States. The shares held by all parties remain unchanged. In case that the funds are not in place in time and may affect the progress of the clinical trial, the investment company may make additional investment according to the actual needs of the project, but the additional capital shall not exceed fifteen million yuan;
At the same time, the technical side can also raise additional funds for the development of large-scale production of cryptoalgin technology, and the production of drugs for clinical trials. These costs should also be used as the investment of the technical side. The specific investment matters shall be confirmed by a separate agreement signed by both parties.
After obtaining the clinical trial approval issued by SFDA, it is expected that the transfer price of the clinical approval of cryptoalgae is more than 25 million yuan, and the investment company can choose to transfer the shares at this time to withdraw. It will take about 4 years to complete the clinical trial and obtain the new drug certificate, and the price of transferring the new drug certificate is expected to be more than 100 million yuan.
|||At present, peptide drugs on the market in China include thymopentin, thymosin A1, somatostatin, octreotide, salmon calcitonin, lipin, glutathione, oxytocin, etc. The dosage form of polypeptide drugs only limits the cost reduction.
However, due to the high cost of peptide synthesis, it is not feasible to make it into tablets and other easy-to-use dosage forms. Therefore, at present, almost all polypeptide varieties are freeze-dried powder injection, which has many objective reasons. As for the prospect of polypeptide drugs, at present, parents in law have their own reasons.
However, in view of the rapid development of bioengineering drugs, the peak period of peptide drugs is far from coming. As for the claim that polypeptides are not suitable for making drugs, there is a large market among researchers of traditional chemical drugs, especially those of "small molecule" drug chemistry. For example, for the research of antimicrobial peptides, many people have a negative attitude. But what will happen in the future depends on the future development.
It seems that it's not comprehensive to discuss this issue in isolation. It's too professional. Please ask biomedical experts for help. You can also consult the relevant research institutes.
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