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Independent research and development of new anti-cancer drugs approved for market! Its price is lowe

On January 8, it was reported that dabushu, an innovative anti-tumor drug independently developed in China, was approved to be listed through the priority review and approval procedure of the State Drug Administration recently, providing a new immunotherapy mode for some cancer patients such as Hodgkin's lymphoma. In 2019, the first journal of the authoritative medical journal Lancet hematology published the clinical research results of 'dabershu'. It is understood that its price is lower than that of similar imported drugs.

Hodgkin's lymphoma is a relatively rare B-cell lymphoma, which occurs in the young people aged 20 to 40 years old. At present, there is no effective treatment. The clinical research led by Shi Yuankai, deputy director of the National Cancer Center and vice president of the Cancer Hospital of the Chinese Academy of Medical Sciences, shows that the remission rate of the treatment of relapsed and refractory Hodgkin's lymphoma with dabushu immunotherapy is as high as 80.4%, its efficacy and safety are equivalent to the imported drugs of the same kind, and the price will be significantly lower than the imported drugs of the same kind.

Shi Yuankai, deputy director of the Cancer Hospital of the Chinese Academy of Medical Sciences, vice president of the National Cancer Center: immunotherapy is to kill tumor cells by mobilizing the functions of T (lymphoid) cells and other immune cells in the body, while the traditional targeted drugs and cytotoxic drugs are mainly aimed at the tumor cells themselves to play its therapeutic role.

It is understood that in addition to the treatment of lymphoma, Dabusu has carried out more than 20 clinical trials of lung cancer, gastric cancer, liver cancer, esophageal cancer, etc.

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A new generation of HPV vaccine developed by Chinese scientists is expected to prevent 99% of cervical cancer

Chinese researchers have made significant progress in the fight against cervical cancer. Their new generation of cervical cancer vaccine is expected to resist all the high-risk human papillomavirus that can cause cancer. Human papillomavirus (HPV) is mainly transmitted by sexual contact. At present, more than 200 types of HPV have been identified, which can be divided into high-risk type and low-risk type. At least 18 high-risk HPVs are associated with 99% of cervical cancer.

Chinese researchers have made great progress in the fight against cervical cancer

Cervical cancer is a serious threat to women's health, second only to breast cancer. At present, the nine valent cervical cancer vaccine developed by American pharmaceutical companies and listed on the market has the widest protection range, which can prevent the infection of seven high-risk and two low-risk HPVs, that is, about 90% of cervical cancer.

However, it is not clear whether the use of similar vaccines for widespread immunization will lead to an increase in other cancer-related virus infections, that is, the remaining 10% of cervical cancer. Therefore, it is necessary to develop a vaccine for cervical cancer with a wider range of protection.

In the first and second generation of cervical cancer vaccines, the virus like particles similar to HPV natural virus particles are used as vaccine antigens. Virus like particles is to remove the genetic material of the virus and reassemble the remaining material. They still have the characteristics of the original virus in structure, but have no replication and infection ability. Virus like particles can make people produce immune response to the virus, and thus produce antibodies to make people have a good defense against the virus.

A HPV like particle can only prevent one type of HPV. According to the traditional method, in order to improve the prevention effect and cover more virus species, it is necessary to continuously increase the number of particles.

But if we use this' one-to-one 'method to make vaccines that can prevent more than a dozen viruses, it will cause a large vaccination dose and increase potential side effects, such as excessive intake of protein and adjuvants, which will cause pain, swelling, and fever at the injection site of the vaccinator, and will also increase the complexity and production cost of vaccine manufacturing.

After six years of research, Professor Xia Ningshao's team of Xiamen University in Fujian Province has made key technological breakthroughs and developed an efficient vaccine that can protect more HPV types with fewer virus like particles.

According to their genetic relationship, they divided 20 cancer related HPV types (including 18 high-risk types and two low-risk types) into seven groups, and found that the closely related HPV types had the same skeleton and different external details in structure.

Xia Ningshao thinks that both HPV like virus particles and natural virus particles can be compared to a 'sphere' in appearance. And the lines, lines, bulges and depressions on the surface of 'sphere' are called 'ring area'. Although the appearance of different types of HPV is similar in general, the bulges and lines in details are obviously different.

Xia Ningshao said: 'it is because of the difference of these regions that the antibodies stimulated by each virus type cannot prevent the infection of other virus types. '

Therefore, the research team designed a complex 'chimeric viroid particle' by using the emerging structural vaccine method. It integrates the 'ring' characteristics of three types of HPV particles (HPV33, HPV58 and hpv52), so that the former one can only simulate the morphology of one type of HPV, and become one that can simulate the morphology of three types of HPV, that is, a new 'sphere' has the characteristics of the previous three 'spheres'.

This also means that a HPV like particle has the function of protecting three types of HPV virus at the same time.

Sure enough, later in tests on mice and monkeys, the researchers found that 'chimeric virus like particles' provided the same immune effect as the previous' one-to-one' method combined with three kinds of virus like particles.

In the same way, they successfully produced four chimeric virus like particles on four other groups of HPV types.

"Our research has opened the way for the development of a new generation of HPV vaccine. It shows that only seven chimeric virus like particles are needed to prevent cervical cancer caused by 20 HPV types. 'said Xia Ningshao.

The research results have been published in the international authoritative journal Nature & middot; communication recently.

Reviewers of the Journal said it was' a remarkable achievement 'because the new vaccine reduces the kinds of virus like particles needed for vaccine antigens while increasing the types of preventable viruses, so it will not increase production costs and difficulties, and reduce the generation of side effects. In an email to the research team, they said: 'I believe the new vaccine will go to clinical practice. '

At present, there are three kinds of cervical cancer vaccines introduced into China, which are bivalent, tetravalent and ninvalent. Nine price vaccines are the most expensive. The price of each vaccine is 1298 yuan, and the total price of three vaccines is 3894 yuan.

Xia Ningshao said the new vaccine will be suitable for women aged 9 to 45, and the production cost will not be high.

Xia Ningshao has been engaged in the research of cervical cancer vaccine for a long time. His team has developed the first domestic first generation cervical cancer vaccine to be launched in China. The second generation of domestic 9-valent vaccine was also approved for clinical trials in 2017.

According to the statistics of the World Health Organization in 2018, there are about 570000 new cases of cervical cancer in the world every year, and about 311000 deaths. Every year, China has 106000 new cases and 48000 deaths.

In recent years, HPV vaccination has been promoted in China, and the government has provided free cervical cancer tests to tens of millions of rural women.