[Transfer] Women's cervical defense war, and the tens of billions of markets behind

Source: amino observation/Cai Jiu

Cervical cancer has always been one of the major public health issues in the world, and the continuous HPV virus infection is the core cause of cervical cancer.

After years of efforts by pharmaceutical companies such as GlaxoSmithg and Merck, the HPV vaccine finally appeared, allowing global women to effectively protect the damage caused by high -risk HPV viruses. At the same time, these pharmaceutical companies also rely on HPV vaccines to earn generous returns.

The road of innovation is endless. Although the vaccine has been released, it is limited by various factors such as the popularization rate, and the HPV virus still plagues the majority of women.

In fact, before the continuous HPV virus infection progress to cervical cancer, there is also a stage of cervical cancer lesions. If you can grasp the "window period" of about 10 years for effective screening, intervention and treatment Great market potential.

From the perspective of the global status quo, for cervical cancer lesions, only surgical treatment, but the surgical invasion is strong, there are side effects such as premature abortion.

A non -surgical treatment product is urgent in the world to target the pre -cervical cancer lesions. The huge clinical clinical has not met the needs, and it has always spurred the pace of accelerating research and development. Today, things are moving in a favorable direction.

On August 9th, Yahong Pharmaceutical (688176), a listed company of science and technology board, announced that she has completed the work of the global third phase of clinical subjects in the global third phase of clinical subjects for high -risk cervical cancer lesions.

This also means that we may soon usher in a powerful weapon for non -surgical treatment of cervical cancer lesions, and a racing race has begun.

/ 01 /

Behind the successful completion of global clinical patients, it is an urgent clinical needs

Innovative medicines are developed, although the drooping fruit can reach the tentacle, but in addition to the advantages of research and development time, the difficulty of follow -up links increases step by step, and the progress is slightly slow. In the clinical session, patients may not even recruit patients.

The fruits at the high place are completely opposite. Although the HARD mode was the beginning, due to the urgency of clinical needs, the subsequent advance resistance will decrease step by step, and even turn on the acceleration.

Under the premise of interference in the epidemic and war, Hervy still successfully completed the recruitment of clinical patients in the world's third phase, mainly because of clinical demand is quite urgent.

Now when we talk about cervical cancer, we first think of the HPV vaccine. Indeed, as the first line of defense, the protection rate of HPV vaccine is excellent, which can largely avoid women's invasion of cervical cancer, but this is still not enough.

The most critical problem is the time of vaccine popularization. Taking the domestic situation as an example, according to the national routine immune report data, from 2018 to 2020, the number of HPV vaccinations in various places was 3.417 million, 6.753 million, and 12.279 million doses. Rate is at a lower level. [8]

According to the above -mentioned HPV vaccination data, as of 2020, the total three -pin immune vaccination was completed in 2020, with a total of less than 10 million people. According to the sixth census data, domestic women (9-45 years old) reached 381 million. Calculated, the HPV vaccine penetration rate is less than 3%.

It is a very long -term project to increase the vaccination rate. According to the first domestic HPV vaccine expert consensus "Eliminating the HPV Vaccine Application of Cervical Cancer's HPV Vaccine Application Guangdong Expert Consensus", experts calculated that in the case of optimism, Guangdong can only complete the goal of preliminary cervical cancer [2], let alone other economic development The level is not as good as the provinces and cities in Guangdong.

In addition to the popularization of vaccine, coupled with many factors such as all subtypes, the age limit of vaccination, and insufficient production capacity, HPV virus still plagues the majority of women around the world. The latest research reports of Catalonia Cancer Research Institute and International Cancer Research Institutions show that the global HPV infection rate in 2019 is as high as 9.9%[1].

There will be differences in different regions, but for the time being, due to factors such as vaccinations in my country, the HPV infection rate is higher than the global average. A survey of an epidemiological survey of 1.7 million women in 2019 showed that the general population HPV infection rate was 15.54% [2].

Fortunately, cervical cancer caused by HPV virus infection is a gradual process. The continuous HPV infection will first cause low -level squamous epithelial internal epithelial disease, and then advance to the advanced squamous epithelial internal lesions, and finally it can evolve into cervical cancer.

According to the "Consensus on Experts related to cervical cancer screening and abnormal management", this cycle usually takes more than 10 years. In other words, as long as it is found in time and cervical lesions, especially the high -level cervical epithelial internal epithelial lesions, can still effectively prevent cervical cancer.

However, unfortunately, for high -risk cervical cancer lesions, the current global treatment methods are extremely limited, and there is only one way for surgical treatment. Although surgical treatment is better, there are three major problems.

First, the invasion is strong and the patient's compliance is low. Although the operation is not complicated, it involves the process of resection lesions and hemostasis, which will bring physical and mental discomfort to patients;

Second, there are side effects of small probability irreversible. Surgical treatment has a certain probability that it can cause cervical damage, or it may further cause sequelae of fertility functions such as premature birth and abortion.

According to a retrospective study of 69 clinical clinicals around the world, women who have received surgical treatment of high -risk cervical cancer have doubled risk of premature birth to 10.7%[3]. For women with fertility, there is a certain psychological pressure on surgical treatment. Third, the HPV virus cannot be completely removed, and there is still a possibility of lesions or recurrence. Whether there are HPV virus residues are mainly affected by the results of doctors and other results. At present, the residual and recurrence of surgical treatment is a dilemma facing the world.

An analysis of 97 studies around the world shows that a total of 44,000 pre -cervical cervical cervical cervical cervical lesions are treated with women with a total proportion of positive cutting. The ratio is 6.6% [4].

The same is true in China. Although there is no national data research, according to some hospitals, the conclusions are similar to the above analysis. For example, a study conducted at Hunan Hospital at the top domestic hospital showed that after receiving cervical cold knife cone cutting, as high as 17.05%of patients was positive, and 2.46%of patients were found to be residual/recur CIN2+ [5].

In summary, it is not difficult to find that the limitations of surgical therapy have made an effective non -surgical therapy in the field of cervical cancer treatment in the field of cervical cancer.

It is also under the urgent clinical needs that she is the treatment product for optical power therapy products for high -risk cervical cancer lesions. The global multi -centered clinical clinical clinical acceleration can be opened to complete the patient's entry goals.

/ 02 /

Innovate non -surgical treatment methods, or 5 billion -level items

As a optical power therapy product, Hervey's core principle is to use the "accumulating lesions of the optical agent to produce a large amount of active oxygen under light, and then apoptosis and necrosis" [6].

In simple terms, what she wants to do is not complicated, that is, to deliver the drug to the lesion cells, and then open the optical treatment mode.

As shown in the figure below, Hervey's structure is simple: it is composed of a round head and light device that placed the ointment. After the doctor applies the ointment (optical agent) to the head of the equipment, put the equipment on the patient's cervix.

After completing the above steps, the patient can leave the hospital. Because the built -in light sources of the product will be automatically opened after the cells are fully absorbed; after completing the setting time, the built -in light source will automatically extinguish it. At that time, the patient can take out the device by themselves, which is simple and easy to use.

Shevi can complete the entire treatment process through light, which can avoid the discomfort of the patient's surgery and the worries of the post -care, and the effect looks good:

According to the results of the clinical trials of Hervi, her IIB phase, it has a significant treatment effect on the high -grade scaled epithelial internal lesions. After 6 months of treatment, 76%of patients have responded, while the response rate of placebo group is only 28%[6].

In addition, it also has a clear effect on all HPV viruses. After 9 months of treatment, the average removal rate of the HPV virus of the patient was 58%, which was significantly higher than the 34%removal rate of the placebo group [6].

It is simple, convenient, and has high clinical value. It is the endogenous logic of non -surgical therapy products that support the pre -cervical cancer lesions, and the demand for huge patients is external driving force.

According to data from Fhstana, the size of domestic cervical cancer patients in 2020 reached 3.5 million. With the expansion of the two cancer (cervical cancer and breast cancer) screening crowd and the gradual improvement of the cervical cancer prevention system, the detection rate of patients with cervical cancer disease will inevitably improve.

According to the Yahong Pharmaceutical Prospectus, the potential scale of this market reached 19.59 billion. Especially at the moment, the problem of aging population is becoming increasingly serious. The state has vigorously advocated more and more cultivation. The "fertility protection" characteristics of such products coincide with the national population strategy. There is imagination space in entry.

In the case of optimism that entered the medical insurance and the penetration rate reached 25%, Hervey's sales in the domestic market can reach nearly 1 billion US dollars. [6]

The domestic market may support a heavy bomb product. If some players can break through overseas, they will inevitably open their own ceiling.

/ 03 /

Who can take the lead in the global market battle?

Going to sea is also a market opportunity for non -surgical treatment products for cervical cancer.

In addition to the United States, the global area, including Europe, has a lot of room for improvement in HPV vaccine.

Take the European market, countries (most Eastern European countries) or countries that use HPV vaccines at their own expense or countries that use common payment models (such as France) have been less than 30%[7].

Even if the HPV vaccination rate is high, non -surgical therapy products are still strong supplements beyond the vaccine. The above numbers mean that even in developed countries overseas, the demand for non -surgical treatment products will be equally strong.

More importantly, there are not many competitors entering the game worldwide worldwide. According to the information disclosed by the clinical information website Clinicaltrics.gov, including Asiahong Pharmaceutical, there are only two non -surgical treatment products for cervical cancer lesions entering the third phase of the clinical stage.

Another product is developed by INOVIO Pharmaceutical, but her product design is slightly different from Hervey. As shown in the figure below, the method of administration of this product is internal injection of the muscle. Compared to Hervy, compliance may be slightly disadvantaged. Of course, these two products are already revolutionary products compared to existing surgical treatment methods. Who can get the first to get the entry voucher, and has the opportunity to get more incremental markets, and then release greater performance elasticity.

This is also a high probability that Yahong Pharmaceuticals promotes the global clinical purpose. At present, Yahong Pharmaceutical has promoted the third phase of clinical trials in Germany, Czech Republic and other countries.

Looking back at the country, the future going to the sea may be expanded. In the current domestic pharmaceutical companies, Fudan Zhangjiang is also developing the optical power therapy products of cervical cancer lesions, but the progress is slightly slower. It is still in the clinical stage of the second phase of the country.

However, overseas has never been an innovative medicine, but a trial field. Over the past year, domestic innovative medicines have been shrouded in the shadow of defeat in the sea. From Kanghong Pharmaceutical's Corbisp, to Purlin of Wanchun Bio, the temporary folding of Cinda Bio PD-1 ...

The core reasons behind it are nothing more than a shortcut to innovative pharmaceutical companies. There is no shortcut to go to sea. Clinical places, patterns and endpoints must be aligned overseas. And this extreme test of the globalization of pharmaceutical companies is huge in challenges.

If you want to stand out on the global stage, it is destined that only a few pharmaceutical companies can succeed. But it is precisely because of scarcity that the "small parts" of pharmaceutical companies are undoubtedly the most worthy of our attention.

source:

[1] "Human Papillomavirus and Related Diseases Report", in September 2019, the literature link: https://hpvcentre.net/statistics/xwx.pdf

[2] "HPV vaccine for eliminating cervical cancer, the consensus of Guangdong Experts", in September 2021, the literature link: http://rs.yiigle.com/cn431274202109/1340029.htmm

[3]《Obstetric outcomes after conservative treatment for cervical intraepithelial lesions and early invasive disease》，2017年11月，文献链接：https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD012847/full

[4]《Incomplete excision of cervical precancer as a predictor of treatment failure: a systematic review and meta-analysis》，2017年11月，文献链接：https://www.thelancet.com/journals/lanonc/article/PIIS1470 -2045 (17) 30700-3/fullText

[5] "The treatment strategy of positive patients with cervical cold knife cone was cut operations -7 -year retrospective research in China", March 2021, literature link: https://obgyn.onlinelibrary.com/doi/ Full/10.1002/IJGO.13683

[6] "The Prospectus Listing Book of Asiah Hong Pharmaceutical Customs Board", in November 2021, the literature link: http://stative.sse.com.cn/stock/information/202112/5F5DF322F3C749452080bf41.pdf41.pdf

[7]《Human papillomavirus vaccination coverage, policies, and practical implementation across Europe》，2020年2月，文献链接：https://www.sciencedirect.com/science/article/pii/S0264410X19316354

[8] "National Health and Health Commission: Focus on promoting free HPV vaccine in areas of mature regions", July 2022, news link: https://baijiahao.baidu.com/s? ID = 173828682556150 & WFR = Spider & For = PC

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