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    Home > Active Ingredient News > Drugs Articles > The battle to defend the cervix of women, and the tens of billions market behind it

    The battle to defend the cervix of women, and the tens of billions market behind it

    • Last Update: 2022-08-20
    • Source: Internet
    • Author: User
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    Cervical cancer has always been one of the major public health problems in the world, and persistent HPV infection is the core cause of cervical cancer


    After years of efforts by pharmaceutical companies such as GlaxoSmithKline and Merck, the HPV vaccine was finally available, allowing women around the world to effectively protect against the harm caused by the high-risk HPV virus


    The road to innovation is endless


    In fact, before persistent HPV infection progresses to cervical cancer, there is still a stage called cervical precancerous lesions.


    As far as the global situation is concerned, surgery is the only method for cervical precancerous lesions, but the surgery is highly invasive, and there is a risk of side effects such as premature miscarriage


    The world is in urgent need of a non-surgical treatment product for cervical precancerous lesions.


    On August 9, Asieris Pharmaceuticals (688176), a company listed on the Science and Technology Innovation Board, announced that its photodynamic therapy product, Sivita, for high-risk cervical precancerous lesions, has completed the enrollment of global Phase III clinical subjects


    This also means that maybe we will soon be able to usher in a powerful weapon for non-surgical treatment of cervical precancerous lesions, and a race has begun


    / 01 /

    / 01 /

    Behind the successful completion of the global clinical patient enrollment,

    Behind the successful completion of the global clinical patient enrollment,

    is an urgent clinical need

    is an urgent clinical need

    In the research and development of innovative drugs, the low-hanging fruit is within reach, but in addition to the advantage of research and development time, the difficulty of the follow-up link is gradually increased, and the progress is slightly slower, and it may not even be able to recruit patients in the clinical link


    The fruit at the top is completely the opposite.


    Under the premise of the interference of factors such as the epidemic and war, Xiweita still successfully completed the recruitment of global phase III clinical patients, mainly because the clinical needs are quite urgent


    When we talk about cervical cancer, the first thing that comes to mind is the HPV vaccine


    The most critical issue is when the vaccine will be available


    According to the above HPV vaccination data, as of 2020, the total number of people who have completed the whole three-shot immunization in China will be less than 10 million


    To increase the vaccination rate is a very long-term project


    In addition to the efficiency of vaccine popularization, coupled with many factors such as difficulty in covering all subtypes, age limit for vaccination, and insufficient production capacity, the HPV virus still plagues women around the world


    There will be differences in different regions, but at present, due to factors such as the late popularization of vaccination in China, the HPV infection rate is higher than the global average
    .
    An epidemiological survey involving 1.
    7 million women in 2019 showed that the HPV infection rate in the total population was 15.
    54% [2]
    .

    Fortunately, cervical cancer caused by HPV infection is a gradual process
    .
    Persistent HPV infection will first lead to low-grade squamous intraepithelial lesions, then advanced to high-grade squamous intraepithelial lesions, and finally it may evolve into cervical cancer
    .

    According to the Expert Consensus on Issues Related to Cervical Cancer Screening and Abnormal Management in China, this cycle usually takes more than 10 years
    .
    That is to say, as long as cervical lesions are detected in time, and cervical lesions, especially high-grade cervical intraepithelial lesions are treated accurately and standardized, cervical cancer can still be effectively prevented
    .

    Unfortunately, for high-risk cervical precancerous lesions, there are currently very limited treatment options worldwide, and only surgery is the only way
    .
    Although surgical treatment is effective, there are three main problems
    .

    First, it is highly invasive and patient compliance is low
    .
    Although the operation is not complicated, it involves excision of diseased tissue, hemostasis and other processes, which will bring physical and mental discomfort to the patient;

    Second, there is a small probability of irreversible side effects
    .
    Surgical treatment has a certain probability of causing organic cervical damage, or further sequelae of reproductive function such as premature birth and miscarriage
    .

    According to a retrospective study of 69 clinical trials worldwide, women who underwent surgery for high-risk cervical precancerous lesions had a doubled risk of preterm birth, reaching 10.
    7% [3]
    .
    For women with reproductive needs, there is a certain psychological pressure on surgical treatment;

    Third, the HPV virus cannot be completely eliminated, and there is still the possibility of residual lesions or recurrence
    .
    The presence or absence of HPV virus residues is mainly affected by the doctor's level and other results
    .
    At present, the problem of residual and recurrence after surgical treatment is a dilemma faced by the world
    .

    A meta-analysis of 97 studies worldwide showed that a total of 44,000 women treated for cervical precancerous lesions who underwent surgery had an overall positive margin of up to 23.
    1%, residual or recurrent CIN2+ (grade 2 or higher precancerous lesions).
    The ratio is 6.
    6% [4]
    .

    The same is true in the country
    .
    Although there is no national data study, according to studies conducted by some hospitals, the conclusions are similar to the above analysis
    .
    For example, a study conducted in Hunan Xiangya Hospital, a top hospital in China, showed that after cervical cold-knife conization, up to 17.
    05% of patients had positive margins, and 2.
    46% of patients found residual/recurrent CIN2+ [5]
    .

    In summary, it is not difficult to find that the limitations of surgical treatment make an effective non-surgical therapy urgently needed in the field of cervical precancerous lesions
    .

    It is also under the urgent clinical needs that as a photodynamic therapy product for high-risk cervical precancerous lesions, the global multi-center clinic can accelerate and complete the patient enrollment goal
    .

    / 02 /

    / 02 /

    Innovative non-surgical treatment methods,

    Innovative non-surgical treatment methods,

    Or become a 5 billion-level single product

    Or become a 5 billion-level single product

    As a photodynamic therapy product, the core principle of Xiweita is to use "the diseased cells that accumulate photosensitizers will generate a large amount of reactive oxygen species under light, and then undergo apoptosis and necrosis" [6]
    .

    To put it simply, what Xiwei has to do is not complicated.
    It is to deliver the drug to the diseased cells and then turn on the light therapy mode
    .

    As shown in the figure below, Xiweita has a simple structure: it consists of a round head for placing ointment and a lighting device
    .
    After the doctor applies the ointment (photosensitizer) to the head of the device, the device can be placed on the patient's cervix
    .

    After completing the above steps, the patient can leave the hospital
    .
    After the diseased cells are fully absorbed, the built-in light source of the product will automatically turn on; after the set duration of illumination is completed, the built-in light source will automatically turn off, and the patient can take out the device by himself, which is easy to use
    .

    Xiwei She can complete the entire treatment process by means of light, which can save the patient's discomfort and worries about surgery, and the effect looks good:

    According to the results of the Phase IIb clinical trial of Silveta, it has a significant therapeutic effect on high-grade squamous intraepithelial lesions, and 76% of patients responded after 6 months of treatment, while the response rate in the placebo group was only 28% [6]
    .

    In addition, it has a clearing effect on all HPV viruses
    .
    After 9 months of treatment with Cevita, the mean clearance rate of HPV virus in patients was 58%, which was significantly higher than the clearance rate of 34% in the placebo group [6]
    .

    Simple and convenient to use, and has high clinical value, it is the endogenous logic supporting the commercialization of non-surgical treatment products for cervical precancerous lesions, while the huge patient demand is the external driving force
    .

    According to data from Frost & Sullivan, the number of patients with cervical precancerous lesions in China has reached 3.
    5 million in 2020
    .
    With the expansion of the screening population for two cancers (cervical cancer and breast cancer) in China and the gradual improvement of the cervical cancer prevention and control system, the detection rate of patients with cervical precancerous lesions is bound to increase further
    .

    According to the prospectus of Asieris, the potential size of this market is 19.
    59 billion
    .
    Especially at present, the problem of population aging is becoming more and more serious, and the state vigorously advocates multiple births and multiple births.
    The "fertility protection" feature of such products coincides with the national population strategy.
    There is room for imagination in terms of entry
    .

    Under the optimistic situation of entering medical insurance and the penetration rate reaching 25%, Xiweita's peak sales in the domestic market alone can reach nearly 1 billion US dollars [6]
    .

    The domestic market is likely to support a blockbuster product.
    If there are players who can break through overseas, it is bound to further open their own ceilings
    .

    / 03 /

    / 03 /

    global market competition,

    global market competition,

    Who can break through first?

    Who can break through first?

    Going overseas is also a market opportunity for non-surgical treatment products for cervical precancerous lesions
    .

    As shown in the figure below, in addition to the United States, there is still much room for improvement in the penetration rate of HPV vaccines in regions around the world, including Europe
    .

    Estimated HPV coverage in 75 Member States in 2019 (Image credit: UNICEF/WHO)

    Taking the European market as an example, coverage has been below 30% in countries where HPV vaccine is paid out-of-pocket (most Eastern European countries) or using a co-payment model (eg France) [7]
    .

    HPV,
    。,,


    。ClinicalTrials.
    gov,,

    Inovio,
    。,
    。,

    ,,
    。,,


    。,、


    。,,,

    ,,
    。,,,,PD-1……

    The core reason behind it is nothing more than that there are no shortcuts for innovative pharmaceutical companies to go overseas, and the clinical location, layout and end point must be aligned with overseas
    .
    And this is an extreme test of the globalization capabilities of pharmaceutical companies, and the challenges can be described as huge
    .

    To truly stand out on the global stage, only a few pharmaceutical companies are destined to succeed
    .
    But it is precisely because of scarcity that those "small" successful pharmaceutical companies are undoubtedly the most worthy of our attention
    .

    source:

    Source: Source:

    [1] "Human Papillomavirus and Related Diseases Report", September 2019, literature link:

    [1] "Human Papillomavirus and Related Diseases Report", September 2019, literature link:

    https://hpvcentre.
    net/statistics/reports/XWX.
    pdf

    https://hpvcentre.
    net/statistics/reports/XWX.
    pdf

    [2] "Guangdong Expert Consensus on the Application of HPV Vaccine to Eliminate Cervical Cancer", September 2021, Literature link:

    [2] "Guangdong Expert Consensus on the Application of HPV Vaccine to Eliminate Cervical Cancer", September 2021, Literature link:

    http://rs.
    yiigle.
    com/CN431274202109/1340029.
    htm

    http://rs.
    yiigle.
    com/CN431274202109/1340029.
    htm

    [3] "Obstetric outcomes after conservative treatment for cervical intraepithelial lesions and early invasive disease", November 2017, literature link:

    [3] "Obstetric outcomes after conservative treatment for cervical intraepithelial lesions and early invasive disease", November 2017, literature link:

    [4] "Incomplete excision of cervical precancer as a predictor of treatment failure: a systematic review and meta-analysis", November 2017, literature link:

    [4] "Incomplete excision of cervical precancer as a predictor of treatment failure: a systematic review and meta-analysis", November 2017, literature link:

    [5] "Treatment strategies for patients with positive surgical margins after cervical cold-knife conization—a 7-year retrospective study in China", March 2021, literature link: https://obgyn.
    onlinelibrary.
    wiley.
    com/doi/ full/10.
    1002/ijgo.
    13683

    [5] "Treatment strategies for patients with positive surgical margins after cervical cold-knife conization—a 7-year retrospective study in China", March 2021, literature link: https://obgyn.
    onlinelibrary.
    wiley.
    com/doi/ full/10.
    1002/ijgo.
    13683

    [6] "Asieris Pharmaceuticals' Prospectus for Listing on the Science and Technology Innovation Board", November 2021, link to literature:

    [6] "Asieris Pharmaceuticals' Prospectus for Listing on the Science and Technology Innovation Board", November 2021, link to literature:

    http://static.
    sse.
    com.
    cn/stock/information/c/202112/5f5df322f3c749459b1ce4f52080bf41.
    pdf

    http://static.
    sse.
    com.
    cn/stock/information/c/202112/5f5df322f3c749459b1ce4f52080bf41.
    pdf

    [7] "Human papillomavirus vaccination coverage, policies, and practical implementation across Europe", February 2020, literature link:

    [7] "Human papillomavirus vaccination coverage, policies, and practical implementation across Europe", February 2020, literature link:

    [8] "National Health Commission: Focus on promoting free HPV vaccination in areas with mature conditions", July 2022, news link:

    [8] "National Health Commission: Focus on promoting free HPV vaccination in areas with mature conditions", July 2022, news link:

    https://baijiahao.
    baidu.
    com/s?id=1738281028682556150&wfr=spider&for=pc

    https://baijiahao.
    baidu.
    com/s?id=1738281028682556150&wfr=spider&for=pc
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