10 billion HER2 single-anti-market quto bead single anti-biosynthic drugs can usher in spring?

the | Sweet orange curcular bead monoclonal antibody - HER2-positive breast cancer patients with the drug "gold standard" quarto bead monoanti (English name Trastuzumab, the product is named Hessetin ®), is a humanized IgG1 xenon antibody developed by Genetek (Roche's subsidiary), which binds to HER2 on tumor cells and mediates the cytoxic effects of antibody dependence (ADCC).
was approved by the U.S. Food and Drug Administration (FDA) on 25 September 1998, by the European Medicines Agency (EMA) on 28 August 2000 and by the Japanese Medicines Agency on 22 April 2001 Approved by the General Medical Devices Agency (PMDA), it was approved for listing by the China Food and F Drug Administration (CFDA) on September 5, 2002 and is sold by Roche (Genentek in the United States, Chinese and foreign pharmaceuticals in Japan) in the United States, Europe, Japan and China.
curto bead monoantigen as an anti-HER2 monoclonal antibody targeted HER2, by attaching itself to HER2 to prevent the body's skin growth factors on HER2 attachment, thereby blocking the growth of cancer cells, and can stimulate the body's own immune cells to destroy cancer cells, its action factors include: 1) anti-HER2 monoantitor can bind to HER2 extracellular domain, and After binding with the subject, the expression of HER2 was reduced; 2) after binding with HER2, the anti-HER2 monoantitor reduced the downstream medium of PI3K pathway signaling and cell cycle progression, such as cell cycle protein D1;3) anti-HER2 monoantitor not only inhibited her2 signaling pathway, but also triggered an immune-mediated response to HER2 over-expression cells.
figure 1 Hessetin® Mechanism of action Data Source: Research report on the latest Chinese instructions for the retrieval of pyridograms based on pharmaceutical intelligence data to obtain the latest chinese instructions for the release of the adaptive disorder: 1) HER2-positive metastasis breast cancer: metastasis breast cancer that has received one or more chemotherapy regimens as a single drug treatment;
2) Complementary treatment of breast cancer: This single drug is suitable for the complementary treatment of HER2-positive breast cancer after surgery, assisted chemotherapy with cyclocetones and radiotherapy (if applicable).
3) HER2-positive metastatic gastric cancer: This product is combined with capedabin or 5-fluorouracil and cisplatin for patients with HER2-positive metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have not previously received treatment for metastatic disease.
present, qutojudan anti-has been recommended by domestic and foreign breast cancer diagnosis and treatment guidelines for all stages of treatment of HER2-positive breast cancer patients, HER2-positive breast cancer patients throughout the standardized treatment recognized as the "gold standard" drug.
China's breast cancer treatment drug market "mixed" breast cancer is the highest incidence of malignant tumors in women, the peak age of breast cancer in China is 45-54 years old, compared with Europe and the United States about 10 years ahead of the time.
2015, the number of new cases of breast cancer among women in China was 304,000, with a morbidity rate of 45.29 per 100,000 and a mortality rate of 10.50 per 100,000, according to data released by the National Cancer Center in 2019.
3 per cent to 10 per cent of new cases of breast cancer each year, women have a distant metastasis at the time of diagnosis.
even in early patients, 30-40% can develop into late stages, with a five-year survival rate of only 20%.
the diagnosis and treatment of advanced breast cancer in China is very serious.
With the ongoing research on molecular biology of breast cancer, breast cancer can be divided into five molecular subtypes (as shown in the table below): luminal type A, luminal, luminal, according to the four indicators of estrogen-like (ER), progesterone-like (PR), HER2, ki-67 Type B (HER2-negative), tri-negative, HER2-positive (HR-negative), HER2-positive (HR-positive), where her2 over-expressions account for 20%-25% of all breast cancers, which usually have higher clinical and pathological stages and poor prognosis.
data source: CSCO Breast Cancer Guidelines 2020 According to Frost and Sullivan cited in Sansheng National Health's prospectus, China's anti-HER2 single-drug market grew from about 1.4 billion yuan in 2014 to about 3.2 billion yuan in 2018, with a compound annual growth rate of 23.9%.
With the accelerated listing of new breast cancer drugs, the market is expected to reach a market size of about 9.4 billion yuan in 2023, with a compound annual growth rate of about 23.9% from 2018 to 2023, and will continue to grow from about 5.3% in 2023 to about 13.6 billion yuan in 2030.
is shown in the figure below.
Figure 2 2014-2030E China anti-HER2 single anti-drug market size Picture: Sansheng National Health Science and Technology's original listing prospecto China Quto Zhudan anti-bio-similar drug competition pattern according to the search, at present, only 1 Fuhong Hanyu research and development of Quto Zhudan anti-bio-similar drugs have been approved for listing, it is worth noting that Sansheng Guojian developed the recombinant anti-HER2 humanized monoclonal antibody Inito monoantigen antibody has also been approved for listing in 2020, but according to the contents disclosed in Sansheng Guojian's prospecto, it does not belong to the biosynthic drug of Quto Zhudan, therefore, the following table is the specific information of the biosynthic drug developed by Fuhong Hanxuan.
data sources: public information in addition, a total of 7 biosypolytic drugs in china are in the phase III clinical progress, the progress of the remaining biosypolytic drugs is shown in the table below.
data sources: drug clinical trial registration and information publicity platform, drug intelligence data market access policy is good, bio-similar drugs will usher in the spring qutozhu single resistance in 2017 negotiations into the National Health Insurance Category B directory, the price per unit from 24,500 yuan to 7600 yuan, a drop of 69%, and in November 2018 was approved to be included in the national basic drug catalog.
In 2019, the price per unit was reduced from 7,600 yuan to 5,500 yuan, while limiting payment for HER2-positive metastatic breast cancer; 2) assisted and newly assisted treatment for her2-positive early breast cancer patients, paid no more than 12 months; and 3) HER2-positive metastatic gastric cancer patients.
As of January 27, 2021, China has been approved and sold only the original research drug Hercetin ® and in 2020 by Fuhong Hanxuan developed China's first listed Qutozhu single anti-biological similar drugs, the latest winning price is shown in the table below.
data source: Pharmaceutical intelligence data in addition, according to the State Health Insurance Administration held on July 15-16, 2020 on biological products (including insulin) and Chinese medicine centralized procurement to listen to expert opinions and suggestions of the symposium can be found that at present, some mono-resistant varieties already have "1 original research and 2 imitation" of the collection conditions, may be the first to choose this part of the varieties for the centralized procurement of biological drugs pilot.
It is worth noting that the current only original research drugs and fuhong Hanyu biosynthic drugs approved for listing in China, the competitive landscape is not expected to change within two years, so it may take some time to enter centralized procurement, and with most of the single anti-drugs negotiated into the health insurance catalog, as well as the listing of bio-similar drugs, the price has dropped significantly, based on monoantigens relative to chemical drugs have higher production costs, even if into centralized procurement, the possibility of significant price reduction is not great.
In accordance with the notice of the Clinical Trial Guidelines for Injection Qutoju monobial-like drugs issued by CDE on July 20, 2020, a bridital clinical effectiveness ratio study may be conducted for foreign-listed quercepto-bead monobial-like drugs, if applied for domestic listing.
therefore, if querceton monobial-like drugs have been approved for sale abroad, clinical trials in China may be progressing slightly faster than similar bio-like drugs that are not available abroad.
In summary, the competition pattern of qutojudan anti-biosimisants is more crowded, the competition is more intense, but the treatment position of qutoju single anti-drug in domestic breast cancer is relatively stable, the overall domestic market space is huge, in addition, the current gastric cancer HER2 detection needs to continue to promote, qutoju single anti-gastric cancer treatment there is still a lot of market penetration space.
after entering the medical insurance, bio-similar drugs do not need too much academic promotion, can be described as opportunities and challenges coexist.
: 1. Sansheng Guojian Pharmaceuticals (Shanghai) Co., Ltd. Prospection 2. Guidelines and Guidelines for breast cancer diagnosis and treatment of the China Anti-Cancer Association (2019 edition) 3. Overview of resistance to systemic therapy in patients with breast cancer4. Sullivan: Innovative Pharmaceuticals Market Research Report (above)