Fight for 10 billion market! The third generation EGFR-TKI market in China will usher in the third

Wen / Linan < br / > recently, Shanghai Ellis Pharmaceutical Technology Co., Ltd(hereinafter referred to as "Ellis") mentioned in the reply report on the audit inquiry letter submitted to the Shanghai stock exchange that the company's efetinib is expected to be approved in the second half of this year, It is expected to become the third generation of EGFR-TKI to be listed in China, after ositini of AstraZeneca and ametini of hausen pharmaceutical< br / >Since 2019, Ellis has completed two rounds of private equity financing, with valuations reaching 4 billion yuan and 4.8 billion yuan respectively< br / > on April 17 this year, according to the information disclosure of the Listing Committee of the science and technology innovation board, the science and technology innovation board has accepted 1.503 billion yuan of capital raised by the Alice IPO planOn May 8, the IPO of Alice's Innovation Board entered the inquiry stageAccording to the data of < br / > < br / >, < br / > < br / / /, efetinib is a kind of EGFR-TKIIt is a kind of small molecule targeting drug independently developed by Ellis, and also the core product under research, which is used for the treatment of advanced non-small cell lung cancer< br / > EGFR sensitive mutations are the most common type of driving gene mutations in NSCLCStudies have shown that EGFR-TKI is the best choice for the treatment of NSCLC patients with EGFR sensitive mutationsUp to now, the drug market has three generations of products on the marketGefitinib, exetane and erlotinib are the first generation egfr-tk1 representatives, afatinib and dakotinib are the second generation EGFR-TKI representatives, the first generation and the second generation EGFR-TKI are the first-line treatment drugs for EGFR sensitive mutation patients with advanced non-small cell lung cancer< br / > according to the market data of frost Sullivan, the scale of China's EGFR-TKI drug market in 2018 is 6.52 billion yuan, which will increase to 18.27 billion yuan by 2023, and the compound annual growth rate from 2018 to 2023 is expected to be 22.9%In 2018, in the EGFR-TKI drug market, the market share of the third generation of EGFR-TKI drugs has reached 38%, the market share of the first generation of EGFR-TKI drugs is 57%, and the market share of the second generation of EGFR-TKI drugs is only 5%< br / > according to the advantages of the third generation EGFR-TKI in EGFR gene mutation positive non small fine second-line treatment and first-line treatment, and with the increase of the number of approved third generation EGFR-TKI drugs, it is expected that the share of the third generation EGFR-TKI in the EGFR-TKI drug market will further increase rapidlyIt is assumed that by 2023, the total market share of all third-generation EGFR-TKI drugs in the EGFR-TKI market will increase to 50% - 60%, corresponding to the market size of the third-generation EGFR-TKI drugs of about 9.14-10.96 billion yuan< br / > in the third generation EGFR-TKI market, it is expected that by 2023, there will be 3-4 domestic original research products and 1 imported original research product (oshitinib) to form a competitive situation Assuming that the domestic products occupy 70% of the market share as a whole, efutinib, as a product expected to be listed as the second domestic original research product, will occupy 30-35% of the market share of the domestic products < br / > < br / > < br / > < br / > < br / / > according to the above assumptions, by 2023, it is expected that efetinib will occupy about 20% - 25% of the third generation EGFR-TKI market, and the terminal sales scale of this product is expected to reach 1.83-2.74 billion < br / > although the market prospect is promising, analysts pointed out that the approved listing of efutinib in the second-line treatment market will directly compete with oshitinib and ametinib, and oshitinib has entered the medical insurance market, and ametinib will face corresponding challenges after its listing due to its advantages in listing first < br / > in April 2020, the Interim Measures for the administration of drugs used in basic medical insurance (Draft for comments) issued by the state medical insurance bureau made it clear that the medical insurance catalogue will establish and improve a dynamic adjustment mechanism, which will be adjusted once a year in principle < br / > for new anti-tumor drugs, due to the high pricing level and heavy economic burden of patients, the accessibility of products will be greatly affected After being included in the medical insurance, although the price has been reduced, the enterprises intend to achieve large-scale, especially the new drug market At present, of the two third-generation EGFR-TKI products that have been listed in China, oshitini has entered the national class B medical insurance < br / > it is worth mentioning that in 2017, oshitinib was approved to be listed, and the sales volume in that year was about 600 million yuan; in 2018, oshitinib's second-line indications entered the medical insurance, and the sales volume in that year was about 2.5 billion yuan, and the sales volume in 2019 is expected to be about 3.8 billion yuan, which will have a sustained and large-scale sales effect after entering the medical insurance < br / > in March 2020, ametinib was approved for listing According to the public information, the price of each box is RMB 19600 (55mg / tablet, 20 tablets / box, once a day, two tablets at a time), and the monthly treatment cost of patients is RMB 58800 At present, ametinib has not entered the medical insurance < br / > in addition, the first and second generation EGFR-TKI drugs that have been listed in China have been included in the national medical insurance catalogue except for dakotini, and the payment price of products that have entered the medical insurance has been reduced to less than 100000 yuan In addition, due to the expiration of the original research patent and the listing of several generic products, gefitinib has been included in the national volume procurement scope, and the annual treatment cost has been reduced to about 10000 yuan As shown in the figure below: < br / > as the core product of Alex, efetinib may need to rely on this product in the short term after being put on the market So it makes a lot of sense for the company to include health insurance In the report, Ellis also revealed that after the approval of the listing, it is expected to apply to enter the medical insurance catalogue through negotiation the next year < br / > Ellis said that if efetinib fails to enter the medical insurance catalog for a long time, or the similar competitive products are covered by the medical insurance catalog, it will be in a disadvantageous position in the market, and its market share and sales revenue will also be affected It's also bad for the company to be included in the medical insurance catalog and transferred out < br / >