Domestic EGFR inhibitors "kill" intensified!

On June 13, Junshi Biotechnology (0187HK; 68818SH) announced that the clinical trial application of its fourth-generation EGFR inhibitor WJ13404 tablets (codenamed JS113) was approved, which is intended to be used in EGFR-mutant non-small cell lung cancer and other Treatment of solid tumo.

On June 15, Hansoh Pharma (0369HK) announced that its self-developed domestic first approved third-generation EGFR-TKI ametinib was approved by its partner EQRx, I.

On June 16, according to CDE's official website, Qilu Pharmaceutical's fourth-generation EGFR inhibitor QLH11811 was first applied for clinical tria.

It can be seen that from the vigorous local research and development to the race against time to go overseas, a new round of "fighting" storm of domestic EGFR inhibitors seems to be on the w.

Continuous iterative upgrade

Domestic EGFR inhibitor competition has intensified

EGFR is a group of cell surface receptors of the epidermal growth factor family with tyrosine kinase activity, consisting of an extracellular ligand-binding domain, a transmembrane domain, and an intracellular domain with a tyrosine kinase doma.

Since EGFR has the highest mutation rate among NSCLC patients with non-small cell lung cancer, EGFR has become one of the main targets for the treatment of non-small cell lung canc.

It is reported that EGFR mutations are the main lung cancer gene mutations in the Asian populati.

At present, the first, second and third generation EGFR inhibitors have been launched in China since 2005: erlotinib, gefitinib, icotinib, afatinib, dacomitinib, osimertinib Ametinib, Ametinib, Fumetin.

Today, the focus of competition in the market is mainly on the third-generation EGFR inhibitors——

Domestic third-generation EGFR-TKI market

Data sources: corporate announcements, public information collation

AstraZeneca Osimertinib:

Three indications have been approved in China, two of which are covered by medical insurance, and the price has dropped from 51,000 yuan/box/month to the highest reimbursement by medical insurance, and the patient is only responsible for 1,674 yuan/box/mon.

Since its first approval in China in 2017, osimertinib has been approved for three indications in China:

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.

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Among them, two indications a and b have been successively entered into the national medical insurance in the past few yea.

From a price point of view-

In 2017, the listing price of Osimertinib in China was 51,000 yuan/box/mon.

In 2018, the indication of osimertinib for second-line treatment of EGFRT790M-mutated non-small cell lung cancer patients entered the National Medical Insurance, from 51,000 yuan/box/month to 15,300 yuan/box/mon.

In the 2020 National Talk, the first-line treatment of osimertinib for EGFR mutation in advanced non-small cell lung cancer was also included in the medical insurance, which was further reduced to 5580 yuan/box/mon.

At the end of 2021, the new indication (c) of osimertinib was not successfully entered into the national medical insurance, and the price remained unchang.

Now that the medical insurance negotiation in 2022 has kicked off, can osimertinib be included in the medical insurance for the new indications in this year's medical insurance negotiation? Will there be further price cuts? become the focus of market attenti.

Hansoh Pharma Ametinib:

Three indications have been approved in China, one of which is covered by medical insurance;

After the price dropped from nearly 30,000/month (3 boxes) to the highest reimbursement by medical insurance, the patient was only responsible for 3,168 yuan/month (3 boxe.

At present, the listing application in the UK has been accepted, and it is expected to become the first domestic product of its kind to successfully go overse.

       Since its first approval in 2020, Ametinib has been approved for two indications in China:

      .

Adult patients with locally advanced or metastatic non-small cell lung cancer who have previously had disease progression during or after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) and who have been confirmed to have EGFR T790M mutation-positive disea.

      .

First-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21L858R substitution mutati.

       In 2021, the medical insurance negotiation of almetinib (the above-mentioned indication a) was successf.

The price was reduced from 9800/box/55mg*20 tablets, and the monthly fee was close to 30,000 (3 boxes) to 3520 yuan/55mg*20 table.

The monthly cost is 10,560 yuan (lower than the price of Osimertinib’s previous second-line treatment into medical insurance: monthly fee of 15,300 yuan), after reimbursement of up to 70% of medical insurance, the patient is only responsible for 3,168 yuan/month (3 boxe.

       From the perspective of sales scale, Ametinib was approved for listing in March 2020, and the sales volume in the first year after listing reached 700 million yuan, and it will exceed 5 billion yuan in 202 After the second-line treatment indications enter medical insurance in 2021, heavy volume growth is expected in 202 Earlier at the 2020 annual performance investor meeting of Hansoh Pharma, the management expressed confidence that Ametinib will achieve sales of 5 billion in three years after being included in the medical insuran.

       Now that the medical insurance negotiation in 2022 has kicked off, the first-line treatment of almetinib (the above-mentioned b indication) will definitely hit the medical insurance catalogue this ye.

       It is worth mentioning that Ametinib is the first domestic original third-generation EGFR inhibitor and the world’s first third-generation EGFR-TKI with a median progression-free survival (mPFS) of more than 1 year (second-line us.

       In July 2020, Hansoh Pharma entered into a strategic cooperation and license agreement with EQRx Corporation, granting EQRx an exclusive license to develop, manufacture and commercialize the former's third-generation EGFR-TKI ametinib (and any product containing or consisting of Aramcotinib) outside Chi.

products consisting of tinib) in the therapeutic areas of cancer, cancer-related and immune-inflammatory diseas.

The transaction is for an initial payment, registration and development milestone payments of approximately $100 milli.

       In May 2022, the phase III AENEAS clinical study of almetinib was published online by JCO, an internationally renowned oncology journal "Journal of Clinical Oncolog.

       Based on the phase III AENEAS clinical data of almetinib published by JCO, in June 2022, the marketing application submitted by almetinib in the UK was approved, indicating that the domestic original third-generation EGFR inhibitor is expected to officially enter the overseas market so.

       Allis Pharma Fumetinib

       One indication has been approved in China, and the medical insurance negotiation will be successful in 2021;

       After the price is reduced from 16,000 yuan/box/month to the highest reimbursement by medical insurance, the patient is only responsible for 2,124 yuan/month (3 boxe.

       New first-line indications are expected to be approved in China soon, with over 800 million US dollars going overseas

       In March 2021, fumetinib was approved for marketing in China, and the approved indications are:

      .

For locally advanced or metastatic non-small cell disease with disease progression during or after previous epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy and confirmed by testing to be positive for the EGFR T790M mutation Treatment of adult patients with lung cancer (NSCL.

       Fumetinib is the second domestically approved third-generation EGFR inhibitor, and at the end of the same year of approval, the price was reduced by 79% and entered the new version of the medical insurance catalogue, from 16,000 yuan per box (40mg * 28 capsules) to 3,304 yuan For each box (40mg*28 capsules), the monthly treatment cost is about 7080 yuan, and the patient is only responsible for 2124 yuan/month after reimbursement by medical insurance up to 7

       In December 2021, Ellis submitted a new application for the first-line treatment of EGFR-mutant NSCLC with fumetinib, and officially entered the first-line treatme.

       The first-line treatment indications of vormetinib have been included in the breakthrough therapy program by C.

Whether it can be approved recently and catch up with the last train of medical insurance negotiation this year has become the focus of the mark.

       In terms of commercialization -

       After being approved for marketing in March 2021, the sales revenue of fumetinib in 2021 will be 236 million yu.

       Currently in the domestic market: In April 2022, Ellis granted Fosun Pharma the exclusive promotion right in the broad market to accelerate the omni-channel commercial layout and market coverage of Fumetin.

       In foreign markets: In July 2021, Ellis reached an exclusive licensing cooperation agreement with ArriVentBiopharma in the United States with a total amount of more than 800 million US dollars, and authorized the exclusive development and commercialization license rights of fumetinib in the world excluding mainland China, Hong Kong, Macao and Taiw.

To the company, successfully go to s.

       summary

       On the whole, with the launch of domestic original third-generation EGFR inhibitors such as almetinib and fumetinib, it has impacted the dominant market position of osimertinib, coupled with the role of the medical insurance payment system, and now domestic patients have third-generation EGFR inhibito.

The treatment cost of inhibitors has dropped from hundreds of thousands to a minimum of 20,000 yuan per year for patien.

This year is expected to usher in a new round of price reductions, and patients are undoubtedly the biggest beneficiari.

       However, the competition of domestic EGFR inhibitors is still intensifying, and enterprises will surely usher in more fierce and cruel competiti.

       In the competitive market of third-generation EGFR inhibitors, Betta Pharmaceuticals’ befotinib, Osaikang ASK120067 tablets, Sanhe Pharmaceutical’s ouritinib, CSPC/Beidarezetinib and other products have been accepted for marketing applicatio.

, have competed for the third domestic third-generation EGFR inhibitor seat, and there are more than ten companies under resear.

       It is worth mentioning that, as the first domestically produced third-generation EGFR inhibitor to be declared for marketing, Avitinib of Aisen Pharmaceuticals, which lasted for 4 years, was finally rejected for approval on May 19, 202

       In the competitive market of fourth-generation EGFR inhibitors, the fourth-generation EGFR inhibitors of Junshi and Qilu have achieved clinical progress respectively, and the fourth-generation EGFR inhibitors of Betta Pharmaceuticals, Chia Tai Tianqing, and Hansen are also in full swi.

In the process, a new round of "fighting" storm is about to emer.

       In addition, in addition to the direct competition of similar products, combination regimens, monoclonal antibodies, dual antibodies, and ADCs are also exploring the efficacy of EGFR-TKI resistance, and the competition in this track has become fier.