Is CDK4/6 inhibitor the next golden track in the field of breast cancer?

Text | MU

Recently, Eli Lilly Pharmaceuticals announced that its new breast cancer drug CDK4/6 inhibitor Abbexili Tablets (trade name: Weise) have been successfully launched in my country.

Breast cancer is known as the "pink killer" and is the most common type of cancer among women.

The "upstart" in the field of breast cancer treatment-CDK4/6 inhibitors

Cyclin Dependent Kinase (CDK) is a key kinase involved in cell cycle regulation.

Chart 1 Mechanism of action of CDK4/6 inhibitor

Source: Public information, Zhongkang Industrial Capital Research Center

Especially in the field of HR+/HER2- advanced breast cancer treatment, the advent of CDK4/6 inhibitors has led the field from the era of endocrine therapy to a new era of targeted combined endocrine therapy.

At present, in the "Chinese Society of Clinical Oncology (CSCO) Breast Diagnosis and Treatment Guidelines (2020 Edition)", "China Advanced Breast Cancer Standardized Diagnosis and Treatment Guidelines (2020 Edition)" and the latest version of the NCCN Guidelines, CDK4/6 inhibitors (CDK4/6i) The level of evidence of combined endocrine therapy has been upgraded from level II to level I, and it has become the first-choice treatment recommendation for patients with hormone receptor positive/HER2-negative (HR+/HER2-) advanced breast cancer.

Global market: CDK4/6 inhibitors are expected to contribute 20 billion in breast cancer by 2029

In terms of market size, according to Nature Reviews Drug Discovery, the total breast cancer market in 2019 was US$20.

Figure 2 Major market sales of key breast cancer treatments estimated by drug category (including forecasts for the seven major markets of the United States, France, Germany, Italy, Spain, the United Kingdom and Japan for 2019-2029)

Source: Nature Reviews Drug Discovery, Zhongkang Industrial Capital Research Center

In 2020, the global CDK4/6 inhibitor market will reach US$6.

Among them, Pfizer's piperacillide, as the first CDK4/6 inhibitor drug to be marketed, has an obvious first-mover advantage, especially in the years when it was marketed, the limelight was once close to Herceptin (Herceptin).

Figure 3 Annual sales of three CDK4/6 inhibitor drugs that have been on the market worldwide (100 million US dollars)

Source: Pfizer, Novartis, Eli Lilly's annual reports, Zhongkang Industrial Capital Research Center

Compare the above three listed CDK4/6 inhibitor drugs for breast cancer treatment.

From this point of view, Abexili seems to be slightly better than pipexili.

Chinese market: Pfizer loses market "exclusive rights", CDK4/6 inhibitor drug melee is about to start

In the domestic CDK4/6 inhibitor drug market, Pfizer's piperacillil is also the dominant player.

As there is no direct competitor in the field of this type of therapy, the market size of piperacillil has been rapidly increased.

Chart 4 Aiboxin’s sales in retail pharmacies (excluding in-hospital self-funded pharmacy channels) and grade hospitals (second and tertiary hospitals) (million yuan)

Source: Zhongkang CMH, Zhongkang CHIS Kaisi System, Zhongkang Industrial Capital Research Center

However, starting this year, competing products of piperacillil will land on the market one after another, and Pfizer will lose its "exclusive right" in the CDK4/6 inhibitor drug market.

On the one hand, Eli Lilly’s Abexicil has already been approved for listing in my country.

Figure 5 Status of some domestic CDK4/6 inhibitors under development

Source: CDE, Zhongkang Industrial Capital Research Center (Note: Hengrui's SHR6390 has a number of clinical trials, the above figure only takes two of the progress in clinical phase III)

On the other hand, the Chinese compound patent of pibacillil will expire on January 10, 2023, when the generic drug army will soon enter the market.

In this regard, Pfizer has also taken measures-in January this year, Pfizer announced that the price of per bottle of piperacillil was reduced from 20,000 to 30,000 yuan to about 10,000 yuan (specification 125mg, from 29,800 yuan to 13,667 yuan; specification 100mg , Dropped from 25,120 yuan to 11,521 yuan; the specification was 75 mg, from 20155 yuan to 9,244 yuan), the price reduction reached 54%, and the aid medicine project was cancelled.

Conclusion

In the past 5-10 years, significant progress has been made in anti-cancer targeted drugs and immune drugs.
Among them, CDK4/6 inhibitors are one of the hottest targeted drugs, especially for HR+/HER2- advanced breast cancer patients, this is an extremely important drug.
Of the four CDK4/6 inhibitors on the global market, three are targeted at breast cancer, and the fourth makes it possible for such drugs to expand other tumor indications, giving people more room for imagination.
In the Chinese market, although the second CDK4/6 inhibitor has just been launched, the future competitive landscape is foreseeable.
If it cannot be listed in the past two years and enters medical insurance, it is likely to be submerged in the domestic me too innovation.
The double encirclement and suppression of drugs and generic drugs has opened up a competition for the price of cabbage.