The research and development of innovative drugs in the field of breast cancer is becoming more and more intense…< /p>
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April 27, according to the public “Medical Representative” reported that Wang Chi, head of the breast cancer treatment field of Pfizer China Oncology Division, announced to the team that starting from June 1, the sales team in the breast cancer field will implement a new structure /strong>, in order to consolidate Pfizer’s HR+ position in breast cancer.
It is reported that Wang Chi used to work on oncology products at Merck, and will join Pfizer China at the end of January 2022 as the oncology business Head of the Breast Cancer Treatment Area.
Industry insiders pointed out that Pfizer’s major structural adjustment in breast cancer field and its blockbuster targeted drugs—— Aiboxin®( Palbociclib)is closely related to the growing competitive pressure.
The diagnosis and treatment of advanced breast cancer has always been an important challenge in the field of breast cancer. Among the various subtypes of advanced breast cancer, HR+ and HER2- are the most common, accounting for about 60%.
Recent studies have found that CDK4/6 inhibitors are an effective means of treating advanced breast cancer. Palbociclib is the world’s first cyclin-dependent kinase (CDK) 4/6 inhibitor. By inhibiting CDK4/6, it restores cell cycle control and blocks tumor cell proliferation, thereby controlling tumor growth and treating cancer.
It is reported that Palbociclib has been approved for marketing in more than 80 countries and regions around the world.
In 2013, the FDA approved palbociclib for the treatment of advanced breast cancer. Breakthrough New Drugs.
In 2015, the FDA approved palbociclib under the fast-track approval process. for the treatment of advanced breast cancer. Meanwhile, the National Comprehensive Cancer Network (NCCN) guidelines recommend palbociclib combined with an aromatase inhibitor as a first-line treatment for HR+/HER2- advanced or metastatic breast cancer.
In July 2018, palbociclib was approved in China for use in In combination with aromatase inhibitor as initial endocrine therapy in locally early or metastatic HR+, HER2- postmenopausal women with breast cancer. It is the first HR+/HER2- advanced breast cancer targeted therapy drug approved in the Chinese market in the past ten years.
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< strong>In terms of performance, by virtue of its first-mover advantage, palbociclib has a brilliant record and is a leader among Pfizer’s new drugs launched in recent years:
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In 2015, the global sales of piperacillin in its first year of listing reached US$723 million.
In 2016, Palbociclib’s global sales exceeded US$2 billion, making it the world’s best-selling breast cancer drug one.
In 2019, the global sales of piperacillin products exceeded US$4.9 billion.
In 2020, the global sales of piperacillin reached 5.392 billion US dollars.
In 2021, the global sales of piperacillin will reach US$5.437 billion.
It can be seen that the growth rate of Palbociclib will slow down in 2021. The main reasons are:
1)Under good business prospects, more and more Chase and intercept. According to statistics, up to now, a total of 5 CDK4/6 inhibitors have been launched in the world, they are:
Pfizer’s palbociclib (palbociclib, First FDA approval in February 2015)
Novartis’ Ribociclib (first FDA approval in March 2017)
Lilly’s abemaciclib (first FDA approval in September 2017)
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G1 Therapeutics’ Cosela (trilaciclib, first FDA approval in February 2021), introduced by Simcere
- < p>Dersili of Hengrui Medicine (first approved by NMPA in December 2021)
Note: For the approval status of global CDK4/6 inhibitors, please click ➡《The first domestic CDK4/6 inhibitor is on the market, and the melee is imminent! 》
2) Key clinical failure in patients with early breast cancer;Although with its first-mover advantage, Pfizer continued to expand the indications of palbociclib, such as adding an aromatase inhibitor in combination with the initial treatment of HR+ and HER2- male breast cancer patients in 2019< span>Endocrine therapy. Unfortunately, in 2020, the drug failed a key clinical trial in HR+/HER2- early breast cancer patients.
It is worth mentioning that among the 5 CDK4/6 inhibitors approved worldwide, Eli Lilly’s A. Bescilli is Palbociclib’s strongest competitor. Since its listing, Abecili’s sales have grown by leaps and bounds. From 2019 to 2021, it has achieved sales performance of US$580 million, US$913 million and US$1.35 billion respectively, although there is still a market size of over US$5 billion compared to Pipercelli. A big gap, but the growth rate is amazing.
Under the good business prospects, more and more entrants are chasing and intercepting Piperacillin.
“Three times” missed medical insurance, patent cliff approaching
Generic drugs are eyeing, and domestic melee is imminent
In the domestic market, the pressure faced by piperacillin also came directly.
01Competition of innovative drugs
The first is the menacing Abesili.
Palbociclib was approved in China in 2018, and from 2019 to 2021, Palbociclib was not successfully included in the medical insurance.
Abexili was approved in China on December 31, 2020, becoming a domestic market after Palbociclib The second CDK4/6 inhibitor. In 2021, the first negotiated Abecili successfully entered the medical insurance.
It is reported that the prices of Abecili after entering the medical insurance are: 1190 yuan/box (150 mg), 872.48 yuan/box (100 mg) , 513.24 yuan / box (50 mg). Before medical insurance reimbursement, according to different specifications, the monthly treatment cost of Abecili was about 2053-4760 yuan. Since the new medical insurance reimbursement was implemented on January 1, the monthly treatment cost was only 616-1428 yuan, a drop of 70%.
The current news about the price reduction of Palbociclib is only, in early 2021, Pfizer announced that Palbociclib 125ml per bottle The price was lowered from 29,799 yuan to 13,667 yuan, a price reduction of about 54%. It is reported that the patient needs to take it once a day and take a 7-day break after taking it for 21 days, which means that 7 boxes, or 95,700 yuan, are needed for half a year.
In addition to the price threat after entering the medical insurance, the pressure brought by abecici to palbociclib continues to increase.
On January 5, 2022, the new indication of albecilli was approved by the NMPA: combined with endocrine therapy (tamoxifen or aromatization) Enzyme inhibitor) is suitable for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, lymph node positive, high recurrence risk and Ki-67≥20% early stage Adjuvant therapy in adults with breast cancer.
In other words, abeccil will treat breast cancer with a CDK4/6 inhibitorFrom late to early stage, and Pfizer is declaring a pivotal clinical failure in HR+/HER2- early breast cancer patients in 2020.
It is worth mentioning that Abecili is also the first and currently the only drug approved for early breast cancer patients in China. CDK4/6 inhibitors. This new indication was just approved by the FDA in October 2021, and it was approved in China only 3 months later in the world.
In addition, in addition to palbociclib and abexili, Hengrui Medicine’s dalcili has been approved for marketing in China. Taking into account the discounted medicines and other conditions, the price of each box of Dalsili is 13,500 yuan (150mg*21 tablets).
While Novartis and G1/Sincere have submitted applications to the NMPA in 2021 for ribociclib and tralacil.
02Generic competition
In addition to the competition among innovative drugs, many companies are also eyeing the generic drug track of CDK4/6 inhibitors.
It is reported that the patent of palbociclib will expire in 2023, and the generic version of palbociclib of Qilu Pharma has been approved in December 2020. Approved, already gearing up to go on sale.
In addition to Qilu Pharmaceutical, according to the statistics of Minet, so far there are Nanjing Simcere TECO Pharmaceuticals, Jiangsu Hansoh Pharmaceutical Group, Jiangxi Shanxiang Pharmaceutical, Jiangsu Osaikang Pharmaceutical, Sichuan Kelun Pharmaceutical Research Institute; Hunan Kelun Pharmaceutical, Beijing Tide Pharmaceutical, Shanghai Acrono Pharmaceutical, Chongqing Yaoyou Pharmaceutical, Chia Tai Tianqing Pharmaceutical Group and many other domestic enterprises declared 4 types of palbociclib are generically marketed.
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