15 drugs have been restricted, and the 26 billion market is making waves again!

Medical Network News on August 13 Recently, 15 protein kinase inhibitors were included in the restricted-use list, causing heated discussions
.
According to data from Meinenet, in recent years, the size of protein kinase inhibitors in the terminal market of public medical institutions in China has maintained a double-digit growth, exceeding 26 billion yuan in 2020, a year-on-year increase of 29.
79%
.
The sales of TOP10 brands all exceeded 1 billion yuan.
Osimertinib led the way with sales of more than 3.
8 billion yuan.
The sales of pyrrotinib increased by 134.
54%.
Anlotinib surpassed apatinib for the first time
.
Since 2020, there are 7 new protein kinase inhibitor drugs approved by local companies, and 6 companies including Qilu Pharmaceutical, Hengrui Pharmaceutical, and Betta Pharmaceuticals are under review for the listing of Class 1 new drugs
.

Anti-tumor drugs are graded and restricted! 15 protein kinase inhibitors were on the list.

Recently, the Guangdong Pharmaceutical Association issued the "Guiding Opinions on the Classification of Anti-tumor Drugs in Medical Institutions of Guangdong Province", which clearly stated that it meets the requirements of "large toxic side effects, less than three years of listing, and a monthly fee of more than 15,000 yuan.
"Oncology drugs that are one of the three major conditions will all be included in the ranks of restricted drugs
.
Being included in the ranks of restricted drugs means that the qualifications of prescribing doctors, medication supervision, and the proportion and amount of medications will be strictly restricted
.
In principle, the anti-tumor drug classification management list is adjusted once a year.
This time, a total of 78 drugs have been included in the "Guangdong Province Medical Institutions' Anti-tumor Drug Classification Management Restricted Use Level Reference List"
.
Among them, immunosuppressive agents, protein kinase inhibitors, monoclonal antibodies, antimetabolites, alkylating agents, plant alkaloids and other anti-tumor drugs are involved
.
As a hot research and development area, protein kinase inhibitors (tinib drugs) and monoclonal antibodies bear the brunt, with as many as 15 drugs on the list
.
Sources of protein kinase inhibitors included in restricted-use management: Guangdong Pharmaceutical Association and Minenet database include 15 protein kinase inhibitors, including domestically produced sunitinib malate capsules and piperacillil capsules, as well as in 2021.
Gerritinib fumarate tablets and vometinib mesylate tablets approved for marketing
.
Among foreign companies, Novartis listed as many as 3 protein kinase inhibitors, while Roche has 2; among local companies, innovative drugs/traditional leading companies such as BeiGene, Hausen Pharmaceuticals, and Qilu Pharmaceuticals all have products involved
.

　　Soaring 30% ! The 26 billion tinib drug market TOP10 exposure.

Tinib, a tyrosine kinase inhibitor, is a small molecule protein kinase inhibitor that can block one or more protein kinases
.
The enthusiasm of domestic pharmaceutical companies for the research and development of tinib drugs is indispensable for the huge market potential behind it
.
According to data from Meinenet, in recent years, protein kinase inhibitors have maintained double-digit growth in the terminal market of Chinese urban public hospitals , county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions).
From over 6 billion yuan to over 26 billion yuan in 2020, the five-year compound growth rate exceeds 33%
.
Sales of terminal protein kinase inhibitors in public medical institutions in China (unit: 10,000 yuan) Source: Menet.
com Among the top 10 protein kinase inhibitor brands in the terminal competition landscape of public medical institutions in China, 10 brands have sales of more than 1 billion yuan.
Aspen Likang and Hengrui Pharmaceutical each have two brands on the list
.
AstraZeneca’s osimertinib topped the list with sales of more than 3.
8 billion yuan, and Chia Tai Tianqing’s anlotinib surpassed Hengrui Pharmaceutical’s apatinib for the first time and ranked second.

.
The top 10 end-point protein kinase inhibitor brands in China's public medical institutions in 2020.
Source: Meinenet China's public medical institutions' end-point competition pattern.
From the perspective of sales growth rate, the sales growth rate of five brands exceeds 50%.
Hengrui Medicine's pyrrotinib Sales increased by as high as 134.
54%, and Johnson & Johnson's Ibrutinib also achieved an 80% increase
.
Sales of the four brands showed negative growth.
AstraZeneca’s gefitinib sales fell 31.
55%, and Novartis’s imatinib sales fell 16.
14%
.
It is worth mentioning that gefitinib and imatinib are the first batch of collected varieties
.
Currently, protein kinase inhibitors only two TOP10 brand products are included in "medical institutions in Guangdong anti -tumor drugs limit the use of hierarchical management level reference list", respectively, Novartis imatinib, erlotinib Johnson Ibrahimovic
.

　　7 new drugs approved! Hengrui, Qilu, Betta.
.
.
Class 1 new drugs .
According to Luminet.
com, there are 7 new class 1 protein kinase inhibitor drugs approved by
local companies since 2020, and 4 of them were approved in 2020, including Nuo Cheng Jianhua’s Obatinib, Hausen Pharmaceutical’s Ametinib, Betta Pharmaceuticals’ Ensatinib, BeiGene’s Zebutinib; 3 of them have been approved since 2021, including Hutchison Volitinib from Pharmaceuticals, Donafinil from Zejing Pharmaceuticals, Vometinib from Iris
.
The approval status of protein kinase inhibitors by domestic companies since 2020.
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database.
At present, there are a total of 6 domestic companies’ protein kinase inhibitor class 1 drug listing applications under review, including Qilu Pharmaceutical and Heng Swiss pharmaceutical, Beta Pharma, Eisen biology
.
Yiluok Tablet (WX-0593) is a new type of ALK/ROS1 inhibitor, and it is Qilu Pharmaceutical's first Class 1 new drug submitted for marketing.

.
Sources of local companies whose applications for protein kinase inhibitors are under review: Meinenet MED2.
0 Chinese drug review database Beida Pharmaceuticals has already approved two tinib drugs such as Icotinib and Ensatinib for marketing.
Fortinib is the company's third Class 1 new drug to be produced
.
Befortinib is a third-generation EGFR-TKI that targets the T790M mutation, and Avitinib under review by Aisen Biotech is also the third-generation EGFR-TKI
.
At present, two domestic third-generation EGFR-TKIs have been approved for listing in China, namely Ametinib and Vometinib
.
Hengrui Medicine has also approved two new tinib drugs, including apatinib and pyrrotinib
.
SHR6390 tablet is an oral, highly effective and selective small molecule CDK4/6 inhibitor, and its marketing application has been included in the priority review
.
At present, two innovative CDK4/6 inhibitor drugs have been approved for the market in China, namely Pfizer’s piperacillil and Eli Lilly’s abbesili.
SHR6390 tablets are expected to become the first domestically produced CDK4/6 inhibitor innovative drugs
.