14 domestic class 1 new drugs are coming!

Under a series of policies, domestic innovative drugs have ushered in an intensive harvest period.
In 2021, 35 domestically produced Class 1 new drugs (excluding preventive biological products) will be approved for marketing by the State Food and Drug Administration for the first time, and the number of approved varieties will reach a new high.
Explosive growth, anti-tumor drugs still account for the majority, and at the same time brought a number of milestone approvals, including the first CAR-T therapy, the first domestic ADC, the first domestic PD-L1 mAb,
etc.
Today is the 23rd World Cancer Day
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According to data from Minet.
com, the antitumor drug market has expanded year by year in recent years.
In 2020, the sales volume of China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) and Chinese urban physical pharmacy terminals It exceeded 100 billion yuan, and still achieved a growth of 13.
3% under the influence of the epidemic
.
Which anti-tumor drugs are expected to be approved in 2022? According to incomplete statistics, Betta’s befotinib, Yingli Pharmaceutical’s Limplix, Kangfang’s Kadeninumab, Hengrui’s SHR3680… 14 domestically produced Class 1 new drugs are expected to be approved for marketing this year.

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Anti-tumor domestic class 1 new drugs that are expected to be approved and marketed in 2022 Note: With * is included in priority review/special review Source: Minet.
com MED2.
0 China Drug Evaluation Database Over-evaluation King, Qilu is expected to usher in the first class 1 drug As the "king" of domestic consistency evaluation of new drugs, more than 90 varieties of Qilu Pharmaceutical have passed or are deemed to have passed the consistency evaluation, leading other domestic enterprises
.
In recent years, Qilu Pharmaceutical has also been transforming and innovating in research and development.
Yiluoke (WX-0593) is the company's first Class 1 new drug to be declared for marketing
.
WX-0593 is a novel ALK/ROS1 inhibitor, which can inhibit the ALK kinase activity of wild-type and ALK inhibitor-resistant mutants of different fusion types, and can effectively inhibit the activity of ROS1 kinase of different fusion types
.
Study shows that WX-0593 has antitumor activity in ALK-positive or ROS1-positive NSCLC with acceptable safety
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At present, 4 ALK inhibitors have been approved for marketing in China, and they have all been included in the national medical insurance category B catalog through negotiation, including crizotinib (Pfizer, 2013/1), ceritinib (Novartis, 2018/6), Alectinib (Roche, 2018/8) and ensatinib (Betta, 2020/11)
.
According to the data of Minet.
com, the total sales volume of 4 ALK inhibitors in Chinese public medical institutions and Chinese urban physical pharmacy terminals in 2020 will be close to 3 billion yuan, of which the sales of crizotinib and alectinib will exceed 1 billion yuan
.
Sales of some ALK inhibitors in Chinese public medical institutions and physical pharmacies in Chinese cities in 2020 (unit: 10,000 yuan) Source: Minet database Innovative Drug One Brother, the first new drug introduced by Hengrui Medicine, known as "Innovative Drug One Brother" Hengrui Medicine, known as Hengrui Medicine, currently has 10 innovative drugs (9 category 1 new drugs) approved for marketing in China, of which anti-tumor drugs account for "half of the country"
.
In the anti-tumor drug R&D pipeline, SHR3680, which will be declared for listing in November 2021, is a new androgen receptor (AR) antagonist independently developed by the company.
It has stronger inhibitory effect than the first-generation AR inhibitor and has been recognized as a breakthrough therapy.
, priority review and other policy blessings
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At present, 6 AR antagonists have been approved for marketing in the world, of which 4 have been approved to enter the domestic market, including AstraZeneca's bicalutamide, Astellas/Pfizer's enzalutamide, and Xi'an Janssen's Apa Bicalutamide and Bayer's dalolamide, among which bicalutamide has been used for a long time in China, and the rest of the products were approved for import after 2019
.
According to data from Minet.
com, in recent years, the total sales volume of bicalutamide in Chinese public medical institutions and physical pharmacy terminals in Chinese cities has expanded year by year, exceeding 1.
6 billion yuan in 2020, a year-on-year increase of 7.
16%
.
Sales of bicalutamide in Chinese public medical institutions and physical pharmacies in Chinese cities (unit: 10,000 yuan) Source: Minet database For Hengrui Medicine, perhaps what the market is most looking forward to is not the approval of its self-developed SHR3680, but the approval of the market.
Whether the products it authorized to introduce in 2021 will blossom and bear fruit
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In 2021, Hengrui Medicine has reached at least 4 new drug cooperation agreements, one of which is Limplix of Yingli Pharmaceutical
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Limplix is ​​the first domestic PI3kδ inhibitor to submit a marketing application in China, and it was included in the priority review on the grounds of "inclusion in the breakthrough therapy drug program"
.
At present, no drug with the same target has been approved.
Except for Limplix, the marketing application of duenzeb introduced by CSPC is also under review and approval
.
The third-generation EGFR-TKI is hot, and competitions such as CSPC, Betta, Osaikang, etc.
are currently in development of protein kinase inhibitors represented by tinib.
As more and more products are approved for marketing, their market size is also expanding year by year
.
According to data from Minet.
com, in 2020, the total sales of terminal protein kinase inhibitors in Chinese public medical institutions and Chinese urban physical pharmacies will exceed 30 billion yuan, and they will still achieve a growth of 28.
64% under the influence of the epidemic, which shows that the market has huge potential
.
Sales of terminal protein kinase inhibitors in Chinese public medical institutions and physical pharmacies in Chinese cities (unit: 10,000 yuan) Source: Minenet database EGFR-TKI targeted drugs are one of the protein kinase inhibitors
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After more than ten years of development, the global marketed EGFR-TKI targeted drugs are divided into three generations: the first generation drugs include gefitinib, erlotinib, icotinib, etc.
, and the second generation drugs include afatinib The third-generation drugs include osimertinib and almetinib
.
In recent years, the development of third-generation EGFR-TKI targeted drugs has become increasingly popular
.
At present, three third-generation EGFR-TKI targeted drugs have been approved in China, namely AstraZeneca's Osimertinib, Hansoh's Ametinib and Alles' Vometinib, all of which have been included through negotiation.
National Health Insurance Directory
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AstraZeneca's osimertinib's global sales in 2020 will exceed 4 billion US dollars, and domestically, the total sales of this product in Chinese public medical institutions and Chinese urban physical pharmacies will exceed 4 billion yuan in 2020, a year-on-year increase of 54.
33%
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In addition, Ametinib, which was approved for listing in March 2020, also achieved domestic sales of more than 400 million yuan in its first year of listing, with rapid volume growth
.
Sales of osimertinib in Chinese public medical institutions and physical pharmacies in Chinese cities (unit: 10,000 yuan) Source: Betta’s befotinib, Beida/Shiyao’s rizatinib, Osaikang’s The third-generation EGFR-TKIs such as ASK120067 and Avetinib from Essen Pharmaceuticals have been reported for domestic production successively
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The PD-(L)1 monoclonal antibody continues its “involution”, and the first double-antibody product is approaching.
The market for antibody drugs is also rapidly expanding, and it has now become the segment with the highest sales among anti-tumor drugs
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According to data from Minet.
com, in recent years, the sales scale of terminal antibody drugs in Chinese public medical institutions and Chinese urban brick-and-mortar pharmacies has increased year by year, reaching nearly 35 billion yuan in 2020, a year-on-year increase of 45.
09%
.
Sales of terminal antibody drugs in Chinese public medical institutions and physical pharmacies in Chinese cities (unit: 10,000 yuan) Source: Minet database PD-(L)1 monoclonal antibody has become one of the driving forces for the surge in the antibody drug market
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At present, 8 PD-1s and 4 PD-L1s have been approved for listing in China.
In 2020, the total sales volume in Chinese public medical institutions and Chinese urban physical pharmacy terminals will exceed 13 billion yuan
.
Sales of PD-(L)1 mAb in Chinese public medical institutions and physical pharmacies in Chinese cities in 2020 (unit: 10,000 yuan) Source: Minet database In 2022, the competition of PD-(L)1 mAb will continue.
PD-1 such as genusumab of Jiahe Biotechnology, slulimumab of Henlius, and putlimumab of Lepu are expected to be launched.
PD-1 mAb for solid tumor indications
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In addition, PD-L1 such as Zhaoke Pharmaceutical's first-gram injection of limumab and Kelun's tetlimumab are also expected to be approved.

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It is worth noting that Kangfang will lead the competition of double-antibody products.
Its self-developed candonilimab (AK104) is a PD-1/CTLA-4 bispecific antibody, which is the first in the world to be submitted for listing.
The PD-1-based bispecific antibody applied for is also the first bispecific antibody independently developed by a domestic company
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Source: Mi intranet database