Osaikang, Chia Tai Tianqing... New anti-bacterial drugs will "blow out"

On March 16, Osaikang announced that the company's clinical application for ASK0912, a class 1 new drug for injection, was accepted.
This new drug is the first new systemic antibacterial drug to be declared this year
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In the past 2021, the systemic antibacterial drug market has ushered in a blowout period for new drugs to be launched
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As a commonly used drug, systemic antibacterial drugs have become the "regular customers" of national procurement.
The number of products that have been reviewed so far is close to 100, and 29 products have been included in the first five batches of national procurement (excluding insulin special) products.
Seven batches are also eyeing 12 best-selling products.
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Under the general trend of competition for new products and centralized procurement and price reduction, this 100 billion market is accelerating the reshuffle
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The 100 billion market is on fire! Class 1 new biological drugs and new compound drugs are coming Table 1: New systemic antibacterial drugs approved for marketing in 2021 , a number of Class 1 new drugs have been approved for marketing, among which Contezolid Tablets, Levoornidazole Phosphate Disodium Phosphate for Injection, Neinofloxacin Malate Sodium Chloride Injection have successfully entered the medical insurance catalogue.
In addition, there are improved New drugs have been approved for marketing, adding color to the 100 billion market
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Table 2: Some of the new systemic antibacterial drugs that were first declared and approved for clinical use in 2021 Source: CDE official website In terms of new drug clinical practice, many new systemic antibacterial drugs that were first declared and approved for clinical use in 2021 are also eye-catching
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SPR206 (EVER206 for injection) is a new-generation polymyxin drug for intravenous injection.
Genting Xinyao signed a licensing agreement with Spero in January 2019.
The company has developed, Exclusive rights to manufacture and commercialize SPR206
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According to data from Minet.
com, Phase I clinical trials of the new drug are currently underway.

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XNW4107 for injection of Suzhou Sinovec is a new type of β-lactamase inhibitor.
Preclinical data show that the new drug has strong killing ability against Gram-negative bacteria, and is also effective against Acinetobacter baumannii and Pseudomonas aeruginosa.
Bacteria and Enterobacteriaceae are effective at the same time, and the antibacterial effect is better than the existing similar products in the market or clinical stage
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Xingmeng Bio's recombinant anti-Staphylococcus aureus toxin humanized monoclonal antibody injection is a new class 1 biological drug.
Currently, there is no monoclonal antibody for Staphylococcus aureus infection in the world
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In terms of improved new drugs, pediatric cefuroxime axetil dry suspension (microsphere) is a children's drug, and only one company has declared it
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In 2020, in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) terminals, cefuroxime is a large variety of antibacterial drugs with a value of over 5 billion, and microsphere preparations are the most popular in recent years.
One of the most popular research and development dosage forms
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YK-1169 and TQD3606 for injection are new compound preparations containing known active ingredients, and both new drugs are currently in Phase I clinical trials
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According to the clinical trial publicity data, it is speculated that YK-1169 may contain cefepime and avibactam, while Chia Tai Tianqing Pharmaceutical Group's TQD360 for injection may contain meropenem and avibactam
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Avibactam is a new type of β-lactamase inhibitor, which can greatly improve the antibacterial activity of cephalosporin products.
Currently, the avibactam compound preparations listed in the domestic market include ceftazidime and avibactam sodium for injection
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ASK0912, a class 1 new drug for injection that will be submitted for clinical application in 2022, is a project jointly developed by the Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences and Osaikang.
It has broad-spectrum activity against Gram-negative bacteria (G-) with severe clinical drug resistance An in vitro and in vivo efficacy study showed stronger antibacterial activity than polymyxins B and E, and reduced toxicity
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Osaikang currently has a number of products on the market in the field of systemic antibacterial drugs, including tigecycline for injection, daptomycin for injection, polymyxin E sodium mesylate for injection, etc.

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Kelun, Jichuan, Puli.
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impacted the first imitation, and many blockbuster products will enter the "scuffle".
In 2021, 84 new approvals in the field of systemic antibacterial drugs have been approved, involving 63 products (product name + enterprise) Among them, the ceftazidime/5% glucose injection of Hunan Kelun Pharmaceutical and the ceftazidime avibactam sodium for injection of Qilu Pharmaceutical are the first domestic imitations, and the products approved by more than 5 companies are moxifloxacin hydrochloride tablets, levofloxacin slice
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Ceftazidime/5% Dextrose Injection for Injection is the first powder-liquid dual-chamber bag product of Kelun.
It can be opened, mixed and used immediately in clinical use.
It is easy to operate and can effectively avoid the risk of mismatch and contamination during the configuration process.
Save configuration time, especially suitable for rapid treatment in emergency
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According to data from Minet.
com, in 2020, the sales of ceftazidime in public medical institutions in China will exceed 5 billion yuan
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The original pharmaceutical company of ceftazidime and avibactam sodium for injection is Pfizer, with global sales of more than 400 million US dollars in 2021.
Qilu will apply for listing in 2019 as a class 3 imitation, and will win the first imitation in October 2021
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Table 3: From 2020 to the present, the products that have been declared for listing and are under review, and are expected to win the first imitation
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Among the more than 200 acceptance numbers reported for production in 2020 and under review, 10 products involved have not yet been approved for domestic generic drugs, and all of them are expected to win approval in 2022
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Cefdinir Granules for Children, Linezolid Dry Suspension, Pediatric Faropenem Sodium Granules, Amoxicillin Sodium Clavulanate Potassium for Injection (10:1), Cefoxitin Sodium/Sodium Chloride Injection for Injection, Cefoxitin Sodium/Glucose Injection for Injection Currently, only 1 company has applied for imitation listing, and relevant companies are more likely to be approved for the first imitation
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The generic application of oral and injection of tedizolid is extremely intense.
This variety is a derivative of linezolid.
The main advantage is that it can be used once a day for six days, which is more convenient than twice a day for ten days of linezolid.
Injections and tablets The drug can be switched clinically, reducing the hospitalization time of patients, thereby reducing the cost.
The original research drug was approved to enter the domestic market in 2019
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Table 4: Products declared for listing and under review since 2020, involving more than 5 companies Source: Minet.
com MED2.
0 China Drug Evaluation Database There are more than 5 companies that have applied for production of each product and are under review, among which moxifloxacin hydrochloride sodium chloride injection and linezolid glucose injection are all over 1 billion products, and the number of companies that have been approved for listing is also more than 10.
, but it still attracts many companies to enter the market.
It is foreseeable that the competition of the above-mentioned products will be more intense in the next few years
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Hundreds of products have been reviewed! 6 varieties of over 1 billion will enter the low-profit period.
Representative 5: The first five batches of systemic antibacterial drugs included in the country.
Source: Mi Neiwang MID Drug Index Comprehensive Database Mi Nei.
The number of products reached 96 (according to the product name), five batches (excluding insulin special) have been carried out by the national procurement, and each batch involves this category, both the number of products and the number of winning bidders have gradually increased The situation of systemic antibacterial drugs, which are commonly used drugs, will be a frequent visitor to the country
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Table 6: Systemic antibacterial drugs to be included in the seventh batch of nationally sourced antibacterial drugs Source: Minet.
com MED2.
0 Chinese Drug Evaluation Database Clindamycin’s sales in China’s public medical institutions exceeded 2.
5 billion yuan in 2020.
Earlier Clindamycin hydrochloride capsules have entered the second batch of national procurement catalogues, and the clindamycin phosphate injection that will be included in the new batch of catalogues has been reviewed by more than 10 companies, and the competition is fierce; cefaclor will be listed in Chinese public medical institutions in 2020 The terminal sales exceeded 1.
6 billion yuan.
Earlier, cefaclor capsules have entered the third batch of national procurement catalogues.
There are 5 companies that will be included in the new batch of cefaclor oral liquids that have been reviewed, and the competition is relatively moderate
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In addition, 6 more than 1 billion varieties were included in the national harvest for the first time
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In 2020, the sales of meropenem in China's public medical institutions will exceed 5.
5 billion yuan.
Japan's Sumitomo leads the market with over 40% of the market share.
There are currently 7 companies that have been evaluated and can take the opportunity to "replace the original research"
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Among the companies that have been evaluated, Shenzhen Haibin Pharmaceutical and CSPC Ouyi Pharmaceutical account for more than 10%, and the market share of other companies is not too high
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In 2020, the sales of cefixime in public medical institutions in China exceeded 3 billion yuan, and Baiyunshan Pharmaceutical Factory accounted for 47.
02%.
The company's cefixime capsules and cefixime granules have been reviewed; Chengdu Better Pharmaceuticals It is the TOP2 enterprise of this variety, with a market share of more than 10%.
The company's Fixoxime Dispersible Tablets and Cefixime Capsules have been reviewed
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In 2020, the sales of ornidazole in China's public medical institutions exceeded 2.
4 billion yuan.
Sichuan Kelun Pharmaceutical leads the market with 45.
25%.
The company's ornidazole tablets have been reviewed, and the market share of other companies that have been reviewed is not considered.
It is too high.
If you want to turn around with the help of centralized purchasing, you need to think carefully about the strategy in terms of quotation
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In 2020, the sales of tigecycline in China's public medical institutions exceeded 2.
4 billion yuan.
Jiangsu Hansoh Pharmaceutical Group overtook Pfizer to lead the market with a 34.
58% share.
The company's product has been reviewed; Zhongzheng Tianqing Pharmaceutical Group and Zhejiang Hisun Pharmaceutical have a market share of more than 10%
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In 2020, the sales of cefmetazole and cefminox in public medical institutions in China will both exceed 1 billion yuan.
Sichuan Hexin Pharmaceutical is the leader of the two varieties, and related products have been reviewed
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Judging from the market situation, the share of other over-evaluated companies is not too high, but there are also a lot of competing companies.
Whether Sichuan Hexin Pharmaceutical can take into account the two varieties at the same time and ensure that its market position is not lost is also worthy of attention on the day of bid opening.
problem
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Source: CDE, Minet database, company announcements, etc.
The review data statistics are as of March 16.
If there are any mistakes or omissions, please correct me
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