Over 2 billion "magic medicine" fell!

A few days ago, the clinical application of Tonghua Dongbao's new class 1 anti-gout drug THDBH130 tablets was accepted by CDE
.

According to incomplete statistics, there are currently 36 new anti-gout drugs (23 new drugs of category 1) in the clinical application and above stage

The market has fallen by nearly 50%! The fall of anti-gout "magic drug"

The market has fallen by nearly 50%! The fall of anti-gout "magic drug"

Under the pressure of centralized procurement, the sales of anti-gout preparations, which have continued to expand in the market, have fallen for the first time in recent years
.

According to data from Mi Nei.
com, in recent years, the terminal anti-gout preparation market for urban public hospitals, county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions) has expanded year by year, exceeding 2 billion yuan in 2019, affected by centralized procurement.
, H1 sales fell for the first time in 2021, by nearly 50%
.

Sales of terminal anti-gout preparations in public medical institutions in China (unit: ten thousand yuan)

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

At present, the commonly used anti-gout preparations in clinical practice in China mainly include febuxostat, benzbromarone, allopurinol, colchicine and probenecid.
Among them, febuxostat is known as the "anti-gout drug".
The combined sales of Chinese public medical institutions and physical pharmacies in Chinese cities exceed 2 billion yuan
.

TOP3 products of terminal anti-gout preparations in Chinese public medical institutions

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

Before centralized procurement, febuxostat had a strong tendency to monopolize the market
.

After being included in the third batch of centralized procurement, its sales fell sharply

In addition to febuxostat, "Second Brother" Benzbromarone and "Sange" Allopurinol have also been reviewed by companies, among which benzbromarone has met the requirements for centralized procurement; Allopurinol has been reviewed by one company.
One company is still under review, and many companies have filed reference preparations
.

The anti-gout drug market may shrink further

Innovative drugs are in the lead, 23 new gout 1 drugs are on the way

Innovative drugs are in the lead, 23 new gout 1 drugs are on the way

Hyperuricemia is the second largest chronic metabolic disease after diabetes.
Chinese patients with hyperuricemia and gout still have an urgent need for efficient and safe anti-gout drugs
.

At present, there are few types of anti-gout drugs on the market in China, and some drugs have certain limitations in efficacy and safety.
For example, benzbromarone has good efficacy, but there is certain liver damage.
Febuxostat is safe in the kidneys.
It is superior to allopurinol in terms of sex, but it has been shown to increase the risk of adverse cardiovascular CV events in clinical practice
.

It is gratifying that, there are many domestic enterprises layout anti-gout drug development, including Henry, Chengdu-invasive, Ying Li medicine, bio-morning delivery, Kang edge medicine and so on
.

According to data from Minaiwang, according to incomplete statistics, there are currently 36 new anti-gout drugs in the clinical application and above stage, of which 23 are Class 1 new drugs

Some new anti-gout drugs under development in China

Source: China Drug Clinical Trial Publicity Library of Meinenet

In terms of drug types, there are 18, 8 and 10 chemical drugs, therapeutic biological products, and Chinese patent medicines
.

In terms of chemical drugs, the development of urate transporter 1 (URAT1) inhibitors is hot.
The target drug can selectively inhibit the reabsorption of uric acid by URAT1 and increase the excretion of uric acid, effectively controlling the level of uric acid in the blood
.

Currently, Hengrui Medicine's SHR4640 tablets and Eisai's Dotinurad tablets have the fastest progress in research and development, both of which are in phase III clinical trials in China.

Topipristat from Fuji Pharmaceuticals is a new type of highly selective and reversible xanthine oxidase inhibitor, which inhibits the production of uric acid by competitively inhibiting xanthine oxidase.
This product is undergoing phase I clinical trials in China ; In addition, a number of pharmaceutical companies are developing generic drugs for topipristat, including Xizhou Pharmaceutical, Aige Biological, and Shandong Benro
.

In terms of therapeutic biological products, Novartis's Cananumab for Injection (ACZ885) has completed phase III clinical trials.
This product can effectively control the acute attack of gout by inhibiting IL-1β, an important pathogenic factor of gout attacks; 3.
Shengsheng Pharmaceutical and modified pegylated uricase derivatives are both in phase I clinical trials.
This type of drug can reduce blood uric acid by catalyzing the oxidation of uric acid into allantoin, which has a higher solubility than uric acid
.

In terms of proprietary Chinese medicines, the 6-category new drug Huzhen Tongfeng Capsules at the Guangzhou Jinan Biomedical Research and Development Base has completed phase III clinical trials; two category 1 new drugs, Qinhuai Capsules and Baijin Granules, have been approved for clinical trials
.

Is there a way out for generic drugs under the haze of centralized procurement?

Is there a way out for generic drugs under the haze of centralized procurement?

Anti-gout drugs are only a therapeutic sub-category shrouded in the haze of centralized mining
.

Since 2018, the state has organized five batches of six rounds of centralized drug procurement, involving more than 200 drugs, with an average price reduction of 54%
.

M data network, a plurality of more than 40 200 relates to therapeutic drugs subclasses, concentrated in systemic antibacterial agents, antineoplastic agents, drugs for diabetes, renin - angiotensin system drugs

Taking diabetes medications as an example, oral hypoglycemic drugs appeared in the second batch of centralized procurement for the first time, and its impact began to appear in 2020.
From 2017 to 2019, the sales growth rate of terminal diabetes medications in China's public medical institutions remained at two levels.
The number of digits will decline for the first time in 2020, and the decline in H1 will further increase in 2021
.

Among the top 10 non-insulin hypoglycemic varieties in China's public medical institutions in 2019, 8 have been included in the collection, of which acarbose tablets will drop by 59.
13% in 2020, H1 will drop by 73.
58% in 2021, and glimepiride In 2020, it will drop by 45.
76% and H1 will drop by 66.
52% in 2021.
.
.
With the implementation of the fourth and fifth batches of centralized procurement, the national procurement of insulin and the new centralized procurement that will be launched in the future will be superimposed, and the entire diabetes drug will be used.
The market shuffle will continue
.

Centralized sourcing "replaces price for volume", although sales have increased, sales have fallen sharply, and the corresponding market size has shrunk
.

Some people believe that the large-scale bargaining of prices in centralized procurement will have a great impact on pharmaceutical companies, and the reduction of corporate profits will indirectly affect the enthusiasm of pharmaceutical companies to develop innovative drugs

In fact, centralized procurement cut off the "sales with gold", the purpose is to return to the rational price of generic drugs that have been inflated for a long time, and aims to lead the company from the traditional re-sales concept to cost and quality competition
.

In accordance with the rules of centralized procurement, the National Medical Insurance Bureau gave a maximum price limit after evaluating the cost of centralized procurement varieties, leaving a certain profit margin for the enterprise, and repeatedly emphasized that "super low price quotations are strictly prohibited", except for the possibility of super low prices.
In addition to affecting supply or product quality, it is more important to promote the healthy development of the domestic pharmaceutical industry
.

Under the normalization of centralized procurement, generic drugs rely on small profits but quick turnover.
Reasonable production profits are the basic logic for making money, and it is very important to have a cost advantage
.

On the one hand, the control of APIs can help control costs.
Companies do not necessarily have to own their own API factories, and they can also obtain APIs through agreements, equity participation, and cooperation
.

On the other hand, companies can also further reduce costs through scale effects, do their homework and make reasonable quotations, and obtain greater profit margins in centralized procurement

It is foreseeable that under a series of policies, ordinary generic drugs will have small profits but quicker sales, and some highly difficult generic drugs will still be a blue ocean.
Innovative drugs will gradually become the main source of profit, and it will become an inevitable trend for pharmaceutical companies to combine imitation and innovation and move from imitation to innovation
.