Over 2 billion "magic medicine" fell!

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

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.

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

Source: Mi Nei.

At present, the commonly used anti-gout preparations in clinical practice in China mainly include febuxostat, benzbromarone, allopurinol, colchicine and probenecid.

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

Source: Mi Nei.

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

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.

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.

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.

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

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.

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.

In terms of therapeutic biological products, Novartis's Cananumab for Injection (ACZ885) has completed phase III clinical trials.

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?

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
.

Source: Mi Nei.
com database, CDE official website, etc.