$2 billion psoriasis oral drug first imitation arrow on the string, monoclonal antibody cuts in price and enters medical insurance to compete for the track

The World Health Assembly resolution WHA67.
9 recognizes that psoriasis is a common, chronic, non-communicable skin disease, commonly referred to as "psoriasis
.

" The prevalence of psoriasis announced by various countries is 0.

Apomilast is a new oral, small-molecule phosphodiesterase 4 (PDE-4) inhibitor developed by Xinji
.

It was approved by the FDA in 2014 and approved in the European Union in January 2015 under the trade name Otezla .

In August 2021, NMPA approved Amgen’s Apomilast tablets (specifications: 10mg, 20mg, 30mg) to enter the Chinese market, under the trade name Ottel, and Canada Patheon Inc.
is responsible for tablet production and HDPE bottle packaging
.

According to the data, Apomilast is a new drug that is urgently needed in clinical practice.

Global sales of Apmilast (unit: US$100 million)

According to data from Meinenet, as of September 15, more than 20 companies have applied for clinical application and 9 have applied for production
.

The Apomilast multi-release tablets of Yueyang Pharmaceutical Development (Guangzhou) were contracted as new drugs in category 2.

Apomisi special report on the status of the product under review

The market for psoriasis chemicals will change

The market for psoriasis chemicals will change

The World Health Assembly resolution WHA67.
9 recognizes that psoriasis is a common, chronic, non-communicable skin disease, commonly referred to as "psoriasis
.

" So far, the cause of psoriasis is unknown, and there is no fundamental cure

There are three main forms of treatment for psoriasis: local treatment, phototherapy, and systemic treatment
.

The choice of treatment is based on the severity of psoriasis

Sales Trends of Psoriasis Chemicals in Public Hospitals in Key Provinces and Cities in 2021H1

According to data from Mi Nei.
com, the psoriasis chemical drug market in public hospitals in key provinces and cities has exceeded 100 million yuan in recent years, and sales in the first half of this year were close to 60 million yuan, an increase of 19.
39% year-on-year
.

2021H1 key provinces and municipalities public hospitals TOP10 market pattern of psoriasis chemical drugs

Human treatment and research on psoriasis have gone through a long period of time.
So far, more than 160 psoriasis treatment drugs have been developed and marketed in various countries around the world
.

The "Guidelines for the Treatment of Psoriasis in China" summarizes the treatment of psoriasis with external medications, internal medications, biopharmaceuticals, traditional Chinese medicine and other therapies

Biological antibodies are competitive

Biological antibodies are competitive

The State Food and Drug Administration has approved 9 monoclonal antibodies for the treatment of human immune diseases and psoriasis
.

Infliximab (like gram) is the first TNF-a inhibitor approved by the US FDA for marketing.

With the implementation of medical insurance for infliximab, adalimumab, skukuzumab, etanercept and other biological agents, the economic pressure on patients with psoriasis, inflammatory bowel disease, and Crohn’s disease is expected to decrease.
The choice of drugs will be greatly increased
.
The Shaanxi Provincial Pharmaceutical Centralized Procurement Platform and the Heilongjiang Centralized Procurement Network have also successively issued notices, stating that they have received active price reduction applications from many pharmaceutical companies, which involve a number of imported original research products, including the psoriasis drugs Iqizumab and Usnu Monoclonal antibodies and so on
.

Psoriasis and human immune disease antibodies approved for marketing in China

Antibody drugs enter the psoriasis drug market

Antibody drugs enter the psoriasis drug market

With the rapid development of new bioengineering drugs, research on the treatment of psoriasis is also developing rapidly, driving changes in the domestic market
.
In 2004, the FDA approved etanercept, the first biological drug for the treatment of psoriasis, Merck’s infliximab was approved in 2005, and AbbVie’s adalimumab was approved in 2006
.
Adalimumab has superior safety and effectiveness and has become the main choice for the treatment of severe psoriasis
.
Biological agents are effective in treating psoriasis.
They mainly inhibit white blood cell T cells and block a substance called tumor necrosis factor (TNF-α), which is one of the main messenger chemicals in the immune system and prevents chemical messengers from the immune system.
——Interleukin, which can be combined with the protein that causes inflammation, can effectively relieve inflammation and reduce the symptoms of scaly skin
.

At present, there are many bioengineered drugs that are highly favored, mainly TNF-α blockers adalimumab, infliximab, pecelizumab, and etanercept
.
In recent years, interleukin-based antibody drugs have been launched, mainly skucilizumab, usnumab, gussetizumab, and broliumab, which reduce the anti-inflammatory protein/interleukin binding The antibody ichizumab
.

According to data from Meinenet, the sales of psoriasis monoclonal antibody drugs in public hospitals in key provinces and cities in the first half of 2021 have increased by more than 10 times year-on-year
.
Under the general trend of entering the national medical insurance catalogue and actively reducing prices of foreign products to compete for the market, monoclonal antibody drugs for the treatment of psoriasis will further expand in the Chinese market
.

Market structure of psoriasis antibodies in public hospitals in key provinces and cities in 2021H1

In the first half of 2021, in the market pattern of psoriasis monoclonal antibody drugs in public hospitals in key provinces and cities, Novartis's cucuzumab (Shan Ting) ranks first, and its entry into the national medical insurance catalogue drives the market volume, occupying more than 90% Although Xi'an Janssen’s Usnumab (Sidano) was approved earlier than Keshan Ting, it only accounts for 2.
76% of the total share of the national medical insurance list because it has not been reduced in price
.
In addition, Eli Lilly’s Ichizumab (Tuozi), Janssen’s Gusekizumab (Tenoya) and Kyowa Fermented Kirin’s Broliumab (Limefox) also have a lower share
.
Although all roads lead to Rome, the water flows thousands of miles to the sea.
In the domestic market, the entry of drugs into the national medical insurance catalog has become one of the important channels for expanding the market
.

Data source: Mi Neiwang database