Domestically-made infliximab listed AID therapeutic drug market competition intensifies

A few days ago, Taizhou Maibotek Pharmaceutical Co.
, Ltd.
(hereinafter referred to as Maibo Pharmaceutical)'s infliximab injection (Infliximab) was approved for marketing, becoming the first domestically-made infliximab product approved for marketing
.
The infliximab antigen research company is Johnson & Johnson of the United States, the trade name is gram, and it was approved by the US FDA in 1998.
The indications include rheumatoid arthritis (RA), Crohn’s disease, ankylosing spondylitis (AS), silver A variety of autoimmune diseases (AI D) such as scoria
.
Like gram can bind to the soluble form (sTNF-α) and the transmembrane form (tmTNF-α) of TNF-α (tumor necrosis factor-α) with high affinity, thereby inhibiting the binding of TNF-α to the receptor and losing TNF Biological activity
.

The rapid growth of AID drug market
AID refers to a type of disease induced by the body's immune system's immune tolerance to its own components, which attacks its own organs, tissues or cells, causing damage, such as multiple sclerosis, autoimmune liver disease , l diabetes mellitus, systemic lupus erythematosus (SLE), RA, AS, Sjogren's syndrome (the SS), polymyositis / dermatomyositis and the like
.
Approximately 7.
6% to 9.
4% of people in the world suffer from various types of AID, and AID has become the third most chronic disease after cardiovascular disease and cancer
.
The global AID therapeutic drugs show a steady growth trend
.
According to data from Yaozhi Consulting, the market size of AID therapeutic drugs was US$109.
9 billion in 2018 and is expected to reach US$152.
2 billion by 2025
.
The market size of AID therapeutic drugs in China is growing rapidly.
In 2015, the market size was 1.
42 billion U.
S.
dollars and increased to 1.
94 billion U.
S.
dollars in 2018.
It is estimated that by 2025, the market size will reach 8.
19 billion U.
S.
dollars
.
Johnson & Johnson’s Leike has been sold globally after its listing.
Between 2012 and 2014, Leike’s sales have soared and reached a peak of US$9.
24 billion in 2014.

.
However, in recent years, due to the expiration of the patent of Leike, its biosimilar drugs have been put on the market one after another
.
For example, Inflectra, an infliximab-like drug produced by Pfizer Pharmaceuticals and Nippon Kayaku Co.
, Ltd.
, was approved for marketing in Europe in September 2013 and the United States in February 2016, respectively
.
Against this background, the sales of Leike in the global market continue to decline.
In 2020, global sales are only 3.
7 billion U.
S.
dollars, which has fallen by 60% from the peak (see figure)
.
With its first-mover advantage and broad indications, Leike performed well in the Chinese market and was included in the National Medical Insurance Catalogue in 2019.
The price was reduced from 6,047 yuan/100mg to 2007 yuan/100mg, a decrease of 66.
8%
.
The competition among domestic TNF-α inhibitors has gradually become fierce
.
In 2019, Leike's sales in major domestic sample hospitals reached 179.
8 million yuan
.
With the approval of domestically produced infliximab, Leike will face fiercer competition in the Chinese market
.
In addition to the infliximab of Maiper Pharmaceuticals recently approved for marketing, Hisun Pharmaceuticals, Jiahe Biologics and Celltrion's infliximab are also in the marketing application stage
.
Judging from the date of application for listing, Hisun Pharmaceutical's HS626 is expected to become the second domestic infliximab approved for marketing
.

　　The competition is becoming increasingly fierce.
When you
mention Lei Ke, you have to mention Adalimumab (trade name Humira).
Humira is jointly developed by Cambridge Antibody Technology of the United Kingdom and Abbott Corporation of the United States.
It was first published in January 2003.
Listed in the United States
.
The drug has been the world's "King of Medicine" for eight consecutive years, and its global sales in 2020 reached 19.
832 billion U.
S.
dollars
.
However, the performance of Xiu Mei Le in the Chinese market is not satisfactory
.
In 2019, the sales of Xiu Meile in China's main sample hospitals were only 14.
15 million yuan, and the high price may be a key factor restricting its sales
.
Regarding drugs for chronic diseases such as RA, there is a view that the single drug price that patients are willing to bear is 3000-5000 yuan/year, while the price of Xiu Meile close to 200,000 yuan/year has far exceeded the psychological price of patients
.
In November 2019, the price of Xiu Mei Le was reduced by 83%, and it was included in the medical insurance together with Lei Ke
.
Due to the original low market share of Xiu Mei Le, sales increased rapidly after being included in medical insurance.
In 2020, sales in sample hospitals reached 70.
08 million yuan
.
Although Xiu Meile will achieve a counterattack in the domestic market in 2020, the successive launch of other adalimumab biosimilar drugs also put huge pressure on Xiu Meile
.
At present, four biosimilars of adalimumab have been approved for marketing in China, including Biotech’s Glali, Hisun’s An Jianning, Cinda Bio’s Su Lixin, and Fuhong Henlius’s Hanlius.
Reach far
.
In terms of the time to market, Glorious was the first to be approved for listing in November 2019.
It has a certain first-mover advantage.
There is not much difference in the prices of the four drugs.
Who can seize the opportunity in the future mainly depends on the competition of market sales capabilities.

.
AID therapeutic drugs in China are mainly divided into small molecule targeted drugs and biological agents
.
At present, small-molecule targeted drugs are represented by tofacitinib, which targets the JAK/STAT signaling pathway, and autoimmune disease biologic drugs are dominated by TNF-α inhibitors.
Sales in 2019 accounted for more than 90%
.
Looking at the market structure of major domestic TNF inhibitors, Yisaipu of 3SBio Group still occupies a dominant position.
Yisaipu will take the initiative to cut its price by 50% in 2020, basically maintaining its leading position in the market
.
The successive entry of interleukin inhibitors, JAK inhibitors and other drugs has intensified competition in this field.

.
Tocilizumab (IL-6 inhibitor) of Biotech, Livzumab Biotech and Hisun Pharmaceuticals is in clinical phase III, and Biotech’s tocilizumab subcutaneous preparation is also in clinical phase III.
Approved in May this year; in 2019, tofacitib (JAK inhibitor) was included in the medical insurance catalog, and Pfizer's Shangjie (tofacitib citrate) significantly reduced its price by 50%
.
In 2020, tofacitinib was included in the third batch of nationally organized drug collections, and a batch of domestically produced tofacitinib announced a price reduction of more than 50%
.
At present, there are a total of more than 10 biological drugs for the treatment of AID in the domestic market.
Among them, the TOP10 global autoimmune system disease drugs in 2019 have all been listed in China
.
However, most drugs that have not entered the national medical insurance catalogue are difficult to increase in volume, so AID biological preparations account for only 20% of the domestic market
.
In the next 5 years, with the improvement of AID diagnosis, the increase in the number of affected groups (the prevalence rate is on the rise), and the policy to promote the improvement of drug accessibility, the market scale of AID therapeutic drugs will be gradually driven to expand, and more AI D will be made in China.
With the launch of drugs, market competition has intensified, and objectively it can also promote more good drugs of high quality and low price to benefit patients
.