The First Domestic Infliximab Price Adjustment

Recently, the Shaanxi Provincial Public Resource Trading Center issued a notice on the dynamic adjustment of drug products listed on the Internet to lower the online price. According to the notice, the online price of Infliximab for injection (specification: 100mg/bottle, trade name: Leidan) of Maibotec Pharmaceuticals has been reduced from 1,288 yuan to 1,268 yuan.

It is understood that there are currently four types of infliximab on the market in China. In addition to the products of Mabotec Pharmaceuticals, there are three other products from Xi'an Janssen, Hisun Pharmaceuticals, and Jiahe Biotechnology. The first two 100mg dosage forms are in The winning bids in Shaanxi Province were 1288 yuan and 5160 yuan respectively. Jiahe Bio's infliximab (trade name: Jiayoujian) has not been officially commercialized because it has just been approved. There are not many price adjustments in the industry, but the lowest price of infliximab for injection in China has been refreshed.

According to public information, the original research drug infliximab is a human-mouse chimeric monoclonal antibody developed by Johnson & Johnson/Mersk & Co. that specifically blocks tumor necrosis factor (TNF-α). The form (sTNF-α) and the transmembrane form (tmTNF-α) bind with high affinity, inhibit the binding of TNF-α to the receptor, and thus make TNF inactive. The product was first approved by the FDA in the United States in 1998, approved in Europe the following year, and approved in China in 2007 (trade name: Leike). Up to now, it has been approved for ulcerative colitis, crot Enn's disease, active rheumatoid arthritis, active ankylosing spondylitis, plaque psoriasis and other indications.

Since its listing, Leike's global sales have been on the rise and achieved a peak sales of $9.24 billion in 2014. However, the successive listing of biosimilars in recent years has had a huge impact on the sales of Leike, such as Pfizer/Nihon Kayaku's infliximab-like drug Inflectra, which was approved for marketing in Europe in September 2013, and launched in February 2016. Approved in the United States, Samsung's infliximab biosimilar Renflexis was launched in the United States in April 2017. In 2021, Leike's sales will be US$3.489 billion, a decline of more than 14% compared to US$4.077 billion in 2020.

In July 2021, Mabtech Pharmaceuticals’ class suspension was approved for marketing, becoming the first domestically produced infliximab biosimilar to be approved for marketing. According to Mabtech Pharmaceuticals’ previous announcement, the drug is a recombinant The TNF-alpha chimeric monoclonal antibody adopts the CHO expression system, which is safer and less immunogenic than the mouse osteoma cell SP2/0 used in the currently marketed infliximab drug.

In September 2021 and February 2022, Anbaite of Hisun Pharmaceuticals and Jiayoujian of Jiahe Biotechnology were also approved for listing.

According to the relevant research report of Frost & Sullivan, the number of patients in China for the approved indications of infliximab exceeds 10 million, and there is a long-term unmet market demand.

Although the market demand is large, with the successive entry of biosimilars, the competition of infliximab in my country tends to be fierce.

In order to better realize the commercial operation of the product, in March this year, Maibo Pharmaceutical signed an exclusive license agreement with Kexing Bio, granting Kexing Bio a license for all products except mainland China, Japan, Europe and North America. Exclusive license for national and regional development and commercialization of infliximab. At the same time, the two parties agreed on the sales target for American countries and regions other than North America: the total sales target for the first and second complete sales years is no less than 200,000 units; from the third complete sales year, the annual sales target Not less than 200,000 pcs/year. For this cooperation, Kexing Pharma paid an exclusive promotion license fee of 150 million yuan to Maibotec Pharmaceuticals.