Domestic Infliximab Refreshes Low Price Again!

On April 18, 2022, the Shaanxi Provincial Public Resources Trading Center issued a notice on the dynamic adjustment of drug products listed on the Internet to lower the online price. The notice shows that the online price of Infliximab for injection (specification: 100mg/bottle) of Maibotec Pharmaceuticals has been reduced from 1,288 yuan to 1,268 yuan.

According to the data from the 1980s, the winning bid price of Hisun Pharmaceutical's infliximab for injection 100mg in Shaanxi Province was 1,288 yuan, and the winning price of Xi'an Janssen's infliximab for injection 100mg in Shaanxi Province was 5,160 yuan earlier.

Although there are not many price adjustments, it can be seen that the price adjustment of Maibotec has once again refreshed the lowest price of infliximab for injection in China.

With the approval of Jiahe Bio's "Infliximab" biosimilar drug on February 28, 2022, there are currently three domestically produced infliximab. On July 12, 2021, Mabotek Pharmaceuticals' infliximab for injection was approved for marketing, becoming the first infliximab biosimilar in China; on September 24, 2021, Hisun Bio's infliximab for injection was approved. Cimumab was approved for marketing, becoming the second domestically produced product.

Interestingly, on March 1, 2022, the Shanxi Provincial Pharmaceutical Equipment Centralized Bidding and Purchasing Center issued a notice on the new online purchase of generic drugs under the national medical insurance negotiation and national shortage drugs during the agreement period (Jin Yaozhao [2022] 18 No.), Hisun Bio's infliximab for injection is in the monitoring list.

According to the data, infliximab is a human-mouse chimeric monoclonal antibody developed by Johnson & Johnson/Mersk that specifically blocks tumor necrosis factor (TNF-α). In 1998, the drug was approved by the US FDA for marketing. In 2006, it was approved for listing in China under the trade name of Leike. Currently, Leike has been approved for multiple indications in China, including ulcerative colitis, Crohn's disease, active rheumatoid arthritis, active ankylosing spondylitis, plaque psoriasis, etc.

In 2014, Leike's sales peaked. Since then, its global market sales have continued to decline due to the successive listing of biosimilars after the expiration of the patent and the challenges of various interleukin inhibitors. The data shows that the global sales revenue of Leike has fallen from US$4.077 billion in 2020 to US$3.489 billion in 2021.

According to FiercePharma website data, in 2020, the global sales of infliximab ranked in the top 20 global drug sales. According to Minet.com, the sales of public hospitals in the first half of 2021 were 550 million yuan, a year-on-year increase of 105%.

According to data from Huajin Securities, according to incomplete statistics, there are currently 40 TNF-α drugs approved for listing in the world, of which adalimumab is the most approved TNF-α drug, followed by infliximab. According to the domestic TNF-α market in 2020, the sales volume of Yisaipu from China Health is about 616 million, accounting for about 46% of the market share; the sales volume of Cilag’s gram is about 334 million, accounting for about 25% of the market share; AbbVie The sales volume of Humira is about 120 million, accounting for about 9% of the market share; the sales volume of Qiangke of Saikin Bio is about 107 million, accounting for about 8% of the market share; the sales volume of Embryo produced by Zhejiang Hisun is about 80 million, About 6% of the market share.

As the first domestically-made infliximab approved for marketing, it originally had certain advantages. However, in the face of increasingly fierce competition, Maibotec has also begun to have a sense of crisis. In addition to lowering prices recently, Maibotec is also seeking to cooperate with old partners to promote its own products.

On March 31, 2022, Sinovac and Mabtec signed the "Infliximab China Mainland Market Exclusive Promotion Service Agreement", granting the company the exclusive rights to promote infliximab in the mainland, and the company will pay Mab-Tec Branch exclusive promotion license fee of 150 million yuan.

It is worth noting that as early as June 28, 2021, Sinovac Pharma signed a cooperation agreement with Mabotec Pharmaceuticals to obtain the commercialization rights of Infliximab in the overseas cooperation area. Since its listing, Sinovac has started registration in 32 overseas countries. After winning the domestic promotion rights this time, it may have a positive impact on the performance of Kexing Pharmaceuticals.

With the successive approvals of domestic infliximab, the track is facing increasingly fierce competition in the domestic market. In addition, among TNF-α antibody drugs, infliximab is also facing fierce competition from other competing products such as adalimumab. At present, in addition to the original research drug Humira, domestic adalimumab has a variety of biological Similar drugs have been approved, and in addition, there are many products in the queue...