Recently, a number of domestic new drugs have ushered in new progress in the market!

With the multiple resonances of policies, capital, and talents, the enthusiasm for research and development of Chinese local pharmaceutical companies has continued to rise in recent years, and batches of new drugs developed independently have begun to emerge
.
It is reported that a number of domestic new drugs have ushered in new progress in the market recently, and some are about to be approved
.
Jiahe Bio's infliximab is about to be approved On February 17, the NMPA website showed that Yuxi Jiahe Biotechnology Co.
, Ltd.
's infliximab biosimilar application was "in the approval" stage
.
If approved, this will be the third infliximab biosimilar in China
.
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), and its sales in 2020 will be 4.
077 billion US dollars
.
Although it has been on the market in China for many years, the first infliximab biosimilar has just been approved in July 2021, from Taizhou Maibotec Pharmaceuticals
.
In September, Hisun Bio's infliximab was also approved for marketing, and Jiahe Bio was the third company to follow
.
The industry believes that, compared with other biosimilars, from the current point of view, the competition of infliximab is generally moderate
.
It is no coincidence that Innovent PCSK9 monoclonal antibody plans to submit a marketing application.
On the same day, Innovent Bio announced that the company's self-developed recombinant fully human anti-proprotein convertase subtilisin 9 (PCSK-9) monoclonal antibody (R&D code: IBI306) Two of China's key registration clinical studies - CREDIT-1 study (treatment of non-familial hypercholesterolemia [non-FH] combined with high/very high risk cardiovascular risk) and CREDIT-4 study (treatment of non-familial hypercholesterolemia Heterozygous familial hypercholesterolemia [non-FH] and heterozygous familial hypercholesterolemia [HeFH]) both met the primary endpoint
.
It is understood that IBI306 is an innovative biological drug independently developed by Innovent.
It is the first PCSK-9 inhibitor to carry out long-term, large-scale, randomized, double-blind phase III clinical studies in China, and has explored and optimized the treatment plan for long-term dosing.

.
After all three pivotal registration clinical studies met their primary study endpoints, Innovent said it expects to submit a new drug application for IBI306 this year for the indications of primary hypercholesterolemia and mixed dyslipidemia
.
Chengdu Baiyue will enter the anticoagulant market of over $10 billion On February 8, Chengdu Baiyu Pharmaceutical entered the administrative approval stage with a generic 4-type apixaban tablet, which is expected to become the company's second over-reviewed antithrombotic drug form medicine
.
According to the data, apixaban is a potent, oral, reversible, direct and highly selective factor Xa active site inhibitor jointly developed by Pfizer and Bristol-Myers Squibb.
It is a new type of oral anticoagulant drug.
, for the prevention of venous thromboembolic events in adult patients undergoing elective hip or knee arthroplasty
.
In 2021, global sales of apixaban will reach a new high, exceeding US$10 billion
.
The drug was approved to enter the domestic market in January 2013.
In addition to the original research, more than 20 apixaban tablets have passed or are deemed to have passed the consistency evaluation, including Qilu, Yangzijiang, CSPC, Kelun, Hao Sen and other companies
.
The industry expects that after Chengdu Baiyu Pharmaceutical's apixaban tablets are approved, the market competition will further intensify
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.