01

CHIA TAI TIANQING [Fulvestrant Injection] has been approved as the first generic drug. 

On August 14, CHIA TAI TIANQING's fulvestrant injection, a new four-class generic drug, was approved by the National Medical Products Administration, becoming the first generic drug in China.

According to INSIGHT Database, a total of 14 generic drugs of Sino Biopharmaceutical have been approved to market as of October 2020, among which 4 are manufactured by its subsidiary Chia Tai Tianqing, all first generic drugs. Generics are still the primary driving force of business. (Click here to view details)

02

Kelun [Empagliflozin Tablets] was approved 

On August 14, Kelun Industry Group's new four-class generic drug [Empagliflozin Tablets] was approved by the National Medical Products Administration as the second generic drug of this type in China, and it has been regarded as having passed the consistent evaluation.

According to Boehringer-Ingelheim and Lilly's financial report in 2019, the global sales of Empagliflozin reached $3.354 billion, making it one of the TOP40 best-selling drugs in the world.

On September 21, 2017, Empagliflozin was approved by the original CFDA to be marketed in China in the name of Jardiance, which could be used alone or combined with metformin to improve the blood glucose control in patients with type 2 diabetes. (Click here to view details)

03

CDE drug evaluation report 

INSIGHT Database has recently released the CDE drug review report in July 2020.

CDE acceptance of this month: the number of acceptance number of this month is less than that of last month, which is 815. (Click here to view details)

04

National centralized-purchase pricing strategy 

On August 4, Shanghai Joint Procurement Office held a training session for enterprises engaged in centralized drug procurement, and the scale was larger than that of the second batch of national drug procurement. In the background of purchasing with specified quantity, there are different challenges and opportunities for different types of products, and it has become a focus of the industry that how to realize "one product and one policy".

Purchasing with specified quantity is also applicable for biological drugs, so that the market access can be obtained while the problem of medical insurance reimbursement is solved, just like patented innovative drugs.

Products must be purchased with specified quantity prior to being included into the NDRL, and products purchased with specified quantity must be included in the NDRL, which is a complementary process. (Click here to view details)

05

Blockbuster launching of new anti-rheumatoid drugs in China 

Simcere Pharmaceutical and Bristol-Myers Squibb have announced recently that Orencia ®, an innovative autoimmune drug, will become in the market of the Chinese mainland completely, benefiting 6 million patients in China.

 

Rheumatoid arthritis (RA) is a disease with slow progress and strong heterogeneity, and it has been always the hot topic and direction for clinical experts to seek individualized treatment. About 80% of RA patients abroad have been generally treated with biological agents. (Click here to view details)

06

Synthetic blood anticoagulant 

Patients with diseases caused by thrombosis, such as pulmonary embolism, ischemic stroke and myocardial infarction, are often given blood-thinning medication, such as aspirin and clopidogrel, so as to stop the formation and growth of blood clots, make the blood flow smooth, and prevent disease progression.

Nevertheless, almost all anticoagulants available will cause serious or life-threatening side effect of hemorrhage after injury. Therefore, it is urgent to develop safe anticoagulants with or without the risk of bleeding.

 

The investigators from the University of Bern and the Lausanne Federal Polytechnic University designed a kind of highly active and stable FXII macrocyclic peptide inhibitor (FXII900) recently, which could reduce the experimental thrombosis in mice caused by ferric chloride, and inhibit blood clotting in the extracorporeal membrane oxygenation (ECMO) environment of rabbit; moreover, it will not increase the risk of bleeding, so it is a prospective drug candidate for safe protection of thrombosis under the acute medical conditions. (Click here to view details)

07

New effect of metformin 

According to the latest research data, metformin (antidiabetic) may benefit patients with esophageal squamous cell carcinoma by improving the immune microenvironment (TIME) in tumor lesions.

 

The results of a phase II clinical study conducted by the investigators from Shantou University and others institutions have been published in a journal of oncology, CLINICAL CANCER RESEARCH. As demonstrated in this article, metformin may benefit patients with esophageal squamous cell carcinoma by improving the immune microenvironment (TIME) in tumor lesions.

According to data from Menet.com.cn, metformin owned a total market size of over RMB 6 billion in China's public medical institutions, physical pharmacies and other sales terminals in 2019. The large market size is also accompanied by great competition, namely, there is not only competition between original research drugs and overrated generic drugs, but also a large number of generic drug companies still in the market. (Click here to view details)

08

Top 100 Pharmaceutical Wholesale and Retail Enterprises of China in 2019 

On August 13, the China Association of Pharmaceutical Commerce officially released the "List of Top 100 Wholesale Enterprises in China's Drug Circulation Industry in 2019" and "List of Top 100 Retail Enterprises in China's Drug Circulation Industry in 2019".

 

On the whole, there was no significant change in the ranking of pharmaceutical wholesale and retail companies. What is noteworthy is that there are new pressure and challenges for pharmaceutical wholesale and retail enterprises under the joint action of the national policy of centralized drug procurement. (Click here to view details)

09

A total of 48 new drugs were approved for clinical use in July 

According to the INSIGHT Database and CDE clinical trial registration and information announcement, there were a total of 81 new drugs approved for clinical use in July, with 48 varieties involved.

 

 

According to the declaration progress database of INSIGHT Database, there were a total of 81 new drugs approved for clinical use in July 2020, involving 48 varieties. A detailed description of the 48 varieties approved clinically this month is attached. (Click here to view details)