The latest list of pharmaceutical companies announced: Qilu, Kelun, CSPC...

Qilu has the most approved varieties

Recently, according to the statistics of Yaochunqiu, the number of generic drugs approved for marketing in the first quarter of 2021 is 125, with a total of 259 acceptance numbers.

In this regard, Yao Chunqiu will sort out the companies that have been approved for generic drugs ≥ 6 in Q1 of 2021.

In addition, a total of 7 products of Dongyang Sunshine have been approved, and 6 products of Yangzijiang Pharmaceutical and Sichuan Huiyu have been approved respectively.

Data show that in Q1 of 2021, Qilu Pharmaceuticals has a total of 10 generic drugs approved for marketing, with trifluridine tepipyrimidine tablets and metformin vildagliptin tablets being the first generic varieties.

It is reported that Trifluridine Tepipyrimidine Tablet is an oral compound preparation composed of Trifluridine (FTD) and Tepipyridine Hydrochloride (TPI) at a molar ratio of 1:0.

On January 29, Qilu Pharmaceutical was approved for the production of metformin and vildagliptin tablets for generic 4 types of applications and was deemed to have been reviewed, becoming the first imitation in China.

Qilu has always been an active responder to the national centralized procurement.

Judging from the logic of national centralized procurement, the first to pass the consistency evaluation is the beginning of all competition.

Generic drugs are the foundation of strategy

According to the data of Yaochunqiu, Kelun Pharmaceutical has been approved for a total of 9 generic products.

Since 2021, Kelun Pharmaceutical has been approved for 6 varieties and deemed to have been evaluated, and 9 varieties have passed the consistency evaluation application.

It is understood that generic drugs are the basis of Kelun Pharmaceutical’s R&D strategy.

The 2020 annual report of Kelun Pharmaceuticals shows that as of December 31, 2020, the company has 606 varieties of pharmaceutical products with a total of 1020 specifications, including 130 varieties with a total of 300 specifications of infusion products, and 414 varieties with a total of 656 specifications.

According to the data, there are 40 varieties (involving 61 acceptance numbers) of generic drugs that are under review by Kelun Pharmaceuticals under the new registration classification, covering ordinary injections and infusion drugs, ordinary oral preparations, complex generic drugs, etc.

Strive for the first imitation?

According to data from Yaochunqiu, CSPC has approved 8 generic products, and nintedanib ethanesulfonate soft capsule is the first generic product in China.

It is reported that nintedanib ethanesulfonate soft capsule (trade name Ofev) is a multi-target tyrosine kinase inhibitor (TKI) developed by Boehringer Ingelheim.

Previously, Cyberlan learned that in the case of relatively limited patients, the listing of generic drugs will surely carve up patients of the original research drug, resulting in a decline in the market share of the original research.

To some extent, public information shows that China is a veritable big country of generic drugs: In 2018, my country's overall generic drug market reached about 500 billion yuan, accounting for about 40% of the total drug consumption market, and its proportion is still relatively low.
Previously, the total number of drug approval documents in my country was 189,000, of which more than 95% were generic drugs, and among the 3244 chemical drug varieties, 262 main varieties accounted for 70% of the total number of registration documents.

Therefore, the establishment of enterprises often focuses on "large varieties" and pursues the first imitation.
Currently.
Many domestic generic drug companies have adopted the three strategies of "product (major disease), time (the time window brought by CFDA approval and first imitation and recruitment standards), and sales (mostly self-operated)" To enhance their core competitiveness, this can also be clearly seen from today's data.