The Yangtze River, Qilu, Chia Tai Tianqing... Harvest!

In the past 2021, the number of approvals of domestic innovative drugs has entered an outbreak period, the number of approvals of generic drugs has also surged, and domestic pharmaceutical companies have harvested a number of blockbuster varieties
.
Based on the drug approval date, in 2021, NMPA has approved a total of 983 chemical drug generic drug approvals (including generic 3/4/6 categories), involving 341 varieties

According to the author's statistics, among the TOP5 domestic generic drugs approved enterprises in 2021, Yangzijiang Pharmaceutical, Qilu Pharmaceutical, and Sino Biopharmaceutical rank the top three, with 31, 21 and 20 approved varieties respectively; 17 varieties were approved; 16 varieties were approved by CSPC
.
Except for China Biopharmaceuticals, the number of approved generic products of TOP5 companies has increased compared with 2020

Among the generic drugs approved by the 5 group companies, a total of 11 varieties are the first domestic generic drugs
.
Among them, Sino Biopharmaceutical leads with 4 first generic drugs, allowing everyone to once again witness the strength of the "king of first imitations"; Qilu Pharmaceutical has won 3 first imitations; Kelun Pharmaceuticals and CSPC have each received 2 first imitations

In 2021, domestic generic drugs will be approved as TOP5 enterprises

31 varieties! Yangtze River Becomes the King of Generic Drugs in 2021

In 2021, Yangzijiang Pharmaceutical Group will have a total of 31 generic drugs (41 product specifications) approved for marketing, ranking first in total and far ahead of the second
.
Among the TOP5 companies, the number of approved varieties of Yangzijiang Pharmaceutical has grown the most, more than doubling from 2020 (13)

Among the 31 varieties, 3 varieties including nalbuphine hydrochloride injection, linagliptin tablets, and raltitrexed for injection are the second domestic ones; lurasidone hydrochloride tablets, dexmedetomidine hydrochloride sodium chloride Three varieties of injection, metformin and vildagliptin tablets are the third domestic company; Erdosteine ​​capsules and voriconazole tablets are the fourth domestic company
.

Except for ornithine aspartate injection, the other 30 varieties were reported and approved for production according to the new registration classification (imitation 3/4 category), which were deemed to have passed the consistency evaluation
.
Among them, erdosteine ​​capsules and raltitrexed for injection of Yangzijiang Pharmaceutical were the first to review

Up to now, 89 varieties (120 product specifications) of Yangzijiang Pharmaceutical have passed/deemed to have passed the consistency evaluation, and the number of over-evaluated varieties is second only to Qilu Pharmaceutical
.
As an enterprise that has tasted the sweetness of centralized procurement, Yangzijiang Pharmaceutical has been actively participating in the national centralized procurement, and has won bids for 31 varieties in the first five batches of national centralized procurement

The "King of the First Imitation" is in full swing! China Biopharmaceuticals won 4 first imitations

Stepping on the tail of 2021, Chia Tai Tianqing's Linezolid Tablets and Nanjing Chia Tai Tianqing's Sitagliptin Metformin Sustained-Release Tablets were approved for listing on December 31, 2021
.

In the whole year of 2021, a total of 20 generic drugs (29 product specifications) of Sino Biopharmaceuticals were approved for marketing, and the number of approved varieties decreased compared with 2020 (23)
.
This is mainly because the company has put more energy into the field of innovative drugs.

Among the 20 varieties, 4 varieties, including polymyxin E sodium mesylate for injection, lenvatinib mesylate capsules, vortioxetine hydrobromide tablets, and sitagliptin metformin sustained-release tablets, are the first in China.
Imitation + first review
.

In the field of generic drugs, Sino Biopharmaceuticals has been focusing on the layout of the first generic drugs and generic drugs with high technical barriers
.
Although the number of first generic drugs approved by Sino Biopharmaceuticals in 2021 is lower than that in 2020 (7), it is still the first generic drug in China

Up to now, 81 varieties (127 specifications) of Sino Biopharmaceutical have passed/deemed to pass the consistency evaluation, and 32 varieties have won the bid in the first five batches of national centralized procurement
.

Qilu Pharmaceutical won 21 varieties, and 3 were the first to imitate

In the whole year of 2021, Qilu Pharmaceutical has a total of 21 generic drugs (37 product specifications) approved for marketing
.

The 21 varieties are all batch-produced according to the new registration classification and are deemed to have passed the consistency evaluation
.
Among them, 3 varieties of ceftazidime and avibactam sodium for injection, rasagiline mesylate tablets, and metformin vildagliptin tablets are the first domestic imitation + the first review
.
Ceftazidime Avibactam Sodium for Injection is a new type of antibiotic.
The only generic drugs are Qilu Pharmaceuticals and Libowei/Ruke Pharmaceuticals (to be approved), and the competition is friendly
.

The original research drug of ceftazidime and avibactam sodium for injection is Pfizer's Sifuto, which was approved for marketing in China in 2019
.
According to data from Minet.
com, in 2020, the sales of terminal Sifuto in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) will reach 280 million yuan, a year-on-year increase of 1343.
39%; in the first half of 2021 Its sales increased by 32.
68% year-on-year
.

"If you want to do a good job, you must first sharpen your tools
.
" Up to now, Qilu Pharmaceutical has passed/deemed to pass the consistency evaluation of 93 varieties (174 specifications), and has won a total of 34 bids in the first five batches of national centralized procurement.
The number of over-evaluated varieties and the number of winning bids ranked first
.

Kelun and CSPC each won two first imitations, and 5 major varieties were looted

In the whole year of 2021, CSPC and Kelun Pharmaceutical each received 2 first imitations
.
The first approved imitations of CSPC are nintedanib ethanesulfonate soft capsules and amphotericin B cholesterol sulfate complex for injection, which has made a breakthrough compared with 2020
.
The number of first simulations approved by Kelun Pharmaceuticals is the same as that in 2020.
Among them, compound amino acid (15AA-II)/glucose (10%) electrolyte injection is a parenteral nutrition product, and ceftazidime for injection/glucose injection is the company's powder solution The first approved product for the dual-chamber bag platform
.

It is worth noting that five companies, including Yangtze River Pharmaceutical, Qilu Pharmaceutical, Sino Biopharmaceutical, Kelun Pharmaceutical, and CSPC, have multiple approved varieties that overlap
.
There are 5 varieties with more than 3 overlapping companies, including sitagliptin phosphate tablets, lenvatinib mesylate capsules, sunitinib malate capsules, afatinib maleate tablets, and moxifloxacin hydrochloride drops eye drops
.

The afatinib maleate tablets of these five companies have all been approved for production.
Among them, the afatinib maleate tablets of Yangzijiang Pharmaceutical, Kelun Pharmaceutical, and CSPC will all be approved for marketing in 2021.
Qilu Pharmaceuticals, Sino Biopharmaceuticals The product has been approved in 2020
.
According to data from Minet.
com, in 2020, the sales of terminal afatinib in Chinese public medical institutions exceeded 400 million yuan, a year-on-year increase of 67.
06%
.

In addition to Qilu Pharmaceutical, the sitagliptin phosphate tablets of four companies including Yangzijiang Pharmaceutical, Sino Biopharmaceuticals, Kelun Pharmaceuticals, and CSPC will all be approved for marketing in 2021
.
According to data from Minet.
com, in 2020, the sales of sitagliptin in China's public medical institutions exceeded 1.
4 billion yuan, a year-on-year increase of 45.
55%
.

The lenvatinib mesylate capsules of Qilu Pharmaceutical, China Biopharmaceuticals, and Kelun Pharmaceuticals are all approved for marketing in 2021
.
CSPC's lenvatinib mesylate capsules were approved for marketing on January 7, 2022, and Yangtze River Pharmaceutical's application for this product is under review and is expected to be approved for marketing this year
.
According to the financial report of Eisai, the sales of lenvatinib in the Chinese market in 2020 will reach 1.
178 billion yuan
.

In addition to moxifloxacin hydrochloride eye drops, four varieties including sitagliptin phosphate tablets, lenvatinib mesylate capsules, sunitinib malate capsules, and afatinib maleate tablets have not been included in the centralized collection.
Competition is getting fiercer
.