Recently, Kelun Pharmaceutical has good news again and again.
Alanyl Glutamine Injection is the first to have been evaluated.
The clinical application of KL590586 Capsules, a new class 1 drug, has been accepted by CDE, Moxifloxacin Hydrochloride Eye Drops, Propofol Fumarate, Tenofo The registration status of four generic drugs including Wei tablets, ticagrelor tablets and ropivacaine hydrochloride injection has been changed to "under approval" and is expected to be approved in the near future.
On April 7, the clinical application of KL590586 capsule, a new class 1 drug of Sichuan Kelun Botai, a subsidiary of Kelun Pharmaceutical, was accepted by CDE, with the acceptance numbers CXHL2101023 and CXHL2101024.
This is the second category 1 new drug that Kelun Pharmaceutical has applied for clinical application in 2021 after KL210122 tablets.
Up to now, Kelun Pharmaceutical has 13 new class 1 drugs under development.
On April 8, the official website of NMPA showed that Kelun Pharmaceutical's alanyl glutamine injection passed the consistency evaluation.
Alanyl glutamine injection is a parenteral nutrition drug.
According to data from Minnet, in 2019, China's urban public hospitals, county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) terminal alanine Acylglutamine injection exceeds 2 billion yuan.
This product of Kelun Pharmaceutical is the first domestic product to be reviewed.
In terms of generic drugs, Kelun Pharmaceutical has ushered in a harvest period.
Recently, the registration status of 4 varieties of Moxifloxacin Hydrochloride Eye Drops, Propofol Fumarate Tablets, Ticagrelor Tablets and Ropivacaine Hydrochloride Injection of Kelun Pharmaceutical has changed to "Under review", it is expected to be approved in the near future.
Among them, 3 varieties are reported for production according to the new classification and will be deemed to have been reviewed after approval.
Kelun Pharmaceutical is approving varieties
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
Moxifloxacin hydrochloride eye drops is a fourth-generation quinolone broad-spectrum antibacterial drug.
Compared with similar quinolone eye drops, it has obvious clinical advantages.
In March of this year, the moxifloxacin hydrochloride eye drops of Shanghai Haohai Biological, China Resources Zizhu Pharmaceutical, and Zhuhai Yisheng Biological Pharmaceutical were approved for listing.
The products of Xingqi Eye Medicine and Kelun Pharmaceutical have also entered the administrative examination and approval stage and will be approved soon.
Ropivacaine Hydrochloride Injection is a new long-acting amide local anesthetic developed by AstraZeneca, and it is the leading drug in the local anesthetic market.
According to data from Menet.
com, the sales of terminal ropivacaine hydrochloride injection in China's public medical institutions exceeded 800 million yuan in 2019, a year-on-year increase of 16.
At present, the products of Renfu Pharmaceutical and Shisiyao have passed the consistency evaluation.
According to data from Minai.
com, Kelun Pharmaceutical has 15 generic drugs (24 product regulations) approved for listing in 2020.
In the first quarter of 2021, Kelun Pharmaceutical has been approved for marketing in 4 varieties (7 specifications), including compound amino acid (15AA-Ⅰ)/glucose electrolyte injection, omega-3 fish oil medium/long-chain fat emulsion injection , Sunitinib malate capsules and levofloxacin tablets.
Source: Minet database