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[Pharmaceutical Network Industry News] Compared with original research drugs, generic drugs have lower R&D costs and looser marketing approval conditions.
After entering the market, they will replace original research drugs to a certain extent, which has the effect of weakening the incentive mechanism of drug patents
.
In order to improve the high-quality development of generic drugs, the consistency evaluation of generic drugs has been introduced as a threshold for centralized procurement
.
Today, since the implementation of the generic drug consistency evaluation policy, most domestic pharmaceutical companies have actively participated in it
.
The data shows that as of April 22, there have been 748 domestically approved or deemed to have passed the consistency evaluation (involving more than 4,200 acceptance numbers)
.
Among them, Yangzijiang Pharmaceutical Group has reviewed 105 varieties, Qilu Pharmaceutical has reviewed 98 varieties, Sino Biopharmaceutical has reviewed 85 varieties, Kelun Pharmaceutical has reviewed 74 varieties, and CSPC has reviewed 72 varieties.
comment
.
In addition, Fosun Pharma, Hengrui Pharma, and Shanghai Pharma have 53, 51, and 49 over-reviewed varieties, respectively, with little difference between them
.
It is understood that 105 varieties of Yangzijiang Pharmaceuticals have been reviewed, mainly focusing on systemic anti-infective drugs (21), anti-tumor and immunomodulators (14), digestive system and metabolizing drugs (13)
.
Among them, 25 varieties have been reviewed by the first home, and a total of 31 varieties have won the first five batches of centralized procurement
.
In addition, the author was informed that on April 6, two generic drugs of Yangzijiang Pharmaceutical (Tedizolid Phosphate for Injection, Levetiracetam Tablets) were approved for marketing.
Among them, Tedizolid Phosphate for Injection was the first generic, which was won on the same day.
The first imitation of super antibiotics and 700 million anti-epileptic drugs
.
Qilu Pharmaceutical's 98 over-reviewed products mainly focus on anti-tumor and immunomodulatory agents (27), systemic anti-infective drugs (19), and nervous system drugs (16)
.
In addition, the author was informed that recently, the marketing applications of several first generic drugs of Qilu Pharmaceutical have been accepted
.
For example, on April 24, Qilu Pharmaceutical's "dotegravir sodium tablet" marketing application was accepted for the treatment of AIDS (HIV infection)
.
On March 22, it was used to treat immune thrombocytopenia; on March 25, its riociguat marketing application was accepted by the CDE
.
In addition to re-generic drugs, Qilu Pharma is also making continuous efforts in the research and development of new drugs, and has established a rich product pipeline through the introduction of cooperative and self-developed research
.
The 85 varieties of China Biopharmaceuticals are mainly concentrated in anti-tumor and immunomodulatory agents (21), digestive system and metabolizing drugs (15), and systemic anti-infective drugs (13)
.
It is reported that China Biopharmaceuticals recently issued an announcement that the diabetes treatment drug sitagliptin phosphate tablets 50mg and 100mg have been approved by the State Food and Drug Administration, and are deemed to have passed the quality and efficacy consistency evaluation of generic drugs
.
Sitagliptin is an approved oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in combination with diet and exercise to improve glycemic control in patients with type 2 diabetes
.
Clinical data show that sitagliptin has basically no risk of hypoglycemia, has no metered titration and no gastrointestinal reactions, and can effectively control blood sugar by oral administration once a day, and can effectively delay the progression of diabetes
.
In addition, in early 2022, Sino Biopharmaceutical's first biosimilar drug adalimumab injection was approved for marketing, further improving the coverage of anti-tumor and immune fields
.
In 2021, a total of 20 generic drugs of Sino Biopharmaceuticals have been approved for marketing, and the first Class 1 biological drug Piamprimab Injection (PD-1 mAb) has been harvested
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
After entering the market, they will replace original research drugs to a certain extent, which has the effect of weakening the incentive mechanism of drug patents
.
In order to improve the high-quality development of generic drugs, the consistency evaluation of generic drugs has been introduced as a threshold for centralized procurement
.
Today, since the implementation of the generic drug consistency evaluation policy, most domestic pharmaceutical companies have actively participated in it
.
The data shows that as of April 22, there have been 748 domestically approved or deemed to have passed the consistency evaluation (involving more than 4,200 acceptance numbers)
.
Among them, Yangzijiang Pharmaceutical Group has reviewed 105 varieties, Qilu Pharmaceutical has reviewed 98 varieties, Sino Biopharmaceutical has reviewed 85 varieties, Kelun Pharmaceutical has reviewed 74 varieties, and CSPC has reviewed 72 varieties.
comment
.
In addition, Fosun Pharma, Hengrui Pharma, and Shanghai Pharma have 53, 51, and 49 over-reviewed varieties, respectively, with little difference between them
.
It is understood that 105 varieties of Yangzijiang Pharmaceuticals have been reviewed, mainly focusing on systemic anti-infective drugs (21), anti-tumor and immunomodulators (14), digestive system and metabolizing drugs (13)
.
Among them, 25 varieties have been reviewed by the first home, and a total of 31 varieties have won the first five batches of centralized procurement
.
In addition, the author was informed that on April 6, two generic drugs of Yangzijiang Pharmaceutical (Tedizolid Phosphate for Injection, Levetiracetam Tablets) were approved for marketing.
Among them, Tedizolid Phosphate for Injection was the first generic, which was won on the same day.
The first imitation of super antibiotics and 700 million anti-epileptic drugs
.
Qilu Pharmaceutical's 98 over-reviewed products mainly focus on anti-tumor and immunomodulatory agents (27), systemic anti-infective drugs (19), and nervous system drugs (16)
.
In addition, the author was informed that recently, the marketing applications of several first generic drugs of Qilu Pharmaceutical have been accepted
.
For example, on April 24, Qilu Pharmaceutical's "dotegravir sodium tablet" marketing application was accepted for the treatment of AIDS (HIV infection)
.
On March 22, it was used to treat immune thrombocytopenia; on March 25, its riociguat marketing application was accepted by the CDE
.
In addition to re-generic drugs, Qilu Pharma is also making continuous efforts in the research and development of new drugs, and has established a rich product pipeline through the introduction of cooperative and self-developed research
.
The 85 varieties of China Biopharmaceuticals are mainly concentrated in anti-tumor and immunomodulatory agents (21), digestive system and metabolizing drugs (15), and systemic anti-infective drugs (13)
.
It is reported that China Biopharmaceuticals recently issued an announcement that the diabetes treatment drug sitagliptin phosphate tablets 50mg and 100mg have been approved by the State Food and Drug Administration, and are deemed to have passed the quality and efficacy consistency evaluation of generic drugs
.
Sitagliptin is an approved oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in combination with diet and exercise to improve glycemic control in patients with type 2 diabetes
.
Clinical data show that sitagliptin has basically no risk of hypoglycemia, has no metered titration and no gastrointestinal reactions, and can effectively control blood sugar by oral administration once a day, and can effectively delay the progression of diabetes
.
In addition, in early 2022, Sino Biopharmaceutical's first biosimilar drug adalimumab injection was approved for marketing, further improving the coverage of anti-tumor and immune fields
.
In 2021, a total of 20 generic drugs of Sino Biopharmaceuticals have been approved for marketing, and the first Class 1 biological drug Piamprimab Injection (PD-1 mAb) has been harvested
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.