Another 65 varieties have been reviewed! Hengrui has reviewed several blockbuster injections, Qilu, Zhengda Tianqing...

May 10, 2021

Highlights:

In April, CDE added 59 new acceptance numbers (43 varieties).
In April, there were 109 approvals (including deemed approval) involving 65 varieties of over-evaluation.

According to the consistency evaluation analysis system of the Pharmaceutical Intelligence Data Enterprise Edition, in April 2021, 59 new consistency evaluation acceptance numbers were added; 109 approvals (including 49 deemed approved approvals) were over-evaluated. (Attached to the end of the article is a detailed form of consistency evaluation between declaration and over-evaluation in April)

Figure 1 Trend of filing/approval from February 2020 to April 2021

Review details

In April, a total of 109 acceptance numbers passed/deemed to pass the consistency evaluation, involving 65 varieties of 69 companies, of which 8 varieties are 289 catalog products, and 15 varieties are the first to pass the evaluation. In terms of over-assessment companies, Qilu Pharmaceutical was a big winner in April, with 7 approvals and 5 varieties passing the consistency evaluation. Qilu Pharmaceutical is a large-scale comprehensive modern pharmaceutical company in China, specializing in the development, production and sales of preparations for the treatment of tumors, cardiovascular, cerebrovascular, anti-infection, mental system, nervous system, and ophthalmological diseases and their raw materials. The company has 331 approval documents in China's listed drug database, involving 208 varieties. The company has currently declared/deemedly declared 96 varieties, and 52 varieties have been evaluated, including tenofovir disoproxil fumarate tablets, ceftriaxone sodium for injection, and bivalrudine for injection. Followed by Huahai, Guangshengtang, Chia Tai Tianqing, and Hengrui all have 3 varieties reviewed.

Figure 2 TOP10 products approved by enterprises in April 2021

In terms of varieties, the most intensely competitive varieties in April were rivaroxaban tablets and amoxicillin capsules, both of which were reviewed by five companies. In addition, 5 varieties including Moxifloxacin Hydrochloride Eye Drops have been reviewed by 3 companies. Up to now, a total of 40 companies in Rivaroxaban have applied for consistency evaluation, and 17 companies have passed the evaluation. Rivaroxaban tablets, a new type of anticoagulant, used in adult patients with elective hip or knee replacement surgery to prevent venous thrombosis (VTE); used to treat adult deep vein thrombosis (DVT) and pulmonary embolism (PE) ; Used to reduce the risk of DVT and/or PE recurrence in patients with persistent risk of recurrence of DVT and/or PE after completing at least 6 months of initial treatment; used in non-valvular rooms with one or more risk factors In adult patients, to reduce the risk of stroke and systemic embolism; under well-controlled conditions with warfarin, compared with warfarin, there are limited data on the relative effectiveness of rivaroxaban in reducing the risk of stroke and systemic embolism. Amoxicillin Capsules currently has 68 companies that have applied for consistency evaluation, of which 32 companies have been evaluated. Amoxicillin is suitable for the following infections of adults and children caused by sensitive bacteria (strains that do not produce β-lactamase), and should refer to the official guidelines for clinical application of antibacterial drugs when using it.

Figure 3 TOP 10 companies passing the variety in April 2021

41 varieties are declared, and injections exceed 60%

In April 2021, CDE added 59 acceptance numbers for consistency evaluation, involving 43 varieties of 43 companies, of which injections accounted for the first place.

Figure 4 Details of dosage forms declared in April 2021

In terms of the declared varieties, in April 2021, 5 acceptance numbers of cefotaxime sodium for injection were accepted. In addition, many varieties such as alanyl glutamine injection have 2 acceptance numbers. Details See below.

Figure 5 TOP10 Number of Variety Application Acceptance Numbers in April 2021

Cefotaxime sodium for injection is suitable for pneumonia and other lower respiratory tract infections, urinary tract infections, meningitis, sepsis, abdominal infections, pelvic infections, skin and soft tissue infections, reproductive tract infections, bone and joint infections caused by sensitive bacteria. Cefotaxime can be used as a drug of choice for children with meningitis. There are 233 approvals for cefotaxime sodium for injection in China, involving 81 companies. At present, four companies have applied for consistency evaluation (including a new registration classification). There is no company that has reviewed it yet. Who can become the first company to review it is worth looking forward to! From an enterprise perspective, in April, North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd., Tongfang Pharmaceutical Group Co., Ltd., and Qilu Pharmaceutical Co., Ltd. all had three acceptance numbers for consistency evaluations. North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd. (hereinafter referred to as Huamin Company) is based on the key construction project of Huayao New Park and the key project of Hebei Province—the new cephalosporin project. The project of the strategic goal of chain integration is a model project of Huayao New Industrial Park, a hope project for Huayao to become more refined and stronger, and a key project for Huayao to build a leading domestic and world-class pharmaceutical company. Huamin Company has 124 approvals, involving 54 varieties, of which 13 varieties have been declared for consistency evaluation/deemed declaration. At present, cephalexin capsules and cefuroxime axetil tablets have been reviewed. Tongfang Pharmaceutical Group has more than 10 companies, forming a development layout of the entire industry chain of drug research and development, production, and sales; it has built differentiated products such as chemical drugs, raw materials, biopharmaceuticals, Chinese patent medicines, laboratory animals and Tibetan medicine system. Tongfang Pharmaceutical Group has multiple production lines including powder injections, tablets, ointments, capsules, pills, granules, etc., producing a full range of products such as Chinese patent medicines, chemical medicines, biochemical medicines, biological raw materials, food, and health products. Tongfang Pharmaceutical Group Co., Ltd. currently has 27 approvals, involving 17 varieties, of which 4 varieties have been declared for consistency evaluation/deemed declaration, and none of them has been evaluated yet.

Figure 6 TOP10 number of enterprise application acceptance numbers in April 2021

Attached Table 1: Details of the consistency evaluation passed (including deemed passed) in April 2021

微信图片_20210510093512.jpg

Data as of May 8, 2021

Data source: Yaozhi Data Generic Drug Consistency Evaluation and Analysis System

Attached Table 2: Details of the consistency evaluation of the declaration in April 2021

微信图片_20210510093521.jpg

Data as of May 8, 2021

Data source: Yaozhi Data Generic Drug Consistency Evaluation and Analysis System

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