Fosun Pharma Tops China's 2025 Generic Drug Consistency Evaluation Rankings with 63 Approved Products

Data from Yaozhi shows that there are a total of3,349Varieties (statistically deduplicated by drug name + group enterprise) have passed/been deemed to pass the consistency evaluation, involving 964 drugs and 930 enterprises (statistically counted by group enterprises). Among them,Fosun PharmaceuticalIn63Number of Approved Varieties, Secures "Annual Enterprise Approved Varieties Count"The First Place。

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Fosun Pharmaceutical,

Ranked First in "Annual Number of Approved Varieties for Enterprises"

1.Overall Status of Consistency Evaluation Approval

In 2025, there are a total of3,349Products (statistically deduplicated by drug name + group enterprise) passed/be deemed to have passed the consistency evaluation, including 47 drugs that passed for the first time via a consistency evaluation application, 223 drugs applied for marketing as generic drugs under the new registration classification, and 129 newly added exclusive products passing the evaluation during the whole year (as of December 31).

From 2017 to 2025, the number of varieties approved through consistency evaluation supplementary applications after 2021Showing a downward trend, the number of varieties applying for marketing under the new generic drug registration classification continuesOn the riseAmong them, the data of varieties that passed the evaluation by supplementary application for consistency in 2025 decreased by 37.6% compared to 2024, and the number of varieties applied for marketing under the new generic drug registration classification increased by 8.3% compared to 2025.

Figure 1 Trend of Consistency Evaluation from 2017 to 2025

Note: The number of varieties passing the evaluation is counted after deduplication by drug name + group company.

2. Number of Company's Approved Varieties

In terms of the number of drugs that have passed the evaluation, a total of 964 drugs passed/were deemed to pass the consistency evaluation in 2025, involving 930 group companies. Among them, 532 companies achieved multi-variety approval, and 59 companies had more than 10 varieties approved. In terms of the number of approvals for individual companies,Fosun Pharmaceutical has the largest number of approved varieties., followed by Shijiazhuang No.4 Pharmaceutical Co., Ltd., and Kelun ranked third.

Figure 2 Number of Group Enterprises' Approved Varieties in 2025

Note: Statistics are calculated after deduplication based on the combination of drug name + holder's group company.

From 2017 to the end of 2025, a total of 1,554 drugs have passed/been deemed to pass the consistency evaluation, involving 1,494 group enterprises. Among them,Qilu PharmaceuticalThe largest number of approved varieties, followed by Sichuan Kelun Pharmaceutical Co., Ltd. and Shanghai Fosun Pharmaceutical (Group) Co., Ltd.

Figure 3 Number of Group Enterprise Products Approved from 2017 to 2025

Note: Statistics are calculated after deduplication based on the pharmaceutical name + the group company of the holder.

3. Number of companies with approved varieties

In terms of the number of companies that have passed the evaluation for product varieties, out of the 964 drugs that passed the evaluation in 2025, 573 drugs were approved by multiple companies. Among them, the most competitive isDiprophylline Injection, with 38 companies passing the evaluation, ranking first; followed by sulfate glucosamine capsules, with 33 companies passing the evaluation, ranking second.

Figure 4 Number of Companies with Approved Varieties in 2025

Note: Statistics are calculated after deduplication based on the combination of drug name + holder's group company.

From 2017 to the end of 2025, among the 1,554 drugs that have passed/been deemed to pass the consistency evaluation, 10 drugs have been approved by more than 50 companies, includingTadalafil TabletsThe number of companies passing the evaluation is the highest, followed by Amlodipine Besylate Tablets, and thirdly, Glucosamine Sulfate Capsules.

Figure 5 Number of companies with approved varieties from 2017 to 2025

Note: Statistics are calculated after deduplication based on the combination of drug name + holder's group company.

4. Centralized Procurement Situation

Among the 964 drugs that passed the evaluation in 2025,361 drugs have been included in the centralized procurement, accounting for 37%., with 603 non-bulk procurement varieties, accounting for 63%. In terms of ATC classification, the most approvals were for the digestive tract and metabolism, with 137 products, accounting for 14%; followed by the cardiovascular system, with 133 products.

Figure 6 ATC Classification of Drugs Passed Evaluation in 2025

Note: Statistics after removing duplicates by drug name.

5. Status of Non-Approval for Consistency Evaluation

In 2025, there were 4,990 acceptance numbers for supplemental applications of consistency evaluation and new generic drug registration classifications that completed the review process, of which548 Acceptance Numbers Not Approved, involving a total of 375 companies and 303 drugs. Among them, the injection of Nalmefene Hydrochloride had the highest number of unapproved companies, involving 17 companies, followed by Bilastine Tablets, involving 9 companies.

Figure 7 Number of companies with drugs that failed to pass the consistency evaluation in 2025

Note: Statistics are calculated after deduplication based on the pharmaceutical name + the group company of the holder.

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Gastrointestinal and Metabolic Fields,

Become a hotspot for declaration

1.Overall Status of Consistency Evaluation Submission

In 2025, regarding the supplementary applications for consistency evaluation and the marketing applications for generic drugs under the new registration classification, a total of3,930Varieties (Drug Name + Group Enterprise Deduplication Statistics).

In terms of the number of varieties for consistency evaluation supplementary applications, there were 316 declared varieties in 2025, continuing a downward trend. A total of 431 application acceptance numbers were filed, covering 203 drugs and involving 190 companies (counted by group enterprises).

In terms of the launch of generic drugs under the new registered classification, there will be a total of 3,614 items (drugs + corporate groups) in 2025, involving 1,060 drugs and 987 companies (counted by corporate groups), marking a 5% decrease compared to 2024.

Figure 8 Consistency Declaration Status from 2017 to 2025

Note: The number of declared varieties is counted after deduplication by drug name + group company.

2.ATC Classification

In terms of the ATC classification of drugs for which consistency applications have been filed, 2025Gastrointestinal and MetabolismAspectThe largest number of drug applications reached 175, accounting for 15%, followed by the nervous system with 156 applications, accounting for 13%.

Figure 9 ATC Classification of Consistency Declaration Drugs in 2025

Note: Statistics after removing duplicates by drug name.

Table 1 Details of Exclusive Consistency Evaluation Varieties Passed in 2025

Data Source: YAOZHI Data Enterprise Edition - Generic Drug Consistency Evaluation Analysis System

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