Qilu Pharmaceutical Crowned Leader in Generic Drug Consistency Evaluation with 206 Approved Products

Data from Yaozhi shows that in the first half of 2025, a total of 1,678 varieties (deduplicated by drug + group + registration type + year) passed or were considered to have passed the consistency evaluation, accounting for 54.57% of the total in 2024. These involved 659 group companies, among which the number of varieties that passed the evaluation via supplemental applications for consistency evaluation significantly decreased compared to 2024, representing only 31.72% of the 2024 figures.

It is worth mentioning that although Qilu Pharmaceutical Co., Ltd. had only 16 approved varieties in the first half of the year, ranking 7th among enterprises in H1 2025, its total number of approved varieties from 2017 to the first half of 2025 still ranks first, with a total of 206 approved varieties, securing the top position.

Passed Review

1.Overall Review Status

Since 2021, the growth rate of the number of varieties passing the consistency evaluation supplementary application has slowed down, while the number of varieties applied for marketing under the new registration classification of generic drugs has significantly increased.

In H1 2025, a total of 1,678 products from 659 group companies passed/were considered to have passed the consistency evaluation, accounting for 54.57% of the total in 2024. Among them, the number of products applied for marketing as Class 3 generic drugs increased the most, accounting for 80.24% of the total in 2024, while the number of products that passed the evaluation via supplementary application for consistency evaluation decreased, accounting for only 31.72% of the total in 2024.

Among the 93 first-batch drugs that passed the evaluation, 43 are exclusively produced by single enterprises, including 33 listed as Category 3, five as Category 4, two as Category 5.2, and three already-marketed drugs that passed the consistency evaluation (see detailed list). Qilu Pharmaceutical and Renfu Medicine each have three Category 3 first-generic drugs on the market.

By H1 2025, the number of approved/presumed approved drug varieties (deduplicated by drug + group + registration type + year) has reached 54.57% of the total for the whole year of 2024. Among various application types, there are 601 varieties of Class 3 generic drugs approved for marketing (accounting for 80.24% of the total for 2024); 826 varieties of Class 4 generic drugs (accounting for 52.24%); 34 varieties of imported generics under Class 5.2 (accounting for 55.74%); and 217 varieties that have passed the consistency evaluation through supplementary applications (accounting for 31.72%).

Figure 1: Trend of Consistency Evaluation Approval from 2017 to the First Half of 2025

Note: The number of varieties passing the evaluation is counted after deduplication by medicine + group + registration type + year.

2.2025H1 Exclusive Approved Drugs

In the first half of the year, a total of 93 non-central procurement products passed or were deemed to have passed the consistency evaluation for the first time (excluding products that had already been marketed as generic drugs under the new registration classification before passing the consistency evaluation). These products involved 73 enterprises, of which 13 enterprises had multiple products that were the first to pass the evaluation. Among them, Humanwell Healthcare (Group) Co., Ltd. and Qilu Pharmaceutical Co., Ltd. had the highest number of products passing the evaluation for the first time, with each having five products passing the evaluation.

Figure 2: Ranking of Companies with Exclusively Approved Drugs

Note: Statistics are calculated after deduplication based on standardized drug names and groups.

3. Number of Approved Varieties by Enterprises

In terms of the number of drug varieties that have passed the evaluation, a total of 697 drugs passed/were deemed to pass the consistency evaluation in the first half of 2025, involving 659 group companies. Kelun Pharmaceuticals had the highest number of approved varieties, followed by Shanghai Fosun Pharma, with Shijiazhuang Fourth Pharmaceutical ranking third.

Figure 3: Number of Approved Varieties by Enterprises in H1 2025

Note: Statistics are calculated after deduplication based on standardized drug names and groups.

In terms of the total number of varieties passing the evaluation across enterprises, currently, 1,460 varieties (in terms of pharmaceuticals) have passed/been deemed to pass the consistency evaluation, involving 1,399 group companies.

Although Qilu Pharmaceutical had only 16 approved varieties in the first half of the year, ranking 7th among enterprises in H1 2025, its total number of approved varieties from 2017 to the first half of 2025 still ranks first, with a total of 206 approved varieties.

In the past two years, the number of generic drugs passing evaluations by Qilu Pharmaceutical and Yangtze River Pharmaceutical has gradually decreased. However, Kelun Pharmaceutical has not slowed down. In the first half of 2025, it made another push, with 37 products passing evaluations. The company now has nearly 200 products that have passed evaluations, closely rivaling Qilu, ranking second in terms of the number of products that have passed evaluations.

Figure 4: 2017-2025H1 Number of Approved Varieties by Enterprises

Note: Statistics are calculated after deduplication based on standardized drug names and groups.

4. Number of Companies with Approved Varieties

In terms of the number of companies that have passed the evaluation for product varieties, the injectable Dihydroxypropyltheophylline has become the variety with the highest number of companies passing the evaluation (22 companies), followed by Famotidine Injection (19 companies), and ranking third is Cefozopran Sodium for Injection (18 companies). In 2024, Tadalafil Tablets had the highest number of companies passing the evaluation, with 12 additional companies passing in 25 years.

Figure 5 Number of enterprises with approved varieties in H1 2025

Note: Statistics are calculated after deduplication based on standardized pharmaceuticals + group.

In terms of the total number of companies that have passed the evaluation for product varieties, tadalafil tablets have the highest number of approved companies (73 group enterprises), followed by amlodipine besylate tablets (62 companies), and rivaroxaban tablets rank third (52 companies).

Figure 6: Number of Companies with Approved Varieties from 2017 to 2025H1

Note: Statistics are calculated after deduplication based on standardized drug names + group enterprises.

5. Centralized Procurement Status

Among the 697 drugs approved in H1 of 2025, the majority are non-volume-based procurement drugs (accounting for 64.42%), with a significant decrease in the proportion of volume-based procurement drugs. Among the volume-based procurement drugs, systemic anti-infectives account for the largest share, with 54 drugs representing 21.77%. Among non-volume-based procurement drugs, the largest category is gastrointestinal and metabolic drugs, with 64 drugs approved.

Figure 7: Status of Drug Procurement for Drugs Meeting Evaluation Standards in H1 2025

Note: Statistics after standardization and deduplication of drugs.

Figure 8: ATC Classification of Centralized Procurement Varieties

Note: Statistics after standardization and deduplication of drugs.

Figure 9: ATC Classification of Non-Volume-Based Procurement Varieties

Note: Statistics after standardization and deduplication of drugs.

Generic Drug Launch

1.Overall Situation of Consistency Declaration

The number of drug products with consistency evaluation supplementary applications in 2025 has significantly decreased compared to the same period in 2024, while the number of drug products applying for marketing authorization as new generic drugs under the new registration classification has increased each month compared to 2024.

Figure 10: Status of Generic Drug Applications in 2024

Note: Statistics based on deduplicated drugs.

Exclusive Application for Generic Drugs of Category 2.3

In the first half of the year, a total of 369 drugs from 426 companies were submitted for marketing approval as generic drug category 3. Among them, 28 drugs were exclusively submitted, including 18 drugs submitted for marketing approval. Of the 9 drugs submitted for clinical trials, 4 have already been approved, namely Bempedoic Acid and Ezetimibe Tablets, Ozenoxacin Lotion, Leuprolide Acetate Suspension for Injection, and Brimonidine Gel.

Table 1: 2025H1, First to Pass Evaluation and Exclusively Produced Drug Information

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

Editor: Liuli

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