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Pemafibrate Tablets(佩玛贝特片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 3 applicationsNo longer listed under review: 1 application
Current coverage may be incomplete
Which companies are listed, and at what stages?
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.
Catalogue holders3View records ↓
Under-review filings24View records ↓
This year’s generic filers8View records ↓
NHSA approval numbers3View records ↓
API companies with A status3View records ↓
Chemical-drug catalogue
Loaded records: 3 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 2 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| 成都倍特药业股份有限公司 | 成都倍特药业股份有限公司 | 国药准字H20266054 | 2026/09/22 | 0.1mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| Kowa Company, Ltd. | Kowa Company, Ltd., Nagoya Factory | 国药准字HJ20250041 | 2025/04/08 | 0.1mg | Imported originator drug (进口原研药品) | CDE |
| 南京正大天晴制药有限公司 | 南京正大天晴制药有限公司 | 国药准字H20266053 | 2026/09/22 | 0.1mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
NHSA drug codes
Loaded records: 3 distinct approval numbers and 3 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 南京正大天晴制药有限公司 | 国药准字H20266053 | 0.1mg | Not stated by source | XC10ABP157A001010101606 | NHSA |
| 成都倍特药业股份有限公司 | 国药准字H20266054 | 0.1mg | Not stated by source | XC10ABP157A001010102013 | NHSA |
| Kowa Company, Ltd. | 国药准字HJ20250041 | 0.1mg | Not stated by source | XC10ABP157A001010178555 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20266053 | 0.1mg | Not stated by source | XC10ABP157A001010201606 | NHSA |
| Kowa Company, Ltd. | 国药准字HJ20250041 | 0.1mg | Not stated by source | XC10ABP157A001010278555 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20266053 | 0.1mg | Not stated by source | XC10ABP157A001010301606 | NHSA |
| Kowa Company, Ltd. | 国药准字HJ20250041 | 0.1mg | Not stated by source | XC10ABP157A001010378555 | NHSA |
Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.
Current under-review applications
Loaded records: 24 filings and 24 distinct first applicants.
Generic 23 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 湖南科伦制药有限公司 | CYHS2601026 | Generic | 2026/05/06 | Not stated by source | CDE |
| 江苏博新医药科技有限公司;江苏利泰尔药业有限公司 | CYHS2503799 | Generic | 2025/10/28 | Not stated by source | CDE |
| 南京海融制药有限公司 | CYHS2503306 | Generic | 2025/09/06 | Not stated by source | CDE |
| 苏州第三制药厂有限责任公司 | CYHS2602349 | Generic | 2026/09/20 | Not stated by source | CDE |
| 南京海鲸药业股份有限公司 | CYHS2501994 | Generic | 2025/06/05 | Not stated by source | CDE |
| 江苏奥赛康药业有限公司;成都硕德药业有限公司 | CYHS2502747 | Generic | 2025/07/30 | Not stated by source | CDE |
| 江苏德源药业股份有限公司 | CYHS2503848 | Generic | 2025/11/01 | Not stated by source | CDE |
| 海南赛立克药业有限公司 | CYHS2602197 | Generic | 2026/09/03 | Not stated by source | CDE |
| 湖南千金协力药业有限公司;兰西哈三联制药有限公司 | CYHB2601657 | Supplement | 2026/08/31 | Not stated by source | CDE |
| 天方药业有限公司 | CYHS2601005 | Generic | 2026/04/30 | Not stated by source | CDE |
| 桂林南药股份有限公司;北京以岭生物工程技术有限公司 | CYHS2600973 | Generic | 2026/04/28 | Not stated by source | CDE |
| 云南龙津康佑生物医药有限公司;北京以岭生物工程技术有限公司 | CYHS2600719 | Generic | 2026/03/26 | Not stated by source | CDE |
| 江西施美药业股份有限公司 | CYHS2600504 | Generic | 2026/02/25 | Not stated by source | CDE |
| 重庆圣华曦药业股份有限公司 | CYHS2600382 | Generic | 2026/02/05 | Not stated by source | CDE |
| 浙江花园药业有限公司 | CYHS2504355 | Generic | 2025/12/23 | Not stated by source | CDE |
| 江西泰吉立生物医药科技有限公司;浙江益汉制药有限公司 | CYHS2504231 | Generic | 2025/12/10 | Not stated by source | CDE |
| 广州一品红制药有限公司 | CYHS2504124 | Generic | 2025/12/02 | Not stated by source | CDE |
| 安徽美来药业股份有限公司;江西亿友药业有限公司 | CYHS2504085 | Generic | 2025/11/27 | Not stated by source | CDE |
| 辰欣药业股份有限公司 | CYHS2503655 | Generic | 2025/10/14 | Not stated by source | CDE |
| 宜昌人福药业有限责任公司 | CYHS2503652 | Generic | 2025/10/13 | Not stated by source | CDE |
| 山西鑫煜制药股份有限公司 | CYHS2503548 | Generic | 2025/09/28 | Not stated by source | CDE |
| 陕西九州制药有限责任公司 | CYHS2503258 | Generic | 2025/09/04 | Not stated by source | CDE |
| 兰西哈三联制药有限公司 | CYHS2502743 | Generic | 2025/07/30 | Not stated by source | CDE |
| 遂成药业股份有限公司 | CYHS2501569 | Generic | 2025/04/25 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 8 filings and 8 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 湖南科伦制药有限公司 | CYHS2601026 | Generic | 2026/05/06 | Not stated by source | CDE |
| 苏州第三制药厂有限责任公司 | CYHS2602349 | Generic | 2026/09/20 | Not stated by source | CDE |
| 海南赛立克药业有限公司 | CYHS2602197 | Generic | 2026/09/03 | Not stated by source | CDE |
| 天方药业有限公司 | CYHS2601005 | Generic | 2026/04/30 | Not stated by source | CDE |
| 桂林南药股份有限公司;北京以岭生物工程技术有限公司 | CYHS2600973 | Generic | 2026/04/28 | Not stated by source | CDE |
| 云南龙津康佑生物医药有限公司;北京以岭生物工程技术有限公司 | CYHS2600719 | Generic | 2026/03/26 | Not stated by source | CDE |
| 江西施美药业股份有限公司 | CYHS2600504 | Generic | 2026/02/25 | Not stated by source | CDE |
| 重庆圣华曦药业股份有限公司 | CYHS2600382 | Generic | 2026/02/05 | Not stated by source | CDE |
API registrations
Non-component matches: 3 companies with A status and 11 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 佩玛贝特 | 浙江普洛康裕制药有限公司 | Y20250001268 | I | Exact ingredient | 2025/12/11 | CDE |
| 佩玛贝特 | 重庆圣华曦药业股份有限公司 | Y20250001073 | I | Exact ingredient | 2025/10/29 | CDE |
| 佩玛贝特 | 浙江赛默制药有限公司 | Y20250000395 | I | Exact ingredient | 2025/08/21 | CDE |
| 佩玛贝特 | 南京海融制药有限公司 | Y20250000653 | I | Exact ingredient | 2025/07/04 | CDE |
| 佩玛贝特 | 重庆瑞泊莱制药有限公司 | Y20250000578 | I | Exact ingredient | 2025/06/23 | CDE |
| 佩玛贝特 | 江西亿友药业有限公司 | Y20250000506 | I | Exact ingredient | 2025/05/28 | CDE |
| 佩玛贝特 | 天方药业有限公司 | Y20250000241 | I | Exact ingredient | 2025/05/19 | CDE |
| 佩玛贝特 | 山东辰龙药业有限公司 | Y20250000386 | A | Exact ingredient | 2026/10/29 | CDE |
| 佩玛贝特 | 河北广祥制药有限公司 | Y20250000200 | I | Exact ingredient | 2025/03/19 | CDE |
| 佩玛贝特 | 江苏普润生物医药有限公司 | Y20250000181 | A | Exact ingredient | 2026/10/01 | CDE |
| 佩玛贝特 | 福建南方制药股份有限公司 | Y20240000509 | I | Exact ingredient | 2024/07/25 | CDE |
| 佩玛贝特 | 南京海鲸药业股份有限公司 | Y20230000448 | I | Exact ingredient | 2023/06/16 | CDE |
| 佩玛贝特 | 四川科伦药业股份有限公司 | Y20230000301 | I | Exact ingredient | 2023/06/01 | CDE |
| 佩玛贝特 | 四川仁安药业有限责任公司 | Y20220000904 | A | Exact ingredient | 2026/10/01 | CDE |
A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.
What changed recently?
Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.
Trial registration does not mean an application will follow.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/11/06No longer listed under review
北京福元医药股份有限公司
CYHS2502259
Fact date: 2026/11/06 · Site observation date: 2026/11/06
Accepted: 2025/06/24
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/09/20Accepted
-
2026/09/03Accepted
-
2026/08/31Accepted
湖南千金协力药业有限公司;兰西哈三联制药有限公司
CYHB2601657
Fact date: 2026/08/31 · Site observation date: 2026/10/22
View source ↗
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/10 07:27
- Chemical-drug catalogue
- Last successful update: 2026/11/10 07:23
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
- Full API register
- Last successful update: 2026/11/10 07:25
- NHSA drug codes
- Last successful update: 2026/11/05 06:45
The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.
- NMPA drug delivery notices
- Last successful update: 2026/11/10 18:31
First index-page publication dates: 2026-10-26 to 2026-11-10; 0 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/10 08:10 · Current coverage may be incomplete
Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
Public-product searches scanned: 3/30; discovered pending details: 20. Record counts in unscanned portions remain unknown.
Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
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