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As of 13 November 2026, for Pemafibrate Tablets, 23 applications are listed as under review at China's CDE; 8 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 3 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 3 applicationsNo longer listed under review: 2 applications
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.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.
Catalogue holders3View records ↓
Under-review filings23View 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 |
|---|---|---|---|---|---|---|
| Chengdu Brilliant Pharmaceutical Co., Ltd. | Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20266054 | 2026/09/22 | 0.1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Kowa Company, Ltd. | Kowa Company, Ltd., Nagoya Factory | 国药准字HJ20250041 | 2025/04/08 | 0.1mg | Imported originator drug | CDE |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20266053 | 2026/09/22 | 0.1mg | Generic approved under the new chemical-drug registration classification | 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 |
|---|---|---|---|---|---|
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20266053 | 0.1mg | Not stated by source | XC10ABP157A001010101606 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 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 |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 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 |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 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: 23 filings and 23 distinct first applicants.
Generic 22 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CYHS2601026 | Generic | 2026/05/06 | Not stated by source | CDE |
| Jiangsu Bo Xin Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Li Tai Er Pharma Co., Ltd. romanized | CYHS2503799 | Generic | 2025/10/28 | Not stated by source | CDE |
| Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized | CYHS2503306 | Generic | 2025/09/06 | Not stated by source | CDE |
| Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized | CYHS2602349 | Generic | 2026/09/20 | Not stated by source | CDE |
| Nanjing Hai Jing Pharma Co., Ltd. romanized | CYHS2501994 | Generic | 2025/06/05 | Not stated by source | CDE |
| Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized; Chengdu Shuo De Pharma Co., Ltd. romanized | CYHS2502747 | Generic | 2025/07/30 | Not stated by source | CDE |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | CYHS2503848 | Generic | 2025/11/01 | Not stated by source | CDE |
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | CYHS2602197 | Generic | 2026/09/03 | Not stated by source | CDE |
| Hunan Qian Jin Xie Li Pharma Co., Ltd. romanized; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | CYHB2601657 | Supplement | 2026/08/31 | Not stated by source | CDE |
| Topfond Pharmaceutical Co., Ltd. | CYHS2601005 | Generic | 2026/04/30 | Not stated by source | CDE |
| Gui Lin Nan Yao Co., Ltd. romanized; Beijing Yi Ling Bio Gong Cheng Technology Co., Ltd. romanized | CYHS2600973 | Generic | 2026/04/28 | Not stated by source | CDE |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized; Beijing Yi Ling Bio Gong Cheng Technology Co., Ltd. romanized | CYHS2600719 | Generic | 2026/03/26 | Not stated by source | CDE |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHS2600504 | Generic | 2026/02/25 | Not stated by source | CDE |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | CYHS2600382 | Generic | 2026/02/05 | Not stated by source | CDE |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | CYHS2504355 | Generic | 2025/12/23 | Not stated by source | CDE |
| Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Yi Han Pharmaceutical Co., Ltd. romanized | CYHS2504231 | Generic | 2025/12/10 | Not stated by source | CDE |
| Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | CYHS2504124 | Generic | 2025/12/02 | Not stated by source | CDE |
| Anhui Mei Lai Pharma Co., Ltd. romanized; Jiangxi Yi You Pharma Co., Ltd. romanized | CYHS2504085 | Generic | 2025/11/27 | Not stated by source | CDE |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2503655 | Generic | 2025/10/14 | Not stated by source | CDE |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2503652 | Generic | 2025/10/13 | Not stated by source | CDE |
| Shanxi Xin Yu Pharmaceutical Co., Ltd. romanized | CYHS2503548 | Generic | 2025/09/28 | Not stated by source | CDE |
| Shaanxi Jiu Zhou Pharmaceutical Co., Ltd. romanized | CYHS2503258 | Generic | 2025/09/04 | Not stated by source | CDE |
| Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | CYHS2502743 | Generic | 2025/07/30 | 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 |
|---|---|---|---|---|---|
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CYHS2601026 | Generic | 2026/05/06 | Not stated by source | CDE |
| Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized | CYHS2602349 | Generic | 2026/09/20 | Not stated by source | CDE |
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | CYHS2602197 | Generic | 2026/09/03 | Not stated by source | CDE |
| Topfond Pharmaceutical Co., Ltd. | CYHS2601005 | Generic | 2026/04/30 | Not stated by source | CDE |
| Gui Lin Nan Yao Co., Ltd. romanized; Beijing Yi Ling Bio Gong Cheng Technology Co., Ltd. romanized | CYHS2600973 | Generic | 2026/04/28 | Not stated by source | CDE |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized; Beijing Yi Ling Bio Gong Cheng Technology Co., Ltd. romanized | CYHS2600719 | Generic | 2026/03/26 | Not stated by source | CDE |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHS2600504 | Generic | 2026/02/25 | Not stated by source | CDE |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 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 · No verified English name | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | Y20250001268 | I | Exact ingredient | 2025/12/11 | CDE |
| 佩玛贝特 · No verified English name | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Y20250001073 | I | Exact ingredient | 2025/10/29 | CDE |
| 佩玛贝特 · No verified English name | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Y20250000395 | I | Exact ingredient | 2025/08/21 | CDE |
| 佩玛贝特 · No verified English name | Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized | Y20250000653 | I | Exact ingredient | 2025/07/04 | CDE |
| 佩玛贝特 · No verified English name | Chongqing Rui Po Lai Pharmaceutical Co., Ltd. romanized | Y20250000578 | I | Exact ingredient | 2025/06/23 | CDE |
| 佩玛贝特 · No verified English name | Jiangxi Yi You Pharma Co., Ltd. romanized | Y20250000506 | I | Exact ingredient | 2025/05/28 | CDE |
| 佩玛贝特 · No verified English name | Topfond Pharmaceutical Co., Ltd. | Y20250000241 | I | Exact ingredient | 2025/05/19 | CDE |
| 佩玛贝特 · No verified English name | Shandong Chen Long Pharma Co., Ltd. romanized | Y20250000386 | A | Exact ingredient | 2026/10/29 | CDE |
| 佩玛贝特 · No verified English name | Hebei Guang Xiang Pharmaceutical Co., Ltd. romanized | Y20250000200 | I | Exact ingredient | 2025/03/19 | CDE |
| 佩玛贝特 · No verified English name | Jiangsu Pu Run Biopharmaceuticals Co., Ltd. romanized | Y20250000181 | A | Exact ingredient | 2026/10/01 | CDE |
| 佩玛贝特 · No verified English name | Fujian Nan Fang Pharmaceutical Co., Ltd. romanized | Y20240000509 | I | Exact ingredient | 2024/07/25 | CDE |
| 佩玛贝特 · No verified English name | Nanjing Hai Jing Pharma Co., Ltd. romanized | Y20230000448 | I | Exact ingredient | 2023/06/16 | CDE |
| 佩玛贝特 · No verified English name | Sichuan Kelun Pharmaceutical Co., Ltd. | Y20230000301 | I | Exact ingredient | 2023/06/01 | CDE |
| 佩玛贝特 · No verified English name | Sichuan Ren An Pharma Co., Ltd. romanized | 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: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
-
2026/11/11No longer listed under review
Sui Cheng Pharma Co., Ltd. romanized
CYHS2501569
Fact date: 2026/11/11 · Site observation date: 2026/11/11
Accepted: 2025/04/25
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/11/06No longer listed under review
Beijing Foyou Pharma CO.,LTD
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
Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized
CYHS2602349
Fact date: 2026/09/20 · Site observation date: 2026/10/21
View source ↗ -
2026/09/03Accepted
Hainan Sai Li Ke Pharma Co., Ltd. romanized
CYHS2602197
Fact date: 2026/09/03 · Site observation date: 2026/10/22
View source ↗ -
2026/08/31Accepted
Hunan Qian Jin Xie Li Pharma Co., Ltd. romanized; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized
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: 2026/11/13 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/13 06:39
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: 2026/11/13 06:41
- 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: 2026/11/12 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/13 08:09 · 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: 7/30; discovered pending details: 13. 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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