Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized
Check drug filings and source records for this company-name string.
Listed by the company name as recorded in the source, without merging affiliated entities.
Page reference 76c17ef611
These counts cover loaded acceptance records only. First-applicant and co-applicant counts are not added together. CDE data as of 2026/11/13 06:42.
Drug filings
26 acceptance records as first applicant, grouped into 16 source drug names. Source data as of 2026/11/13 06:42.
Acceptance records are de-duplicated by acceptance number. Drug names are normalized only for width and whitespace; dosage forms and combinations remain separate. Application types are retained from the source. Expand a drug to inspect each record. Published drugs link to their drug pages; other names do not create new public drug pages.
注射用多西他赛(白蛋白结合型) · No verified English name 1 records · Latest accepted 2022/09/22
New drug · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CXHL2200716 | New drug | 2022/09/22 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized | CDE ↗ |
布瑞哌唑口溶膜 · No verified English name 2 records · Latest accepted 2022/08/12
New drug · 2
Enzalutamide Tablets 1 records · Latest accepted 2022/05/28
New drug · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CXHL2200339 | New drug | 2022/05/28 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized | CDE ↗ |
盐酸左沙丁胺醇雾化吸入溶液 · No verified English name 3 records · Latest accepted 2022/04/19
Generic · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2200613 | Generic | 2022/04/19 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2200612 | Generic | 2022/04/19 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2200611 | Generic | 2022/04/19 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Regorafenib Tablets 1 records · Latest accepted 2022/01/28
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2200217 | Generic | 2022/01/28 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Sorafenib Tosylate Tablets 1 records · Latest accepted 2022/01/24
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2200167 | Generic | 2022/01/24 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Compound Ipratropium Bromide Solution For Inhalation 1 records · Latest accepted 2022/01/11
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2200044 | Generic | 2022/01/11 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Nintedanib Esilate Soft Capsules 2 records · Latest accepted 2021/12/17
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2102199 | Generic | 2021/12/17 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. | CDE ↗ |
| CYHS2102198 | Generic | 2021/12/17 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. | CDE ↗ |
Obeticholic Acid Tablets 2 records · Latest accepted 2021/11/16
Generic · 2
Teneligliptin Hydrobromide Hydrate Tablets 1 records · Latest accepted 2021/11/10
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2102004 | Generic | 2021/11/10 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. | CDE ↗ |
Palonosetron Hydrochloride Injection 2 records · Latest accepted 2021/09/16
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2101724 | Generic | 2021/09/16 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2101723 | Generic | 2021/09/16 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Pregabalin Capsules 2 records · Latest accepted 2021/09/02
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2101676 | Generic | 2021/09/02 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. | CDE ↗ |
| CYHS2101675 | Generic | 2021/09/02 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. | CDE ↗ |
硫酸特布他林雾化吸入用溶液 · No verified English name 1 records · Latest accepted 2021/08/24
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2101627 | Generic | 2021/08/24 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Tofacitinib Citrate Extended Release tablets 1 records · Latest accepted 2021/08/18
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2101602 | Generic | 2021/08/18 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. | CDE ↗ |
Sacubitril Valsartan Sodium Tablets 2 records · Latest accepted 2021/06/11
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2101286 | Generic | 2021/06/11 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. | CDE ↗ |
| CYHS2101285 | Generic | 2021/06/11 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. | CDE ↗ |
Palbociclib Capsules 3 records · Latest accepted 2021/04/15
Generic · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2101063 | Generic | 2021/04/15 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2101062 | Generic | 2021/04/15 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2101061 | Generic | 2021/04/15 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Changes in the last 90 days
0 events from 2026/08/16 to 2026/11/13. CDE data as of 2026/11/13 06:42; NMPA data as of 2026/11/12 18:32.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately. 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.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
Under review
0 acceptance numbers with this company as first applicant are currently listed as under review by CDE. Source data as of 2026/11/13 06:42.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | |||||
Catalogue holder records
8 loaded active catalogue records whose holder name matches this source company name. Source data as of 2026/11/13 06:39. Manufacturer-only records are excluded.
| Drug | Marketing authorization holder | Manufacturer | Approval number | Approved | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Tofacitinib Citrate Extended Release tablets | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized | Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20233568 | 2023/05/19 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Pregabalin Capsules | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized | Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20233134 | 2023/02/07 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Pregabalin Capsules | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized | Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20233133 | 2023/02/07 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Palbociclib Capsules | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20223935 | 2022/12/30 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Palbociclib Capsules | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20223934 | 2022/12/30 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Palbociclib Capsules | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20223936 | 2022/12/30 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Palonosetron Hydrochloride Injection | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20223448 | 2022/06/28 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Palonosetron Hydrochloride Injection | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20223449 | 2022/06/28 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
Only active catalogue records matching the source holder name are listed. A manufacturer role does not count as a holder record. The catalogue covers only part of the chemical-drug market; source categories do not establish complete market coverage or qualifications.
API registrations
0 loaded active API registrations whose first registered company matches this source company name. Source data as of 2026/11/13 06:41.
| Name | Company / applicant | Registration number | Status | Source update date | View source |
|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | |||||
Only loaded active API registrations not listed as cancelled are shown. A/I are source registration statuses. Records are listed by registration number and do not establish capacity or supply. The register does not identify the associated formulation.
Co-applicant records
1 acceptance records name this company after the first applicant. They are listed separately and are not included in first-applicant drug or filing counts. Source data as of 2026/11/13 06:42.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| KL0011034注射液 · No verified English name | CXHL2501370 | New drug | 2025/12/10 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized; Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized | CDE ↗ |
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
- Full API register
- Last successful update: 2026/11/13 06:41
- 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.
Listed by the company name as recorded in the source, without merging affiliated entities.
This page summarizes loaded records only, without new source queries or collection. Parent companies, subsidiaries, former names and aliases are not merged. Counts from different sources must not be added together. No loaded record does not establish the absence of a filing or registration. Check original records where coverage is incomplete, an update has failed, or a source lies outside the loaded scope.
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.
Drugs with a verified official English name use that name only. Other drug names retain the Chinese source name marked No verified English name; names with a Chinese public page link to that page. Company labels use verified official names, Latin source names, then fixed-rule transliterations marked romanized; Chinese company names are not displayed. Marked unverified drug names and original statutory reference numbers may appear in Chinese.
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.