Hui Sheng Biopharmaceutical 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 99b91643f1
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
41 acceptance records as first applicant, grouped into 22 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.
德谷胰岛素注射液 · No verified English name 4 records · Latest accepted 2026/05/08
Supplement · 2New drug · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYSB2600140 | Supplement | 2026/05/08 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYSB2600139 | Supplement | 2026/05/08 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
| CXSS2200067 | New drug | 2022/07/15 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
| CXSS2200066 | New drug | 2022/07/15 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
德谷门冬双胰岛素注射液 · No verified English name 4 records · Latest accepted 2026/05/08
Supplement · 2New drug · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYSB2600138 | Supplement | 2026/05/08 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYSB2600137 | Supplement | 2026/05/08 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
| CXSS2300029 | New drug | 2023/05/07 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
| CXSS2300028 | New drug | 2023/05/07 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
司美格鲁肽注射液 · No verified English name 5 records · Latest accepted 2025/08/16
New drug · 5
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CXSS2500084 | New drug | 2025/08/16 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
| CXSS2500083 | New drug | 2025/08/16 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
| CXSL2400394 | New drug | 2024/06/15 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
| CXSL2400393 | New drug | 2024/06/15 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
| CXSL2300274 | New drug | 2023/04/20 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
P052注射液 · No verified English name 2 records · Latest accepted 2025/07/04
New drug · 2
Repaglinide Tablets 3 records · Latest accepted 2024/11/05
Generic · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2403754 | Generic | 2024/11/05 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2403753 | Generic | 2024/11/05 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2403752 | Generic | 2024/11/05 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Dapagliflozin Tablets 2 records · Latest accepted 2023/11/10
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2303090 | Generic | 2023/11/10 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2303089 | Generic | 2023/11/10 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Linagliptin Tablets 1 records · Latest accepted 2023/09/11
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2302436 | Generic | 2023/09/11 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized | CDE ↗ |
Empagliflozin Tablets 2 records · Latest accepted 2023/08/17
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2302170 | Generic | 2023/08/17 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2302169 | Generic | 2023/08/17 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CDE ↗ |
德谷胰岛素利拉鲁肽注射液 · No verified English name 1 records · Latest accepted 2023/07/26
New drug · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CXSL2300515 | New drug | 2023/07/26 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
Epalrestat Tablets 1 records · Latest accepted 2023/05/06
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2301215 | Generic | 2023/05/06 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | CDE ↗ |
Calcium Dobesilate Capsules 1 records · Latest accepted 2022/10/20
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2201783 | Generic | 2022/10/20 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CDE ↗ |
西格列汀二甲双胍片(I) · No verified English name 1 records · Latest accepted 2022/09/09
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2201495 | Generic | 2022/09/09 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized | CDE ↗ |
Sitagliptin Phosphate and Metformin Hydrochloride Tablets (II) 1 records · Latest accepted 2022/09/09
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2201496 | Generic | 2022/09/09 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized | CDE ↗ |
Vildagliptin Tablets 1 records · Latest accepted 2022/08/16
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2201303 | Generic | 2022/08/16 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized | CDE ↗ |
加格列净片 · No verified English name 4 records · Latest accepted 2022/02/28
New drug · 4
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CXHS2200015 | New drug | 2022/02/28 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Beijing Si Huan Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CXHS2200014 | New drug | 2022/02/28 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Beijing Si Huan Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CXHS2200013 | New drug | 2022/02/28 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Beijing Si Huan Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CXHS2200012 | New drug | 2022/02/28 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Beijing Si Huan Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Mecobalamin Injection 1 records · Latest accepted 2022/01/28
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2200225 | Generic | 2022/01/28 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Beijing Si Huan Pharmaceutical Co., Ltd. romanized | CDE ↗ |
门冬胰岛素30注射液 · No verified English name 1 records · Latest accepted 2022/01/28
New drug · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CXSS2200009 | New drug | 2022/01/28 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
门冬胰岛素注射液 · No verified English name 1 records · Latest accepted 2022/01/28
New drug · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CXSS2200008 | New drug | 2022/01/28 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
门冬胰岛素50注射液 · No verified English name 1 records · Latest accepted 2022/01/26
New drug · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CXSS2200007 | New drug | 2022/01/26 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
Sitagliptin Phosphate Tablets 2 records · Latest accepted 2021/12/27
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2102290 | Generic | 2021/12/27 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | CDE ↗ |
| CYHS2102289 | Generic | 2021/12/27 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | CDE ↗ |
Thioctic Acid Injection 1 records · Latest accepted 2021/10/11
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2101836 | Generic | 2021/10/11 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Beijing Si Huan Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Mecobalamin Tablets 1 records · Latest accepted 2021/09/13
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2101716 | Generic | 2021/09/13 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Jilin Si Huan Ao Kang Pharma 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
4 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 |
|---|---|---|---|---|---|
| 德谷门冬双胰岛素注射液 · No verified English name | CYSB2600138 | Supplement | 2026/05/08 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
| 德谷门冬双胰岛素注射液 · No verified English name | CYSB2600137 | Supplement | 2026/05/08 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
| 司美格鲁肽注射液 · No verified English name | CXSS2500084 | New drug | 2025/08/16 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
| 司美格鲁肽注射液 · No verified English name | CXSS2500083 | New drug | 2025/08/16 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
Catalogue holder records
18 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 |
|---|---|---|---|---|---|---|
| Repaglinide Tablets | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20263997 | 2026/04/14 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Repaglinide Tablets | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20263998 | 2026/04/14 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Repaglinide Tablets | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20263999 | 2026/04/14 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Dapagliflozin Tablets | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20253933 | 2025/04/15 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Dapagliflozin Tablets | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20253934 | 2025/04/15 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Empagliflozin Tablets | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20249836 | 2024/12/25 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Linagliptin Tablets | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Tianjin Han Rui Pharma Co., Ltd. romanized | 国药准字H20249802 | 2024/12/25 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Empagliflozin Tablets | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20249837 | 2024/12/25 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Epalrestat Tablets | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | 国药准字H20249380 | 2024/11/15 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Calcium Dobesilate Capsules | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Name not romanized | 国药准字H20244055 | 2024/06/18 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Sitagliptin Phosphate and Metformin Hydrochloride Tablets (II) | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Tianjin Han Rui Pharma Co., Ltd. romanized | 国药准字H20243802 | 2024/05/21 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| 西格列汀二甲双胍片(I) · No verified English name | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Tianjin Han Rui Pharma Co., Ltd. romanized | 国药准字H20243801 | 2024/05/21 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Vildagliptin Tablets | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Tianjin Han Rui Pharma Co., Ltd. romanized | 国药准字H20243159 | 2024/02/06 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Mecobalamin Injection | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Beijing Si Huan Pharmaceutical Co., Ltd. romanized | 国药准字H20234116 | 2023/09/05 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Sitagliptin Phosphate Tablets | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | 国药准字H20233903 | 2023/06/30 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Sitagliptin Phosphate Tablets | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | 国药准字H20233902 | 2023/06/30 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Thioctic Acid Injection | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Beijing Si Huan Pharmaceutical Co., Ltd. romanized | 国药准字H20233766 | 2023/06/21 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Mecobalamin Tablets | Hui Sheng Biopharmaceutical Co., Ltd. romanized | Jilin Si Huan Ao Kang Pharma Co., Ltd. romanized | 国药准字H20233571 | 2023/05/19 | 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
0 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 |
|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | |||||
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.