Shandong Ji Kun 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 feb1168b5b
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
19 acceptance records as first applicant, grouped into 15 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.
Orlistat Capsules 2 records · Latest accepted 2026/08/26
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2602134 | Generic | 2026/08/26 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2602133 | Generic | 2026/08/26 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Upadacitinib Sustained-release Tablets 1 records · Latest accepted 2026/06/25
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2601493 | Generic | 2026/06/25 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CDE ↗ |
复方聚乙二醇(3350)电解质散 · No verified English name 1 records · Latest accepted 2026/05/20
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600882 | Supplement | 2026/05/20 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution 1 records · Latest accepted 2026/05/18
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600957 | Supplement | 2026/05/18 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized | CDE ↗ |
聚乙二醇钠钾散 · No verified English name 1 records · Latest accepted 2026/05/14
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600954 | Supplement | 2026/05/14 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Iron Proteinsuccinylate Oral Solution 1 records · Latest accepted 2026/05/12
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600895 | Supplement | 2026/05/12 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CDE ↗ |
Minoxidil Liniment 1 records · Latest accepted 2026/04/13
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600734 | Supplement | 2026/04/13 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CDE ↗ |
腺苷钴胺胶囊 · No verified English name 1 records · Latest accepted 2026/04/13
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600733 | Supplement | 2026/04/13 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized | CDE ↗ |
复方匹可硫酸钠颗粒 · No verified English name 1 records · Latest accepted 2026/01/05
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2600022 | Generic | 2026/01/05 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Alfacalcidol Tablets 1 records · Latest accepted 2025/10/14
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2503659 | Generic | 2025/10/14 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Sildenafil Citrate Tablets 2 records · Latest accepted 2025/09/09
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2503329 | Generic | 2025/09/09 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2503328 | Generic | 2025/09/09 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Dapoxetine Hydrochloride Tablets 2 records · Latest accepted 2025/07/28
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2502714 | Generic | 2025/07/28 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2502713 | Generic | 2025/07/28 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Metformin Hydrochloride Extended-release Tablets 2 records · Latest accepted 2025/04/08
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2501330 | Generic | 2025/04/08 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2501329 | Generic | 2025/04/08 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Ambroxol Hydrochloride Tablets 1 records · Latest accepted 2024/12/03
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2404144 | Generic | 2024/12/03 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CDE ↗ |
维生素B6注射液 · No verified English name 1 records · Latest accepted 2024/10/25
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2403631 | Generic | 2024/10/25 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
Changes in the last 90 days
2 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.
Accepted: 2 applications
- 2026/08/26Accepted
Orlistat Capsules
CYHS2602134
Fact date: 2026/08/26 · Site observation date: 2026/10/22
View source ↗ - 2026/08/26Accepted
Orlistat Capsules
CYHS2602133
Fact date: 2026/08/26 · Site observation date: 2026/10/22
View source ↗
Under review
10 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 |
|---|---|---|---|---|---|
| Orlistat Capsules | CYHS2602134 | Generic | 2026/08/26 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Orlistat Capsules | CYHS2602133 | Generic | 2026/08/26 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Upadacitinib Sustained-release Tablets | CYHS2601493 | Generic | 2026/06/25 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Iron Proteinsuccinylate Oral Solution | CYHB2600895 | Supplement | 2026/05/12 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CDE ↗ |
| 复方匹可硫酸钠颗粒 · No verified English name | CYHS2600022 | Generic | 2026/01/05 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Alfacalcidol Tablets | CYHS2503659 | Generic | 2025/10/14 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Sildenafil Citrate Tablets | CYHS2503329 | Generic | 2025/09/09 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Sildenafil Citrate Tablets | CYHS2503328 | Generic | 2025/09/09 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Dapoxetine Hydrochloride Tablets | CYHS2502714 | Generic | 2025/07/28 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Dapoxetine Hydrochloride Tablets | CYHS2502713 | Generic | 2025/07/28 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Catalogue holder records
4 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 |
|---|---|---|---|---|---|---|
| 维生素B6注射液 · No verified English name | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20265623 | 2026/08/18 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Ambroxol Hydrochloride Tablets | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | 国药准字H20265171 | 2026/07/14 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Metformin Hydrochloride Extended-release Tablets | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20264921 | 2026/06/23 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Metformin Hydrochloride Extended-release Tablets | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20264920 | 2026/06/23 | 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
11 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 |
|---|---|---|---|---|---|
| 巴瑞替尼 · No verified English name | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Y20260000592 | I | 2026/07/14 | CDE ↗ |
| 乌帕替尼 · No verified English name | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Y20260000007 | I | 2026/04/16 | CDE ↗ |
| 米诺地尔 · No verified English name | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Y20250001475 | I | 2026/01/07 | CDE ↗ |
| 匹可硫酸钠 · No verified English name | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Y20250001187 | I | 2025/12/09 | CDE ↗ |
| 多替诺雷 · No verified English name | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Y20250001188 | I | 2025/11/12 | CDE ↗ |
| 依伏卡塞 · No verified English name | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Y20250000871 | I | 2025/09/08 | CDE ↗ |
| 盐酸伐地那非 · No verified English name | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Y20250000708 | I | 2025/07/16 | CDE ↗ |
| 盐酸胺碘酮 · No verified English name | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Y20250000128 | I | 2025/02/07 | CDE ↗ |
| 蛋白琥珀酸铁 · No verified English name | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Y20240001528 | I | 2025/02/06 | CDE ↗ |
| 盐酸氨溴索 · No verified English name | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Y20240001128 | A | 2026/01/16 | CDE ↗ |
| 硫酸钾 · No verified English name | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Y20240000131 | A | 2025/07/05 | CDE ↗ |
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.