Ren He Xi De Long Pharma 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 fc82c57620
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
23 acceptance records as first applicant, grouped into 13 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.
Nilotinib Capsules 4 records · Latest accepted 2026/09/10
Generic · 4
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2602263 | Generic | 2026/09/10 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
| CYHS2602262 | Generic | 2026/09/10 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
| CYHS2502247 | Generic | 2025/06/23 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
| CYHS2502246 | Generic | 2025/06/23 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
Vincriscristine Sulfate Injection 1 records · Latest accepted 2026/02/25
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2600496 | Generic | 2026/02/25 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
Carboplatin Injection 2 records · Latest accepted 2025/09/28
Generic · 2
Pazopanib Tablets 1 records · Latest accepted 2025/06/14
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2502126 | Generic | 2025/06/14 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
Methotrexate For Injection 3 records · Latest accepted 2024/10/29
Supplement · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2401736 | Supplement | 2024/10/29 | Ren He Xi De Long Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2350239 | Supplement | 2023/03/08 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2350238 | Supplement | 2023/03/08 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
Ibrutinib Capsules 1 records · Latest accepted 2024/10/11
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2403368 | Generic | 2024/10/11 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
Sorafenib Tosylate Tablets 1 records · Latest accepted 2024/07/02
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2401962 | Generic | 2024/07/02 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
Cytarabine for Injection 2 records · Latest accepted 2024/05/08
Generic · 2
Regorafenib Tablets 1 records · Latest accepted 2024/03/14
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2400835 | Generic | 2024/03/14 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
Pemetrexed Disodium for Injection 2 records · Latest accepted 2023/06/03
Generic · 2
Temozolomide Capsules 2 records · Latest accepted 2022/08/11
Generic · 2
Bortezomib For Injection 1 records · Latest accepted 2021/11/17
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2102042 | Generic | 2021/11/17 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
Irinotecan Hydrochloride Injection 2 records · Latest accepted 2021/08/10
Generic · 2
Changes in the last 90 days
3 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.
Marketing application approved: 1 applicationAccepted: 2 applications
- 2026/10/20Marketing application approved
Pazopanib Tablets
CYHS2502126 · 国药准字H20266356
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
View source · Table row 71 ↗ - 2026/09/10Accepted
Nilotinib Capsules
CYHS2602263
Fact date: 2026/09/10 · Site observation date: 2026/10/22
View source ↗ - 2026/09/10Accepted
Nilotinib Capsules
CYHS2602262
Fact date: 2026/09/10 · Site observation date: 2026/10/22
View source ↗
Under review
5 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 |
|---|---|---|---|---|---|
| Nilotinib Capsules | CYHS2602263 | Generic | 2026/09/10 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
| Nilotinib Capsules | CYHS2602262 | Generic | 2026/09/10 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
| Vincriscristine Sulfate Injection | CYHS2600496 | Generic | 2026/02/25 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
| Carboplatin Injection | CYHS2503546 | Generic | 2025/09/28 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
| Carboplatin Injection | CYHS2503544 | Generic | 2025/09/28 | Ren He Xi De Long Pharma Co., Ltd. romanized | CDE ↗ |
Catalogue holder records
11 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 |
|---|---|---|---|---|---|---|
| Methotrexate For Injection | Ren He Xi De Long Pharma Co., Ltd. romanized | Shanxi Pu De Pharma Co., Ltd. romanized | 国药准字H20269102 | 2026/04/29 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Regorafenib Tablets | Ren He Xi De Long Pharma Co., Ltd. romanized | Ren He Xi De Long Pharma Co., Ltd. romanized | 国药准字H20255571 | 2025/09/23 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Cytarabine for Injection | Ren He Xi De Long Pharma Co., Ltd. romanized | Ren He Xi De Long Pharma Co., Ltd. romanized | 国药准字H20254867 | 2025/07/15 | Not stated by source | CDE ↗ |
| Cytarabine for Injection | Ren He Xi De Long Pharma Co., Ltd. romanized | Ren He Xi De Long Pharma Co., Ltd. romanized | 国药准字H20254866 | 2025/07/15 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Pemetrexed Disodium for Injection | Ren He Xi De Long Pharma Co., Ltd. romanized | Ren He Xi De Long Pharma Co., Ltd. romanized | 国药准字H20249290 | 2024/11/05 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Temozolomide Capsules | Ren He Xi De Long Pharma Co., Ltd. romanized | Ren He Xi De Long Pharma Co., Ltd. romanized | 国药准字H20244725 | 2024/08/27 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Temozolomide Capsules | Ren He Xi De Long Pharma Co., Ltd. romanized | Ren He Xi De Long Pharma Co., Ltd. romanized | 国药准 字H20244726 | 2024/08/27 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Bortezomib For Injection | Ren He Xi De Long Pharma Co., Ltd. romanized | Ren He Xi De Long Pharma Co., Ltd. romanized | 国药准字H20244587 | 2024/07/30 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Methotrexate For Injection | Ren He Xi De Long Pharma Co., Ltd. romanized | Ren He Xi De Long Pharma Co., Ltd. romanized | 国药准字H20074231 | 2024/04/15 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Irinotecan Hydrochloride Injection | Ren He Xi De Long Pharma Co., Ltd. romanized | Ren He Xi De Long Pharma Co., Ltd. romanized | 国药准字H20223910 | 2022/11/30 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Irinotecan Hydrochloride Injection | Ren He Xi De Long Pharma Co., Ltd. romanized | Ren He Xi De Long Pharma Co., Ltd. romanized | 国药准字H20223909 | 2022/11/30 | 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.