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As of 13 November 2026, for Sivelestat Sodium for Injection, 5 applications are listed as under review at China's CDE; 5 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 1 holder.
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 1 applicationNotification delivery: 1 application
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 holders1View records ↓
Under-review filings5View records ↓
This year’s generic filers5View records ↓
NHSA approval numbers1View records ↓
API companies with A status2View records ↓
Chemical-drug catalogue
Loaded records: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 1 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 |
|---|---|---|---|---|---|---|
| Name not romanized | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized | 国药准字H20203093 | 2020/03/11 | See source | 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: 1 distinct approval numbers and 1 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized | 国药准字H20203093 | See source | Not stated by source | XR07AXX245B001010110104 | NHSA |
| Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized | 国药准字H20203093 | See source | Not stated by source | XR07AXX245B001010210104 | NHSA |
| Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized | 国药准字H20203093 | See source | Not stated by source | XR07AXX245B001010310104 | 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: 5 filings and 5 distinct first applicants.
Generic 5
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | CYHS2601944 | Generic | 2026/08/10 | Not stated by source | CDE |
| Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized | CYHS2601887 | Generic | 2026/08/04 | Not stated by source | CDE |
| Chongqing Lai Mei Pharma Co., Ltd. romanized | CYHS2601320 | Generic | 2026/06/05 | Not stated by source | CDE |
| Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized | CYHS2601242 | Generic | 2026/06/01 | Not stated by source | CDE |
| Chongqing Huapont Pharmaceutical Co., Ltd. | CYHS2602695 | Generic | 2026/11/04 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 6 filings and 5 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | CYHS2601944 | Generic | 2026/08/10 | Not stated by source | CDE |
| Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized | CYHS2601887 | Generic | 2026/08/04 | Not stated by source | CDE |
| Chongqing Lai Mei Pharma Co., Ltd. romanized | CYHS2601320 | Generic | 2026/06/05 | Not stated by source | CDE |
| Chongqing Huapont Pharmaceutical Co., Ltd. | CYHS2601279 | Generic | 2026/06/03 | Not stated by source | CDE |
| Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized | CYHS2601242 | Generic | 2026/06/01 | Not stated by source | CDE |
| Chongqing Huapont Pharmaceutical Co., Ltd. | CYHS2602695 | Generic | 2026/11/04 | Not stated by source | CDE |
API registrations
Non-component matches: 2 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 |
|---|---|---|---|---|---|---|
| 西维来司他钠 · No verified English name | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | Y20260000887 | I | Exact ingredient | 2026/10/19 | CDE |
| 西维来司他钠 · No verified English name | Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20260000801 | I | Exact ingredient | 2026/09/21 | CDE |
| 西维来司他钠 · No verified English name | Lanzhou Dong Rui Pharmaceutical Co., Ltd. romanized | Y20260000534 | I | Exact ingredient | 2026/06/29 | CDE |
| 西维来司他钠 · No verified English name | Jiangsu Yu Tian Pharmaceuticals Co., Ltd. romanized | Y20260000117 | I | Exact ingredient | 2026/02/28 | CDE |
| 西维来司他钠 · No verified English name | Da Lian Wan Fu Pharmaceutical Co., Ltd. romanized | Y20250001493 | I | Exact ingredient | 2026/01/09 | CDE |
| 西维来司他钠 · No verified English name | Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20250001474 | I | Exact ingredient | 2026/01/06 | CDE |
| 西维来司他钠 · No verified English name | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | Y20250001252 | I | Exact ingredient | 2025/11/21 | CDE |
| 西维来司他钠 · No verified English name | Wu Yi Ci Hang Pharma Co., Ltd. romanized | Y20250000955 | I | Exact ingredient | 2025/09/17 | CDE |
| 西维来司他钠 · No verified English name | Han Rui Pharma (Jing Men) Co., Ltd. romanized | Y20250000862 | I | Exact ingredient | 2025/09/11 | CDE |
| 西维来司他钠 · No verified English name | Chongqing Lai Mei Long Yu Pharma Co., Ltd. romanized | Y20250000497 | I | Exact ingredient | 2025/06/03 | CDE |
| 西维来司他钠 · No verified English name | Hubei Mei Lin Pharma Co., Ltd. romanized | Y20250000097 | I | Exact ingredient | 2025/02/10 | CDE |
| 西维来司他钠 · No verified English name | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20240001529 | A | Exact ingredient | 2026/06/01 | CDE |
| 西维来司他钠 · No verified English name | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized | Y20190001060 | A | Exact ingredient | 2026/10/21 | 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.
-
2026/11/04Accepted
Chongqing Huapont Pharmaceutical Co., Ltd.
CYHS2602695
Fact date: 2026/11/04 · Site observation date: 2026/11/05
View source ↗ -
2026/10/28Notification delivery
Chongqing Huapont Pharmaceutical Co., Ltd.
CYHS2601279
Fact date: 2026/10/28 (Publication date) · Publication date: 2026/10/28 · Site observation date: 2026/11/03
Notification delivered; the specific outcome remains to be checked.
View source · Table row 21 ↗
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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