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Sign in to subscribeEdaravone and Dexborneol Concentrated Solution for Injection
As of 13 November 2026, for Edaravone and Dexborneol Concentrated Solution for Injection, 34 applications are listed as under review at China's CDE; 29 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 4 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 6 applications
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 holders4View records ↓
Under-review filings34View records ↓
This year’s generic filers29View records ↓
NHSA approval numbers5View records ↓
API companies with A status0View records ↓
Chemical-drug catalogue
Loaded records: 4 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 4 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 |
|---|---|---|---|---|---|---|
| Shaanxi Li Cai Pharma Co., Ltd. romanized | Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | 国药准字H20265960 | 2026/09/15 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing You Ke Pharmaceutical Co., Ltd. romanized | Nanjing You Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20265515 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Fujian Da Pu Biopharmaceuticals Co., Ltd. romanized | Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized | 国药准字H20265503 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized | Guangdong Sunho Pharmaceutical Co., Ltd. | 国药准字H20265537 | 2026/08/04 | 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: 5 distinct approval numbers and 5 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Xian Sheng Pharma Co., Ltd. romanized | 国药准字H20200007 | See source | Category B | XN07XXY322B004010101594 | NHSA |
| Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized | 国药准字H20265537 | See source | Category B | XN07XXY322B004010105075 | NHSA |
| Nanjing You Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20265515 | See source | Category B | XN07XXY322B004010180542 | NHSA |
| Shaanxi Li Cai Pharma Co., Ltd. romanized | 国药准字H20265960 | See source | Category B | XN07XXY322B004010183540 | NHSA |
| Fujian Da Pu Biopharmaceuticals Co., Ltd. romanized | 国药准字H20265503 | See source | Category B | XN07XXY322B004010186007 | NHSA |
| Xian Sheng Pharma Co., Ltd. romanized | 国药准字H20200007 | See source | Category B | XN07XXY322B004010201594 | NHSA |
| Nanjing You Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20265515 | See source | Category B | XN07XXY322B004010280542 | NHSA |
| Shaanxi Li Cai Pharma Co., Ltd. romanized | 国药准字H20265960 | See source | Category B | XN07XXY322B004010283540 | NHSA |
| Fujian Da Pu Biopharmaceuticals Co., Ltd. romanized | 国药准字H20265503 | See source | Category B | XN07XXY322B004010286007 | 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: 34 filings and 34 distinct first applicants.
Generic 34
New generic filings in 2026
Loaded records: 29 filings and 29 distinct first applicants.
API registrations
Non-component matches: 0 companies with A status and 0 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 |
|---|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | ||||||
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.
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.
-
2026/11/06Accepted
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
CYHS2602732
Fact date: 2026/11/06 · Site observation date: 2026/11/07
View source ↗ -
2026/11/05Accepted
Shandong Qidu Pharmaceutical Co., Ltd.
CYHS2602714
Fact date: 2026/11/05 · Site observation date: 2026/11/06
View source ↗ -
2026/09/29Accepted
Chongqing Lai Mei Pharma Co., Ltd. romanized
CYHS2602424
Fact date: 2026/09/29 · Site observation date: 2026/10/22
View source ↗ -
2026/09/28Accepted
Beijing Hua Su Pharmaceutical Co., Ltd. romanized
CYHS2602420
Fact date: 2026/09/28 · Site observation date: 2026/10/22
View source ↗ -
2026/09/28Accepted
Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized
CYHS2602418
Fact date: 2026/09/28 · Site observation date: 2026/10/21
View source ↗ -
2026/09/01Accepted
NORTH CHINA PHARMACEUTICAL COMPANY.LTD
CYHS2602168
Fact date: 2026/09/01 · Site observation date: 2026/10/22
View source ↗
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.
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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