YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 226 drug applications between 20 April 2021 and 26 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 31, covering 21 drug names.
2021/04/20 – 2021/04/26
- New acceptances this week
- 226
- Drugs with new generic filings (by drug name, de-duplicated)
- 21
- Accepted this week, now under review
- 0
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
226filings, 31 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 97 |
| New drug | 49 |
| Generic | 31 |
| Import | 22 |
| Import re-registration | 17 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 156 |
| TCM | 36 |
| Therapeutic biologic | 34 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
21 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 4 | 1 | 23 |
| 2 | Rivaroxaban Tablets | 3 | 2 | 3 |
| 3 | Ornidazole Injection | 2 | 1 | 0 |
| 4 | Obeticholic Acid Tablets | 2 | 1 | 0 |
| 5 | Ticagrelor Tablets | 2 | 1 | 10 |
| 6 | Vitamin K1 Injection | 2 | 1 | 6 |
| 7 | Cabozantinib Tablets | 2 | 1 | 0 |
| 8 | Sodium Valproate Concentrated Solution for Injection | 1 | 1 | 0 |
| 9 | Doxofylline Injection | 1 | 1 | 5 |
| 10 | Tenofovir alafenamide Fumarate Tablets | 1 | 1 | 0 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
122 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized | 25 | 25 | 0 |
| 2 | Lilly France | 8 | 2 | 0 |
| 3 | AstraZeneca AB | 6 | 1 | 0 |
| 4 | Novartis Pharma Schweiz AG | 5 | 2 | 0 |
| 5 | Yan Tai Yuan Sheng Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 6 | Shanghai Quan Yu Bio Technology (Zhu Ma Dian) Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 4 | 2 | 0 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Astellas pharma Europe B.V. | 4 | 1 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
73 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/04/26Import · Class 1 | IMG-020注射液 · No verified English nameJXSL2101014 | Affibody AB; Inmagene Biopharmaceuticals (Hangzhou) Co. Ltd. |
| 2021/04/26Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2101016 | AstraZeneca AB; Astrazeneca Investment (China) Co. Ltd. |
| 2021/04/26Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2101015 | AstraZeneca AB; Astrazeneca Investment (China) Co. Ltd. |
| 2021/04/26Import · Class 1 | BBP-398 胶囊 · No verified English nameJXHL2101014 | Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd. |
| 2021/04/26Import · Class 1 | BBP-398胶囊 · No verified English nameJXHL2101013 | Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd. |
| 2021/04/26Import · Class 1 | BBP-398胶囊 · No verified English nameJXHL2101012 | Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd. |
| 2021/04/26Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2101100 | Chengdu Hui De Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Di Kang Pharma Co., Ltd. romanized |
| 2021/04/26Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2101098 | Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized; Yang Zi Jiang Pharma Group Jiangsu Pharmaceutical Co., Ltd. romanized |
| 2021/04/26Generic · Class 3 | Ulipristal Acetate TabletsCYHL2101006 | Henan Tai Feng Bio Technology Co., Ltd. romanized |
| 2021/04/26New drug · Class 1 | BAT6021注射液 · No verified English nameCXSL2101040 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2021/04/26New drug · Class 1 | 多扎格列艾汀片 · No verified English nameCXHS2101004 | Hua Ling Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Shanghai Di Sai Nuo Biopharmaceuticals Co., Ltd. romanized |
| 2021/04/26New drug · Class 1 | CX1440胶囊 · No verified English nameCXHL2101075 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
| 2021/04/26New drug · Class 1 | CX1440胶囊 · No verified English nameCXHL2101074 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
| 2021/04/26New drug · Class 1 | CX1440胶囊 · No verified English nameCXHL2101073 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
| 2021/04/26New drug · Class 1 | CX1440胶囊 · No verified English nameCXHL2101072 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
| 2021/04/23Import · Class 1 | 注射用Oregovomab · No verified English nameJXSL2101013 | OncoQuest Pharmaceuticals Inc.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2021/04/23Import · Class 1 | Tiragolumab注射液 · No verified English nameJXSL2101012 | F.Hoffmann-La Roche Ltd; Roche(China)Holding Ltd |
| 2021/04/23Generic · Class 3 | Ornidazole InjectionCYHS2101097 | Kang Pu Pharma Co., Ltd. romanized |
| 2021/04/23Generic · Class 3 | Ornidazole InjectionCYHS2101096 | Kang Pu Pharma Co., Ltd. romanized |
| 2021/04/23Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2101086 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2021/04/23Generic · Class 3 | Clonidine hydrochloride extended-release tabletsCYHS2101084 | Li Pin Pharma (Xiamen) Co., Ltd. romanized |
| 2021/04/23Generic · Class 3 | Obeticholic Acid TabletsCYHL2101005 | Tai Zhou Fu Dan Zhang Jiang Pharma Co., Ltd. romanized |
| 2021/04/23Generic · Class 3 | Obeticholic Acid TabletsCYHL2101004 | Tai Zhou Fu Dan Zhang Jiang Pharma Co., Ltd. romanized |
| 2021/04/23Generic · Class 3 | Vitamin K1 InjectionCYHL2101002 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2021/04/23Generic · Class 3 | Vitamin K1 InjectionCYHL2101001 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2021/04/23Generic · Class 3 | Butalbital, Acetaminophen, and Caffeine CapsulesCYHL2101000 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/04/23New drug · Class 1 | 斯鲁利单抗注射液 · No verified English nameCXSS2101000 | Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized |
| 2021/04/23New drug · Class 1 | 重组人源化抗BTLA单克隆抗体注射液 · No verified English nameCXSL2101039 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/04/23New drug · Class 1 | ES102注射液 · No verified English nameCXSL2101038 | Ke Wang (Suzhou) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/04/23New drug · Class 1 | 注射用LBL-015 · No verified English nameCXSL2101036 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized |
43 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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