YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 232 drug applications between 11 August 2021 and 17 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 35 drug names.
2021/08/11 – 2021/08/17
- New acceptances this week
- 232
- Drugs with new generic filings (by drug name, de-duplicated)
- 35
- Accepted this week, now under review
- 1
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
232filings, 49 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 117 |
| Generic | 49 |
| New drug | 36 |
| Import | 14 |
| Unspecified | 8 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 162 |
| Therapeutic biologic | 47 |
| TCM | 21 |
| In vitro diagnostic reagent | 1 |
| Biologic | 1 |
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
35 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ornidazole Injection | 4 | 2 | 0 |
| 2 | Rivaroxaban Tablets | 3 | 2 | 3 |
| 3 | Omeprazole and Sodium Bicarbonate Capsules | 3 | 2 | 0 |
| 4 | 草酸艾司西酞普兰口服溶液 · No verified English name | 3 | 2 | 11 |
| 5 | Meropenem for Injection | 3 | 1 | 5 |
| 6 | Gemcitabine Hydrochloride for Injection | 2 | 1 | 1 |
| 7 | Iopamidol Injection | 2 | 1 | 0 |
| 8 | Sugammadex Sodium Injection | 2 | 1 | 6 |
| 9 | Tadalafil Tablets | 1 | 1 | 23 |
| 10 | Olmesartan Medoxomil and Hydrochlorothiazide Tablets | 1 | 1 | 3 |
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
143 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Janssen Research & Development LLC | 6 | 4 | 0 |
| 2 | Upjohn EESV | 6 | 3 | 0 |
| 3 | AstraZeneca AB | 6 | 2 | 0 |
| 4 | Novartis Pharma Schweiz AG | 6 | 2 | 0 |
| 5 | Jilin Hua Kang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 7 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 8 | Haerbin Han Bang Medical Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized | 4 | 2 | 1 |
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
69 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/08/17Import · Class 1 | Relatlimab/Nivolumab固定剂量复方注射液 · No verified English nameJXSL2101097 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2021/08/17Import · Class 1 | JNJ-63733657注射液 · No verified English nameJXSL2101091 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/08/17Import · Class 1 | 注射用普那布林浓溶液 · No verified English nameJXHS2101041 | BeyondSpring Pharmaceuticals Inc.; Pharmaceutics International Incorporated(Pii); Dalian Wanchun Bulin Pharmaceutical Co. Ltd. |
| 2021/08/17Import · Class 1 | Difelikefalin注射液 · No verified English nameJXHL2101166 | Vifor Fresenius Medical Care Renal Pharma Ltd.; Hangzhou Tigermed Consulting Co. Ltd. |
| 2021/08/17Generic · Class 3 | Paracetamol and Caffeine TabletsCYHS2101600 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2021/08/17Generic · Class 3 | Ornidazole InjectionCYHS2101599 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2021/08/17Generic · Class 3 | Ornidazole InjectionCYHS2101598 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2021/08/17Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2101595 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized |
| 2021/08/17Generic · Class 3 | Iopamidol InjectionCYHS2101594 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized |
| 2021/08/17Generic · Class 3 | Iopamidol InjectionCYHS2101593 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized |
| 2021/08/17Generic · Class 3 | Omeprazole and Sodium Bicarbonate CapsulesCYHS2101590 | Hebei Xin Rui Wei Lai Technology Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2021/08/17Generic · Class 3 | Trelagliptin Succinate TabletsCYHS2101573 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2021/08/17Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2101561 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2021/08/17New drug · Class 1 | CM326注射液 · No verified English nameCXSL2101271 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2021/08/17New drug · Class 1 | TQB2928注射液 · No verified English nameCXSL2101269 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2021/08/17New drug · Class 1 | AK119注射液 · No verified English nameCXSL2101265 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/08/17New drug · Class 1 | AK104注射液 · No verified English nameCXSL2101264 | Kang Fang Pharma Co., Ltd. romanized |
| 2021/08/17New drug · Class 1 | HRS-8080片 · No verified English nameCXHL2101409 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2021/08/17New drug · Class 1 | HRS-8080片 · No verified English nameCXHL2101408 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2021/08/17New drug · Class 1 | HS-10342片 · No verified English nameCXHL2101407 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/08/16Import · Class 1 | Teclistamab 注射液 · No verified English nameJXSL2101096 | Janssen Research & Development, LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/08/16Import · Class 1 | Teclistamab 注射液 · No verified English nameJXSL2101095 | Janssen Research & Development, LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/08/16Import · Class 1 | Tiragolumab注射液 · No verified English nameJXSL2101094 | F.Hoffmann-La Roche Ltd.; Roche(China)Holding Ltd. |
| 2021/08/16Import · Class 1 | MHV370胶囊 · No verified English nameJXHL2101164 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/08/16Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2101584 | Chengdu Kang Hong Pharma Group Co., Ltd. romanized; Chengdu Di Kang Pharma Co., Ltd. romanized |
| 2021/08/16Generic · Class 3 | Ornidazole InjectionCYHS2101578 | Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2021/08/16Generic · Class 3 | Ornidazole InjectionCYHS2101577 | Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2021/08/16New drug · Class 1 | 冻干GT90008抗体蛋白 · No verified English nameCXSL2101268 | Kai Tuo Pharma (Guangdong) Co., Ltd. romanized |
| 2021/08/16New drug · Class 1 | 靶向间皮素嵌合抗原受体NK细胞注射液 · No verified English nameCXSL2101267 | Guo Jian Cheng Nuo Bio Technology (Beijing) Co., Ltd. romanized |
| 2021/08/16New drug · Class 1 | 注射用SHR-A1921 · No verified English nameCXSL2101266 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
39 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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