YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 209 drug applications between 18 November 2021 and 24 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 29 drug names.
2021/11/18 – 2021/11/24
- New acceptances this week
- 209
- Drugs with new generic filings (by drug name, de-duplicated)
- 29
- 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
209filings, 38 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 108 |
| Generic | 38 |
| New drug | 31 |
| Import | 22 |
| Unspecified | 6 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 159 |
| Therapeutic biologic | 28 |
| TCM | 18 |
| Prophylactic biologic | 3 |
| 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
29 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Moxifloxacin Hydrochloride Eye Drops | 2 | 2 | 4 |
| 2 | Obeticholic Acid Tablets | 2 | 1 | 0 |
| 3 | Tolvaptan Tablets | 2 | 1 | 0 |
| 4 | Tandospirone Citrate Tablets | 2 | 1 | 2 |
| 5 | Fluorouracil Injection | 2 | 1 | 6 |
| 6 | Aminophylline Injection | 2 | 1 | 3 |
| 7 | Dexmedetomidine Hydrochloride Injection | 2 | 1 | 1 |
| 8 | Dexmedetomidine Hydrochloride Injection | 2 | 1 | 0 |
| 9 | Aprepitant Capsules | 2 | 1 | 0 |
| 10 | Propofol Medium And Long Chain Fat Emulsion Injection | 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
126 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | 16 | 16 | 0 |
| 2 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 3 | Hainan Tao Sheng Pharmaceuticals Technology Research Institute Co., Ltd. romanized | 7 | 4 | 0 |
| 4 | Pan Shi Ju Kang Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 5 | F.Hoffmann-La Roche Ltd. | 4 | 3 | 0 |
| 6 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | 4 | 3 | 4 |
| 7 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Sichuan Guo Rui Pharma Co., Ltd. romanized | 4 | 2 | 4 |
| 9 | Chengdu Brilliant Pharmaceutical Co., Ltd. | 4 | 2 | 4 |
| 10 | Sanofi Mature IP | 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
65 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/11/24Import · Class 2.2 | 纳武利尤单抗注射液 · No verified English nameJXSL2101138 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2021/11/24Import · Class 1 | NKTR-214 · No verified English nameJXSL2101137 | Nektar Therapeutics; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2021/11/24Import · Class 1 | NKTR-214 · No verified English nameJXSL2101136 | Nektar Therapeutics; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2021/11/24Import · Class 2.3; 2.4 | CARDIX-101胶囊 · No verified English nameJXHL2101254 | CARDIX THERAPEUTICS LLC; SHANGHAI GENOMICS INC |
| 2021/11/24Import · Class 2.3; 2.4 | CARDIX-101胶囊 · No verified English nameJXHL2101253 | CARDIX THERAPEUTICS LLC; SHANGHAI GENOMICS INC |
| 2021/11/24Import · Class 2.3 | CARDIX-101胶囊 · No verified English nameJXHL2101252 | CARDIX THERAPEUTICS LLC; SHANGHAI GENOMICS INC |
| 2021/11/24Generic · Class 3 | Sumatriptan and Naproxen Sodium TabletsCYHS2102076 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2021/11/24Generic · Class 3 | Fluorouracil InjectionCYHS2102075 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2021/11/24Generic · Class 3 | Fluorouracil InjectionCYHS2102074 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2021/11/24New drug · Class 1 | 自体自然杀伤细胞注射液 · No verified English nameCXSL2101444 | Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized |
| 2021/11/24New drug · Class 1 | CAStem细胞注射液 · No verified English nameCXSL2101443 | Beijing Ze Hui Chen Xing Bio Technology Co., Ltd. romanized |
| 2021/11/24New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101442 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/24New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101441 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/24New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101440 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/24New drug · Class 1 | CAB-ROR2-ADC注射剂 · No verified English nameCXSL2101438 | Kai Bo Si (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/24New drug · Class 2.4 | 环泊酚注射液 · No verified English nameCXHS2101054 | Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2021/11/24New drug · Class 2.2 | 丁苯酞注射液 · No verified English nameCXHL2101684 | Jilin Sheng Qi Jian Bio Technology Co., Ltd. romanized |
| 2021/11/23Import · Class 1 | PF-07220060 · No verified English nameJXHL2101251 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2021/11/23Import · Class 1 | PF-07220060 · No verified English nameJXHL2101250 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2021/11/23Import · Class 1 | PF-07220060 · No verified English nameJXHL2101249 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2021/11/23Import · Class 1 | ZN-c3片 · No verified English nameJXHL2101248 | Zentera Therapeutics HK Limited; Zentera Therapeutics Shanghai Co. Ltd |
| 2021/11/23Import · Class 1 | ZN-c3片 · No verified English nameJXHL2101247 | Zentera Therapeutics HK Limited; Zentera Therapeutics Shanghai Co. Ltd |
| 2021/11/23Generic · Class 3 | Isotretinoin Soft CapsulesCYHS2102071 | Chongqing Hua Bang Sheng Kai Pharmaceutical Co., Ltd. romanized; Chongqing Huapont Pharmaceutical Co., Ltd. |
| 2021/11/23Generic · Class 3 | 卡格列净二甲双胍缓释片 · No verified English nameCYHS2102070 | Le Pu Pharma Co., Ltd. romanized |
| 2021/11/23Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2102069 | Sichuan Guo Rui Pharma Co., Ltd. romanized |
| 2021/11/23Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2102068 | Sichuan Guo Rui Pharma Co., Ltd. romanized |
| 2021/11/23Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2102062 | Sichuan Guo Rui Pharma Co., Ltd. romanized |
| 2021/11/23Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2102061 | Sichuan Guo Rui Pharma Co., Ltd. romanized |
| 2021/11/23Generic · Class 3 | Obeticholic Acid TabletsCYHL2101042 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2021/11/23Generic · Class 3 | Obeticholic Acid TabletsCYHL2101041 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
35 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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