YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 222 drug applications between 26 August 2022 and 1 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 40 drug names.
2022/08/26 – 2022/09/01
- New acceptances this week
- 222
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- 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
222filings, 50 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 94 |
| Generic | 50 |
| New drug | 34 |
| Import | 26 |
| Import re-registration | 12 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 142 |
| Therapeutic biologic | 55 |
| TCM | 20 |
| Prophylactic biologic | 5 |
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
40 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Solution For Inhalation | 2 | 2 | 4 |
| 2 | Perampanel Tablets | 2 | 1 | 2 |
| 3 | Vortioxetine Hydrobromide Tablets | 2 | 1 | 10 |
| 4 | Potassium Chloride Injection | 2 | 1 | 10 |
| 5 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 2 | 1 | 2 |
| 6 | Memantine Hydrochloride Oral Solution | 2 | 1 | 0 |
| 7 | Moxifloxacin Hydrochloride Eye Drops | 2 | 1 | 4 |
| 8 | Citicoline Injection | 2 | 1 | 0 |
| 9 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 10 | Aripiprazole Tablets | 2 | 1 | 2 |
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 | Roche Pharma (Schweiz) AG | 9 | 2 | 0 |
| 2 | Eli Lilly and Company | 7 | 2 | 0 |
| 3 | Guo Jiu Tang Shandong E Jiao Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Janssen Research & Development LLC | 6 | 3 | 0 |
| 5 | Pfizer Inc. | 6 | 3 | 0 |
| 6 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Hubei Kang Wei Yuan Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized | 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
74 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/09/01Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2200153 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/09/01Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2200152 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/09/01Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2200151 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/09/01Import · Class 2.4 | Lazertinib片 · No verified English nameJXHL2200269 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/09/01Import · Class 1 | OPS-2071片 · No verified English nameJXHL2200268 | Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Institute |
| 2022/09/01Generic · Class 3 | 薁磺酸钠片 · No verified English nameCYHS2201431 | Sichuan Guo Kang Pharma Co., Ltd. romanized |
| 2022/09/01Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2201430 | Yunnan Xian Shi Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2022/09/01Generic · Class 3 | Piracetam InjectionCYHS2201429 | Henan Ke Lun Pharma Co., Ltd. romanized |
| 2022/09/01Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2201428 | Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized |
| 2022/08/31Import · Class 1 | 注射用MK-2060 · No verified English nameJXSL2200150 | Merck Sharp & Dohme LLC; Name not romanized |
| 2022/08/31Import · Class 1 | PF-07104091片 · No verified English nameJXHL2200267 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2022/08/31Import · Class 1 | PF-07104091片 · No verified English nameJXHL2200266 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2022/08/31Import · Class 1 | PF-07220060 · No verified English nameJXHL2200265 | Pfizer Inc; Pfizer Investment CO. Ltd |
| 2022/08/31Import · Class 2.4 | 阿贝西利片 · No verified English nameJXHL2200264 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/08/31Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2201420 | Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2022/08/31Generic · Class 3 | Epinastine Hydrochloride Eye DropsCYHL2200074 | Can Tian Pharmaceutical (Zhongguo) Co., Ltd. romanized |
| 2022/08/31New drug · Class 1 | 人脐带间充质干细胞膜片 · No verified English nameCXSL2200430 | Jing Dong Fang Zai Sheng Yi Xue Technology Co., Ltd. romanized |
| 2022/08/31New drug · Class 1 | KH631眼用注射液 · No verified English nameCXSL2200429 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2022/08/31New drug · Class 1 | KH631眼用注射液 · No verified English nameCXSL2200428 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2022/08/31New drug · Class 1 | KH631眼用注射液 · No verified English nameCXSL2200427 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2022/08/31New drug · Class 1 | KH631眼用注射液 · No verified English nameCXSL2200426 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2022/08/31New drug · Class 1 | KH631眼用注射液 · No verified English nameCXSL2200425 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2022/08/31New drug · Class 3.4 | 重组人神经生长因子滴眼液 · No verified English nameCXSL2200424 | Chongqing Ke Run Biopharmaceuticals Research and Development Co., Ltd. romanized |
| 2022/08/31New drug · Class 1 | BA2101注射液 · No verified English nameCXSL2200417 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2022/08/31New drug · Class 1 | BA2101注射液 · No verified English nameCXSL2200416 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2022/08/31New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2200409 | Hangzhou Yi Wen Sai Bio Technology Co., Ltd. romanized |
| 2022/08/31New drug · Class 1 | TR128胶囊 · No verified English nameCXHL2200640 | Anhui Zhong Ke Tuo Ran Drug Ke Xue Research Co., Ltd. romanized |
| 2022/08/31New drug · Class 1 | QY211凝胶 · No verified English nameCXHL2200639 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized |
| 2022/08/31New drug · Class 1 | QY211凝胶 · No verified English nameCXHL2200638 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized |
| 2022/08/31New drug · Class 1 | QY211凝胶 · No verified English nameCXHL2200637 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized |
44 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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