YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 228 drug applications between 4 August 2021 and 10 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 32, covering 22 drug names.
2021/08/04 – 2021/08/10
- New acceptances this week
- 228
- Drugs with new generic filings (by drug name, de-duplicated)
- 22
- 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
228filings, 32 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 96 |
| New drug | 43 |
| Generic | 32 |
| Unspecified | 22 |
| Import re-registration | 18 |
| Import | 17 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 156 |
| Therapeutic biologic | 43 |
| TCM | 29 |
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
22 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Pregabalin Capsules | 3 | 1 | 12 |
| 2 | Enoxaparin Sodium Injection | 2 | 1 | 16 |
| 3 | Torsemide Injection | 2 | 1 | 1 |
| 4 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 5 | Irinotecan Hydrochloride Injection | 2 | 1 | 2 |
| 6 | Vardenafil Hydrochloride Tablets | 2 | 1 | 4 |
| 7 | 硫酸沙丁胺醇吸入溶液 · No verified English name | 2 | 1 | 0 |
| 8 | Fosphenytoin Sodium Injection | 2 | 1 | 5 |
| 9 | Febuxostat Tablets | 2 | 1 | 12 |
| 10 | 丙酸氟替卡松吸入粉雾剂 · No verified English name | 1 | 1 | 1 |
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
121 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 11 | 3 | 0 |
| 2 | Shanxi Fu Ren Heng Feng Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Oncotec Pharma Produktion GmbH | 8 | 1 | 0 |
| 4 | Eurofins Analytical Science Laboratories Inc. | 6 | 6 | 0 |
| 5 | Chengdu Rong Sheng Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 7 | Novartis Pharma Schweiz AG | 6 | 2 | 0 |
| 8 | Fresenius Kabi Deutschland GmbH | 6 | 1 | 0 |
| 9 | Huang Shi Wei Sheng Cai Liao Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Pfizer Europe MA EEIG | 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 |
|---|---|---|
| 2021/08/10Import · Class 1 | LNP023胶囊 · No verified English nameJXHL2101160 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/08/10Import · Class 1 | BMS-986278-01片 · No verified English nameJXHL2101159 | Bristol Myers Squibb Company; Name not romanized |
| 2021/08/10Import · Class 1 | BMS-986278-01片 · No verified English nameJXHL2101158 | Bristol Myers Squibb Company; Name not romanized |
| 2021/08/10Generic · Class 3 | 硫酸沙丁胺醇吸入溶液 · No verified English nameCYHS2101552 | Jinan Jing Sheng Technology Co., Ltd. romanized; Wei Fang Zhong Shi Pharmaceutical Co., Ltd. romanized |
| 2021/08/10Generic · Class 3 | 硫酸沙丁胺醇吸入溶液 · No verified English nameCYHS2101551 | Jinan Jing Sheng Technology Co., Ltd. romanized; Wei Fang Zhong Shi Pharmaceutical Co., Ltd. romanized |
| 2021/08/10Generic · Class 3 | Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHL2101022 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2021/08/10New drug · Class 1 | CM338注射液 · No verified English nameCXSL2101251 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2021/08/10New drug · Class 1 | BAT7104注射液 · No verified English nameCXSL2101250 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2021/08/10New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2101249 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2021/08/10New drug · Class 3.4 | 重组人促卵泡激素注射液 · No verified English nameCXSL2101248 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2021/08/10New drug · Class 3.4 | 重组人促卵泡激素注射液 · No verified English nameCXSL2101247 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2021/08/10New drug · Class 3.4 | 重组人促卵泡激素注射液 · No verified English nameCXSL2101246 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2021/08/10New drug · Class 2.4 | 丁苯酞软胶囊 · No verified English nameCXHL2101390 | Shi Yao Group En Bi Pu Pharma Co., Ltd. romanized |
| 2021/08/10New drug · Class 2.2 | 拉考沙胺缓释片 · No verified English nameCXHL2101389 | Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized |
| 2021/08/10New drug · Class 1 | FCN-338片 · No verified English nameCXHL2101388 | Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized |
| 2021/08/10New drug · Class 1 | FCN-338片 · No verified English nameCXHL2101387 | Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized |
| 2021/08/10New drug · Class 1 | FCN-338片 · No verified English nameCXHL2101386 | Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized |
| 2021/08/10New drug · Class 1 | QY201片 · No verified English nameCXHL2101385 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized |
| 2021/08/10New drug · Class 1 | QY201片 · No verified English nameCXHL2101384 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized |
| 2021/08/10New drug · Class 1 | NIP142胶囊 · No verified English nameCXHL2101310 | Zhongguo Pharmaceuticals Research Kai Fa Center Co., Ltd. romanized |
| 2021/08/10New drug · Class 1 | NIP142胶囊 · No verified English nameCXHL2101309 | Zhongguo Pharmaceuticals Research Kai Fa Center Co., Ltd. romanized |
| 2021/08/09Import · Class 1 | ES104 · No verified English nameJXSL2101090 | Elpiscience Biopharmaceuticals Co. Limited; Elpiscience (Suzhou) Biopharma Ltd. |
| 2021/08/09Import · Class 2.4 | 环硅酸锆钠散 · No verified English nameJXHL2101157 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2021/08/09Import · Class 2.4 | 环硅酸锆钠散 · No verified English nameJXHL2101156 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2021/08/09Import · Class 1 | CPI-818片 · No verified English nameJXHL2101155 | Corvus Pharmaceuticals Inc.; Angel Pharmaceuticals |
| 2021/08/09Import · Class 1 | CPI-818片 · No verified English nameJXHL2101154 | Corvus Pharmaceuticals Inc.; Angel Pharmaceuticals |
| 2021/08/09Import · Class 1 | BI 1701963片 · No verified English nameJXHL2101153 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/08/09Import · Class 1 | BI 1701963片 · No verified English nameJXHL2101152 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/08/09Import · Class 1 | TAK-981 注射液 · No verified English nameJXHL2101151 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2021/08/09Generic · Class 3 | 非洛地平片 · No verified English nameCYHS2101538 | Hunan Jiudian Pharmaceutical Co., Ltd |
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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