YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 236 drug applications between 6 August 2021 and 12 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 27 drug names.
2021/08/06 – 2021/08/12
- New acceptances this week
- 236
- Drugs with new generic filings (by drug name, de-duplicated)
- 27
- 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
236filings, 38 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 99 |
| New drug | 51 |
| Generic | 38 |
| Unspecified | 24 |
| Import | 16 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 172 |
| Therapeutic biologic | 46 |
| TCM | 17 |
| In vitro diagnostic reagent | 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
27 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 | Meropenem for Injection | 3 | 1 | 5 |
| 3 | Omeprazole and Sodium Bicarbonate Capsules | 2 | 1 | 0 |
| 4 | Torsemide Injection | 2 | 1 | 1 |
| 5 | Gemcitabine Hydrochloride for Injection | 2 | 1 | 1 |
| 6 | Irinotecan Hydrochloride Injection | 2 | 1 | 2 |
| 7 | Vardenafil Hydrochloride Tablets | 2 | 1 | 4 |
| 8 | 硫酸沙丁胺醇吸入溶液 · No verified English name | 2 | 1 | 0 |
| 9 | 草酸艾司西酞普兰口服溶液 · No verified English name | 2 | 1 | 11 |
| 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
130 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 | AstraZeneca AB | 8 | 3 | 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 | Novartis Pharma Schweiz AG | 6 | 2 | 0 |
| 7 | Huang Shi Wei Sheng Cai Liao Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Pfizer Europe MA EEIG | 5 | 2 | 0 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Upjohn EESV | 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
81 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/08/12Import · Class 1 | Ziltivekimab 注射液 · No verified English nameJXSL2101092 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2021/08/12Import · Class 1 | ricolinostat · No verified English nameJXHL2101163 | Beijing B3R Pharmaceutical Technology HK Limited; PAREXEL CHINA CO. LTD |
| 2021/08/12Generic · Class 3 | Omeprazole and Sodium Bicarbonate CapsulesCYHS2101565 | Zhejiang Hua Yuan Pharma Co., Ltd. romanized |
| 2021/08/12Generic · Class 3 | Omeprazole and Sodium Bicarbonate CapsulesCYHS2101564 | Zhejiang Hua Yuan Pharma Co., Ltd. romanized |
| 2021/08/12Generic · Class 3 | Metronidazole and Sodium Chloride InjectionCYHS2101559 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2021/08/12New drug · Class 1 | QX002N注射液 · No verified English nameCXSL2101259 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2021/08/12New drug · Class 1 | GZR18 · No verified English nameCXSL2101258 | Gan Li Pharma Co., Ltd. romanized |
| 2021/08/12New drug · Class 1 | GZR18 · No verified English nameCXSL2101257 | Gan Li Pharma Co., Ltd. romanized |
| 2021/08/12New drug · Class 1 | GZR18 · No verified English nameCXSL2101256 | Gan Li Pharma Co., Ltd. romanized |
| 2021/08/12New drug · Class 1 | GZR18 · No verified English nameCXSL2101255 | Gan Li Pharma Co., Ltd. romanized |
| 2021/08/12New drug · Class 1 | TQB2450注射液 · No verified English nameCXSL2101241 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/08/12New drug · Class 1 | 注射用HTPEP-001 · No verified English nameCXHL2101396 | Chengdu Hui Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/08/12New drug · Class 2.4; 2.2 | BH011注射液 · No verified English nameCXHL2101395 | Zhuhai Bei Hai Bio Technology Co., Ltd. romanized |
| 2021/08/11Import · Class 1 | CC-99677胶囊 · No verified English nameJXHL2101162 | Celgene Corporation; Name not romanized |
| 2021/08/11Import · Class 1 | CC-99677胶囊 · No verified English nameJXHL2101161 | Celgene Corporation; Name not romanized |
| 2021/08/11Generic · Class 3 | Peramivir InjectionCYHS2101558 | Yunnan Xian Shi Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2021/08/11Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2101554 | Zhejiang Guo Jing Pharma Co., Ltd. romanized |
| 2021/08/11Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2101553 | Zhejiang Guo Jing Pharma Co., Ltd. romanized |
| 2021/08/11New drug · Class 2.2 | 注射用卡瑞利珠单抗 · No verified English nameCXSL2101254 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/08/11New drug · Class 2.2 | 重组GLP-1受体激动剂注射液 · No verified English nameCXSL2101253 | Beijing Le Pu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/08/11New drug · Class 1 | 9MW2821 · No verified English nameCXSL2101252 | Jiangsu Mai Wei Kang Xin Yao Research and Development Co., Ltd. romanized |
| 2021/08/11New drug · Class 2.2 | PTBC胶囊 · No verified English nameCXHL2101394 | Xiamen En Cheng Pharmaceutical Co., Ltd. romanized |
| 2021/08/11New drug · Class 2.2 | 枸橼酸托法替布多释片 · No verified English nameCXHL2101393 | Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized |
| 2021/08/11New drug · Class 1 | 苹果酸法米替尼胶囊 · No verified English nameCXHL2101392 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/08/11New drug · Class 1 | 苹果酸法米替尼胶囊 · No verified English nameCXHL2101391 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 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 |
51 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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