YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 252 drug applications between 10 August 2021 and 16 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 47, covering 33 drug names.
2021/08/10 – 2021/08/16
- New acceptances this week
- 252
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- 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
252filings, 47 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 115 |
| Generic | 47 |
| New drug | 44 |
| Unspecified | 24 |
| Import | 14 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 169 |
| Therapeutic biologic | 55 |
| TCM | 27 |
| 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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Rivaroxaban Tablets | 3 | 2 | 3 |
| 2 | 草酸艾司西酞普兰口服溶液 · No verified English name | 3 | 2 | 11 |
| 3 | Pregabalin Capsules | 3 | 1 | 12 |
| 4 | Meropenem for Injection | 3 | 1 | 5 |
| 5 | Ornidazole Injection | 2 | 1 | 0 |
| 6 | Omeprazole and Sodium Bicarbonate Capsules | 2 | 1 | 0 |
| 7 | Gemcitabine Hydrochloride for Injection | 2 | 1 | 1 |
| 8 | Irinotecan Hydrochloride Injection | 2 | 1 | 2 |
| 9 | Vardenafil Hydrochloride Tablets | 2 | 1 | 4 |
| 10 | 硫酸沙丁胺醇吸入溶液 · No verified English name | 2 | 1 | 0 |
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
139 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Oncotec Pharma Produktion GmbH | 8 | 1 | 0 |
| 2 | Eurofins Analytical Science Laboratories Inc. | 6 | 6 | 0 |
| 3 | Upjohn EESV | 6 | 3 | 0 |
| 4 | Chengdu Rong Sheng Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 5 | AstraZeneca AB | 6 | 2 | 0 |
| 6 | Novartis Pharma Schweiz AG | 6 | 2 | 0 |
| 7 | Huang Shi Wei Sheng Cai Liao Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Janssen Research & Development LLC | 5 | 3 | 0 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 10 | Pfizer Europe MA EEIG | 5 | 2 | 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
70 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2021/08/13Import · Class 2.2 | DS-8201a · No verified English nameJXSL2101093 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2021/08/13Generic · Class 3 | Pregabalin Oral SolutionCYHS2101579 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Nanjing Xing Yin Pharma Group Co., Ltd. romanized |
| 2021/08/13Generic · Class 3 | Calcitriol Oral SolutionCYHS2101575 | Zheng Da Pharmaceutical (Qingdao) Co., Ltd. romanized |
| 2021/08/13New drug · Class 1 | ADG126注射液 · No verified English nameCXSL2101263 | Tian Yan Pharma (Suzhou) Co., Ltd. romanized |
| 2021/08/13New drug · Class 1 | 重组人源化抗CD47单克隆抗体注射液 · No verified English nameCXSL2101262 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2021/08/13New drug · Class 1 | ASC22注射液 · No verified English nameCXSL2101261 | Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2021/08/13New drug · Class 1 | TQB2450注射液 · No verified English nameCXSL2101260 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/08/13New drug · Class 1 | SHR8554注射液 · No verified English nameCXHL2101403 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/08/13New drug · Class 1 | SHR8554注射液 · No verified English nameCXHL2101402 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/08/13New drug · Class 1 | SHR0410注射液 · No verified English nameCXHL2101401 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/08/13New drug · Class 1 | CGT-6321片 · No verified English nameCXHL2101400 | Sheng Shi Tai Ke Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2021/08/13New drug · Class 1 | CGT-6321片 · No verified English nameCXHL2101399 | Sheng Shi Tai Ke Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2021/08/13New drug · Class 2.3 | YK-1169 · No verified English nameCXHL2101398 | Nanjing Li Bo Wei Pharmaceutical Co., Ltd. romanized |
| 2021/08/13New drug · Class 1 | SHR2285片 · No verified English nameCXHL2101397 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 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 |
40 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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