YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 255 drug applications between 9 August 2022 and 15 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 47, covering 37 drug names.
2022/08/09 – 2022/08/15
- New acceptances this week
- 255
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- 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
255filings, 47 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 156 |
| Generic | 47 |
| New drug | 29 |
| Import | 12 |
| Import re-registration | 6 |
| Unspecified | 4 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 173 |
| TCM | 46 |
| Therapeutic biologic | 33 |
| Prophylactic biologic | 2 |
| 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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Salbutamol Sulfate Inhalation Solution | 3 | 1 | 2 |
| 2 | Midazolam Injection | 3 | 1 | 0 |
| 3 | Piperacillin Sodium And Tazobactam Sodium For Injection | 3 | 1 | 5 |
| 4 | Empagliflozin Tablets | 2 | 1 | 18 |
| 5 | Temozolomide Capsules | 2 | 1 | 0 |
| 6 | Vortioxetine Hydrobromide Tablets | 2 | 1 | 10 |
| 7 | Ambroxol Hydrochloride Oral Solution | 2 | 1 | 46 |
| 8 | 丁酸氯维地平乳状注射液 · No verified English name | 1 | 1 | 0 |
| 9 | Pentazocine Injection | 1 | 1 | 0 |
| 10 | Compound Amino Acid Injection | 1 | 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
152 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Yu Sheng Tang Group Shijiazhuang Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Shanxi Tong Da Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Roche Pharma (Schweiz) AG | 7 | 3 | 0 |
| 4 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized | 7 | 3 | 7 |
| 5 | Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Shanxi Fen He Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Hebei Wu Luo Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Merck Sharp & Dohme B.V. | 4 | 3 | 0 |
| 9 | Shanghai Hao Hai Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Hainan Tong Yong Kang Li Pharmaceutical 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
54 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/08/15Import · Class 2.2 | Amivantamab注射液 · No verified English nameJXSL2200133 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/08/15Generic · Class 3 | 甲硝唑凝胶 · No verified English nameCYHS2201296 | Wuxi Lang Run Pharmaceuticals Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd. |
| 2022/08/15Generic · Class 3 | Pentazocine InjectionCYHS2201295 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2022/08/15Generic · Class 3 | Peramivir InjectionCYHS2201294 | Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2022/08/15New drug · Class 1.1 | 双根口服液 · No verified English nameCXZL2200038 | Zhongguo Ren Min Jie Fang Jun Zong Hospital Di Wu Yi Xue Center romanized |
| 2022/08/15New drug · Class 1 | U16注射液 · No verified English nameCXSL2200375 | Shanghai You Ka Di Zhi Zao Sheng Ming Technology Co., Ltd. romanized; Shanghai You Ka Di Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/08/15New drug · Class 2.1 | 人干扰素α2b喷雾剂 · No verified English nameCXSL2200374 | Ke Xing Biopharmaceutical Co., Ltd. romanized |
| 2022/08/15New drug · Class 2.4 | 奥布替尼片 · No verified English nameCXHS2200044 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2022/08/15New drug · Class 1 | HRS-1780片 · No verified English nameCXHL2200589 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/08/15New drug · Class 1 | HRS-1780片 · No verified English nameCXHL2200588 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/08/15New drug · Class 2.3 | 格隆溴铵奥达特罗吸入喷雾剂 · No verified English nameCXHL2200587 | Shanghai Gu Sen Pharmaceuticals Co., Ltd. romanized |
| 2022/08/12Import · Class 3.1 | Faricimab注射液 · No verified English nameJXSS2200032 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd |
| 2022/08/12Import · Class 2.4 | Lenvatinib Mesilate CapsulesJXHL2200237 | Eisai Europe Ltd. |
| 2022/08/12Import · Class 2.4 | Lenvatinib Mesilate CapsulesJXHL2200236 | Eisai Europe Ltd. |
| 2022/08/12New drug · Class 3.3 | 冻干人用狂犬病疫苗（Vero细胞） · No verified English nameCXSS2200072 | Fu Xing Ya Li Feng (Da Lian) Biopharmaceutical Co., Ltd. romanized |
| 2022/08/12New drug · Class 1 | 血浆生物净化柱 · No verified English nameCXSL2200373 | Shanghai Wei Zhi Zhuo Bio Technology Co., Ltd. romanized |
| 2022/08/12New drug · Class 1 | LD013自体T细胞注射液 · No verified English nameCXSL2200372 | Nanjing Lan Dun Bio Technology Co., Ltd. romanized |
| 2022/08/12New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHL2200586 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized |
| 2022/08/12New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHL2200585 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized |
| 2022/08/12New drug · Class 2.2 | HECB1502201注射液 · No verified English nameCXHL2200584 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2022/08/12New drug · Class 2.2 | HECB1502201注射液 · No verified English nameCXHL2200583 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2022/08/11Import · Class 1 | XXB750注射液 · No verified English nameJXSL2200132 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/08/11Import · Class 1 | LOXO-783片 · No verified English nameJXHL2200239 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/08/11Import · Class 1 | LOXO-783片 · No verified English nameJXHL2200238 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/08/11Generic · Class 3 | Lamotrigine Extended Release TabletsCYHS2201288 | Shanghai Ao Ke Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2022/08/11Generic · Class 3 | Minoxidil LinimentCYHS2201287 | Zhejiang Yuan Li Jian Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/08/11Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2201283 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2022/08/11Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2201282 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2022/08/11Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2201281 | Tong He Biopharmaceuticals (Shandong) Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2022/08/11New drug · Class 1 | CUD002注射液 · No verified English nameCXSL2200371 | Sichuan Kang De Sai Medical Technology Co., Ltd. romanized |
24 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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