YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 297 drug applications between 10 August 2022 and 16 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 37 drug names.
2022/08/10 – 2022/08/16
- New acceptances this week
- 297
- 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
297filings, 53 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 175 |
| Generic | 53 |
| New drug | 33 |
| Import | 19 |
| Import re-registration | 10 |
| Unspecified | 6 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 211 |
| TCM | 45 |
| Therapeutic biologic | 38 |
| 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 | 泊马度胺胶囊 · No verified English name | 4 | 1 | 4 |
| 2 | Minoxidil Liniment | 3 | 2 | 52 |
| 3 | Midazolam Injection | 3 | 1 | 0 |
| 4 | Piperacillin Sodium And Tazobactam Sodium For Injection | 3 | 1 | 5 |
| 5 | Acetylcysteine Solution For Inhalation | 2 | 2 | 4 |
| 6 | Empagliflozin Tablets | 2 | 1 | 18 |
| 7 | Temozolomide Capsules | 2 | 1 | 0 |
| 8 | Vortioxetine Hydrobromide Tablets | 2 | 1 | 10 |
| 9 | Ambroxol Hydrochloride Oral Solution | 2 | 1 | 46 |
| 10 | Sevelamer Carbonate Powder for oral suspension | 2 | 1 | 3 |
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
173 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 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized | 9 | 4 | 7 |
| 3 | Roche Pharma (Schweiz) AG | 7 | 3 | 0 |
| 4 | Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Merck Sharp & Dohme B.V. | 6 | 4 | 0 |
| 6 | Shanxi Fen He Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Qilu Pharmaceutical Co., Ltd. | 5 | 2 | 5 |
| 8 | Shanxi Tong Da Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Hebei Wu Luo Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 4 | 4 | 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
68 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/08/16Import · Class 1 | STN1013400滴眼液 · No verified English nameJXHL2200243 | Santen Pharmaceutical Co. Ltd. |
| 2022/08/16Import · Class 1 | STN1013400滴眼液 · No verified English nameJXHL2200242 | Santen Pharmaceutical Co. Ltd. |
| 2022/08/16Import · Class 1 | STN1013400滴眼液 · No verified English nameJXHL2200241 | Santen Pharmaceutical Co. Ltd. |
| 2022/08/16Import · Class 1 | INCB000928片 · No verified English nameJXHL2200240 | Incyte Corporation; Incyte Biosciences Shanghai Co. Ltd. |
| 2022/08/16Generic · Class 3 | Minoxidil LinimentCYHS2201319 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2022/08/16Generic · Class 3 | Minoxidil LinimentCYHS2201318 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2022/08/16Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2201313 | Hangzhou An Yuan Biopharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2022/08/16Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2201312 | Hangzhou An Yuan Biopharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2022/08/16Generic · Class 3 | 泊马度胺胶囊 · No verified English nameCYHS2201310 | Qilu Pharmaceutical Co., Ltd. |
| 2022/08/16Generic · Class 3 | 泊马度胺胶囊 · No verified English nameCYHS2201308 | Qilu Pharmaceutical Co., Ltd. |
| 2022/08/16Generic · Class 3 | 泊马度胺胶囊 · No verified English nameCYHS2201307 | Qilu Pharmaceutical Co., Ltd. |
| 2022/08/16Generic · Class 3 | 泊马度胺胶囊 · No verified English nameCYHS2201306 | Qilu Pharmaceutical Co., Ltd. |
| 2022/08/16Generic · Class 3 | Nifedipine Extended-Release TabletsCYHS2201304 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/08/16Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2201301 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2022/08/16Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2201300 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2022/08/16Generic · Class 3 | 盐酸氨酮戊酸口服溶液用粉末 · No verified English nameCYHL2200065 | Zhao Ke Pharma (Hefei) Co., Ltd. romanized |
| 2022/08/16Generic · Class 3 | Clobazam Oral SuspensionCYHL2200064 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/08/16New drug · Class 3.3 | 特立帕肽注射液 · No verified English nameCXSS2200073 | Wuxi He Bang Bio Technology Co., Ltd. romanized |
| 2022/08/16New drug · Class 1 | HBG基因修饰的自体CD34+造血干细胞注射液 · No verified English nameCXSL2200378 | Guangzhou Rui Feng Bio Technology Co., Ltd. romanized |
| 2022/08/16New drug · Class 1 | JCXH-211注射液 · No verified English nameCXSL2200377 | Jia Chen Xi Hai (Hangzhou) Bio Technology Co., Ltd. romanized |
| 2022/08/16New drug · Class 1 | 注射用JSKN003 · No verified English nameCXSL2200376 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2022/08/16New drug · Class 2.2 | 注射用醋酸戈舍瑞林缓释微球 · No verified English nameCXHS2200045 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 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 |
38 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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