YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 387 drug applications between 11 August 2023 and 17 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 105, covering 73 drug names.
2023/08/11 – 2023/08/17
- New acceptances this week
- 387
- Drugs with new generic filings (by drug name, de-duplicated)
- 73
- 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
387filings, 105 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 188 |
| Generic | 105 |
| New drug | 55 |
| Import re-registration | 21 |
| Import | 13 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 269 |
| TCM | 75 |
| Therapeutic biologic | 37 |
| Prophylactic biologic | 4 |
| In vitro diagnostic reagent | 1 |
| Biologic | 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
73 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Nicorandil for Injection | 4 | 2 | 1 |
| 2 | Empagliflozin Tablets | 3 | 2 | 18 |
| 3 | Aminophylline Injection | 3 | 2 | 3 |
| 4 | 恩那度司他片 · No verified English name | 3 | 1 | 0 |
| 5 | Peramivir Injection | 2 | 2 | 7 |
| 6 | 氧 · No verified English name | 2 | 2 | 15 |
| 7 | Avatrombopag Maleate Tablets | 2 | 2 | 0 |
| 8 | Lactulose Oral Solution | 2 | 1 | 34 |
| 9 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 10 | Piracetam Injection | 2 | 1 | 9 |
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
222 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | GE Healthcare AS | 14 | 1 | 0 |
| 2 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 13 | 8 | 1 |
| 3 | Shenyang Qing Gong Pharma Group Co., Ltd. romanized | 11 | 11 | 0 |
| 4 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 11 | 11 | 0 |
| 5 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 6 | Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 7 | Ren He Yi Kang Group Co., Ltd. romanized | 4 | 3 | 4 |
| 8 | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 4 | 3 | 4 |
| 9 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 4 | 2 | 2 |
| 10 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 2 | 1 |
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
104 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/08/17Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2302178 | Sui Cheng Pharma Co., Ltd. romanized |
| 2023/08/17Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2302177 | Sui Cheng Pharma Co., Ltd. romanized |
| 2023/08/17Generic · Class 3 | Nicorandil for InjectionCYHS2302173 | Changzhou Si Yao Pharmaceutical Co., Ltd. romanized |
| 2023/08/17Generic · Class 3 | Nicorandil for InjectionCYHS2302172 | Changzhou Si Yao Pharmaceutical Co., Ltd. romanized |
| 2023/08/17Generic · Class 3 | Thiotepa for InjectionCYHS2302164 | Name not romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2023/08/17Generic · Class 3 | Thiotepa for InjectionCYHS2302163 | Name not romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2023/08/17Generic · Class 3 | Calcium Folinate InjectionCYHS2302161 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2023/08/17Generic · Class 3 | Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2302159 | Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/08/17Generic · Class 3 | 恩那度司他片 · No verified English nameCYHL2300102 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2023/08/17Generic · Class 3 | 恩那度司他片 · No verified English nameCYHL2300101 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2023/08/17Generic · Class 3 | 恩那度司他片 · No verified English nameCYHL2300100 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2023/08/17Generic · Class 3 | 血管紧张素II注射液 · No verified English nameCYHL2300099 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/08/17New drug · Class 3.1 | 苓桂术甘汤颗粒 · No verified English nameCXZS2300016 | Hua Run San Jiu (Ya An) Pharma Co., Ltd. romanized |
| 2023/08/17New drug · Class 1 | STSA-1301 皮下注射液 · No verified English nameCXSL2300552 | Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized |
| 2023/08/17New drug · Class 1.2 | 重组脊髓灰质炎疫苗(汉逊酵母) · No verified English nameCXSL2300551 | Guo Yao Zhong Sheng Bio Technology Research Institute Co., Ltd. romanized; Beijing Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2023/08/17New drug · Class 1 | SSGJ-621注射液 · No verified English nameCXSL2300550 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2023/08/17New drug · Class 1 | 注射用HLX43 · No verified English nameCXSL2300549 | Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2023/08/17New drug · Class 1 | 注射用HLX42 · No verified English nameCXSL2300548 | Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2023/08/17New drug · Class 2.2 | 注射用N2107(纳米晶) · No verified English nameCXHL2300889 | Jiangsu Hui Ju Pharma Co., Ltd. romanized |
| 2023/08/17New drug · Class 1 | THDBH110胶囊 · No verified English nameCXHL2300888 | Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2023/08/17New drug · Class 1 | THDBH110胶囊 · No verified English nameCXHL2300887 | Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2023/08/17New drug · Class 1 | THDBH110胶囊 · No verified English nameCXHL2300886 | Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2023/08/17New drug · Class 1 | HW091077片 · No verified English nameCXHL2300885 | Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized |
| 2023/08/17New drug · Class 1 | HW091077片 · No verified English nameCXHL2300884 | Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized |
| 2023/08/16Import · Class 2.2 | ASKC200搽剂 · No verified English nameJXHL2300185 | Propella Therapeutics Inc.; Jiangsu Aosaikang Pharmaceutical Co. LTD |
| 2023/08/16Import · Class 2.2 | ASKC200搽剂 · No verified English nameJXHL2300184 | Propella Therapeutics Inc.; Jiangsu Aosaikang Pharmaceutical Co. LTD |
| 2023/08/16Import · Class 2.2 | ASKC200搽剂 · No verified English nameJXHL2300183 | Propella Therapeutics Inc.; Jiangsu Aosaikang Pharmaceutical Co. LTD |
| 2023/08/16Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2302156 | Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized |
| 2023/08/16Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2302151 | Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/08/16Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2302150 | Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
74 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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