YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 426 drug applications between 12 August 2023 and 18 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 116, covering 79 drug names.
2023/08/12 – 2023/08/18
- New acceptances this week
- 426
- Drugs with new generic filings (by drug name, de-duplicated)
- 79
- 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
426filings, 116 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 202 |
| Generic | 116 |
| New drug | 62 |
| Import | 23 |
| Import re-registration | 20 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 299 |
| TCM | 74 |
| Therapeutic biologic | 47 |
| Prophylactic biologic | 5 |
| 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
79 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 | Gadoteridol Injection | 4 | 1 | 3 |
| 3 | Empagliflozin Tablets | 3 | 2 | 18 |
| 4 | Aminophylline Injection | 3 | 2 | 3 |
| 5 | Urapidil Hydrochloride Injection | 3 | 2 | 6 |
| 6 | 恩那度司他片 · No verified English name | 3 | 1 | 0 |
| 7 | 氧 · No verified English name | 2 | 2 | 15 |
| 8 | Mupirocin Ointment | 2 | 2 | 30 |
| 9 | Avatrombopag Maleate Tablets | 2 | 2 | 0 |
| 10 | Lactulose Oral Solution | 2 | 1 | 34 |
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
241 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 15 | 10 | 1 |
| 2 | GE Healthcare AS | 14 | 1 | 0 |
| 3 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 11 | 11 | 0 |
| 4 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 5 | Shenyang Qing Gong Pharma Group Co., Ltd. romanized | 8 | 8 | 0 |
| 6 | Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 7 | Myokardia Inc. | 5 | 1 | 0 |
| 8 | Ren He Yi Kang Group Co., Ltd. romanized | 4 | 3 | 4 |
| 9 | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 4 | 3 | 4 |
| 10 | Janssen Research & Development LLC | 4 | 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
124 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/08/18Import · Class 2.2 | Guselkumab Final Vialed Product for Intravenous Infusion (FVP(IV)) · No verified English nameJXSL2300156 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/08/18Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSL2300155 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/08/18Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSL2300154 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/08/18Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSL2300153 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/08/18Import · Class 1 | BION-1301注射液 · No verified English nameJXSL2300152 | Chinook Therapeutics Inc.; SanReno Therapeutics (Shanghai) Limited |
| 2023/08/18Import · Class 2.4 | Mavacamten胶囊 · No verified English nameJXHL2300190 | Myokardia Inc.; Shanghai LianBio Development Co. Ltd. |
| 2023/08/18Import · Class 2.4 | Mavacamten胶囊 · No verified English nameJXHL2300189 | Myokardia Inc.; Shanghai LianBio Development Co. Ltd. |
| 2023/08/18Import · Class 2.4 | Mavacamten胶囊 · No verified English nameJXHL2300188 | Myokardia Inc.; Shanghai LianBio Development Co. Ltd. |
| 2023/08/18Import · Class 2.4 | Mavacamten胶囊 · No verified English nameJXHL2300187 | Myokardia Inc.; Shanghai LianBio Development Co. Ltd. |
| 2023/08/18Import · Class 2.4 | Mavacamten胶囊 · No verified English nameJXHL2300186 | Myokardia Inc.; Shanghai LianBio Development Co. Ltd. |
| 2023/08/18Generic · Class 3 | 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2302190 | Hua Run Shuang He Pharma Co., Ltd. romanized |
| 2023/08/18Generic · Class 3 | Methocarbamol InjectionCYHS2302187 | Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized |
| 2023/08/18Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2302186 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2023/08/18Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2302181 | Shaanxi Li Cai Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2023/08/18New drug · Class 1 | VT-101注射液 · No verified English nameCXSL2300558 | Jiangsu Wan Rong Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Wan Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/08/18New drug · Class 3.3 | 司库奇尤单抗注射液 · No verified English nameCXSL2300557 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2023/08/18New drug · Class 1 | CM313(SC)注射液 · No verified English nameCXSL2300556 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2023/08/18New drug · Class 1 | 自体抗CLL-1嵌合抗原受体T细胞注射液 · No verified English nameCXSL2300555 | Guangzhou Bai Ji Ji Yin Technology Co., Ltd. romanized |
| 2023/08/18New drug · Class 1 | 注射用IMM2510 · No verified English nameCXSL2300554 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/08/18New drug · Class 1 | IMM27M注射液 · No verified English nameCXSL2300553 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/08/18New drug · Class 1 | 注射用HRS-9057 · No verified English nameCXHL2300890 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 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 |
94 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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