YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 408 drug applications between 14 August 2023 and 20 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 107, covering 75 drug names.
2023/08/14 – 2023/08/20
- New acceptances this week
- 408
- Drugs with new generic filings (by drug name, de-duplicated)
- 75
- 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
408filings, 107 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 208 |
| Generic | 107 |
| New drug | 58 |
| Import | 29 |
| Import re-registration | 5 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 291 |
| TCM | 68 |
| Therapeutic biologic | 43 |
| 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
75 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Gadoteridol Injection | 4 | 1 | 3 |
| 2 | Lactulose Oral Solution | 3 | 2 | 34 |
| 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 | Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral Solution | 2 | 2 | 2 |
| 8 | Mupirocin Ointment | 2 | 2 | 30 |
| 9 | Avatrombopag Maleate Tablets | 2 | 2 | 0 |
| 10 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
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
235 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 24 | 19 | 1 |
| 2 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 11 | 11 | 0 |
| 3 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 5 | Guangdong Da Zhong Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 6 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 3 | 1 |
| 7 | Myokardia Inc. | 5 | 1 | 0 |
| 8 | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 4 | 3 | 4 |
| 9 | Janssen Research & Development LLC | 4 | 2 | 0 |
| 10 | Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 4 | 2 | 2 |
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
120 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/08/19Import · Class 3.1 | 特立妥单抗注射液 · No verified English nameJXSS2300070 | Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd. |
| 2023/08/19Import · Class 3.1 | 特立妥单抗注射液 · No verified English nameJXSS2300069 | Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd. |
| 2023/08/19Import · Class 2.2 | Faricimab注射液 · No verified English nameJXSL2300157 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/08/19Generic · Class 3 | Hydrotalcite SuspensionCYHS2302200 | Guangxi Bai Hui Pharmaceuticals Technology Co., Ltd. romanized; Guangxi Nanning Bai Hui Pharma Group Co., Ltd. romanized |
| 2023/08/19Generic · Class 3 | Digoxin InjectionCYHS2302199 | Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/08/19Generic · Class 3 | 头孢丙烯干混悬剂 · No verified English nameCYHS2302198 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2023/08/19Generic · Class 3 | Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2302197 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/08/19Generic · Class 3 | Bumetanide InjectionCYHS2302195 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2023/08/19Generic · Class 3 | Labetalol Hydrochloride InjectionCYHS2302193 | Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Guangxi Ming Lei Wei Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/08/19New drug · Class 2.3 | 连榆烧伤膏 · No verified English nameCXZL2300052 | Yang Zi Jiang Pharma Group Jiangsu Pharmaceutical Co., Ltd. romanized |
| 2023/08/19New drug · Class 2.2 | SPH(ZX)003 · No verified English nameCXHL2300897 | Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized |
| 2023/08/19New drug · Class 2.2 | SPH(ZX)003 · No verified English nameCXHL2300896 | Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized |
| 2023/08/19New drug · Class 1 | WXWH0240片 · No verified English nameCXHL2300895 | CISEN PHARMACEUTICAL CO., LTD. |
| 2023/08/19New drug · Class 1 | WXWH0240片 · No verified English nameCXHL2300894 | CISEN PHARMACEUTICAL CO., LTD. |
| 2023/08/19New drug · Class 1 | HS-10374片 · No verified English nameCXHL2300893 | Changzhou Heng Bang Pharma Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/08/19New drug · Class 1 | HS-10374片 · No verified English nameCXHL2300892 | Changzhou Heng Bang Pharma Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/08/19New drug · Class 2.2 | 伏立康唑滴眼液 · No verified English nameCXHL2300891 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 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 |
90 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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