YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 396 drug applications between 9 November 2024 and 15 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 130, covering 88 drug names.
2024/11/09 – 2024/11/15
- New acceptances this week
- 396
- Drugs with new generic filings (by drug name, de-duplicated)
- 88
- Accepted this week, now under review
- 7
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
396filings, 130 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 173 |
| Generic | 130 |
| New drug | 65 |
| Import | 13 |
| Unspecified | 9 |
| Import re-registration | 5 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 289 |
| TCM | 55 |
| Therapeutic biologic | 35 |
| Prophylactic biologic | 12 |
| Biologic | 4 |
| 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
88 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Propranolol Hydrochloride Injection | 4 | 2 | 4 |
| 2 | Fluoxetine Hydrochloride Oral Solution | 4 | 1 | 0 |
| 3 | Glucosamine Sulfate Capsules | 3 | 3 | 51 |
| 4 | Multiple Electrolyte Additive For Injection | 3 | 3 | 2 |
| 5 | Nicergoline Tablets | 3 | 2 | 1 |
| 6 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 7 | Pregabalin Oral Solution | 3 | 1 | 5 |
| 8 | Sodium sulfate, magnesium sulfate, and potassium chloride Tablets | 2 | 2 | 2 |
| 9 | Tobramycin Eye Drops | 2 | 2 | 2 |
| 10 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 2 | 2 | 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
258 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 12 | 11 | 0 |
| 2 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 0 |
| 3 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized | 6 | 4 | 0 |
| 4 | Celgene Corporation | 6 | 1 | 0 |
| 5 | Chengdu Di Kang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized | 5 | 4 | 0 |
| 7 | Chengdu Brilliant Pharmaceutical Co., Ltd. | 4 | 3 | 1 |
| 8 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 4 |
| 9 | Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanized | 4 | 2 | 4 |
| 10 | Bristol-Myers Squibb Australia Pty Ltd | 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
131 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/15Generic · Class 3 | Loxoprofen Sodium Oral SolutionCYHS2403938 | Name not romanized; Hefei Hua Wei Pharma Co., Ltd. romanized |
| 2024/11/15Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2403936 | Chongqing Tian Zhi Pharma Co., Ltd. romanized; Henan Tian Zhi Pharma Co., Ltd. romanized |
| 2024/11/15Generic · Class 3 | Piperacillin Sodium for InjectionCYHS2403935 | Jiangsu Rui Shi Bio Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized |
| 2024/11/15Generic · Class 3 | Piperacillin Sodium for InjectionCYHS2403934 | Jiangsu Rui Shi Bio Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized |
| 2024/11/15Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2403928 | Jiangsu Qian Ren Bio Technology Co., Ltd. romanized |
| 2024/11/15Generic · Class 3 | Ferrous Succinate TabletsCYHS2403926 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2024/11/15Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2403923 | Hai Xi Xin Yao Chuang Zhi (Fuzhou) Co., Ltd. romanized; Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized |
| 2024/11/15Generic · Class 3 | Pregabalin Oral SolutionCYHS2403917 | Gai Tian Li Pharmaceuticals Holding Group Pharmaceutical Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2024/11/15Generic · Class 3 | Pregabalin Oral SolutionCYHS2403916 | Gai Tian Li Pharmaceuticals Holding Group Pharmaceutical Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2024/11/15Generic · Class 3 | Pregabalin Oral SolutionCYHS2403915 | Gai Tian Li Pharmaceuticals Holding Group Pharmaceutical Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2024/11/15Generic · Class 3 | Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHL2400227 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 2024/11/15New drug · Class 3.3 | 13价肺炎球菌多糖结合疫苗 · No verified English nameCXSS2400123 | Ai Mei Jian Chi Biopharmaceutical Co., Ltd. romanized |
| 2024/11/15New drug · Class 1.2 | SYS6017(带状疱疹mRNA疫苗) · No verified English nameCXSL2400778 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2024/11/15New drug · Class 1 | 重组抗CD19m-CD3抗体注射液 · No verified English nameCXSL2400777 | Tian Mai Yuan He Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2024/11/15New drug · Class 1 | HSK44459片 · No verified English nameCXHL2401244 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2024/11/15New drug · Class 1 | HSK44459片 · No verified English nameCXHL2401243 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2024/11/15New drug · Class 1 | NBB-002 · No verified English nameCXHL2401242 | Zhong Peng (Xiamen) Biopharmaceuticals Co., Ltd. romanized |
| 2024/11/15New drug · Class 1 | HWH340片 · No verified English nameCXHL2401241 | Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized |
| 2024/11/15New drug · Class 1 | HWH340片 · No verified English nameCXHL2401240 | Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized |
| 2024/11/15New drug · Class 1 | ADC308片 · No verified English nameCXHL2401239 | Jia Xing An Di Kang Bio Technology Co., Ltd. romanized |
| 2024/11/15New drug · Class 2.4 | 甲磺酸伏美替尼片 · No verified English nameCXHL2401238 | Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/15New drug · Class 2.2; 2.4 | 注射用紫杉醇聚合物胶束 · No verified English nameCXHL2401237 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized |
| 2024/11/14Import · Class 1 | 注射用MK-2400 · No verified English nameJXSL2400222 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2024/11/14Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2400221 | Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd. |
| 2024/11/14Import · Class 1 | Itepekimab注射液 · No verified English nameJXSL2400220 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2024/11/14Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2403909 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2024/11/14Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2403908 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2024/11/14Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2403905 | Kang Pu Pharma Co., Ltd. romanized |
| 2024/11/14Generic · Class 3 | Cefmetazole Sodium for InjectionCYHS2403901 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Shenyang San Jiu Pharma Co., Ltd. romanized |
| 2024/11/14Generic · Class 3 | Cefmetazole Sodium for InjectionCYHS2403900 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Shenyang San Jiu Pharma Co., Ltd. romanized |
101 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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