YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 363 drug applications between 1 July 2024 and 7 July 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 100, covering 73 drug names.
2024/07/01 – 2024/07/07
- New acceptances this week
- 363
- Drugs with new generic filings (by drug name, de-duplicated)
- 73
- Accepted this week, now under review
- 5
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
363filings, 100 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 182 |
| Generic | 100 |
| New drug | 36 |
| Import | 23 |
| Import re-registration | 14 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 263 |
| TCM | 48 |
| Therapeutic biologic | 44 |
| Prophylactic biologic | 8 |
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 | Dapoxetine Hydrochloride Tablets | 5 | 3 | 20 |
| 2 | Epalrestat Tablets | 3 | 3 | 1 |
| 3 | Diquafosol Sodium Eye Drops | 3 | 2 | 5 |
| 4 | 地氯雷他定口服溶液 · No verified English name | 3 | 1 | 26 |
| 5 | Vortioxetine Hydrobromide Tablets | 2 | 2 | 10 |
| 6 | Nicardipine Hydrochloride Injection | 2 | 2 | 13 |
| 7 | 维生素B12滴眼液 · No verified English name | 2 | 2 | 2 |
| 8 | Acetylcysteine Granules | 2 | 1 | 4 |
| 9 | Lactulose Oral Solution | 2 | 1 | 34 |
| 10 | Tadalafil Tablets | 2 | 1 | 23 |
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
217 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Luo Yang Hao Long Pharma Co., Ltd. romanized | 17 | 8 | 0 |
| 2 | Janssen Research & Development LLC | 9 | 3 | 0 |
| 3 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 6 | 4 | 0 |
| 4 | AstraZeneca AB | 6 | 3 | 0 |
| 5 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 4 | 3 | 4 |
| 6 | Sanofi Winthrop Industrie | 4 | 2 | 0 |
| 7 | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 4 | 2 | 4 |
| 8 | Chengdu Di Yi Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Suzhou Erye Pharmaceutical Co., 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
93 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/07/06Import · Class 1 | Bleximenib片 · No verified English nameJXHL2400164 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/07/06Import · Class 1 | Bleximenib片 · No verified English nameJXHL2400163 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/07/06Import · Class 1 | Bleximenib片 · No verified English nameJXHL2400162 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/07/06Generic · Class 3 | Pregabalin Oral SolutionCYHS2402049 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/07/06Generic · Class 3 | Tebipenem Pivoxil Fine GranulesCYHL2400135 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2024/07/06Generic · Class 3 | Ibuprofen and Phenylephrine Hydrochloride TabletsCYHL2400134 | Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized |
| 2024/07/06New drug · Class 1 | ZL-1218注射液 · No verified English nameCXSL2400433 | Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2024/07/06New drug · Class 3.3 | 注射用人生长激素 · No verified English nameCXSL2400432 | Changchun Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2024/07/06New drug · Class 3.3 | 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2400431 | Fu Xing Ya Li Feng (Da Lian) Biopharmaceutical Co., Ltd. romanized |
| 2024/07/06New drug · Class 2.2 | 三价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2400430 | Chengdu Ou Lin Bio Technology Co., Ltd. romanized; Lanzhou Bai Ling Bio Technology Co., Ltd. romanized; Chengdu Xin Nuo Ming Bio Technology Co., Ltd. romanized |
| 2024/07/06New drug · Class 1 | SDTM001注射液 · No verified English nameCXSL2400429 | Sai De Te Biopharmaceutical Co., Ltd. romanized |
| 2024/07/06New drug · Class 1 | DX1002片 · No verified English nameCXHL2400660 | Guangzhou An Hao Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/07/06New drug · Class 1 | DX1002片 · No verified English nameCXHL2400659 | Guangzhou An Hao Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/07/05Import · Class 2.4 | DS-3201b片 · No verified English nameJXHL2400161 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2024/07/05Import · Class 2.4 | DS-3201b片 · No verified English nameJXHL2400160 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2024/07/05Generic · Class 3 | Amoxicillin and Clavulanate Potassium TabletsCYHS2402042 | Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized |
| 2024/07/05Generic · Class 3 | Ferrous Succinate TabletsCYHS2402039 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2024/07/05Generic · Class 3 | Gatifloxacin Eye DropsCYHS2402038 | Hainan Ying Da Run Ze Pharma Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanized |
| 2024/07/05Generic · Class 3 | Naproxen Sodium TabletsCYHS2402037 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/07/05Generic · Class 3 | Naproxen Sodium TabletsCYHS2402036 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/07/05Generic · Class 3 | Haloperidol TabletsCYHS2402031 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2024/07/05New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2400428 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/07/05New drug · Class 1 | 重组抗NKG2A人源化单克隆抗体注射液 · No verified English nameCXSL2400427 | Shanghai Huai Yue Bio Technology Co., Ltd. romanized |
| 2024/07/05New drug · Class 1 | CB03-154片 · No verified English nameCXHL2400658 | Shanghai Zhi Meng Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/07/05New drug · Class 1 | YL-13027片 · No verified English nameCXHL2400657 | Shanghai Ying Li Pharma Co., Ltd. romanized |
| 2024/07/05New drug · Class 1 | YL-13027片 · No verified English nameCXHL2400656 | Shanghai Ying Li Pharma Co., Ltd. romanized |
| 2024/07/04Import · Class 1 | Bleximenib胶囊 · No verified English nameJXHL2400159 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/07/04Import · Class 1 | Bleximenib胶囊 · No verified English nameJXHL2400158 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/07/04Import · Class 1 | Bleximenib胶囊 · No verified English nameJXHL2400157 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/07/04Import · Class 1 | Dexpramipexole片 · No verified English nameJXHL2400156 | Areteia Therapeutics Inc.; Parexel China Co Ltd. |
63 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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