YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 381 drug applications between 5 November 2023 and 11 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 66 drug names.
2023/11/05 – 2023/11/11
- New acceptances this week
- 381
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- 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
381filings, 97 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 193 |
| Generic | 97 |
| New drug | 59 |
| Import | 14 |
| Unspecified | 11 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 265 |
| TCM | 87 |
| Therapeutic biologic | 27 |
| Biologic | 2 |
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
66 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Norepinephrine Bitartrate Injection | 6 | 3 | 9 |
| 2 | Potassium Chloride Granules | 4 | 2 | 4 |
| 3 | Ibuprofen Injection | 3 | 2 | 8 |
| 4 | Potassium Chloride Oral Solution | 3 | 2 | 11 |
| 5 | 中/长链脂肪乳注射液(C6~24) · No verified English name | 3 | 1 | 0 |
| 6 | Piracetam Injection | 3 | 1 | 9 |
| 7 | Famotidine Injection | 2 | 2 | 8 |
| 8 | Oseltamivir Phosphate For Oral Suspension | 2 | 2 | 2 |
| 9 | Ethyl Iosapentate Capsules | 2 | 1 | 27 |
| 10 | Etoricoxib Tablets | 2 | 1 | 8 |
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
216 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Shuang Yan Pharma Co., Ltd. romanized | 14 | 14 | 0 |
| 2 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 11 | 4 | 0 |
| 3 | Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 4 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 10 | 3 | 0 |
| 5 | Sanofi Winthrop Industrie | 7 | 3 | 0 |
| 6 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 7 | 2 | 1 |
| 7 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 5 | 4 | 5 |
| 8 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | Merck Sharp & Dohme LLC | 5 | 2 | 0 |
| 10 | Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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
119 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/11Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2300192 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2023/11/11Generic · Class 3 | Potassium Chloride GranulesCYHS2303100 | Shanxi Huang Cheng Xiang Fu Pharma Co., Ltd. romanized |
| 2023/11/11Generic · Class 3 | Potassium Chloride GranulesCYHS2303099 | Shanxi Huang Cheng Xiang Fu Pharma Co., Ltd. romanized |
| 2023/11/11New drug · Class 1 | ZS805注射液 · No verified English nameCXSL2300775 | Sichuan Zhi Shan Wei Xin Bio Technology Co., Ltd. romanized |
| 2023/11/11New drug · Class 1 | 注射用MK-2870 · No verified English nameCXSL2300774 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2023/11/11New drug · Class 2.4; 2.2 | 硫酸阿托品滴眼液 · No verified English nameCXHL2301262 | Le Pu Pharma Co., Ltd. romanized |
| 2023/11/11New drug · Class 2.4; 2.2 | 硫酸阿托品滴眼液 · No verified English nameCXHL2301261 | Le Pu Pharma Co., Ltd. romanized |
| 2023/11/11New drug · Class 2.4 | 盐酸氨酮戊酸颗粒剂 · No verified English nameCXHL2301260 | Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized |
| 2023/11/11New drug · Class 1 | FCN-338片 · No verified English nameCXHL2301259 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized |
| 2023/11/11New drug · Class 1 | FCN-338片 · No verified English nameCXHL2301258 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized |
| 2023/11/11New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2301257 | Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized |
| 2023/11/11New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2301256 | Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized |
| 2023/11/10Import · Class 2.3 | 马昔腾坦他达拉非片 · No verified English nameJXHL2300281 | Actelion Pharmaceuticals Ltd; Johnson & Johnson (China) Investment Ltd. |
| 2023/11/10Import · Class 1 | LNP023胶囊 · No verified English nameJXHL2300280 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/11/10Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2303094 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2023/11/10Generic · Class 3 | Sodium Acetate Ringer's InjectionCYHS2303093 | Zhejiang Kang Ji Er Pharma Co., Ltd. romanized |
| 2023/11/10Generic · Class 3 | Paracetamol and Ibuprofen TabletsCYHS2303092 | Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized |
| 2023/11/10Generic · Class 3 | Vitamin K1 InjectionCYHS2303088 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2023/11/10Generic · Class 3 | Vitamin K1 InjectionCYHS2303087 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2023/11/10Generic · Class 3 | Pioglitazone and Metformin Hydrochloride TabletsCYHS2303085 | Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/11/10Generic · Class 3 | Ibuprofen InjectionCYHL2300136 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2023/11/10New drug · Class 3.4 | 人凝血酶原复合物 · No verified English nameCXSS2300087 | Guo Yao Group Lanzhou Biopharmaceutical Co., Ltd. romanized |
| 2023/11/10New drug · Class 1 | 重组抗IL-1β人源化单克隆抗体注射液 · No verified English nameCXSL2300773 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2023/11/10New drug · Class 1 | BR115注射液 · No verified English nameCXSL2300772 | Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized; Hai Zheng Biopharmaceutical Co., Ltd. romanized; Chengdu En Mu Bio Technology Co., Ltd. romanized |
| 2023/11/10New drug · Class 1 | 注射用AMT-116 · No verified English nameCXSL2300771 | Pu Zhong Fa Xian Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/11/10New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2300770 | Shenzhen Shi Yin Guan Bio Technology Co., Ltd. romanized |
| 2023/11/10New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2300769 | Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized |
| 2023/11/10New drug · Class 2.3 | HR20031片(Ⅱ) · No verified English nameCXHS2300100 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/11/10New drug · Class 2.3 | HR20031片(Ⅰ) · No verified English nameCXHS2300099 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/11/10New drug · Class 2.4 | 盐酸右美托咪定鼻喷剂 · No verified English nameCXHL2301255 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
89 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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