YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 315 drug applications between 8 October 2021 and 14 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 46, covering 32 drug names.
2021/10/08 – 2021/10/14
- New acceptances this week
- 315
- Drugs with new generic filings (by drug name, de-duplicated)
- 32
- 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
315filings, 46 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 187 |
| New drug | 48 |
| Generic | 46 |
| Import | 14 |
| Unspecified | 13 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 159 |
| TCM | 101 |
| Therapeutic biologic | 48 |
| Biologic | 7 |
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
32 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿普米司特片 · No verified English name | 6 | 2 | 3 |
| 2 | Parecoxib Sodium for Injection | 3 | 2 | 2 |
| 3 | Sitagliptin Phosphate Tablets | 3 | 1 | 2 |
| 4 | 氧 · No verified English name | 2 | 2 | 15 |
| 5 | Ornidazole Injection | 2 | 1 | 0 |
| 6 | Cyclophosphamide Capsules | 2 | 1 | 2 |
| 7 | 磷酸奥司他韦干糖浆 · No verified English name | 2 | 1 | 0 |
| 8 | Esomeprazole Magnesium Enteric-Coated Capsules | 2 | 1 | 4 |
| 9 | 依托咪酯乳状注射液 · No verified English name | 1 | 1 | 1 |
| 10 | Lidocaine Cataplasms | 1 | 1 | 7 |
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
156 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Wan Hui Pharmaceutical Co., Ltd. romanized | 64 | 48 | 0 |
| 2 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 6 | 3 | 0 |
| 3 | Novo Nordisk A/S | 5 | 4 | 0 |
| 4 | Jiangxi Di Kang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Pfizer Europe MA EEIG | 4 | 2 | 0 |
| 6 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 4 | 2 | 1 |
| 7 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 2 |
| 8 | Hebei Yao Wang Group Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Shenzhen Li Jian Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Qilu Pharmaceutical Co., Ltd. | 4 | 2 | 3 |
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
73 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/10/14Import · Class 1 | Rozanolixizumab注射液 · No verified English nameJXSL2101117 | UCB Pharma SA; UCB Trading (Shanghai) Co. Ltd |
| 2021/10/14Import · Class 1 | TAK-935片 · No verified English nameJXHL2101200 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2021/10/14Import · Class 1 | TAK-935片 · No verified English nameJXHL2101199 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2021/10/14Generic · Class 3 | Desonide CreamCYHS2101866 | Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized |
| 2021/10/14Generic · Class 3 | Haloperidol Oral SolutionCYHS2101865 | Xinjiang Te Feng Pharma Co., Ltd. romanized |
| 2021/10/14Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2101861 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2021/10/14Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2101860 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2021/10/14Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2101856 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2021/10/14Generic · Class 3 | Tranexamic Acid InjectionCYHS2101833 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2021/10/14New drug · Class 3.3 | 地舒单抗注射液 · No verified English nameCXSS2101033 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2021/10/14New drug · Class 1 | 注射用DNV3 · No verified English nameCXSL2101369 | Zhejiang Shi Mai Pharma Co., Ltd. romanized |
| 2021/10/14New drug · Class 1 | Ociperlimab注射液 · No verified English nameCXSL2101368 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2021/10/14New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2101367 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/10/14New drug · Class 3.2 | 静注人免疫球蛋白(10%) · No verified English nameCXSL2101366 | Bo Ya Biopharmaceutical Group Co., Ltd. romanized |
| 2021/10/14New drug · Class 1 | SSGJ-706注射液 · No verified English nameCXSL2101365 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/10/14New drug · Class 1 | SSGJ-706注射液 · No verified English nameCXSL2101364 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/10/14New drug · Class 1 | SH009注射液 · No verified English nameCXSL2101362 | Nanjing Sheng He Pharma Co., Ltd. romanized |
| 2021/10/14New drug · Class 1 | 阴道乳杆菌活菌胶囊 · No verified English nameCXSL2101361 | Suzhou Ou Sai Wei Ke Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/10/14New drug · Class 1 | JL15003注射液 · No verified English nameCXSL2101359 | Jie Ke (Tianjin) Biopharmaceuticals Co., Ltd. romanized |
| 2021/10/14New drug · Class 1 | TQB2450注射液 · No verified English nameCXSL2101357 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/10/14New drug · Class 1 | 全人源抗PD-L1抗体注射液 · No verified English nameCXSL2101356 | Bao Chuan Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2021/10/14New drug · Class 1 | TJ033721注射液 · No verified English nameCXSL2101352 | Tian Jing Bio Technology (Shanghai) Co., Ltd. romanized |
| 2021/10/14New drug · Class 1 | 重组抗EGFR人源化单克隆抗体注射液 · No verified English nameCXSL2101349 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2021/10/14New drug · Class 1 | TCR1672片 · No verified English nameCXHL2101560 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2021/10/14New drug · Class 1 | TCR1672片 · No verified English nameCXHL2101559 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2021/10/14New drug · Class 1 | SHR1459片 · No verified English nameCXHL2101558 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/10/14New drug · Class 1 | SHR1459片 · No verified English nameCXHL2101557 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/10/14New drug · Class 1 | 安喹利司片 · No verified English nameCXHL2101556 | Zhongguo Yi Xue Ke College Drug Research Institute romanized; Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized |
| 2021/10/14New drug · Class 2.4 | 盐酸米托蒽醌脂质体注射液 · No verified English nameCXHL2101544 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2021/10/13New drug · Class 2.2 | 维格列汀缓释片 · No verified English nameCXHL2101538 | Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized |
43 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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