YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 266 drug applications between 4 November 2022 and 10 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 55, covering 40 drug names.
2022/11/04 – 2022/11/10
- New acceptances this week
- 266
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- 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
266filings, 55 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 142 |
| Generic | 55 |
| New drug | 33 |
| Import | 22 |
| Unspecified | 7 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 183 |
| TCM | 55 |
| Therapeutic biologic | 26 |
| Biologic | 1 |
| Prophylactic biologic | 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
40 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ibuprofen Injection | 4 | 2 | 8 |
| 2 | Pentoxifylline Injection | 2 | 2 | 3 |
| 3 | Bromhexine Hydrochloride Oral Solution | 2 | 2 | 22 |
| 4 | Voriconazole Tablets | 2 | 1 | 1 |
| 5 | Piracetam Injection | 2 | 1 | 9 |
| 6 | Fesoterodine Fumarate Prolonged-Release Tablets | 2 | 1 | 0 |
| 7 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 8 | Nicorandil for Injection | 2 | 1 | 1 |
| 9 | Rocuronium Bromide Injection | 2 | 1 | 1 |
| 10 | Sugammadex Sodium Injection | 2 | 1 | 6 |
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
149 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Gansu Xin Min Hai Pharmaceutical Co., Ltd. romanized | 18 | 18 | 0 |
| 2 | Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized | 10 | 9 | 0 |
| 3 | Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized | 8 | 1 | 0 |
| 4 | Guangxi Lian He Sheng Sheng Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Jilin Sheng Yi Pu Bio Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Jiangsu Pu Lai Pharmaceuticals Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Fresenius Kabi Austria GmbH | 4 | 1 | 0 |
| 9 | IBSA Institut Biochimique SA | 4 | 1 | 0 |
| 10 | Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized | 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
68 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/11/10Generic · Class 3 | Nicorandil for InjectionCYHS2201940 | Ke Bei Yuan (Beijing) Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2022/11/10Generic · Class 3 | Nicorandil for InjectionCYHS2201939 | Ke Bei Yuan (Beijing) Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2022/11/10Generic · Class 3 | Compound Dextran 40 InjectionCYHS2201937 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/11/10Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2201933 | Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2022/11/10Generic · Class 3 | Fesoterodine Fumarate Prolonged-Release TabletsCYHS2201932 | Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized |
| 2022/11/10Generic · Class 3 | Fesoterodine Fumarate Prolonged-Release TabletsCYHS2201931 | Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized |
| 2022/11/10New drug · Class 1 | IBR854细胞注射液 · No verified English nameCXSL2200568 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2022/11/10New drug · Class 1 | IBR854细胞注射液 · No verified English nameCXSL2200567 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2022/11/10New drug · Class 1 | 注射用LP-98 · No verified English nameCXHL2200889 | Zhongguo Yi Xue Ke College Bing Yuan Bio Xue Research Institute romanized; Shanxi Kang Bao Bio Zhi Pin Co., Ltd. romanized |
| 2022/11/10New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2200888 | Qilu Pharmaceutical Co., Ltd. |
| 2022/11/10New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2200887 | Qilu Pharmaceutical Co., Ltd. |
| 2022/11/09Generic · Class 3 | Ibuprofen InjectionCYHS2201925 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2022/11/09Generic · Class 3 | Ibuprofen InjectionCYHS2201924 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2022/11/09Generic · Class 3 | Ibuprofen InjectionCYHS2201923 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2022/11/09Generic · Class 3 | Ibuprofen InjectionCYHS2201922 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2022/11/09Generic · Class 3 | 醋酸维持液(含葡萄糖) · No verified English nameCYHS2201921 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2022/11/09Generic · Class 3 | 醋酸维持液(含葡萄糖) · No verified English nameCYHS2201920 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2022/11/09Generic · Class 3 | Omeprazole and Sodium Bicarbonate CapsulesCYHS2201919 | Xiamen En Cheng Pharmaceutical Co., Ltd. romanized |
| 2022/11/09Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2201918 | Zhejiang Xiong Di Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2022/11/09New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2200566 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2022/11/09New drug · Class 1 | HB0045注射液 · No verified English nameCXSL2200565 | Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/11/09New drug · Class 1 | 抗菌肽PL-18栓 · No verified English nameCXHL2200886 | Jiangsu Pu Lai Pharmaceuticals Bio Technology Co., Ltd. romanized |
| 2022/11/09New drug · Class 1 | 抗菌肽PL-18栓 · No verified English nameCXHL2200885 | Jiangsu Pu Lai Pharmaceuticals Bio Technology Co., Ltd. romanized |
| 2022/11/09New drug · Class 1 | 抗菌肽PL-18栓 · No verified English nameCXHL2200884 | Jiangsu Pu Lai Pharmaceuticals Bio Technology Co., Ltd. romanized |
| 2022/11/09New drug · Class 1 | 抗菌肽PL-18栓 · No verified English nameCXHL2200883 | Jiangsu Pu Lai Pharmaceuticals Bio Technology Co., Ltd. romanized |
| 2022/11/09New drug · Class 1 | 抗菌肽PL-18栓 · No verified English nameCXHL2200882 | Jiangsu Pu Lai Pharmaceuticals Bio Technology Co., Ltd. romanized |
| 2022/11/09New drug · Class 2.2 | RM301B滴眼液 · No verified English nameCXHL2200881 | Chengdu Rui Mu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/09New drug · Class 1 | PH005片 · No verified English nameCXHL2200878 | Suzhou Pu He Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/09New drug · Class 1 | PH005片 · No verified English nameCXHL2200877 | Suzhou Pu He Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/08Import · Class 1 | Tiragolumab注射液 · No verified English nameJXSL2200197 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd |
38 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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