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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

Period
2022/11/04 to 2022/11/10, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
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 typeFilings
Supplement142
Generic55
New drug33
Import22
Unspecified7
Import re-registration7

By drug type

Drug typeFilings
Chemical drug183
TCM55
Therapeutic biologic26
Biologic1
Prophylactic biologic1

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

#DrugNew generic filingsFiling companiesUnder review, all years
1Ibuprofen Injection428
2Pentoxifylline Injection223
3Bromhexine Hydrochloride Oral Solution2222
4Voriconazole Tablets211
5Piracetam Injection219
6Fesoterodine Fumarate Prolonged-Release Tablets210
7Sacubitril Valsartan Sodium Tablets2170
8Nicorandil for Injection211
9Rocuronium Bromide Injection211
10Sugammadex Sodium Injection216

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)FilingsDrugsGeneric
1Gansu Xin Min Hai Pharmaceutical Co., Ltd. romanized18180
2Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized1090
3Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized810
4Guangxi Lian He Sheng Sheng Pharma Co., Ltd. romanized660
5Jilin Sheng Yi Pu Bio Technology Co., Ltd. romanized550
6Jiangsu Pu Lai Pharmaceuticals Bio Technology Co., Ltd. romanized510
7Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized420
8Fresenius Kabi Austria GmbH410
9IBSA Institut Biochimique SA410
10Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized410

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

AcceptedDrugApplicants
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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