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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 302 drug applications between 8 November 2022 and 14 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 54 drug names.

2022/11/08 – 2022/11/14

Period
2022/11/08 to 2022/11/14, 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
302
Drugs with new generic filings (by drug name, de-duplicated)
54
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

302filings, 81 of them generic

By application type

Application typeFilings
Supplement156
Generic81
New drug36
Import13
Unspecified12
Import re-registration4

By drug type

Drug typeFilings
Chemical drug207
TCM68
Therapeutic biologic25
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

54 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ibuprofen Injection538
2Pregabalin Capsules3112
3Tranexamic Acid Injection3111
4Lidocaine Hydrochloride Injection316
5Moxifloxacin Hydrochloride Eye Drops224
6Oseltamivir Phosphate For Oral Suspension222
7Voriconazole Tablets211
8Fesoterodine Fumarate Prolonged-Release Tablets210
9Hydrocodone Bitartrate and Ibuprofen Tablets210
10Tandospirone Citrate Tablets212

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

166 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Gansu Xin Min Hai Pharmaceutical Co., Ltd. romanized18180
2Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized13130
3Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized1090
4Guangxi Lian He Sheng Sheng Pharma Co., Ltd. romanized660
5Haerbin Han Bang Medical Technology Co., Ltd. romanized510
6Jiangsu Pu Lai Pharmaceuticals Bio Technology Co., Ltd. romanized510
7Chengdu Brilliant Pharmaceutical Co., Ltd.421
8Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized420
9Excella GmbH & Co. KG410
10IBSA Institut Biochimique SA410

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

71 this week

AcceptedDrugApplicants
2022/11/14Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2201979 Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized
2022/11/14Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2201978 Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized
2022/11/14Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2201977 Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized
2022/11/14Generic · Class 3 Calcium Dobesilate TabletsCYHS2201974 Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized; Ningxia Kang Ya Pharma Co., Ltd. romanized
2022/11/14New drug · Class 1 SIM0270胶囊 · No verified English nameCXHL2200894 Xian Sheng Pharma Co., Ltd. romanized
2022/11/13Import · Class 2.2; 2.4 INOpulse · No verified English nameJXHL2200334 Bellerophon Pulse Technologies LLC; Baylor Biosciences Inc
2022/11/12Import · Class 1 Remternetug注射液(静脉注射) · No verified English nameJXSL2200200 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/11/12Import · Class 1 Remternetug注射液 · No verified English nameJXSL2200199 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/11/12Import · Class 1 注射用Oregovomab · No verified English nameJXSL2200198 OncoQuest Pharmaceuticals Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2022/11/12Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2201970 Shanghai Bao Long Bio Technology Co., Ltd. romanized; Shanghai Mei You Pharmaceutical Co., Ltd. romanized
2022/11/12Generic · Class 3 Ibuprofen InjectionCYHS2201969 Shandong Luo Xin Pharma Group Co., Ltd. romanized
2022/11/12Generic · Class 3 镥[177Lu]氧奥曲肽注射液 · No verified English nameCYHL2200102 Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/11/12New drug · Class 1 SM3321注射液 · No verified English nameCXSL2200572 Beijing Shuo Xing Biopharmaceuticals Technology Co., Ltd. romanized
2022/11/12New drug · Class 1 NMM肿瘤治疗性DNA疫苗裸质粒注射液 · No verified English nameCXSL2200571 Gu An Ding Tai Hai Gui Bio Technology Co., Ltd. romanized
2022/11/12New drug · Class 1 注射用IMM01 · No verified English nameCXSL2200570 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/11/12New drug · Class 1 莫非赛定利托那韦片 · No verified English nameCXHL2200893 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2022/11/12New drug · Class 1 注射用贺普拉肽 · No verified English nameCXHL2200892 Shanghai He Pu Pharma Co., Ltd. romanized
2022/11/12New drug · Class 2.2 HECB1701001缓释片 · No verified English nameCXHL2200891 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2022/11/12New drug · Class 2.2 HECB1701001缓释片 · No verified English nameCXHL2200890 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2022/11/11Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2201959 Hainan Si Da Pharmaceutical Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2022/11/11Generic · Class 3 钠钾镁钙葡萄糖注射液 · No verified English nameCYHS2201956 Yi Chang Ren Fu Pharma Co., Ltd. romanized; Yi Chang San Xia Pharmaceutical Co., Ltd. romanized
2022/11/11Generic · Class 3 Hydrocodone Bitartrate and Ibuprofen TabletsCYHS2201954 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/11/11Generic · Class 3 Hydrocodone Bitartrate and Ibuprofen TabletsCYHS2201953 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/11/11Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2201947 Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized
2022/11/11Generic · Class 3 盐酸非索非那定干混悬剂 · No verified English nameCYHS2201943 Ji Chuan Pharma Group Co., Ltd. romanized
2022/11/11Generic · Class 3 盐酸非索非那定干混悬剂 · No verified English nameCYHS2201942 Ji Chuan Pharma Group Co., Ltd. romanized
2022/11/11New drug · Class 1.1 风叶咳喘平口服液 · No verified English nameCXZS2200014 Zhuo He Pharma Group Co., Ltd. romanized; Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized
2022/11/11New drug · Class 1.1 止得咳颗粒 · No verified English nameCXZL2200049 Guangxi Zhong Pharmaceuticals University Fu Shu Rui Kang Hospital romanized; Guangxi Zhong Pharmaceuticals University romanized
2022/11/11New drug · Class 1 GC001溶瘤痘苗病毒注射液 · No verified English nameCXSL2200569 Hangzhou Gong Chu Bio Technology Co., Ltd. romanized
2022/11/10Generic · Class 3 Nicorandil for InjectionCYHS2201940 Ke Bei Yuan (Beijing) Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized

41 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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