YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 368 drug applications between 2 February 2023 and 8 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 121, covering 85 drug names.

2023/02/02 – 2023/02/08

Period
2023/02/02 to 2023/02/08, 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
368
Drugs with new generic filings (by drug name, de-duplicated)
85
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

368filings, 121 of them generic

By application type

Application typeFilings
Supplement160
Generic121
New drug59
Import14
Unspecified9
Import re-registration5

By drug type

Drug typeFilings
Chemical drug280
Therapeutic biologic47
TCM40
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

85 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution5223
2Lactulose Oral Solution4234
3Phenylephrine Hydrochloride Injection425
4Calcium Levofolinate Injection410
5Oxaliplatin Injection324
6Peramivir Injection327
7Amoxicillin Sodium for Injection310
8Indobufen Tablets226
9Potassium Chloride Granules224
10Mecobalamin Tablets2216

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

232 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Yunnan Shen Wei Shi Pu Rui Pharma Co., Ltd. romanized15150
2Anhui Pioneer Pharmaceutical Co., Ltd830
3Ping Guang Pharmaceutical Co., Ltd. romanized760
4Tianjin Bai Te Medical Yong Pin Co., Ltd. romanized666
5Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized510
6Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized440
7Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized422
8Astellas Pharma Europe B.V.410
9Patheon Inc.410
10Roche Pharma(Schweiz)AG410

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

127 this week

AcceptedDrugApplicants
2023/02/08Import · Class 1 Nipocalimab注射液 · No verified English nameJXSL2300034 Janssen Research &Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/02/08Import · Class 1 注射用Abelacimab · No verified English nameJXSL2300033 Anthos Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2023/02/08Generic · Class 3 Potassium Chloride GranulesCYHS2300403 Guangdong Jiu Ming Pharmaceutical Co., Ltd. romanized
2023/02/08Generic · Class 3 Levofloxacin InjectionCYHS2300402 Hebei Tian Cheng Pharma Co., Ltd. romanized
2023/02/08Generic · Class 3 Levofloxacin InjectionCYHS2300401 Hebei Tian Cheng Pharma Co., Ltd. romanized
2023/02/08Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2300395 Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized; Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized
2023/02/08Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2300394 Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized; Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized
2023/02/08Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2300393 Changzhou Si Yao Pharmaceutical Co., Ltd. romanized
2023/02/08Generic · Class 3 Oxaliplatin InjectionCYHS2300391 Jian Jin Pharmaceutical Co., Ltd. romanized
2023/02/08Generic · Class 3 Oxaliplatin InjectionCYHS2300390 Jian Jin Pharmaceutical Co., Ltd. romanized
2023/02/08Generic · Class 3 Potassium Chloride GranulesCYHS2300386 Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2023/02/08Generic · Class 3 溴吡斯的明缓释片 · No verified English nameCYHL2300017 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized
2023/02/08New drug · Class 2.2 瑞基奥仑赛注射液 · No verified English nameCXSL2300097 Shanghai Yao Ming Ju Nuo Bio Technology Co., Ltd. romanized
2023/02/08New drug · Class 1 阿得贝利单抗注射液 · No verified English nameCXSL2300096 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/02/08New drug · Class 1 注射用XNW27011 · No verified English nameCXSL2300095 Shanghai Xin Nuo Wei Biopharmaceuticals Co., Ltd. romanized
2023/02/08New drug · Class 1 SYS6010 · No verified English nameCXSL2300094 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2023/02/08New drug · Class 1 KD6005注射液 · No verified English nameCXSL2300093 Shanghai Kang Dai Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Sai Jin Biopharmaceuticals Co., Ltd. romanized
2023/02/08New drug · Class 3.3 德谷胰岛素利拉鲁肽注射液 · No verified English nameCXSL2300092 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized
2023/02/08New drug · Class 1 PB-718注射液 · No verified English nameCXHL2300181 Pai Ge Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2023/02/08New drug · Class 1 AL2846胶囊 · No verified English nameCXHL2300180 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/02/08New drug · Class 2.2 布立西坦缓释片 · No verified English nameCXHL2300179 Jiangsu Ai Li Kang Pharmaceuticals Technology Co., Ltd. romanized
2023/02/08New drug · Class 2.2 布立西坦缓释片 · No verified English nameCXHL2300178 Jiangsu Ai Li Kang Pharmaceuticals Technology Co., Ltd. romanized
2023/02/07Import · Class 2.2 索安非托片 · No verified English nameJXHL2300020 Axsome Malta Ltd.; Ignis Therapeutics (Suzhou) Limited
2023/02/07Generic · Class 3 Trimebutine Maleate TabletsCYHS2300384 Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized
2023/02/07Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300383 Zhejiang Kang Run Pharmaceutical Co., Ltd. romanized
2023/02/07Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300382 Zhejiang Kang Run Pharmaceutical Co., Ltd. romanized
2023/02/07Generic · Class 3 Potassium Aspartate InjectionCYHS2300373 Jilin Si Zhang Pharmaceutical Co., Ltd. romanized
2023/02/07Generic · Class 3 Methocarbamol InjectionCYHS2300368 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/02/07Generic · Class 3 Penicillin G Sodium For InjectionCYHS2300364 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2023/02/07New drug · Class 3.3 托珠单抗注射液 · No verified English nameCXSS2300005 Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized

97 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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