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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 270 drug applications between 3 May 2023 and 9 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 40 drug names.

2023/05/03 – 2023/05/09

Period
2023/05/03 to 2023/05/09, 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
270
Drugs with new generic filings (by drug name, de-duplicated)
40
Accepted this week, now under review
2

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

270filings, 53 of them generic

By application type

Application typeFilings
Supplement122
New drug71
Generic53
Import11
Import re-registration10
Unspecified3

By drug type

Drug typeFilings
Chemical drug182
Therapeutic biologic50
TCM37
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
1Dasatinib Tablets414
2Arginine and Ibuprofen Granules3111
3Roxatidine Acetate Hydrochloride For Injection225
4Minoxidil Liniment2252
5Crisaborole Ointment2126
6Nimodipine Oral Solution214
7Fluorouracil Injection216
8Nicorandil for Injection211
9硝酸甘油葡萄糖注射液 · No verified English name210
10Amikacin Sulfate injection214

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

151 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized14130
2Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized1210
3Novo Nordisk A/S820
4Shaanxi Qing Hua Zi Guang Bio Technology Co., Ltd. romanized660
5Sichuan He Li Xin Jian Pharma Co., Ltd. romanized440
6Xian Li Jun Pharmaceutical Co., Ltd. romanized440
7Qilu Pharmaceutical Co., Ltd.432
8McNeil Sweden AB410
9Ha Yao Group Pharmaceutical Factory romanized410
10Jin Zhou Ao Hong Pharma 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

103 this week

AcceptedDrugApplicants
2023/05/09Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2301255 Hefei Hao Yi Pharmaceuticals Technology Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2023/05/09Generic · Class 3 Nimodipine Oral SolutionCYHS2301254 Yunnan Xian Shi Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/05/09Generic · Class 3 Nimodipine Oral SolutionCYHS2301253 Yunnan Xian Shi Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/05/09Generic · Class 3 Minoxidil LinimentCYHS2301247 Changzhou Si Yao Pharmaceutical Co., Ltd. romanized
2023/05/09Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2301242 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2023/05/09New drug · Class 3.3 注射用重组人促卵泡激素 · No verified English nameCXSS2300033 Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized; Ao Si Kang Bio (Nan Tong) Co., Ltd. romanized
2023/05/09New drug · Class 3.4 聚乙二醇化重组人粒细胞刺激因子注射液 · No verified English nameCXSS2300032 Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2023/05/09New drug · Class 3.4 聚乙二醇化重组人粒细胞刺激因子注射液 · No verified English nameCXSS2300031 Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2023/05/09New drug · Class 3.4 聚乙二醇化重组人粒细胞刺激因子注射液 · No verified English nameCXSS2300030 Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2023/05/09New drug · Class 1 注射用MCLA-129 · No verified English nameCXSL2300322 Bei Da Pharma Co., Ltd. romanized
2023/05/09New drug · Class 1 注射用SHR-A2009 · No verified English nameCXSL2300321 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/05/09New drug · Class 1 STSA-1201 皮下注射液 · No verified English nameCXSL2300320 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized
2023/05/09New drug · Class 1 甲磺酸贝福替尼胶囊 · No verified English nameCXHL2300495 Bei Da Pharma Co., Ltd. romanized
2023/05/09New drug · Class 1 甲磺酸贝福替尼胶囊 · No verified English nameCXHL2300494 Bei Da Pharma Co., Ltd. romanized
2023/05/09New drug · Class 1 QJ-19-0002片 · No verified English nameCXHL2300493 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2023/05/09New drug · Class 1 QJ-19-0002片 · No verified English nameCXHL2300492 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2023/05/09New drug · Class 1 QJ-19-0002片 · No verified English nameCXHL2300491 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2023/05/09New drug · Class 1 PG-018片 · No verified English nameCXHL2300489 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2023/05/09New drug · Class 1 IPG11406片 · No verified English nameCXHL2300488 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/09New drug · Class 1 IPG11406片 · No verified English nameCXHL2300487 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/09New drug · Class 1 PG-018片 · No verified English nameCXHL2300486 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2023/05/09New drug · Class 1 IPG11406片 · No verified English nameCXHL2300485 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/09New drug · Class 1 IPG11406片 · No verified English nameCXHL2300484 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/09New drug · Class 1 IPG11406片 · No verified English nameCXHL2300483 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/09New drug · Class 1 HZ012注射液 · No verified English nameCXHL2300482 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized
2023/05/09New drug · Class 1 IPG11406片 · No verified English nameCXHL2300481 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/09New drug · Class 1 IPG11406片 · No verified English nameCXHL2300480 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/09New drug · Class 1 IPG11406片 · No verified English nameCXHL2300479 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/09New drug · Class 1 IPG11406片 · No verified English nameCXHL2300478 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/09New drug · Class 1 IPG11406片 · No verified English nameCXHL2300477 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized

73 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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