YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 237 drug applications between 29 November 2021 and 5 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 34 drug names.

2021/11/29 – 2021/12/05

Period
2021/11/29 to 2021/12/05, 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
237
Drugs with new generic filings (by drug name, de-duplicated)
34
Accepted this week, now under review
1

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

237filings, 48 of them generic

By application type

Application typeFilings
Supplement125
Generic48
New drug31
Import17
Unspecified9
Import re-registration7

By drug type

Drug typeFilings
Chemical drug152
TCM55
Therapeutic biologic27
Biologic3

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

34 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Esomeprazole Magnesium for Delayed-release Oral Suspension324
2Rabeprazole Sodium Enteric-coated Tablets320
3Lactulose Oral Solution3134
4Citicoline Sodium Injection313
5Perindopril tert-Butylamine Tablets215
6Pregabalin Capsules2112
7Cefminox Sodium for Injection210
8Parecoxib Sodium for Injection212
9Palonosetron Hydrochloride Injection211
10Sitagliptin Phosphate 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

130 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Wuhan Ai Min Pharmaceutical Co., Ltd. romanized21170
2Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized14130
3Shijiazhuang Yu He Tang Pharma Co., Ltd. romanized880
4Hua Run Shuang He Pharma Co., Ltd. romanized740
5Novartis Pharma AG530
6Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized530
7Jiangsu En Hua Pharma Co., Ltd. romanized530
8Roche Pharma (Schweiz) AG410
9Shandong Xin Shi Dai Pharma Co., Ltd. romanized332
10Lilly France320

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

60 this week

AcceptedDrugApplicants
2021/12/03Import · Class 1 OMS721注射液 · No verified English nameJXSL2101144 Omeros Corporation; George (Beijing) Clinical Research Co. Ltd.
2021/12/03Generic · Class 3 Milnacipran Hydrochloride TabletsCYHS2102131 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2021/12/03New drug · Class 1 JS009注射液 · No verified English nameCXSL2101462 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/12/03New drug · Class 1 MSB0254注射液 · No verified English nameCXSL2101449 Mai Bo Si Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2021/12/03New drug · Class 1 MSB2311注射液 · No verified English nameCXSL2101448 Mai Bo Si Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2021/12/03New drug · Class 1 ASKC202片 · No verified English nameCXHL2101712 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2021/12/03New drug · Class 1 ASKC202片 · No verified English nameCXHL2101711 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2021/12/03New drug · Class 1 HY010101胶囊 · No verified English nameCXHL2101709 Beijing Yuan Ji Hua Yi Bio Technology Co., Ltd. romanized
2021/12/03New drug · Class 1 HY010101胶囊 · No verified English nameCXHL2101708 Beijing Yuan Ji Hua Yi Bio Technology Co., Ltd. romanized
2021/12/03New drug · Class 1 HY010101胶囊 · No verified English nameCXHL2101707 Beijing Yuan Ji Hua Yi Bio Technology Co., Ltd. romanized
2021/12/03New drug · Class 1 TLL-018片 · No verified English nameCXHL2101706 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2021/12/02Import · Class 2.2 注射用维博妥珠单抗(拟定) · No verified English nameJXSS2101035 Roche Pharma (Schweiz)AG; F. Hoffmann-La Roche AG
2021/12/02Import · Class 2.2 注射用维博妥珠单抗(拟定) · No verified English nameJXSS2101034 Roche Pharma (Schweiz)AG; BSP Pharmaceuticals S.p.A.
2021/12/02Import · Class 3.3 特立帕肽注射液 · No verified English nameJXSL2101143 Alvogen Inc.; Beijing Kangchen Biological Technology Co. Ltd.
2021/12/02Import · Class 1 QGE031注射液 · No verified English nameJXSL2101141 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2021/12/02Generic · Class 3 Carbocisteine Oral SolutionCYHS2102126 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2021/12/02Generic · Class 3 Flurbiprofen Axetil InjectionCYHL2101046 Shandong Wei Gao Pharma Co., Ltd. romanized
2021/12/02Generic · Class 3 Daunorubicin and Cytarabine liposome For InjectionCYHL2101045 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2021/12/02Generic · Class 3 Minodronic acid TabletsCYHL2101044 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2021/12/02Generic · Class 3 Esketamine Hydrochloride InjectionCYHL2101043 Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2021/12/02New drug · Class 2.2 小儿盐酸小檗碱无水吞服颗粒 · No verified English nameCXHL2101705 Kunming Bang Yu Pharmaceutical Co., Ltd. romanized
2021/12/02New drug · Class 2.2 小儿盐酸小檗碱无水吞服颗粒 · No verified English nameCXHL2101704 Kunming Bang Yu Pharmaceutical Co., Ltd. romanized
2021/12/02New drug · Class 1 IMP4297胶囊 · No verified English nameCXHL2101703 Shanghai Jun Pai Ying Shi Pharma Co., Ltd. romanized
2021/12/01Import · Class 1 注射用Zolbetuximab · No verified English nameJXSL2101142 Astellas Pharma Global Development Inc.; Astellas Pharma China Inc.
2021/12/01Import · Class 1 LOU064片 · No verified English nameJXHL2101264 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co.,Ltd.
2021/12/01Import · Class 1 LOU064片 · No verified English nameJXHL2101263 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co.,Ltd.
2021/12/01Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2102122 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized
2021/12/01Generic · Class 3 Lidocaine Hydrochloride GelCYHS2102117 Beijing Ming Ze Zhong He Drug Research Co., Ltd. romanized; Tong Fang Pharma Group Co., Ltd. romanized
2021/12/01Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2102111 Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2021/12/01New drug · Class 1 注射用重组抗PD1/TIM3人源化双特异抗体 · No verified English nameCXSL2101458 Shanghai Jian Xin Biopharmaceuticals Technology Co., Ltd. romanized

30 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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