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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 333 drug applications between 14 September 2023 and 20 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 50 drug names.

2023/09/14 – 2023/09/20

Period
2023/09/14 to 2023/09/20, 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
333
Drugs with new generic filings (by drug name, de-duplicated)
50
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

333filings, 63 of them generic

By application type

Application typeFilings
Supplement185
Generic63
New drug49
Import19
Import re-registration9
Unspecified8

By drug type

Drug typeFilings
Chemical drug229
TCM60
Therapeutic biologic38
Prophylactic biologic6

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

50 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sodium Valproate Sustained-release Tablets(I)224
2Diprophylline Injection227
3Calcium Folinate Injection224
4Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
5Tacrolimus Ointment216
6Celecoxib Tablets213
7Omeprazole and Sodium Bicarbonate Capsules210
8Vortioxetine Hydrobromide Tablets2110
9Sacubitril Valsartan Sodium Tablets2170
10Famotidine Injection218

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

195 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan Yue Ren Pharma Co., Ltd. romanized12120
2Henan Shuang He Hua Li Pharma Co., Ltd. romanized1230
3Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized970
4Boehringer Ingelheim International GmbH710
5Bard Pharmaceuticals Limited660
6Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized550
7Novartis Pharma Schweiz AG520
8Jiangsu Fei Sen You Si Pharmaceuticals Yong Pin Co., Ltd. romanized440
9AstraZeneca AB430
10Shanxi Huang He Zhong Yao Co., Ltd. romanized430

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

87 this week

AcceptedDrugApplicants
2023/09/20Generic · Class 3 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2302536 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/09/20Generic · Class 3 羧甲司坦糖浆 · No verified English nameCYHS2302535 Anhui Mao Kang Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized
2023/09/20Generic · Class 3 羧甲司坦糖浆 · No verified English nameCYHS2302534 Anhui Mao Kang Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized
2023/09/20Generic · Class 3 Acetylcysteine InjectionCYHS2302530 Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/09/20Generic · Class 3 硝唑尼特干混悬剂 · No verified English nameCYHL2300121 Rui Yang Pharmaceutical Co., Ltd. romanized
2023/09/20Generic · Class 3 Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHL2300120 Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized
2023/09/20New drug · Class 2.2 连花清咳颗粒 · No verified English nameCXZL2300062 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2023/09/20New drug · Class 1 注射用人脐带间充质干细胞 · No verified English nameCXSL2300637 Ai Er Pu Zai Sheng Yi Xue Technology (Shenzhen) Co., Ltd. romanized
2023/09/20New drug · Class 1 注射用RB0021 · No verified English nameCXSL2300636 Rui Yang (Suzhou) Bio Technology Co., Ltd. romanized
2023/09/20New drug · Class 1 GZR18片 · No verified English nameCXSL2300635 Gan Li Pharma Shandong Co., Ltd. romanized
2023/09/20New drug · Class 1 GZR18片 · No verified English nameCXSL2300634 Gan Li Pharma Shandong Co., Ltd. romanized
2023/09/20New drug · Class 1 GZR18片 · No verified English nameCXSL2300633 Gan Li Pharma Shandong Co., Ltd. romanized
2023/09/20New drug · Class 2.3 SMF-216 · No verified English nameCXHL2301021 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/09/20New drug · Class 1 BGB-26808片 · No verified English nameCXHL2301020 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/09/20New drug · Class 1 BGB-26808片 · No verified English nameCXHL2301019 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/09/20New drug · Class 1 BGB-26808片 · No verified English nameCXHL2301018 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/09/20New drug · Class 2.2 LN1000 · No verified English nameCXHL2301017 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2023/09/20New drug · Class 1 HZ-H08905片 · No verified English nameCXHL2301016 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized
2023/09/20New drug · Class 1 HZ-A-018胶囊 · No verified English nameCXHL2301015 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized
2023/09/20New drug · Class 1 HZ-A-018胶囊 · No verified English nameCXHL2301014 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized
2023/09/19Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300235 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/19Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300234 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/19Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300233 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/19Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300232 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/19Generic · Class 3 Diprophylline InjectionCYHS2302525 Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized
2023/09/19Generic · Class 3 水合氯醛灌肠剂 · No verified English nameCYHS2302523 Chengdu Shuo De Pharma Co., Ltd. romanized
2023/09/19Generic · Class 3 复方匹可硫酸钠颗粒 · No verified English nameCYHS2302522 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/09/19Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2302519 Sui Cheng Pharma Co., Ltd. romanized
2023/09/19Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2302518 Sui Cheng Pharma Co., Ltd. romanized
2023/09/19Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302510 Nanjing Yi Teng Drug Research Institute Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized

57 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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