YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 350 drug applications between 13 September 2023 and 19 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 52 drug names.

2023/09/13 – 2023/09/19

Period
2023/09/13 to 2023/09/19, 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
350
Drugs with new generic filings (by drug name, de-duplicated)
52
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

350filings, 70 of them generic

By application type

Application typeFilings
Supplement190
Generic70
New drug51
Import16
Unspecified13
Import re-registration10

By drug type

Drug typeFilings
Chemical drug244
TCM61
Therapeutic biologic37
Prophylactic biologic8

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

52 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
6利伐沙班颗粒 · No verified English name212
7Celecoxib Tablets213
8Omeprazole and Sodium Bicarbonate Capsules210
9Pregabalin Oral Solution215
10Vortioxetine Hydrobromide Tablets2110

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

202 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan Yue Ren Pharma Co., Ltd. romanized12120
2Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized1290
3Henan Shuang He Hua Li Pharma Co., Ltd. romanized1230
4Bard Pharmaceuticals Limited880
5Boehringer Ingelheim International GmbH710
6Xian Jing Xi Shuang He Pharma Co., Ltd. romanized610
7Guangxi Shi Wan Shan Pharmaceutical Co., Ltd. romanized550
8Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized550
9Novartis Pharma Schweiz AG520
10Jiangsu Fei Sen You Si Pharmaceuticals Yong Pin Co., Ltd. romanized440

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

95 this week

AcceptedDrugApplicants
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
2023/09/19Generic · Class 3 Pentoxifylline InjectionCYHS2302509 Da Yi Pharma (Hubei) Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized
2023/09/19Generic · Class 3 Celecoxib TabletsCYHS2302505 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/09/19Generic · Class 3 Celecoxib TabletsCYHS2302504 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/09/19Generic · Class 3 Diprophylline InjectionCYHS2302503 Xizang Nuo Ze Biopharmaceuticals Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/09/19Generic · Class 3 Methylnaltrexone Bromide TabletsCYHL2300119 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2023/09/19New drug · Class 1 注射用AP026 · No verified English nameCXSL2300632 An Yuan Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/09/19New drug · Class 3.2 UNODC0407注射液 · No verified English nameCXSL2300631 Guangdong You Nuo Biopharmaceuticals Technology Co., Ltd. romanized
2023/09/19New drug · Class 1 人脂肪间充质干细胞注射液 · No verified English nameCXSL2300630 Beijing Ai Ge Gan Xi Bao Technology Co., Ltd. romanized
2023/09/19New drug · Class 1 CM313(SC)注射液 · No verified English nameCXSL2300629 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2023/09/19New drug · Class 1 JMKX003948片 · No verified English nameCXHL2301013 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/09/19New drug · Class 1 JMKX003948片 · No verified English nameCXHL2301012 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/09/19New drug · Class 1 JMKX003948片 · No verified English nameCXHL2301011 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/09/19New drug · Class 2.2 氢溴酸右美沙芬硫酸奎尼丁口崩片 · No verified English nameCXHL2301010 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized
2023/09/18Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300231 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/18Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300230 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/18Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300229 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/18Import · Class 1 LOXO-435片 · No verified English nameJXHL2300228 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/09/18Import · Class 1 LOXO-435片 · No verified English nameJXHL2300227 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/09/17New drug · Class 1 艾帕洛利单抗注射液 · No verified English nameCXSS2300077 Qilu Pharmaceutical Co., Ltd.
2023/09/16Import · Class 2.4 米罗那非片 · No verified English nameJXHL2300226 AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd.

65 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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