YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 393 drug applications between 16 August 2023 and 22 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 105, covering 76 drug names.

2023/08/16 – 2023/08/22

Period
2023/08/16 to 2023/08/22, 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
393
Drugs with new generic filings (by drug name, de-duplicated)
76
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

393filings, 105 of them generic

By application type

Application typeFilings
Supplement196
Generic105
New drug47
Import33
Unspecified7
Import re-registration5

By drug type

Drug typeFilings
Chemical drug291
TCM53
Therapeutic biologic39
Prophylactic biologic6
Biologic3
In vitro diagnostic reagent1

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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Gadoteridol Injection413
2Urapidil Hydrochloride Injection326
3Iopromide Injection3227
4恩那度司他片 · No verified English name310
5Tadalafil Tablets2223
6Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral Solution222
7Potassium Chloride Injection2210
8Lornoxicam for Injection222
9Bortezomib For Injection221
10Labetalol Hydrochloride Injection224

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

237 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized24191
2Changsha Ai Bei Gao Pharma Co., Ltd. romanized11110
3Janssen Research & Development LLC630
4Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized550
5Guangdong Da Zhong Pharmaceutical Co., Ltd. romanized530
6Hainan Brilliant Pharmaceutical Co., Ltd.531
7Myokardia Inc.510
8Zhejiang AngLiKang Pharmaceutical CO.,LTD.422
9Eli Lilly and Company410
10Shandong Er Ye Pharmaceutical 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

120 this week

AcceptedDrugApplicants
2023/08/22Import · Class 1 BI685509片 · No verified English nameJXHL2300195 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/08/22Import · Class 1 BI685509片 · No verified English nameJXHL2300194 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/08/22Import · Class 1 BI685509片 · No verified English nameJXHL2300193 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/08/22Import · Class 1 JNJ-77242113-AAC片 · No verified English nameJXHL2300192 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/08/22Import · Class 1 JNJ-77242113-AAC片 · No verified English nameJXHL2300191 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/08/22Generic · Class 3 Epalrestat TabletsCYHS2302233 Le Pu Pharmaceutical Technology Co., Ltd. romanized
2023/08/22Generic · Class 3 复方奥美拉唑干混悬剂 · No verified English nameCYHS2302230 Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2023/08/22Generic · Class 3 复方奥美拉唑干混悬剂 · No verified English nameCYHS2302229 Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2023/08/22Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2302228 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2023/08/22Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2302227 Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/08/22Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2302225 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized; Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized
2023/08/22Generic · Class 3 Fudosteine oral solutionCYHS2302224 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/08/22Generic · Class 3 Sodium Thiosulfate InjectionCYHS2302223 Chengdu Brilliant Pharmaceutical Co., Ltd.
2023/08/22Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2302220 Wuhan Jiu An Pharma Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized
2023/08/22Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2302217 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2023/08/22Generic · Class 3 Famotidine InjectionCYHS2302215 Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized
2023/08/22Generic · Class 3 Ketotifen Fumarate Oral SolutionCYHS2302211 Haikou Tian Xing Jian Drug Research Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2023/08/22Generic · Class 3 Nimodipine Oral SolutionCYHS2302210 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2023/08/22Generic · Class 3 Potassium Chloride InjectionCYHS2302209 Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Hubei Ke Lun Pharma Co., Ltd. romanized
2023/08/22Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2302207 Hubei Jin Yao Pharma Co., Ltd. romanized
2023/08/22Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2302206 Hubei Jin Yao Pharma Co., Ltd. romanized
2023/08/22Generic · Class 3 Levetiracetam in Sodium Chloride InjectionCYHS2302205 Guizhou Fu Kang Ren Pharmaceutical Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2023/08/22Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2302204 Wuhan Fu Xing Bio Pharma Co., Ltd. romanized
2023/08/22Generic · Class 3 Methylprednisolone Aceponate CreamCYHL2300104 Guangdong Hua Run Shun Feng Pharma Co., Ltd. romanized
2023/08/22New drug · Class 3.3 利拉鲁肽注射液 · No verified English nameCXSS2300067 Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized
2023/08/22New drug · Class 1 异体内皮祖细胞(EPCs)注射液 · No verified English nameCXSL2300561 Cheng Nuo Zai Sheng Yi Xue Technology (Beijing) Co., Ltd. romanized
2023/08/22New drug · Class 1 注射用DR10624 · No verified English nameCXSL2300560 Zhejiang Dao Er Bio Technology Co., Ltd. romanized
2023/08/22New drug · Class 1 注射用DR10624 · No verified English nameCXSL2300559 Zhejiang Dao Er Bio Technology Co., Ltd. romanized
2023/08/22New drug · Class 1 ANS014004片 · No verified English nameCXHL2300904 Beijing An Shi Bio Technology Co., Ltd. romanized
2023/08/22New drug · Class 1 ANS014004片 · No verified English nameCXHL2300903 Beijing An Shi Bio Technology Co., Ltd. romanized

90 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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