YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 421 drug applications between 17 August 2023 and 23 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 103, covering 72 drug names.

2023/08/17 – 2023/08/23

Period
2023/08/17 to 2023/08/23, 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
421
Drugs with new generic filings (by drug name, de-duplicated)
72
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

421filings, 103 of them generic

By application type

Application typeFilings
Supplement225
Generic103
New drug45
Import29
Unspecified12
Import re-registration7

By drug type

Drug typeFilings
Chemical drug285
TCM85
Therapeutic biologic39
Biologic6
Prophylactic biologic5
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

72 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nicorandil for Injection421
2Gadoteridol Injection413
3Potassium Chloride Injection3310
4Iopromide Injection3227
5恩那度司他片 · No verified English name310
6Tadalafil Tablets2223
7Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral Solution222
8Famotidine Injection228
9Lornoxicam for Injection222
10Bortezomib For Injection221

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

247 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized33320
2Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized11110
3Changsha Ai Bei Gao Pharma Co., Ltd. romanized11110
4Janssen Research & Development LLC730
5Guangdong Da Zhong Pharmaceutical Co., Ltd. romanized530
6Hainan Brilliant Pharmaceutical Co., Ltd.531
7Myokardia Inc.510
8Eli Lilly and Company410
9Shandong Er Ye Pharmaceutical Co., Ltd. romanized410
10Hainan Guang Sheng Yu 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

124 this week

AcceptedDrugApplicants
2023/08/23Import · Class 1 JNJ-77242113-AAC片 · No verified English nameJXHL2300196 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/08/23Generic · Class 3 Famotidine InjectionCYHS2302251 Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2023/08/23Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2302250 Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/08/23Generic · Class 3 Sodium Bicarbonate InjectionCYHS2302249 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/08/23Generic · Class 3 Nicorandil for InjectionCYHS2302248 Chongqing Lai Mei Pharma Co., Ltd. romanized
2023/08/23Generic · Class 3 Nicorandil for InjectionCYHS2302247 Chongqing Lai Mei Pharma Co., Ltd. romanized
2023/08/23Generic · Class 3 Atenolol TabletsCYHS2302246 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2023/08/23Generic · Class 3 Atenolol TabletsCYHS2302245 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2023/08/23Generic · Class 3 Magnesium Sulfate InjectionCYHS2302240 Fujian Tian Quan Pharma Co., Ltd. romanized
2023/08/23Generic · Class 3 Magnesium Sulfate InjectionCYHS2302238 Fujian Tian Quan Pharma Co., Ltd. romanized
2023/08/23Generic · Class 3 Scopolamine Butylbromide InjectionCYHS2302236 Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/08/23Generic · Class 3 Potassium Chloride InjectionCYHS2302235 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/08/23Generic · Class 3 维A酸外用乳 · No verified English nameCYHL2300105 Chongqing Huapont Pharmaceutical Co., Ltd.
2023/08/23New drug · Class 1 依若奇单抗注射液 · No verified English nameCXSS2300069 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized; Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized
2023/08/23New drug · Class 3.4 注射用替奈普酶 · No verified English nameCXSS2300068 Shi Mao Tian Jie Pharmaceutical (Jiangsu) Co., Ltd. romanized
2023/08/23New drug · Class 1 SYS6011 · No verified English nameCXSL2300563 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2023/08/23New drug · Class 1 NCR300注射液 · No verified English nameCXSL2300562 Anhui Zhong Sheng Su Yuan Bio Technology Co., Ltd. romanized
2023/08/23New drug · Class 2.4 氟唑帕利胶囊 · No verified English nameCXHS2300070 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/08/23New drug · Class 1 HRS-8080片 · No verified English nameCXHL2300906 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/08/23New drug · Class 1 HRS-8080片 · No verified English nameCXHL2300905 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
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

94 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.