YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 302 drug applications between 10 August 2023 and 16 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 59 drug names.

2023/08/10 – 2023/08/16

Period
2023/08/10 to 2023/08/16, 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
302
Drugs with new generic filings (by drug name, de-duplicated)
59
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

302filings, 80 of them generic

By application type

Application typeFilings
Supplement145
Generic80
New drug44
Import re-registration18
Import11
Unspecified4

By drug type

Drug typeFilings
Chemical drug207
TCM59
Therapeutic biologic32
Prophylactic biologic3
Biologic1

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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Aminophylline Injection323
2Peramivir Injection227
3氧 · No verified English name2215
4Lactulose Oral Solution2134
5Tacrolimus Sustained-release Capsules216
6Piracetam Injection219
7Procaterol Hydrochloride Solution for Inhalation212
8复方电解质醋酸钠葡萄糖注射液 · No verified English name2122
9Brivaracetam Tablets2119
10昂丹司琼口溶膜 · No verified English name212

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

170 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1GE Healthcare AS1410
2Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized1381
3Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized990
4Shenyang Qing Gong Pharma Group Co., Ltd. romanized990
5Changsha Ai Bei Gao Pharma Co., Ltd. romanized660
6Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized430
7Jiangsu Vanguard Pharmaceutical Co., Ltd.434
8Shandong Xin Shi Dai Pharma Co., Ltd. romanized422
9Shijiazhuang No.4 Pharmaceutical Co., Ltd.421
10Wuxi Fu Qi 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

82 this week

AcceptedDrugApplicants
2023/08/16Import · Class 2.2 ASKC200搽剂 · No verified English nameJXHL2300185 Propella Therapeutics Inc.; Jiangsu Aosaikang Pharmaceutical Co. LTD
2023/08/16Import · Class 2.2 ASKC200搽剂 · No verified English nameJXHL2300184 Propella Therapeutics Inc.; Jiangsu Aosaikang Pharmaceutical Co. LTD
2023/08/16Import · Class 2.2 ASKC200搽剂 · No verified English nameJXHL2300183 Propella Therapeutics Inc.; Jiangsu Aosaikang Pharmaceutical Co. LTD
2023/08/16Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2302156 Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized
2023/08/16Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2302151 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/08/16Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2302150 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/08/16Generic · Class 3 阿奇霉素颗粒 · No verified English nameCYHS2302149 Jiangxi Yi You Pharma Co., Ltd. romanized
2023/08/16New drug · Class 1 人脐带间充质干细胞(异体)注射液 · No verified English nameCXSL2300547 Zhejiang Jin Shi Dai Bio Technology Co., Ltd. romanized
2023/08/16New drug · Class 1 ES004注射液 · No verified English nameCXSL2300546 Ke Wang (Suzhou) Biopharmaceuticals Technology Co., Ltd. romanized
2023/08/16New drug · Class 1 MAX-10181片 · No verified English nameCXHL2300883 Guangzhou Zai Ji Pharmaceuticals Technology Co., Ltd. romanized
2023/08/16New drug · Class 1 MAX-10181片 · No verified English nameCXHL2300882 Guangzhou Zai Ji Pharmaceuticals Technology Co., Ltd. romanized
2023/08/16New drug · Class 1 MAX-10181片 · No verified English nameCXHL2300881 Guangzhou Zai Ji Pharmaceuticals Technology Co., Ltd. romanized
2023/08/16New drug · Class 1 ARTS-021片 · No verified English nameCXHL2300880 An Rui Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2023/08/16New drug · Class 1 ARTS-021片 · No verified English nameCXHL2300879 An Rui Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2023/08/16New drug · Class 1 CS32582胶囊 · No verified English nameCXHL2300878 Chengdu Wei Xin Pharma Co., Ltd. romanized
2023/08/16New drug · Class 1 CS32582胶囊 · No verified English nameCXHL2300877 Chengdu Wei Xin Pharma Co., Ltd. romanized
2023/08/15Import · Class 2.2 注射用tisotumab vedotin · No verified English nameJXSL2300151 Seagen Inc.; Zai Lab (Shanghai) CO. Ltd
2023/08/15Import · Class 1 MEDI3506注射液 · No verified English nameJXSL2300150 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/08/15Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2302133 Liao Cheng Gao Xin Bio Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2023/08/15Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2302132 Liao Cheng Gao Xin Bio Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2023/08/15Generic · Class 3 头孢克肟颗粒 · No verified English nameCYHS2302131 Chongqing Ji Si Rui Pharmaceutical Co., Ltd. romanized; Sichuan He Xin Pharma Co., Ltd. romanized
2023/08/15Generic · Class 3 Aminophylline InjectionCYHS2302129 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/08/15Generic · Class 3 Potassium Phosphates InjectionCYHS2302126 Hubei Ke Lun Pharma Co., Ltd. romanized
2023/08/15Generic · Class 3 Acetylcysteine InjectionCYHS2302124 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2023/08/15Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302123 Hai Men Pu Shi Pharmaceuticals Co., Ltd. romanized
2023/08/15Generic · Class 3 Peramivir InjectionCYHS2302122 Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2023/08/15Generic · Class 3 Nitroglycerin InjectionCYHS2302118 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2023/08/15Generic · Class 3 Nitroglycerin InjectionCYHS2302117 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2023/08/15Generic · Class 3 Sodium Bicarbonate InjectionCYHS2302115 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/08/15Generic · Class 3 Famotidine InjectionCYHS2302113 Suzhou Hai Jing Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Shen Long Pharma Co., Ltd. romanized

52 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.