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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 323 drug applications between 20 August 2024 and 26 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 64 drug names.

2024/08/20 – 2024/08/26

Period
2024/08/20 to 2024/08/26, 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
323
Drugs with new generic filings (by drug name, de-duplicated)
64
Accepted this week, now under review
2

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

323filings, 95 of them generic

By application type

Application typeFilings
Supplement148
Generic95
New drug38
Unspecified21
Import re-registration11
Import10

By drug type

Drug typeFilings
Chemical drug199
TCM73
Therapeutic biologic35
Biologic12
Prophylactic biologic4

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

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nicardipine Hydrochloride Injection5313
2Lactulose Oral Solution4234
3Oxacillin Sodium for Injection3213
4Ambroxol Hydrochloride Oral Solution3246
5Riociguat Tablets314
6Vonoprazan Fumarate Tablets2260
7Bisoprolol Fumarate and Amlodipine Besylate Tablets229
8Dapoxetine Hydrochloride Tablets2220
9Sodium Bicarbonate Injection2210
10Sodium Picosulfate Oral Solution210

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

206 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1010
2Janssen Research & Development LLC720
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
4Guangxi Chan Fang Pharma Co., Ltd. romanized440
5CISEN PHARMACEUTICAL CO., LTD.440
6Zhong Jing Wan Xi Pharmaceutical Co., Ltd. romanized430
7Anhui Pioneer Pharmaceutical Co., Ltd434
8Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized424
9Hubei Mei Lin Pharma Co., Ltd. romanized420
10Novo Nordisk Pharma AG410

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

84 this week

AcceptedDrugApplicants
2024/08/26Import · Class 2.2 司美格鲁肽注射液 · No verified English nameJXSS2400069 Novo Nordisk Pharma AG; Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2024/08/26Import · Class 2.2 司美格鲁肽注射液 · No verified English nameJXSS2400068 Novo Nordisk Pharma AG; Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2024/08/26Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2400156 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/26Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2400155 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/26Import · Class 2.4 Lazertinib片 · No verified English nameJXHL2400207 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/26New drug · Class 2.2 九价人乳头瘤病毒疫苗(大肠埃希菌) · No verified English nameCXSS2400089 Xiamen Wan Tai Cang Hai Bio Technology Co., Ltd. romanized
2024/08/26New drug · Class 2.2 九价人乳头瘤病毒疫苗(大肠埃希菌) · No verified English nameCXSS2400088 Xiamen Wan Tai Cang Hai Bio Technology Co., Ltd. romanized
2024/08/26New drug · Class 1 CA1001注射液 · No verified English nameCXSL2400563 Xi Xi Ou Ai (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2024/08/24Import · Class 1 Nivolumab/Relatlimab固定剂量复方注射液 · No verified English nameJXSL2400154 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2024/08/24Generic · Class 3 Oxacillin Sodium for InjectionCYHS2402775 Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized
2024/08/24New drug · Class 1 KYS202003A注射液 · No verified English nameCXSL2400562 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2024/08/24New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2400561 Beijing Bei Lai Pharma Co., Ltd. romanized
2024/08/24New drug · Class 2.4 苯环喹溴铵鼻喷雾剂 · No verified English nameCXHS2400083 Yin Gu Pharmaceutical Co., Ltd. romanized
2024/08/24New drug · Class 2.4 苯环喹溴铵鼻喷雾剂 · No verified English nameCXHS2400082 Yin Gu Pharmaceutical Co., Ltd. romanized
2024/08/24New drug · Class 1 HYP-6589片 · No verified English nameCXHL2400863 Name not romanized
2024/08/24New drug · Class 1 HYP-6589片 · No verified English nameCXHL2400862 Name not romanized
2024/08/24New drug · Class 2.2 醋酸地非法林片 · No verified English nameCXHL2400861 Chengdu Guo Wei Biopharmaceuticals Co., Ltd. romanized
2024/08/24New drug · Class 2.2 醋酸地非法林片 · No verified English nameCXHL2400860 Chengdu Guo Wei Biopharmaceuticals Co., Ltd. romanized
2024/08/24New drug · Class 2.2 醋酸地非法林片 · No verified English nameCXHL2400859 Chengdu Guo Wei Biopharmaceuticals Co., Ltd. romanized
2024/08/23Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2400153 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/23Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2400152 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/23Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2400151 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/23Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2400150 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/23Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2402759 Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2024/08/23Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2402756 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/08/23Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2402755 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/08/23Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2402754 Haerbin Kui Hua Pharma Co., Ltd. romanized; Kui Hua Pharma Group (Tang Shan) Biopharmaceutical Co., Ltd. romanized
2024/08/23Generic · Class 3 水合氯醛灌肠剂 · No verified English nameCYHS2402753 Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2024/08/23Generic · Class 3 Lidocaine Hydrochloride Ophthalmic GelCYHL2400175 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2024/08/23Generic · Class 3 Epinastine Hydrochloride Eye DropsCYHL2400174 Bai Shan Technology (Hu Zhou) Co., Ltd. romanized

54 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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