YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 309 drug applications between 21 August 2024 and 27 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 62 drug names.

2024/08/21 – 2024/08/27

Period
2024/08/21 to 2024/08/27, 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
309
Drugs with new generic filings (by drug name, de-duplicated)
62
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

309filings, 85 of them generic

By application type

Application typeFilings
Supplement138
Generic85
New drug40
Unspecified22
Import13
Import re-registration11

By drug type

Drug typeFilings
Chemical drug188
TCM70
Therapeutic biologic36
Biologic11
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

62 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nicardipine Hydrochloride Injection5313
2Lactulose Oral Solution4234
3Ambroxol Hydrochloride Oral Solution3246
4Riociguat Tablets314
5Vonoprazan Fumarate Tablets2260
6Dapoxetine Hydrochloride Tablets2220
7Sodium Picosulfate Oral Solution210
8Brexpiprazole Tablets2131
9Bumetanide Injection2113
10Empagliflozin Tablets2118

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

194 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1010
2Janssen Research & Development LLC720
3Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized610
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
5Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized440
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

83 this week

AcceptedDrugApplicants
2024/08/27Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2402789 Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized
2024/08/27Generic · Class 3 Azilsartan and Amlodipine TabletsCYHS2402787 Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized; Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized
2024/08/27Generic · Class 3 Bumetanide InjectionCYHS2402785 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2024/08/27Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2402784 Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized
2024/08/27Generic · Class 3 Bumetanide InjectionCYHS2402783 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2024/08/27Generic · Class 3 Salbutamol Sulfate injectionCYHS2402782 Henan Pu Rui Pharma Co., Ltd. romanized
2024/08/27Generic · Class 3 Metronidazole TabletsCYHS2402779 Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2024/08/27Generic · Class 3 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2400176 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2024/08/27New drug · Class 3.1 桃核承气颗粒 · No verified English nameCXZS2400028 Guangdong Yi Fang Pharmaceutical Co., Ltd. romanized
2024/08/27New drug · Class 1 ZT006片 · No verified English nameCXSL2400569 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/27New drug · Class 1 ZT006片 · No verified English nameCXSL2400568 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/27New drug · Class 1 ZT006片 · No verified English nameCXSL2400567 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/27New drug · Class 1 ZT006片 · No verified English nameCXSL2400566 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/27New drug · Class 1 ZT006片 · No verified English nameCXSL2400565 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/27New drug · Class 1 ZT006片 · No verified English nameCXSL2400564 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/27New drug · Class 2.4 注射用艾博韦泰 · No verified English nameCXHL2400865 Qian Yan Bio Pharma (Nanjing) Co., Ltd. romanized
2024/08/27New drug · Class 1 注射用AC02 · No verified English nameCXHL2400864 Nanjing Han Xin Pharmaceuticals Technology Co., Ltd. romanized
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

53 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.