YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 507 drug applications between 6 May 2023 and 12 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 68 drug names.

2023/05/06 – 2023/05/12

Period
2023/05/06 to 2023/05/12, 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
507
Drugs with new generic filings (by drug name, de-duplicated)
68
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

507filings, 93 of them generic

By application type

Application typeFilings
Supplement273
Generic93
New drug87
Import31
Import re-registration12
Unspecified11

By drug type

Drug typeFilings
Chemical drug335
TCM110
Therapeutic biologic61
Prophylactic 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

68 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1硝普钠氯化钠注射液 · No verified English name413
2Dasatinib Tablets414
3Levofloxacin Eye Drops3316
4吸入用七氟烷 · No verified English name310
5Arginine and Ibuprofen Granules3111
6Famotidine Injection228
7Minoxidil Liniment2252
8Crisaborole Ointment2126
9Carbazochrome Sodium Sulfonate Injection211
10Ipratropium Bromide Inhalation Solution212

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

234 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1An Yang Guang Sheng Heng Pharmaceutical Co., Ltd. romanized62500
2Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized28230
3Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized15140
4Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized1210
5Novo Nordisk A/S820
6Bard Pharmaceuticals Limited730
7Qilu Pharmaceutical (Hainan) Co., Ltd624
8AbbVie Limited610
9Eli Lilly and Company610
10Changsha Ai Bei Gao Pharma Co., Ltd. romanized550

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

145 this week

AcceptedDrugApplicants
2023/05/12Import · Class 3.1 Nirsevimab注射液 · No verified English nameJXSS2300038 AstraZeneca AB; Patheon Manufacturing Services LLC; Name not romanized
2023/05/12Import · Class 3.1 Nirsevimab注射液 · No verified English nameJXSS2300037 AstraZeneca AB; Patheon Manufacturing Services LLC; Name not romanized
2023/05/12Import · Class 2.2 Anifrolumab注射液 · No verified English nameJXSL2300092 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2023/05/12Generic · Class 3 Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2301300 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu He Chen Pharma Co., Ltd. romanized
2023/05/12Generic · Class 3 Formoterol Fumarate Inhalation SolutionCYHS2301297 Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/05/12Generic · Class 3 硝普钠氯化钠注射液 · No verified English nameCYHS2301295 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2023/05/12Generic · Class 3 硝普钠氯化钠注射液 · No verified English nameCYHS2301294 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2023/05/12Generic · Class 3 硝普钠氯化钠注射液 · No verified English nameCYHS2301293 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2023/05/12Generic · Class 3 硝普钠氯化钠注射液 · No verified English nameCYHS2301292 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2023/05/12New drug · Class 3.3 SAL023注射液 · No verified English nameCXSL2300332 Xin Li Tai (Chengdu) Bio Technology Co., Ltd. romanized; Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2023/05/12New drug · Class 1 注射用QLS31905 · No verified English nameCXSL2300331 Qilu Pharmaceutical Co., Ltd.
2023/05/12New drug · Class 1 镥[177Lu]JH020002注射液 · No verified English nameCXHL2300514 Jing He Biopharmaceuticals Technology (Nanjing) Co., Ltd. romanized; Jing He Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/05/12New drug · Class 1 KH607片 · No verified English nameCXHL2300513 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2023/05/12New drug · Class 1 KH607片 · No verified English nameCXHL2300512 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2023/05/12New drug · Class 1 KH607片 · No verified English nameCXHL2300511 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2023/05/12New drug · Class 2.3 海博麦布阿托伐他汀钙片 · No verified English nameCXHL2300510 Han Hui Pharmaceutical Co., Ltd. romanized
2023/05/12New drug · Class 2.3 海博麦布阿托伐他汀钙片 · No verified English nameCXHL2300509 Han Hui Pharmaceutical Co., Ltd. romanized
2023/05/11Import · Class 1 EYP-1901玻璃体内植入剂 · No verified English nameJXHL2300114 EyePoint Pharmaceuticals Inc.; Betta Pharmaceuticals Co. Ltd.
2023/05/11Import · Class 1 EYP-1901玻璃体内植入剂 · No verified English nameJXHL2300113 EyePoint Pharmaceuticals Inc.; Betta Pharmaceuticals Co. Ltd.
2023/05/11Import · Class 1 BRII-835 (VIR-2218) 注射液 · No verified English nameJXHL2300112 Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited
2023/05/11Generic · Class 3 Famotidine InjectionCYHS2301278 Shaanxi Li Cai Pharma Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/05/11Generic · Class 3 Famotidine InjectionCYHS2301277 Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized
2023/05/11Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2301276 Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2023/05/11Generic · Class 3 阿瑞匹坦注射液 · No verified English nameCYHS2301274 Sichuan Kelun Pharmaceutical Co., Ltd.
2023/05/11Generic · Class 3 Peramivir InjectionCYHS2301271 Hubei Min Kang Pharma Group Co., Ltd. romanized; Hubei Mei Lin Pharma Co., Ltd. romanized
2023/05/11New drug · Class 1 注射用A166 · No verified English nameCXSS2300034 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2023/05/11New drug · Class 1 FL115注射液 · No verified English nameCXSL2300329 Suzhou Fu Rong Bio Technology Co., Ltd. romanized
2023/05/11New drug · Class 1 ReT01 ACT 注射液 · No verified English nameCXSL2300328 Beijing An Wei Sen Biopharmaceuticals Co., Ltd. romanized
2023/05/11New drug · Class 1 ISM8207胶囊 · No verified English nameCXHL2300508 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized
2023/05/11New drug · Class 1 ISM8207胶囊 · No verified English nameCXHL2300507 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized

115 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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