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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 427 drug applications between 8 May 2023 and 14 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 52 drug names.

2023/05/08 – 2023/05/14

Period
2023/05/08 to 2023/05/14, 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
427
Drugs with new generic filings (by drug name, de-duplicated)
52
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

427filings, 72 of them generic

By application type

Application typeFilings
Supplement248
Generic72
New drug66
Import20
Import re-registration12
Unspecified9

By drug type

Drug typeFilings
Chemical drug279
TCM108
Therapeutic biologic40

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

52 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
3吸入用七氟烷 · No verified English name310
4Levofloxacin Eye Drops2216
5Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
6Famotidine Injection228
7Crisaborole Ointment2126
8Carbazochrome Sodium Sulfonate Injection211
9Ipratropium Bromide Inhalation Solution212
10Vonoprazan Fumarate Tablets2160

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

196 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. romanized19150
3Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized15140
4Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized1210
5Bard Pharmaceuticals Limited730
6Qilu Pharmaceutical (Hainan) Co., Ltd624
7Eli Lilly and Company610
8Changsha Ai Bei Gao Pharma Co., Ltd. romanized550
9Hua Bei Pharmaceutical Group Xian Tai Pharma Co., Ltd. romanized520
10Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized510

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

107 this week

AcceptedDrugApplicants
2023/05/13Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2301309 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/05/13Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2301308 Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2023/05/13Generic · Class 3 Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2301307 Henan Run Hong Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/05/13Generic · Class 3 Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2301306 Henan Run Hong Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/05/13New drug · Class 1.1 参蓉颗粒 · No verified English nameCXZL2300034 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2023/05/13New drug · Class 1 BAT1308注射液 · No verified English nameCXSL2300336 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2023/05/13New drug · Class 2.4 BAT4706注射液 · No verified English nameCXSL2300335 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2023/05/13New drug · Class 2.4 BAT4706注射液 · No verified English nameCXSL2300334 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2023/05/13New drug · Class 1 SIM0278注射液 · No verified English nameCXSL2300333 Jiangsu Xian Sheng Pharma Co., Ltd. romanized
2023/05/13New drug · Class 1 XH-5102片 · No verified English nameCXHL2300516 Shanghai Xun He Pharmaceuticals Technology Co., Ltd. romanized
2023/05/13New drug · Class 1 XH-5102片 · No verified English nameCXHL2300515 Shanghai Xun He Pharmaceuticals Technology Co., Ltd. romanized
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.

77 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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