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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 390 drug applications between 29 December 2022 and 4 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 50 drug names.

2022/12/29 – 2023/01/04

Period
2022/12/29 to 2023/01/04, 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
390
Drugs with new generic filings (by drug name, de-duplicated)
50
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

390filings, 74 of them generic

By application type

Application typeFilings
Supplement229
Generic74
New drug72
Import9
Unspecified3
Import re-registration3

By drug type

Drug typeFilings
Chemical drug269
TCM79
Therapeutic biologic36
Prophylactic biologic4
In vitro diagnostic reagent1
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

50 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Esmolol Hydrochloride Injection333
2Clindamycin Injection314
3Remifentanil Hydrochloride for Injection312
4Gadobutrol Injection318
5Gadoteric Acid Meglumine Salt Injection311
6Pregabalin Oral Solution225
7Famotidine Injection228
8Vildagliptin Tablets220
9Sitagliptin Phosphate and Metformin Hydrochloride Tablets (II)223
10Phloroglucinol Injection222

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

173 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Lang De Pharma Co., Ltd. romanized32160
2Guo Da (Heilongjiang) Pharmaceutical Technology Co., Ltd. romanized30300
3Fresenius Kabi Deutschland GmbH2420
4Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized16160
5Qi Yuan Bio (Hangzhou) Co., Ltd. romanized810
6Jilin Te Yan Pharma Co., Ltd. romanized550
7Jiangxi Xin Zheng Pharma Co., Ltd. romanized550
8Yi Chang Ren Fu Pharma Co., Ltd. romanized534
9Xian Tang Chen Pharmaceutical Co., Ltd. romanized520
10Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized440

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

114 this week

AcceptedDrugApplicants
2023/01/04Import · Class 1 MEDI3506注射液 · No verified English nameJXSL2300004 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/01/04Import · Class 1 Epcoritamab注射液 · No verified English nameJXSL2300003 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2023/01/04Import · Class 1 Epcoritamab注射用浓溶液 · No verified English nameJXSL2300002 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2023/01/04Import · Class 2.2 Ravulizumab注射液 · No verified English nameJXSL2300001 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2023/01/04Generic · Class 3 Famotidine InjectionCYHS2300014 Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/01/04Generic · Class 3 Famotidine InjectionCYHS2300012 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/01/04Generic · Class 3 Azilsartan TabletsCYHS2300009 Zhejiang Nord Pharmaceutical Co., Ltd
2023/01/04Generic · Class 3 Pregabalin Oral SolutionCYHS2300005 Shanghai Mei You Pharmaceutical Co., Ltd. romanized
2023/01/04Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2300004 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2023/01/04Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2300003 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2023/01/04Generic · Class 3 布洛芬混悬滴剂 · No verified English nameCYHS2300001 Tian Da Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized
2023/01/04New drug · Class 1 HLX51 · No verified English nameCXSL2300003 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2023/01/04New drug · Class 1 MHB018A注射液 · No verified English nameCXSL2300002 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2023/01/04New drug · Class 1 注射用VDJ010 · No verified English nameCXSL2300001 Beijing Wei De Jie Bio Technology Co., Ltd. romanized
2023/01/04New drug · Class 1 恩替诺特片 · No verified English nameCXHS2300002 Tai Zhou Yi Teng Jing Ang Pharma Co., Ltd. romanized
2023/01/04New drug · Class 1 恩替诺特片 · No verified English nameCXHS2300001 Tai Zhou Yi Teng Jing Ang Pharma Co., Ltd. romanized
2023/01/04New drug · Class 2.2 Umeclidinium Bromide And Vilanterol Trifenatate Powder for InhalationCXHL2300006 Tianjin Jin Yao Pharma Co., Ltd. romanized
2023/01/04New drug · Class 1 HSK40118片 · No verified English nameCXHL2300005 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2023/01/04New drug · Class 1 HSK40118片 · No verified English nameCXHL2300004 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2023/01/04New drug · Class 1 HSK40118片 · No verified English nameCXHL2300003 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2023/01/04New drug · Class 1 GPN00068注射液 · No verified English nameCXHL2300002 Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized; Wuhan Wu Yao Technology Co., Ltd. romanized
2023/01/03Generic · Class 3 Fesoterodine Fumarate Prolonged-Release TabletsCYHL2300002 CISEN PHARMACEUTICAL CO., LTD.
2023/01/03Generic · Class 3 Fesoterodine Fumarate Prolonged-Release TabletsCYHL2300001 CISEN PHARMACEUTICAL CO., LTD.
2023/01/03New drug · Class 1 注射用MT1009 · No verified English nameCXHL2300001 Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized
2023/01/01New drug · Class 2.1; 2.2 泰它西普注射液 · No verified English nameCXSL2200641 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2022/12/31Import · Class 2.4 Ganaxolone口服混悬剂 · No verified English nameJXHL2200354 Marinus Pharmaceuticals Inc.; Tenacia Biotechnology (Shanghai) Co. Ltd
2022/12/31Generic · Class 3 Diprophylline InjectionCYHS2202175 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2022/12/31Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2202174 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2022/12/31New drug · Class 2.2; 2.3 淫羊藿苷元胶囊 · No verified English nameCXZL2200057 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2022/12/31New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSS2200095 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized

84 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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