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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 445 drug applications between 30 December 2022 and 5 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 51 drug names.

2022/12/30 – 2023/01/05

Period
2022/12/30 to 2023/01/05, 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
445
Drugs with new generic filings (by drug name, de-duplicated)
51
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

445filings, 73 of them generic

By application type

Application typeFilings
Supplement279
Generic73
New drug66
Import12
Import re-registration9
Unspecified6

By drug type

Drug typeFilings
Chemical drug294
TCM107
Therapeutic biologic38
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

51 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Clindamycin Injection314
2Remifentanil Hydrochloride for Injection312
3Penicillin G Sodium 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

191 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized44440
2Hubei Lang De Pharma Co., Ltd. romanized32160
3Guo Da (Heilongjiang) Pharmaceutical Technology Co., Ltd. romanized31310
4Fresenius Kabi Deutschland GmbH2420
5Jiangxi Xin Zheng Pharma Co., Ltd. romanized12110
6Guangzhou Bai Te Medical Yong Pin Co., Ltd. romanized960
7Qi Yuan Bio (Hangzhou) Co., Ltd. romanized810
8Jilin Te Yan Pharma Co., Ltd. romanized550
9Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized440
10Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized443

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

110 this week

AcceptedDrugApplicants
2023/01/05Import · Class 1 Marstacimab注射液 · No verified English nameJXSL2300008 Pfizer Inc.; Pfizer Investment Co. Ltd.
2023/01/05Import · Class 1 Marstacimab注射液 · No verified English nameJXSL2300007 Pfizer Inc.; Pfizer Investment Co. Ltd.
2023/01/05Import · Class 1 重组人REIC/Dkk-3基因复制缺陷5型腺病毒注射液 · No verified English nameJXSL2300006 Momotaro Gene Inc.; Adreic Therapeutics Inc.
2023/01/05Import · Class 1 VAY736注射液 · No verified English nameJXSL2300005 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/01/05Import · Class 2.4 Empagliflozin TabletsJXHS2300001 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/01/05Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2300029 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/01/05Generic · Class 3 Vigabatrin Powder for Oral SolutionCYHS2300027 Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized
2023/01/05Generic · Class 3 Aminocaproic Acid InjectionCYHS2300023 Ningbo Zhuo Lun Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/01/05Generic · Class 3 非洛地平片 · No verified English nameCYHS2300022 Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2023/01/05Generic · Class 3 Penicillin G Sodium For InjectionCYHS2300019 Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2023/01/05Generic · Class 3 Penicillin G Sodium For InjectionCYHS2300018 Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2023/01/05Generic · Class 3 Penicillin G Sodium For InjectionCYHS2300017 Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2023/01/05Generic · Class 3 Pregabalin Extended release TabletsCYHS2300016 Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized
2023/01/05Generic · Class 3 Brivaracetam Oral SolutionCYHL2300003 Jiangsu Ai Li Kang Pharmaceuticals Technology Co., Ltd. romanized
2023/01/05New drug · Class 1 VUM02注射液 · No verified English nameCXSL2300006 Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized
2023/01/05New drug · Class 1 注射用EX105 · No verified English nameCXSL2300005 Guangzhou Ai Si Mai Biopharmaceuticals Technology Co., Ltd. romanized
2023/01/05New drug · Class 1 注射用LM-108 · No verified English nameCXSL2300004 Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized
2023/01/05New drug · Class 2.4 Azithromycin For InjectionCXHS2300005 Changchun Hai Yue Pharma Co., Ltd. romanized
2023/01/05New drug · Class 2.4 Azithromycin For InjectionCXHS2300004 Changchun Hai Yue Pharma Co., Ltd. romanized
2023/01/05New drug · Class 2.4 Azithromycin For InjectionCXHS2300003 Changchun Hai Yue Pharma Co., Ltd. romanized
2023/01/05New drug · Class 1 SPH4336片 · No verified English nameCXHL2300011 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2023/01/05New drug · Class 1 PA9159乳膏 · No verified English nameCXHL2300010 Anhui Bai La A Tu Pharmaceuticals Technology Co., Ltd. romanized
2023/01/05New drug · Class 2.2 HQ-0124片 · No verified English nameCXHL2300009 Ze Zheng (Shanghai) Bio Technology Co., Ltd. romanized
2023/01/05New drug · Class 2.2 HQ-0124片 · No verified English nameCXHL2300008 Ze Zheng (Shanghai) Bio Technology Co., Ltd. romanized
2023/01/05New drug · Class 1 注射用RN-0001 · No verified English nameCXHL2300007 Rui Nuo Medical Technology (Shanghai) Co., Ltd. romanized
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

80 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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