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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 392 drug applications between 1 January 2023 and 7 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 52 drug names.

2023/01/01 – 2023/01/07

Period
2023/01/01 to 2023/01/07, 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
392
Drugs with new generic filings (by drug name, de-duplicated)
52
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

392filings, 67 of them generic

By application type

Application typeFilings
Supplement219
Generic67
New drug54
Import33
Import re-registration16
Unspecified3

By drug type

Drug typeFilings
Chemical drug249
TCM81
Therapeutic biologic58
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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Penicillin G Sodium For Injection312
2Dopamine Hydrochloride Injection313
3Ritonavir Tablets220
4Famotidine Injection228
5Lactulose Oral Solution2134
6Fesoterodine Fumarate Prolonged-Release Tablets210
7Empagliflozin Tablets2118
8Torasemide Tablets210
9Lacosamide Injection210
10Bromhexine Hydrochloride Oral Solution2122

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

199 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized40400
2Guo Da (Heilongjiang) Pharmaceutical Technology Co., Ltd. romanized16160
3Guangzhou Bai Te Medical Yong Pin Co., Ltd. romanized960
4Jiangxi Xin Zheng Pharma Co., Ltd. romanized760
5Novo Nordisk A/S620
6Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized550
7Novartis Pharma Schweiz AG530
8Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized530
9Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized520
10Shanghai Huang Xiang Tie Li Lan Tian 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

113 this week

AcceptedDrugApplicants
2023/01/07Import · Class 3.1 赖脯胰岛素注射液 · No verified English nameJXSS2300004 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd
2023/01/07Import · Class 3.1 赖脯胰岛素注射液 · No verified English nameJXSS2300003 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd
2023/01/07Import · Class 3.1 注射用Vonicog alfa · No verified English nameJXSS2300002 Baxalta US Inc.; Takeda (China) International Trading Co. Ltd
2023/01/07Import · Class 3.1 注射用Vonicog alfa · No verified English nameJXSS2300001 Baxalta US Inc.; Takeda (China) International Trading Co. Ltd
2023/01/07Import · Class 2.1 RO7030816 · No verified English nameJXSL2300019 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/01/07Import · Class 2.1 RO7030816 · No verified English nameJXSL2300018 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/01/07Import · Class 2.4 Baricitinib TabletsJXHS2300006 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd
2023/01/07Import · Class 2.4 Baricitinib TabletsJXHS2300005 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd
2023/01/07Import · Class 1 BAY 2433334片 · No verified English nameJXHL2300002 Bayer AG; Bayer Healthcare Company Ltd.
2023/01/07Import · Class 1 AMG 890 · No verified English nameJXHL2300001 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2023/01/07Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2300062 Guangzhou Shi Yi Yuan Pharmaceuticals Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/01/07Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2300060 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/01/07New drug · Class 1.1 诺丽通颗粒 · No verified English nameCXZS2300002 Guangdong Fang Sheng Jian Meng Pharma Co., Ltd. romanized; Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized
2023/01/07New drug · Class 3.3 托珠单抗注射液 · No verified English nameCXSS2300001 Jin Yu Bo Wo Run Ze Bio Technology Co., Ltd. romanized; Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized
2023/01/07New drug · Class 2.1; 2.2 注射用维迪西妥单抗 · No verified English nameCXSL2300019 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/01/07New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSL2300018 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/01/07New drug · Class 1 IBI362注射液 · No verified English nameCXHL2300027 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/01/07New drug · Class 1 IBI362注射液 · No verified English nameCXHL2300026 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/01/07New drug · Class 1 IBI362注射液 · No verified English nameCXHL2300025 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/01/07New drug · Class 1 IBI362注射液 · No verified English nameCXHL2300024 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/01/07New drug · Class 1 BY101298胶囊 · No verified English nameCXHL2300023 Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2023/01/07New drug · Class 1 BY101298胶囊 · No verified English nameCXHL2300022 Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2023/01/07New drug · Class 2.4 Nemonoxacin Malate CapsulesCXHL2300021 Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized
2023/01/06Import · Class 1 Ziltivekimab 注射液 · No verified English nameJXSL2300017 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2023/01/06Import · Class 1 MK-3475A注射液 · No verified English nameJXSL2300016 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2023/01/06Import · Class 1 Bemarituzumab注射液 · No verified English nameJXSL2300015 Amgen Inc.; Zai Lab (Shanghai) CO. Ltd.
2023/01/06Import · Class 1 BIIB059 · No verified English nameJXSL2300014 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2023/01/06Import · Class 2.2 司美格鲁肽注射液 · No verified English nameJXSL2300013 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/01/06Import · Class 2.2 司美格鲁肽注射液 · No verified English nameJXSL2300012 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/01/06Import · Class 2.2 司美格鲁肽注射液 · No verified English nameJXSL2300011 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.

83 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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