YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 449 drug applications between 3 January 2023 and 9 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 55 drug names.

2023/01/03 – 2023/01/09

Period
2023/01/03 to 2023/01/09, 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
449
Drugs with new generic filings (by drug name, de-duplicated)
55
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

449filings, 74 of them generic

By application type

Application typeFilings
Supplement246
Generic74
New drug66
Import36
Import re-registration20
Unspecified7

By drug type

Drug typeFilings
Chemical drug300
TCM84
Therapeutic biologic59
Prophylactic biologic6

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

55 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
5Phloroglucinol Injection222
6Lactulose Oral Solution2134
7Fesoterodine Fumarate Prolonged-Release Tablets210
8布比卡因脂质体注射液 · No verified English name217
9Metformin Hydrochloride And Empagliflozin Extended Release Tablets2112
10Empagliflozin Tablets2118

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

225 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
5Pfizer Europe MA EEIG630
6Novo Nordisk A/S620
7Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized550
8Novartis Pharma Schweiz AG530
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

133 this week

AcceptedDrugApplicants
2023/01/09Import · Class 1 Balcinrenone达格列净胶囊 · No verified English nameJXHL2300004 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/01/09Import · Class 1 Balcinrenone达格列净胶囊 · No verified English nameJXHL2300003 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/01/09Generic · Class 3 布比卡因脂质体注射液 · No verified English nameCYHS2300071 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/01/09Generic · Class 3 布比卡因脂质体注射液 · No verified English nameCYHS2300070 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/01/09Generic · Class 3 Levofolinate Calcium for InjectionCYHS2300068 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2023/01/09Generic · Class 3 Levofolinate Calcium for InjectionCYHS2300067 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2023/01/09Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2300066 Le Pu Pharma Co., Ltd. romanized
2023/01/09Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2300065 Le Pu Pharma Co., Ltd. romanized
2023/01/09New drug · Class 2.4 注射用重组促皮质素 · No verified English nameCXSL2300021 Shanghai Duo Mi Rui Bio Technology Co., Ltd. romanized
2023/01/08New drug · Class 1 BRG01注射液 · No verified English nameCXSL2300020 Guangzhou Bai Ji Biopharmaceutical Co., Ltd. romanized
2023/01/08New drug · Class 1 XZP-6877片 · No verified English nameCXHL2300038 Xuan Zhu Bio Technology Co., Ltd. romanized; Shandong Xuan Zhu Pharmaceuticals Technology Co., Ltd. romanized
2023/01/08New drug · Class 1 XZP-6877片 · No verified English nameCXHL2300037 Xuan Zhu Bio Technology Co., Ltd. romanized; Shandong Xuan Zhu Pharmaceuticals Technology Co., Ltd. romanized
2023/01/08New drug · Class 1 XZP-6877片 · No verified English nameCXHL2300036 Xuan Zhu Bio Technology Co., Ltd. romanized; Shandong Xuan Zhu Pharmaceuticals Technology Co., Ltd. romanized
2023/01/08New drug · Class 1 WXFL10030390片 · No verified English nameCXHL2300035 Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized
2023/01/08New drug · Class 1 WXFL10030390片 · No verified English nameCXHL2300034 Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized
2023/01/08New drug · Class 1 WXFL10030390片 · No verified English nameCXHL2300033 Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized
2023/01/08New drug · Class 1 WXFL10030390片 · No verified English nameCXHL2300032 Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized
2023/01/08New drug · Class 1 HS-10506片 · No verified English nameCXHL2300031 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/01/08New drug · Class 1 HS-10506片 · No verified English nameCXHL2300030 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/01/08New drug · Class 1 CGT-2201胶囊 · No verified English nameCXHL2300029 Sheng Shi Tai Ke Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2023/01/08New drug · Class 1 CGT-2201胶囊 · No verified English nameCXHL2300028 Sheng Shi Tai Ke Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized
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.

103 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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