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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 255 drug applications between 26 October 2022 and 1 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 38 drug names.

2022/10/26 – 2022/11/01

Period
2022/10/26 to 2022/11/01, 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
255
Drugs with new generic filings (by drug name, de-duplicated)
38
Accepted this week, now under review
1

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

255filings, 48 of them generic

By application type

Application typeFilings
Supplement119
Generic48
New drug35
Import21
Unspecified16
Import re-registration16

By drug type

Drug typeFilings
Chemical drug195
Therapeutic biologic31
TCM19
Biologic7
Prophylactic biologic3

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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ibuprofen Injection228
2Metaraminol Tartrate Injection222
3Olaparib Tablets210
4Flumazenil Injection212
5Urapidil Hydrochloride Injection216
6Ambroxol Hydrochloride Drops218
7Magnesium Sulfate Injection217
8Esomeprazole Magnesium Enteric-Coated Capsules214
9Dapagliflozin Tablets2184
10Norepinephrine Bitartrate Injection219

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

146 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized12110
2Hubei Mei Lin Pharma Co., Ltd. romanized960
3Novo Nordisk A/S910
4Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized660
5Shandong Han Fang Pharmaceutical Co., Ltd. romanized550
6Anhui Mei Yu Pharmaceutical Co., Ltd. romanized530
7Chengdu Shi Hai Tong Pharma Co., Ltd. romanized520
8Hong Jian Pharmaceutical (Shanghai) Co., Ltd. romanized420
9AstraZeneca UK Limited410
10Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized410

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

84 this week

AcceptedDrugApplicants
2022/11/01Import · Class 1 BION-1301注射液 · No verified English nameJXSL2200190 Chinook Therapeutics Inc.; SanReno Therapeutics (Shanghai) Limited
2022/11/01Import · Class 1 KarXT胶囊 · No verified English nameJXHL2200323 Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2022/11/01Import · Class 1 KarXT胶囊 · No verified English nameJXHL2200322 Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2022/11/01Import · Class 1 KarXT胶囊 · No verified English nameJXHL2200321 Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2022/11/01Import · Class 1 AZD2693注射液 · No verified English nameJXHL2200320 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/11/01Import · Class 1 AZD2693注射液 · No verified English nameJXHL2200319 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/11/01Generic · Class 3 Fluconazole TabletsCYHS2201872 Shandong Fang Ming Pharma Group Co., Ltd. romanized
2022/11/01Generic · Class 3 Doxofylline GranulesCYHS2201871 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/11/01Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2201868 Le Pu Pharma Co., Ltd. romanized
2022/11/01Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2201867 Le Pu Pharma Co., Ltd. romanized
2022/11/01Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2201866 Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2022/11/01Generic · Class 3 Pentoxifylline InjectionCYHS2201865 Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized
2022/11/01Generic · Class 3 Raltitrexed for InjectionCYHS2201863 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2022/11/01Generic · Class 3 Ibuprofen InjectionCYHS2201861 Shandong Luo Xin Pharma Group Co., Ltd. romanized
2022/11/01New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2200551 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2022/11/01New drug · Class 1 QL1706注射液 · No verified English nameCXSL2200550 Qilu Pharmaceutical Co., Ltd.
2022/11/01New drug · Class 1 GS1191-0445注射液 · No verified English nameCXSL2200549 Suzhou Hua Yi Le Jian Bio Technology Co., Ltd. romanized
2022/11/01New drug · Class 1 LQ043H单域抗体雾化液 · No verified English nameCXSL2200548 Shanghai Luo Qi Biopharmaceuticals Technology Co., Ltd. romanized
2022/11/01New drug · Class 2.2 葡萄糖口服溶液 · No verified English nameCXHL2200857 Guo Ren Health Pharmaceutical (Beijing) Co., Ltd. romanized
2022/11/01New drug · Class 1 APG-2575片 · No verified English nameCXHL2200856 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2022/11/01New drug · Class 1 APG-2575片 · No verified English nameCXHL2200855 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2022/11/01New drug · Class 1 ECC4703胶囊 · No verified English nameCXHL2200854 Shanghai Cheng Yi Bio Technology Co., Ltd. romanized
2022/11/01New drug · Class 1 ECC4703胶囊 · No verified English nameCXHL2200853 Shanghai Cheng Yi Bio Technology Co., Ltd. romanized
2022/11/01New drug · Class 1 ECC4703胶囊 · No verified English nameCXHL2200852 Shanghai Cheng Yi Bio Technology Co., Ltd. romanized
2022/11/01New drug · Class 2.2 SBK010口服溶液 · No verified English nameCXHL2200851 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized
2022/11/01New drug · Class 1 ABSK021胶囊 · No verified English nameCXHL2200850 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2022/11/01New drug · Class 1 ABSK021胶囊 · No verified English nameCXHL2200849 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2022/11/01New drug · Class 1 ABSK021胶囊 · No verified English nameCXHL2200848 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2022/11/01New drug · Class 1 注射用HRS-8427 · No verified English nameCXHL2200847 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/10/29Import · Class 1 VAY736注射液 · No verified English nameJXSL2200189 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.

54 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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