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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 273 drug applications between 30 August 2022 and 5 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 46, covering 37 drug names.

2022/08/30 – 2022/09/05

Period
2022/08/30 to 2022/09/05, 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
273
Drugs with new generic filings (by drug name, de-duplicated)
37
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

273filings, 46 of them generic

By application type

Application typeFilings
Supplement139
Generic46
New drug44
Import26
Import re-registration12
Unspecified6

By drug type

Drug typeFilings
Chemical drug190
Therapeutic biologic49
TCM31
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

37 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sitagliptin Phosphate Tablets312
2Diquafosol Sodium Eye Drops225
3Lornoxicam for Injection222
4Perampanel Tablets212
5Ozagrel Sodium Injection213
6Ornidazole Injection210
7Palonosetron Hydrochloride Injection211
8Dapagliflozin Tablets2184
9Sodium Valproate Oral Solution111
10Piracetam Injection119

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

157 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Roche Pharma (Schweiz) AG920
2Guo Jiu Tang Shandong E Jiao Co., Ltd. romanized880
3Eli Lilly and Company720
4Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized660
5Janssen Research & Development LLC630
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
7Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized610
8Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized550
9Chengdu Hong Ji Bio Technology Co., Ltd. romanized510
10Guangxi Sheng 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

77 this week

AcceptedDrugApplicants
2022/09/05New drug · Class 1 LM-101注射液 · No verified English nameCXSL2200438 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/09/05New drug · Class 1 KP104注射液 · No verified English nameCXSL2200437 Ke Yue Pharmaceuticals (Suzhou) Co., Ltd. romanized
2022/09/05New drug · Class 1 AB-218 胶囊 · No verified English nameCXHL2200649 Bao Yuan Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2022/09/05New drug · Class 2.2; 2.4 TML-023软膏 · No verified English nameCXHL2200648 Wuhan Ke Fu Xin Yao Co., Ltd. romanized
2022/09/04New drug · Class 1 AK0707胶囊 · No verified English nameCXHL2200647 Suzhou Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized
2022/09/04New drug · Class 1 AK0707胶囊 · No verified English nameCXHL2200646 Suzhou Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized
2022/09/03Import · Class 2.4 INC280 · No verified English nameJXHL2200274 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2022/09/03Import · Class 2.4 INC280 · No verified English nameJXHL2200273 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2022/09/03Import · Class 2.4 镥(177Lu)vipivotide tetraxetan注射液 · No verified English nameJXHL2200271 Advanced Accelerator Applications USA Inc. A Novartis Company; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/09/03Generic · Class 3 Mannitol-S InjectionCYHS2201452 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2022/09/03Generic · Class 3 Ozagrel Sodium InjectionCYHS2201446 Ben Xi Heng Kang Pharmaceutical Co., Ltd. romanized
2022/09/03Generic · Class 3 Ozagrel Sodium InjectionCYHS2201445 Ben Xi Heng Kang Pharmaceutical Co., Ltd. romanized
2022/09/03Generic · Class 3 Levetiracetam extended-release tabletsCYHS2201443 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized
2022/09/03New drug · Class 1 TC-N201注射液 · No verified English nameCXSL2200436 Guangdong Tian Ke Ya Biopharmaceuticals Technology Co., Ltd. romanized
2022/09/02Import · Class 1 BIIB059 · No verified English nameJXSL2200154 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2022/09/02Generic · Class 3 Olprinone Hydrochloride InjectionCYHS2201442 Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2022/09/02Generic · Class 3 Methocarbamol InjectionCYHS2201436 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2022/09/02Generic · Class 3 Ornidazole InjectionCYHS2201425 Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2022/09/02Generic · Class 3 Ornidazole InjectionCYHS2201424 Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2022/09/02New drug · Class 1.1 芪黄明目胶囊 · No verified English nameCXZS2200007 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2022/09/02New drug · Class 1 注射用ZW25 · No verified English nameCXSL2200435 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/09/02New drug · Class 1 注射用ZW25 · No verified English nameCXSL2200434 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/09/02New drug · Class 1 注射用QLF32101 · No verified English nameCXSL2200433 Qilu Pharmaceutical Co., Ltd.
2022/09/02New drug · Class 1 GC304腺相关病毒注射液 · No verified English nameCXSL2200432 Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized
2022/09/02New drug · Class 1 注射用LM-305 · No verified English nameCXSL2200431 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/09/02New drug · Class 1 WS016干混悬剂 · No verified English nameCXHL2200645 Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized
2022/09/02New drug · Class 1 IMG-004胶囊 · No verified English nameCXHL2200644 Ying Mai Biopharmaceuticals (Hangzhou) Co., Ltd. romanized
2022/09/02New drug · Class 1 IMG-004胶囊 · No verified English nameCXHL2200643 Ying Mai Biopharmaceuticals (Hangzhou) Co., Ltd. romanized
2022/09/02New drug · Class 1 ASC61片 · No verified English nameCXHL2200642 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized
2022/09/02New drug · Class 1 PA9159吸入气雾剂 · No verified English nameCXHL2200641 Anhui Bai La A Tu Pharmaceuticals Technology Co., Ltd. romanized

47 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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