YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 242 drug applications between 19 November 2021 and 25 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 41, covering 30 drug names.

2021/11/19 – 2021/11/25

Period
2021/11/19 to 2021/11/25, 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
242
Drugs with new generic filings (by drug name, de-duplicated)
30
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

242filings, 41 of them generic

By application type

Application typeFilings
Supplement131
Generic41
New drug33
Import23
Unspecified10
Import re-registration4

By drug type

Drug typeFilings
Chemical drug182
Therapeutic biologic33
TCM19
Prophylactic biologic5
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

30 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets3223
2Dexmedetomidine Hydrochloride Injection311
3Moxifloxacin Hydrochloride Eye Drops224
4Obeticholic Acid Tablets210
5Tolvaptan Tablets210
6Tandospirone Citrate Tablets212
7Fluorouracil Injection216
8Dexmedetomidine Hydrochloride Injection210
9Aprepitant Capsules210
10Propofol Medium And Long Chain Fat Emulsion Injection113

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

143 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized19190
2Actelion Pharmaceuticals Ltd810
3Hainan Tao Sheng Pharmaceuticals Technology Research Institute Co., Ltd. romanized740
4Pan Shi Ju Kang Pharma Co., Ltd. romanized540
5Sichuan Guo Rui Pharma Co., Ltd. romanized525
6F.Hoffmann-La Roche Ltd.430
7Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized434
8Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized420
9Chengdu Brilliant Pharmaceutical Co., Ltd.424
10Pfizer Europe MA EEIG410

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

64 this week

AcceptedDrugApplicants
2021/11/25Generic · Class 3 Levofloxacin InjectionCYHS2102083 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2021/11/25Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2102064 Sichuan Guo Rui Pharma Co., Ltd. romanized
2021/11/25New drug · Class 1.2 注射用丹酚酸A · No verified English nameCXZL2101034 Jiangxi Qing Feng Pharma Co., Ltd. romanized
2021/11/25New drug · Class 1 WJ05129片 · No verified English nameCXHL2101686 Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/25New drug · Class 1 WJ05129片 · No verified English nameCXHL2101685 Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/24Import · Class 2.2 纳武利尤单抗注射液 · No verified English nameJXSL2101138 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/11/24Import · Class 1 NKTR-214 · No verified English nameJXSL2101137 Nektar Therapeutics; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/11/24Import · Class 1 NKTR-214 · No verified English nameJXSL2101136 Nektar Therapeutics; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/11/24Import · Class 2.3; 2.4 CARDIX-101胶囊 · No verified English nameJXHL2101254 CARDIX THERAPEUTICS LLC; SHANGHAI GENOMICS INC
2021/11/24Import · Class 2.3; 2.4 CARDIX-101胶囊 · No verified English nameJXHL2101253 CARDIX THERAPEUTICS LLC; SHANGHAI GENOMICS INC
2021/11/24Import · Class 2.3 CARDIX-101胶囊 · No verified English nameJXHL2101252 CARDIX THERAPEUTICS LLC; SHANGHAI GENOMICS INC
2021/11/24Generic · Class 3 Sumatriptan and Naproxen Sodium TabletsCYHS2102076 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2021/11/24Generic · Class 3 Fluorouracil InjectionCYHS2102075 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2021/11/24Generic · Class 3 Fluorouracil InjectionCYHS2102074 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2021/11/24New drug · Class 1 自体自然杀伤细胞注射液 · No verified English nameCXSL2101444 Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized
2021/11/24New drug · Class 1 CAStem细胞注射液 · No verified English nameCXSL2101443 Beijing Ze Hui Chen Xing Bio Technology Co., Ltd. romanized
2021/11/24New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101442 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/24New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101441 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/24New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101440 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/24New drug · Class 1 CAB-ROR2-ADC注射剂 · No verified English nameCXSL2101438 Kai Bo Si (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2021/11/24New drug · Class 2.4 环泊酚注射液 · No verified English nameCXHS2101054 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2021/11/24New drug · Class 2.2 丁苯酞注射液 · No verified English nameCXHL2101684 Jilin Sheng Qi Jian Bio Technology Co., Ltd. romanized
2021/11/23Import · Class 1 PF-07220060 · No verified English nameJXHL2101251 Pfizer Inc.; Pfizer Investment CO. Ltd
2021/11/23Import · Class 1 PF-07220060 · No verified English nameJXHL2101250 Pfizer Inc.; Pfizer Investment CO. Ltd
2021/11/23Import · Class 1 PF-07220060 · No verified English nameJXHL2101249 Pfizer Inc.; Pfizer Investment CO. Ltd
2021/11/23Import · Class 1 ZN-c3片 · No verified English nameJXHL2101248 Zentera Therapeutics HK Limited; Zentera Therapeutics Shanghai Co. Ltd
2021/11/23Import · Class 1 ZN-c3片 · No verified English nameJXHL2101247 Zentera Therapeutics HK Limited; Zentera Therapeutics Shanghai Co. Ltd
2021/11/23Generic · Class 3 Isotretinoin Soft CapsulesCYHS2102071 Chongqing Hua Bang Sheng Kai Pharmaceutical Co., Ltd. romanized; Chongqing Huapont Pharmaceutical Co., Ltd.
2021/11/23Generic · Class 3 卡格列净二甲双胍缓释片 · No verified English nameCYHS2102070 Le Pu Pharma Co., Ltd. romanized
2021/11/23Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2102069 Sichuan Guo Rui Pharma Co., Ltd. romanized

34 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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