YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 202 drug applications between 17 November 2021 and 23 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 26 drug names.

2021/11/17 – 2021/11/23

Period
2021/11/17 to 2021/11/23, 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
202
Drugs with new generic filings (by drug name, de-duplicated)
26
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

202filings, 36 of them generic

By application type

Application typeFilings
Supplement102
Generic36
New drug28
Import25
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug155
Therapeutic biologic25
TCM19
Prophylactic biologic2
Biologic1

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

26 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1阿普米司特片 · No verified English name313
2Moxifloxacin Hydrochloride Eye Drops224
3Obeticholic Acid Tablets210
4Tolvaptan Tablets210
5Tandospirone Citrate Tablets212
6Aminophylline Injection213
7Dexmedetomidine Hydrochloride Injection211
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

129 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized10100
2Actelion Pharmaceuticals Ltd810
3Pan Shi Ju Kang Pharma Co., Ltd. romanized540
4Shijiazhuang Yu He Tang Pharma Co., Ltd. romanized440
5Sichuan Guo Rui Pharma Co., Ltd. romanized424
6Chengdu Brilliant Pharmaceutical Co., Ltd.424
7Sanofi Mature IP410
8CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD320
9Fresenius Kabi AB310
10Pfizer Inc.310

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

60 this week

AcceptedDrugApplicants
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
2021/11/23Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2102068 Sichuan Guo Rui Pharma Co., Ltd. romanized
2021/11/23Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2102062 Sichuan Guo Rui Pharma Co., Ltd. romanized
2021/11/23Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2102061 Sichuan Guo Rui Pharma Co., Ltd. romanized
2021/11/23Generic · Class 3 Obeticholic Acid TabletsCYHL2101042 Chengdu Brilliant Pharmaceutical Co., Ltd.
2021/11/23Generic · Class 3 Obeticholic Acid TabletsCYHL2101041 Chengdu Brilliant Pharmaceutical Co., Ltd.
2021/11/23New drug · Class 2.4 Flutemetamol (18F) 注射液 · No verified English nameCXHL2101682 Tong Yong Dian Qi Pharma (Shanghai) Co., Ltd. romanized
2021/11/23New drug · Class 1 注射用舒尼铂 · No verified English nameCXHL2101681 Yunnan Sheng Drug Research Institute romanized
2021/11/23New drug · Class 1 AST-001 注射液 · No verified English nameCXHL2101680 Shenzhen Ai Xin Da Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/11/22Import · Class 3.1 赖脯胰岛素注射液 · No verified English nameJXSS2101032 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2021/11/22Import · Class 3.1 赖脯胰岛素注射液 · No verified English nameJXSS2101031 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2021/11/22Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2101135 Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2021/11/22Import · Class 2.4 Alectinib Hydrochloride CapsulesJXHL2101246 F.Hoffmann-La Roche Ltd; Roche(China) Holding Ltd.
2021/11/22Import · Class 2.4 Alectinib Hydrochloride CapsulesJXHL2101245 F.Hoffmann-La Roche Ltd; Roche(China) Holding Ltd.
2021/11/22Generic · Class 3 Oxytocin InjectionCYHS2102059 Yuan Da Sheng Ming Ke Xue (Wuhan) Co., Ltd. romanized
2021/11/22New drug · Class 1 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2101434 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2021/11/22New drug · Class 2.2 重组人源化抗VEGF单克隆抗体注射液 · No verified English nameCXSL2101433 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2021/11/22New drug · Class 1 人肌母细胞注射液 · No verified English nameCXSL2101432 Luo Gai Ji Mu Xi Bao Yi Xue Research Institute Wuhan Co., Ltd. romanized
2021/11/22New drug · Class 2.2 注射用全氟丙烷人血白蛋白微球 · No verified English nameCXSL2101431 Xiamen Li Zhuo Pharma Co., Ltd. romanized
2021/11/22New drug · Class 1 AK115注射液 · No verified English nameCXSL2101430 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/11/22New drug · Class 1 AK115注射液 · No verified English nameCXSL2101429 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/11/22New drug · Class 1 注射用IAP0971 · No verified English nameCXSL2101428 Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized
2021/11/22New drug · Class 1 SHR7280片 · No verified English nameCXHL2101679 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized

30 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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