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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 312 drug applications between 16 September 2022 and 22 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 46 drug names.

2022/09/16 – 2022/09/22

Period
2022/09/16 to 2022/09/22, 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
312
Drugs with new generic filings (by drug name, de-duplicated)
46
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

312filings, 63 of them generic

By application type

Application typeFilings
Supplement148
Generic63
New drug60
Unspecified18
Import16
Import re-registration7

By drug type

Drug typeFilings
Chemical drug231
TCM34
Therapeutic biologic31
Biologic15
In vitro diagnostic reagent1

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

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapagliflozin And Metformin Hydrochloride Extended-Release Tablets510
2Indobufen Tablets326
3Oseltamivir Phosphate For Oral Suspension322
4Oseltamivir Phosphate Capsules3139
5Tandospirone Citrate Tablets212
6Tranexamic Acid Injection2111
7Teicoplanin for Injection216
8Hydrocortisone Sodium Succinate for Injection2116
9Doxorubicin Hydrochloride Liposome Injection212
10Calcium Gluconate in Sodium Chloride Injection215

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

170 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Mei Lin Pharma Co., Ltd. romanized22160
2Shanghai Yan An Pharma Co., Ltd. romanized12110
3Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized860
4Vetter Pharma-Fertigung GmbH & Co. KG820
5Da Lian Tian Shan Pharma Co., Ltd. romanized660
6Actelion Pharmaceuticals Ltd620
7Boehringer Ingelheim International GmbH510
8Sanofi -aventis France510
9Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized515
10Fuzhou Ji Shi Pharmaceuticals Technology 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

105 this week

AcceptedDrugApplicants
2022/09/22Import · Class 2.2 注射用戈沙妥珠单抗 · No verified English nameJXSL2200169 Everest Medicines (Singapore) Pte. Ltd.; Everest Medicines (Suzhou) Inc.
2022/09/22Import · Class 1 TAK-861片 · No verified English nameJXHL2200292 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2022/09/22Import · Class 1 TAK-861片 · No verified English nameJXHL2200291 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2022/09/22Import · Class 1 TAK-861片 · No verified English nameJXHL2200290 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2022/09/22Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2201582 Hebei Tian Cheng Pharma Co., Ltd. romanized
2022/09/22Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2201581 Hebei Tian Cheng Pharma Co., Ltd. romanized
2022/09/22Generic · Class 3 Ampicillin Sodium For InjectionCYHS2201580 Guangxi Wei Chao Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized
2022/09/22Generic · Class 3 Lidocaine CataplasmsCYHL2200081 Beijing Pai Chi Tai Ke Pharmaceuticals Technology Co., Ltd. romanized
2022/09/22New drug · Class 1 BC3402注射液 · No verified English nameCXSL2200474 Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized
2022/09/22New drug · Class 1 FKC889 · No verified English nameCXSL2200473 Fu Xing Kai Te Bio Technology Co., Ltd. romanized
2022/09/22New drug · Class 1 CYH33片 · No verified English nameCXHL2200723 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized
2022/09/22New drug · Class 1 CYH33片 · No verified English nameCXHL2200722 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized
2022/09/22New drug · Class 1 JL1132胶囊 · No verified English nameCXHL2200721 Jilin Sheng Jiang Lin Bio Technology Co., Ltd. romanized
2022/09/22New drug · Class 1 JL1132胶囊 · No verified English nameCXHL2200720 Jilin Sheng Jiang Lin Bio Technology Co., Ltd. romanized
2022/09/22New drug · Class 1 HL-003片 · No verified English nameCXHL2200719 Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized
2022/09/22New drug · Class 1 HL-003片 · No verified English nameCXHL2200718 Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized
2022/09/22New drug · Class 1 HL-003片 · No verified English nameCXHL2200717 Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized
2022/09/22New drug · Class 2.2 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2200716 Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized
2022/09/22New drug · Class 1 THDBH151片 · No verified English nameCXHL2200715 Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2022/09/22New drug · Class 1 THDBH151片 · No verified English nameCXHL2200714 Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2022/09/22New drug · Class 1 THDBH151片 · No verified English nameCXHL2200713 Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2022/09/22New drug · Class 1 ZX-4081片 · No verified English nameCXHL2200712 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2022/09/22New drug · Class 1 ZX-4081片 · No verified English nameCXHL2200711 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2022/09/21Import · Class 2.2 注射用Tafasitamab · No verified English nameJXSL2200168 Incyte Biosciences Distribution B.V.; Beijing InnoCare Pharma Tech Co. Ltd.
2022/09/21Import · Class 1 LEO 152020 薄膜包衣片 · No verified English nameJXHL2200289 LEO Pharma A/S; LEO Pharma Consultany(Shanghai) company Limited
2022/09/21Import · Class 1 注射用TNP-2092 · No verified English nameJXHL2200288 TenNor Therapeutics Inc.; TenNor (Suzhou) Therapeutics Limited
2022/09/21Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2201577 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2022/09/21Generic · Class 3 Cilostazol TabletsCYHS2201576 Beijing Foyou Pharma CO.,LTD
2022/09/21Generic · Class 3 Indobufen TabletsCYHS2201574 Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized
2022/09/21New drug · Class 1.2 枳实总黄酮苷提取物 · No verified English nameCXZS2200009 Jiangxi Qing Feng Pharma Co., Ltd. romanized

75 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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