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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 303 drug applications between 17 September 2022 and 23 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 41 drug names.

2022/09/17 – 2022/09/23

Period
2022/09/17 to 2022/09/23, 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
303
Drugs with new generic filings (by drug name, de-duplicated)
41
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

303filings, 51 of them generic

By application type

Application typeFilings
Supplement149
New drug62
Generic51
Unspecified18
Import16
Import re-registration7

By drug type

Drug typeFilings
Chemical drug225
TCM31
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

41 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Indobufen Tablets326
2Oseltamivir Phosphate Capsules3139
3Teicoplanin for Injection216
4Hydrocortisone Sodium Succinate for Injection2116
5Doxorubicin Hydrochloride Liposome Injection212
6Calcium Gluconate in Sodium Chloride Injection215
7Cytarabine Injection210
8Choline Fenofibrate Sustained-release Capsules211
9Acetylcysteine Granules114
10Tacrolimus Sustained-release Capsules116

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

168 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
3Vetter Pharma-Fertigung GmbH & Co. KG820
4Da Lian Tian Shan Pharma Co., Ltd. romanized660
5Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized660
6Actelion Pharmaceuticals Ltd620
7Boehringer Ingelheim International GmbH510
8Sanofi -aventis France510
9Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized440
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

97 this week

AcceptedDrugApplicants
2022/09/23Import · Class 1 Mezagitamab 注射剂 · No verified English nameJXSL2200170 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd.
2022/09/23Generic · Class 3 Lidocaine Hydrochloride GelCYHS2201594 Nanjing Han Xin Pharmaceuticals Technology Co., Ltd. romanized; Mei Yao Xing (Nanjing) Pharmaceutical Co., Ltd. romanized
2022/09/23Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2201593 Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized
2022/09/23Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2201592 Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Jian Min Pharma Group Co., Ltd. romanized
2022/09/23New drug · Class 1 C-13-60细胞制剂 · No verified English nameCXSL2200478 Chongqing Jing Zhun Bio Technology Co., Ltd. romanized
2022/09/23New drug · Class 1 ILB-2101注射液 · No verified English nameCXSL2200477 Ying Nuo Hu Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2022/09/23New drug · Class 1 YH001注射液 · No verified English nameCXSL2200476 Name not romanized
2022/09/23New drug · Class 1 1A46注射液 · No verified English nameCXSL2200475 Chengdu En Mu Bio Technology Co., Ltd. romanized; Hai Zheng Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized
2022/09/23New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2200734 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2022/09/23New drug · Class 1 伊匹乌肽滴眼液 · No verified English nameCXHL2200733 Shenzhen Yi Xin Kang Bio Technology Co., Ltd. romanized
2022/09/23New drug · Class 1 GT919胶囊 · No verified English nameCXHL2200732 Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/09/23New drug · Class 1 GT919胶囊 · No verified English nameCXHL2200731 Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/09/23New drug · Class 1 GT919胶囊 · No verified English nameCXHL2200730 Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/09/23New drug · Class 1 NH130枸橼酸盐片 · No verified English nameCXHL2200729 Jiangsu En Hua Pharma Co., Ltd. romanized
2022/09/23New drug · Class 1 NH130枸橼酸盐片 · No verified English nameCXHL2200728 Jiangsu En Hua Pharma Co., Ltd. romanized
2022/09/23New drug · Class 1 NH130枸橼酸盐片 · No verified English nameCXHL2200727 Jiangsu En Hua Pharma Co., Ltd. romanized
2022/09/23New drug · Class 2.2 利多卡因软膏 · No verified English nameCXHL2200726 Hu Zhou Yi Nuo Wei Xin Drug Formulations Co., Ltd. romanized
2022/09/23New drug · Class 2.3 维格列汀恩格列净二甲双胍缓释片 · No verified English nameCXHL2200725 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized
2022/09/23New drug · Class 1 JMKX000197注射液 · No verified English nameCXHL2200724 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
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

67 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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