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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 354 drug applications between 11 January 2022 and 17 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 55 drug names.

2022/01/11 – 2022/01/17

Period
2022/01/11 to 2022/01/17, 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
354
Drugs with new generic filings (by drug name, de-duplicated)
55
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

354filings, 73 of them generic

By application type

Application typeFilings
Supplement203
Generic73
New drug42
Import21
Import re-registration10
Unspecified5

By drug type

Drug typeFilings
Chemical drug289
Therapeutic biologic39
TCM21
Biologic3
In vitro diagnostic reagent1
Prophylactic 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

55 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Urapidil Hydrochloride Injection326
2Latamoxef Sodium for Injection311
3阿普米司特片 · No verified English name313
4Rivaroxaban Tablets223
5Atomoxetine Hydrochloride Oral Solution220
6吸入用七氟烷 · No verified English name210
7Lenalidomide Capsules213
8Neostigmine Methylsulfate Injection214
9Edoxaban Tosilate Tablets219
10Dexmedetomidine Hydrochloride Injection211

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

197 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Kun Ze Pharma Co., Ltd. romanized2130
2Hubei Rui Ze Pharma Co., Ltd. romanized18180
3Hua Run Shuang He Pharma Co., Ltd. romanized1190
4Hua Bei Pharmaceutical Group Xian Tai Pharma Co., Ltd. romanized940
5Bayer Vital GmbH920
6Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.530
7Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized510
8LES LABORATOIRES SERVIER430
9Chengdu Easton Biopharmaceuticals Co.,Ltd.424
10Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized410

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

81 this week

AcceptedDrugApplicants
2022/01/17Import · Class 1 VAY736注射液 · No verified English nameJXSL2200007 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/01/17Import · Class 1 RO7191863注射液 · No verified English nameJXHL2200020 F. Hoffmann-La Roche Ltd.; Roche R & D Center (China) Ltd.
2022/01/17Import · Class 1 RO7445482注射液 · No verified English nameJXHL2200019 F. Hoffmann-La Roche Ltd.; Roche R & D Center (China) Ltd.
2022/01/17Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2200101 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2022/01/17Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2200100 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2022/01/17Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2200099 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/01/17Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2200098 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/01/17Generic · Class 3 Terbutaline Sulfate InjectionCYHS2200096 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2022/01/17Generic · Class 3 Terbutaline Sulfate InjectionCYHS2200095 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2022/01/17New drug · Class 3.1 苓桂术甘颗粒 · No verified English nameCXZS2200002 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2022/01/17New drug · Class 1 CM352注射液 · No verified English nameCXSL2200023 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2022/01/17New drug · Class 1 GC101腺相关病毒注射液 · No verified English nameCXSL2200022 Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized
2022/01/17New drug · Class 1 GC101腺相关病毒注射液 · No verified English nameCXSL2200021 Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized
2022/01/17New drug · Class 1 JYB1904注射液 · No verified English nameCXSL2200020 Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized
2022/01/17New drug · Class 1 HRX0701片(Ⅱ) · No verified English nameCXHL2200025 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/01/17New drug · Class 1 HRX0701片(Ⅰ) · No verified English nameCXHL2200024 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/01/17New drug · Class 2.2 ABRJ口服微乳溶液 · No verified English nameCXHL2200013 Shenzhen Hai Wang Pharmaceuticals Technology Research Institute Co., Ltd. romanized
2022/01/14Import · Class 1 Depemokimab注射液 · No verified English nameJXSL2200006 GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline(China) Investment Co. Ltd
2022/01/14Import · Class 1 Depemokimab注射液 · No verified English nameJXSL2200005 GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline(China) Investment Co. Ltd
2022/01/14Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2200069 Le Pu Pharmaceutical Technology Co., Ltd. romanized
2022/01/14New drug · Class 3.3 注射用曲妥珠单抗 · No verified English nameCXSS2200005 Hai Zheng Biopharmaceutical Co., Ltd. romanized
2022/01/14New drug · Class 1 注射用DP303c · No verified English nameCXSL2200019 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2022/01/14New drug · Class 3.3 美泊利珠单抗注射液 · No verified English nameCXSL2200018 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2022/01/14New drug · Class 1 FHND5071片 · No verified English nameCXHL2200023 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2022/01/14New drug · Class 1 FHND5071片 · No verified English nameCXHL2200022 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2022/01/14New drug · Class 1 AC682胶囊 · No verified English nameCXHL2200021 Bing Zhou Shi Bio Technology (Shanghai) Co., Ltd. romanized
2022/01/13Generic · Class 3 Omeprazole and Sodium Bicarbonate CapsulesCYHS2200074 Hebei Xin Rui Wei Lai Technology Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2022/01/13Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2200063 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2022/01/13Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2200031 Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized
2022/01/13Generic · Class 3 磷酸奥司他韦干糖浆 · No verified English nameCYHS2200030 Zhong Run Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.

51 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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