YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 343 drug applications between 9 January 2022 and 15 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 56 drug names.

2022/01/09 – 2022/01/15

Period
2022/01/09 to 2022/01/15, 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
343
Drugs with new generic filings (by drug name, de-duplicated)
56
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

343filings, 71 of them generic

By application type

Application typeFilings
Supplement198
Generic71
New drug38
Import16
Import re-registration11
Unspecified9

By drug type

Drug typeFilings
Chemical drug271
Therapeutic biologic39
TCM26
Biologic4
Prophylactic biologic2
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

56 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
8Edoxaban Tosilate Tablets219
9Dexmedetomidine Hydrochloride Injection211
10Nalbuphine Hydrochloride Injection2111

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

196 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hua Bei Pharmaceutical Group Xian Tai Pharma Co., Ltd. romanized2160
2Guangxi Kun Ze Pharma Co., Ltd. romanized2130
3Hua Run Shuang He Pharma Co., Ltd. romanized1190
4Hubei Rui Ze Pharma Co., Ltd. romanized10100
5Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.530
6Jiangxi Jiu Hua Pharma Co., Ltd. romanized520
7LES LABORATOIRES SERVIER430
8Novartis Pharma Schweiz AG430
9CSPC OUYI PHARMACEUTICAL CO., LTD.433
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

75 this week

AcceptedDrugApplicants
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.
2022/01/13New drug · Class 1.1 石榴花栓 · No verified English nameCXZL2200003 Xinjiang Wei Wu Er Zi Zhi Qu Wei Wu Er Pharmaceuticals Research Institute romanized
2022/01/13New drug · Class 1 葎草花粉点刺液 · No verified English nameCXSS2200004 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2022/01/13New drug · Class 2.2 注射用醋酸戈舍瑞林缓释微球 · No verified English nameCXHS2101059 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2022/01/13New drug · Class 1 SCR-6920胶囊 · No verified English nameCXHL2200020 Jiangsu Xian Sheng Pharma Co., Ltd. romanized
2022/01/13New drug · Class 1 SCR-6920胶囊 · No verified English nameCXHL2200019 Jiangsu Xian Sheng Pharma Co., Ltd. romanized
2022/01/13New drug · Class 1 SCR-6920胶囊 · No verified English nameCXHL2200018 Jiangsu Xian Sheng Pharma Co., Ltd. romanized
2022/01/13New drug · Class 1 MAX-40279-01胶囊 · No verified English nameCXHL2200017 Guangzhou Zai Ji Pharmaceuticals Technology Co., Ltd. romanized
2022/01/13New drug · Class 1 MAX-40279-01胶囊 · No verified English nameCXHL2200016 Guangzhou Zai Ji Pharmaceuticals Technology Co., Ltd. romanized
2022/01/13New drug · Class 1 LLT311202注射液 · No verified English nameCXHL2101862 Beijing Le Pu Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Ao Da Bio Technology Co., Ltd. romanized
2022/01/12Import · Class 1 MK-7684A注射液 · No verified English nameJXSL2101154 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2022/01/12Import · Class 1 MK-7684A注射液 · No verified English nameJXSL2101153 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2022/01/12Import · Class 2.4 Finerenone TabletsJXHS2200014 Bayer AG; Bayer Healthcare Company Ltd.
2022/01/12Import · Class 2.4 Finerenone TabletsJXHS2200013 Bayer AG; Bayer Healthcare Company Ltd.
2022/01/12Import · Class 1 177Lu-PSMA-617注射液 · No verified English nameJXHL2200014 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/01/12Import · Class 1 用于制备放射性药物68Ga-PSMA-11的PSMA-11药盒 · No verified English nameJXHL2200013 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/01/12Import · Class 1 Belvarafenib Dihydrochloride · No verified English nameJXHL2200012 F.Hoffmann-La Roche Ltd.; Roche (China) Holding Ltd.
2022/01/12Generic · Class 3 Flurbiprofen Axetil InjectionCYHS2200062 Guangdong Jia Bo Pharmaceutical Co., Ltd. romanized

45 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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