YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 344 drug applications between 7 January 2022 and 13 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 59 drug names.

2022/01/07 – 2022/01/13

Period
2022/01/07 to 2022/01/13, 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
344
Drugs with new generic filings (by drug name, de-duplicated)
59
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

344filings, 74 of them generic

By application type

Application typeFilings
Supplement184
Generic74
New drug38
Import30
Unspecified9
Import re-registration9

By drug type

Drug typeFilings
Chemical drug261
Therapeutic biologic40
TCM36
Biologic4
Prophylactic biologic3

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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Urapidil Hydrochloride Injection326
2Palbociclib Capsules310
3Latamoxef Sodium for Injection311
4阿普米司特片 · No verified English name313
5Lenalidomide Capsules213
6Octreotide Acetate Microspheres for Injection210
7Dexmedetomidine Hydrochloride Injection211
8Nalbuphine Hydrochloride Injection2111
9Dacomitinib Tablets210
10Febuxostat Tablets2112

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

191 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. romanized1520
3Hua Run Shuang He Pharma Co., Ltd. romanized1190
4Haerbin Hong Dou Shan Biopharmaceutical Co., Ltd. romanized870
5Jiangxi Jiu Hua Pharma Co., Ltd. romanized630
6Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.530
7LES LABORATOIRES SERVIER430
8CSPC OUYI PHARMACEUTICAL CO., LTD.433
9NewAmsterdam Pharma B.V.420
10YaoPharma Co., Ltd.424

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

86 this week

AcceptedDrugApplicants
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
2022/01/12Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2200054 Hangzhou Minsheng Pharmaceutical Co., Ltd
2022/01/12Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2200053 Hangzhou Minsheng Pharmaceutical Co., Ltd
2022/01/12Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2200010 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2022/01/12Generic · Class 3 双氯芬酸依泊胺贴 · No verified English nameCYHL2200006 Nanjing Healthnice Pharmaceutical Technology Co., Ltd
2022/01/12New drug · Class 3.3 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSS2200003 Jiangsu Kang Run Bio Technology Co., Ltd. romanized
2022/01/12New drug · Class 1 JAB-BX102注射液 · No verified English nameCXSL2200017 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2022/01/12New drug · Class 3.3 14028注射液 · No verified English nameCXSL2200016 Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized
2022/01/12New drug · Class 3.3 14028注射液 · No verified English nameCXSL2200015 Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized
2022/01/12New drug · Class 1 HH-009注射液 · No verified English nameCXSL2200014 Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized

56 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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