YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 319 drug applications between 6 January 2022 and 12 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 61, covering 50 drug names.

2022/01/06 – 2022/01/12

Period
2022/01/06 to 2022/01/12, 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
319
Drugs with new generic filings (by drug name, de-duplicated)
50
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

319filings, 61 of them generic

By application type

Application typeFilings
Supplement175
Generic61
New drug34
Import32
Import re-registration9
Unspecified8

By drug type

Drug typeFilings
Chemical drug228
Therapeutic biologic45
TCM39
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

50 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Palbociclib Capsules310
2Latamoxef Sodium for Injection311
3Lenalidomide Capsules213
4Octreotide Acetate Microspheres for Injection210
5Urapidil Hydrochloride Injection216
6Dexmedetomidine Hydrochloride Injection211
7Nalbuphine Hydrochloride Injection2111
8Dacomitinib Tablets210
9Febuxostat Tablets2112
10Carbazochrome Sodium Sulfonate Injection111

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

180 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hua Bei Pharmaceutical Group Xian Tai Pharma Co., Ltd. romanized2160
2Hua Run Shuang He Pharma Co., Ltd. romanized1080
3Guangxi Kun Ze Pharma Co., Ltd. romanized920
4Haerbin Hong Dou Shan Biopharmaceutical Co., Ltd. romanized870
5Jiangxi Jiu Hua Pharma Co., Ltd. romanized730
6Hubei Rui Ze Pharma Co., Ltd. romanized660
7CSPC OUYI PHARMACEUTICAL CO., LTD.433
8NewAmsterdam Pharma B.V.420
9Pfizer Europe MA EEIG420
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

80 this week

AcceptedDrugApplicants
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
2022/01/12New drug · Class 3.4 静注人免疫球蛋白(pH4) · No verified English nameCXSL2200013 Guangdong Dan Xia Biopharmaceutical Co., Ltd. romanized
2022/01/12New drug · Class 3.4 静注人免疫球蛋白(pH4) · No verified English nameCXSL2200012 Guangdong Dan Xia Biopharmaceutical Co., Ltd. romanized
2022/01/12New drug · Class 2.2 枸橼酸西地那非口溶膜 · No verified English nameCXHS2200005 Sichuan Kelun Pharmaceutical Co., Ltd.
2022/01/12New drug · Class 2.2 枸橼酸西地那非口溶膜 · No verified English nameCXHS2200004 Sichuan Kelun Pharmaceutical Co., Ltd.
2022/01/11Generic · Class 3 Nalbuphine Hydrochloride InjectionCYHS2200043 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/01/11Generic · Class 3 Nalbuphine Hydrochloride InjectionCYHS2200042 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/01/11Generic · Class 3 Latamoxef Sodium for InjectionCYHS2200040 Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2022/01/11Generic · Class 3 Latamoxef Sodium for InjectionCYHS2200039 Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2022/01/11Generic · Class 3 Latamoxef Sodium for InjectionCYHS2200038 Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2022/01/11Generic · Class 3 Levofloxacin InjectionCYHS2200036 Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2022/01/11Generic · Class 3 Timolol Maleate Eye DropsCYHS2200033 Wuhan Wu Jing Pharmaceuticals Technology Co., Ltd. romanized; Wuhan Wu Jing Pharma Co., Ltd. romanized
2022/01/11Generic · Class 3 Gadobenate Dimeglumine InjectionCYHS2200032 Hainan Brilliant Pharmaceutical Co., Ltd.
2022/01/11Generic · Class 3 Nimodipine Oral SolutionCYHS2200017 Zhejiang Guo Jing Pharma Co., Ltd. romanized

50 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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