YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 208 drug applications between 1 January 2022 and 7 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 25 drug names.

2022/01/01 – 2022/01/07

Period
2022/01/01 to 2022/01/07, 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
208
Drugs with new generic filings (by drug name, de-duplicated)
25
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

208filings, 36 of them generic

By application type

Application typeFilings
Supplement94
New drug41
Generic36
Import28
Import re-registration7
Unspecified2

By drug type

Drug typeFilings
Chemical drug142
Therapeutic biologic39
TCM26
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

25 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Gabapentin Capsules310
2Palbociclib Capsules310
3Enarodustat Tablets310
4Nicorandil for Injection311
5地氯雷他定口服溶液 · No verified English name2226
6Octreotide Acetate Microspheres for Injection210
7Febuxostat Tablets2112
8Lactulose Oral Solution1134
9Voriconazole for Oral Suspension111
10Olmesartan Medoxomil and Amlodipine Besylate Tablets112

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

127 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Haerbin Hong Dou Shan Biopharmaceutical Co., Ltd. romanized660
2Henan Fu Ren Tang Pharmaceutical Co., Ltd. romanized660
3Hubei Rui Ze Pharma Co., Ltd. romanized440
4NewAmsterdam Pharma B.V.420
5Pfizer Europe MA EEIG420
6YaoPharma Co., Ltd.424
7Fresenius Kabi AB410
8Nian Yan Pharma (Zhuhai) Co., Ltd. romanized410
9Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized410
10Hua Bei Pharmaceutical Hebei Hua Nuo Co., Ltd. romanized320

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

70 this week

AcceptedDrugApplicants
2022/01/07Import · Class 3.1 马吉妥昔单抗注射液 · No verified English nameJXSS2200001 MacroGenics Inc.; Baxter Pharmaceutical Solutions LLC
2022/01/07Import · Class 1 Oleclumab Injection · No verified English nameJXSL2200004 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/01/07Import · Class 1 注射用Monalizumab · No verified English nameJXSL2200003 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/01/07Import · Class 2.4 Upadacitinib Sustained-release TabletsJXHS2200007 AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2022/01/07Import · Class 2.4 Upadacitinib Sustained-release TabletsJXHS2200006 AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2022/01/07Import · Class 2.4 Upadacitinib Sustained-release TabletsJXHS2200005 AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2022/01/07Import · Class 1 Obicetrapib片 · No verified English nameJXHL2200010 NewAmsterdam Pharma B.V.; Nanjing CR Medicon Pharmaceutical Technology Co Ltd
2022/01/07Import · Class 1 Obicetrapib 片 · No verified English nameJXHL2200009 NewAmsterdam Pharma B.V.; Nanjing CR Medicon Pharmaceutical Technology Co Ltd
2022/01/07Import · Class 1 Obicetrapib 片 · No verified English nameJXHL2200008 NewAmsterdam Pharma B.V.; Nanjing CR Medicon Pharmaceutical Technology Co Ltd
2022/01/07Import · Class 1 Obicetrapib 片 · No verified English nameJXHL2200007 NewAmsterdam Pharma B.V.; Nanjing CR Medicon Pharmaceutical Technology Co Ltd
2022/01/07Import · Class 1 TAK-981 注射液 · No verified English nameJXHL2200005 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2022/01/07Import · Class 1 BN102片 · No verified English nameJXHL2200004 Carna Biosciences Inc.; BioNova Pharmaceuticals (Shanghai) Limited
2022/01/07Import · Class 1 BN102片 · No verified English nameJXHL2200003 Carna Biosciences Inc.; BioNova Pharmaceuticals (Shanghai) Limited
2022/01/07Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2200020 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/01/07New drug · Class 1.1 太子神悦胶囊 · No verified English nameCXZS2200001 Xinjiang Hua Chun Bio Pharma Co., Ltd. romanized; Guo Yao Group De Zhong (Fo Shan) Pharma Co., Ltd. romanized
2022/01/07New drug · Class 3.3 重组人生长激素注射液 · No verified English nameCXSL2200009 Jun He Meng Biopharmaceutical (Hangzhou) Co., Ltd. romanized
2022/01/07New drug · Class 1 BC3402注射液 · No verified English nameCXSL2200004 Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized
2022/01/07New drug · Class 1 重组草酸脱羧酶散 · No verified English nameCXSL2101536 Wuhan Kang Fu De Mi Niao Xi Jie Shi Research Institute Co., Ltd. romanized
2022/01/07New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2101837 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/01/07New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2101835 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/01/06Import · Class 1 MRTX849片 · No verified English nameJXHL2200006 Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2022/01/06Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2200014 Guizhou Fu Kang Ren Pharmaceutical Co., Ltd. romanized; Shandong Yi Kang Pharma Co., Ltd. romanized
2022/01/06New drug · Class 1 PM1015 注射液 · No verified English nameCXSL2200006 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2022/01/06New drug · Class 1 HLX301 · No verified English nameCXSL2200005 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2022/01/06New drug · Class 1 重组人源化抗PD-L1单克隆抗体/人TGF-β融合蛋白注射液 · No verified English nameCXSL2101535 Le Pu Bio Technology Co., Ltd. romanized
2022/01/06New drug · Class 1 CP0119片 · No verified English nameCXHL2200008 Nan Kai University romanized
2022/01/06New drug · Class 1 CP0119片 · No verified English nameCXHL2200007 Nan Kai University romanized
2022/01/05Import · Class 1 输注用无菌冻干粉Telisotuzumab vedotin · No verified English nameJXSL2200002 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai)Co. Ltd
2022/01/05Import · Class 1 SQZ-AAC-HPV · No verified English nameJXSL2200001 SQZ Biotechnologies Company; ICON Clinical Research (Beijing No.2) Co. Ltd.
2022/01/05Import · Class 1 SHR8008胶囊 · No verified English nameJXHS2101101 eVENUS PHARMACEUTICAL LABORATORIES INC.; PATHEON INC.; Jiangsu Hengrui Pharmaceuticals Co. Ltd

40 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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