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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 282 drug applications between 24 February 2023 and 2 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 52, covering 41 drug names.

2023/02/24 – 2023/03/02

Period
2023/02/24 to 2023/03/02, 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
282
Drugs with new generic filings (by drug name, de-duplicated)
41
Accepted this week, now under review
1

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

282filings, 52 of them generic

By application type

Application typeFilings
Supplement151
Generic52
New drug33
Import21
Import re-registration17
Unspecified8

By drug type

Drug typeFilings
Chemical drug198
TCM51
Therapeutic biologic28
Prophylactic biologic4
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

41 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride Oral Solution3246
2Sildenafil Citrate Oral Disintegrating Tablets228
3Sodium Valproate Oral Solution211
4Tacrolimus Sustained-release Capsules216
5Carbazochrome Sodium Sulfonate Injection211
6Brivaracetam Tablets2119
7Sodium Hyaluronate Eye Drops2130
8生理氯化钠溶液 · No verified English name2117
9Bromhexine Hydrochloride Oral Solution2122
10Enalapril Maleate Tablets213

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

176 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized13110
2Guangdong Song Xia Pharma Co., Ltd. romanized11110
3NAPP PHARMACEUTICALS LIMITED910
4Bracco Imaging S.P.A.610
5Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized530
6Name not romanized434
7Beijing Jia Cheng Biopharmaceuticals Technology Kai Fa Co., Ltd. romanized410
8Merck & Co. Inc.330
9Nei Menggu Yi Li Pharmaceutical Co., Ltd. romanized330
10Henan Pu Rui Pharmaceutical Co., Ltd. romanized330

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

76 this week

AcceptedDrugApplicants
2023/03/02Import · Class 1 RO7200220 注射液 · No verified English nameJXSL2300047 F. Hoffmann-La Roche Ltd.
2023/03/02Import · Class 1 RO7200220 注射液 · No verified English nameJXSL2300046 F. Hoffmann-La Roche Ltd.
2023/03/02Import · Class 1 LY3471851注射液 · No verified English nameJXSL2300045 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/03/02Import · Class 1 AZD3427注射用浓溶液 · No verified English nameJXSL2300044 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/03/02Generic · Class 3 Oxaliplatin InjectionCYHS2300670 Guizhou Fu Kang Ren Pharmaceutical Co., Ltd. romanized; Haerbin Yi Da Pharma Co., Ltd. romanized
2023/03/02Generic · Class 3 Potassium Chloride Oral SolutionCYHS2300668 Hunan Ou La Pharmaceuticals Technology Co., Ltd. romanized; Hunan Xin Hui Pharmaceutical Co., Ltd. romanized
2023/03/02Generic · Class 3 镥[177Lu]氧奥曲肽注射液 · No verified English nameCYHL2300032 Yuan Zi Gao Ke Co., Ltd. romanized
2023/03/02Generic · Class 3 Midazolam Nasal SprayCYHL2300030 Jiangsu En Hua Pharma Co., Ltd. romanized
2023/03/02New drug · Class 1.1 小儿复方没食子软膏 · No verified English nameCXZL2300015 Xin Qi Kang Pharma Co., Ltd. romanized
2023/03/02New drug · Class 1 TAEST16001注射液 · No verified English nameCXSL2300165 Xiang Xue Sheng Ming Ke Xue Technology (Guangdong) Co., Ltd. romanized
2023/03/02New drug · Class 3.2 伤寒Vi多糖蛋白结合疫苗 · No verified English nameCXSL2300164 Lanzhou Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/03/02New drug · Class 2.2 HECB1800301吸入喷雾剂 · No verified English nameCXHL2300261 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2023/03/02New drug · Class 2.2 HECB1800301吸入喷雾剂 · No verified English nameCXHL2300260 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2023/03/02New drug · Class 2.2 HECB1800301吸入喷雾剂 · No verified English nameCXHL2300259 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2023/03/01Generic · Class 3 Verapamil Hydrochloride InjectionCYHS2300667 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/03/01Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2300666 Name not romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2023/03/01Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2300665 Name not romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2023/03/01Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2300663 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/03/01Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2300662 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/03/01New drug · Class 1.1 栀黄贴膏 · No verified English nameCXZL2300014 Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Shanghai Tu Feng Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhong Pharmaceuticals University romanized
2023/03/01New drug · Class 1 注射用SHR-2001 · No verified English nameCXSL2300163 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/03/01New drug · Class 2.2; 2.4 BTP0717 · No verified English nameCXHL2300258 Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2023/02/28Import · Class 2.2 注射用阿地白介素 · No verified English nameJXSL2300043 CLINIGEN HEALTHCARE LIMITED
2023/02/28Import · Class 1 KM-001乳膏 · No verified English nameJXHL2300040 Kamari Pharma Ltd; WuXi Clinical Development Services (Shanghai) Co. Ltd.
2023/02/28Import · Class 1 KM-001乳膏 · No verified English nameJXHL2300039 Kamari Pharma Ltd; WuXi Clinical Development Services (Shanghai) Co. Ltd.
2023/02/28Generic · Class 3 Formoterol Fumarate Inhalation SolutionCYHS2300661 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/02/28Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2300656 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2023/02/28Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2300655 Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanized
2023/02/28New drug · Class 2.2 舒格利单抗注射液 · No verified English nameCXSS2300007 Hui Rui Investment Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized
2023/02/28New drug · Class 1 聚乙二醇化重组门冬酰胺酶注射液 · No verified English nameCXSL2300162 Chongqing Pai Jin Bio Technology Co., Ltd. romanized

46 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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