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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 289 drug applications between 14 February 2025 and 20 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 56 drug names.

2025/02/14 – 2025/02/20

Period
2025/02/14 to 2025/02/20, 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
289
Drugs with new generic filings (by drug name, de-duplicated)
56
Accepted this week, now under review
17

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

289filings, 79 of them generic

By application type

Application typeFilings
Supplement144
Generic79
New drug44
Import13
Unspecified8
Import re-registration1

By drug type

Drug typeFilings
Chemical drug197
TCM45
Therapeutic biologic41
Prophylactic biologic4
Biologic2

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
1Ruxolitinib Phosphate Tablets5327
2Esomeprazole Magnesium for Delayed-release Oral Suspension424
3Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules412
4Brexpiprazole Tablets3231
5Diclofenac Sodium Sustained Release Tablets2110
6Multiple Electrolytes and Sodium Acetate Injection214
7Oxcarbazepine Tablets214
8氯雷他定口服溶液 · No verified English name213
9Sacubitril Valsartan Sodium Tablets2170
10Trelagliptin Succinate Tablets211

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

175 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized14140
2Janssen-Cilag International NV1240
3Henan Ying Feng Pharmaceuticals Co., Ltd. romanized1060
4Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized880
5Hua Chuan Pharmaceutical Co., Ltd. romanized540
6CSPC OUYI PHARMACEUTICAL CO., LTD.523
7Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized432
8Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized414
9Xian Li Bang Pharmaceutical Co., Ltd. romanized410
10Hebei Hua Chen Pharma Group 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

85 this week

AcceptedDrugApplicants
2025/02/20Import · Class 2.4 硫酸氢司美替尼胶囊 · No verified English nameJXHS2500026 ASTRAZENECA UK LIMITED; PATHEON PHARMACEUTICALS INCORPORATED; AstraZeneca Investment (China) Co. Ltd
2025/02/20Import · Class 2.4 硫酸氢司美替尼胶囊 · No verified English nameJXHS2500025 ASTRAZENECA UK LIMITED; PATHEON PHARMACEUTICALS INCORPORATED; AstraZeneca Investment (China) Co. Ltd
2025/02/20Import · Class 1 ABBV-932胶囊 · No verified English nameJXHL2500029 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/02/20Import · Class 1 ABBV-932胶囊 · No verified English nameJXHL2500028 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/02/20Import · Class 1 ABBV-932胶囊 · No verified English nameJXHL2500027 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/02/20Generic · Class 3 小儿多种维生素注射液(13) · No verified English nameCYHS2500807 Shandong Lu Sheng Pharmaceutical Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2025/02/20Generic · Class 3 氯雷他定口服溶液 · No verified English nameCYHS2500803 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/02/20Generic · Class 3 氯雷他定口服溶液 · No verified English nameCYHS2500802 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/02/20Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2500798 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2025/02/20New drug · Class 3.3 德谷胰岛素注射液 · No verified English nameCXSS2500030 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2025/02/20New drug · Class 2.1 SHR-1316(sc)注射液 · No verified English nameCXSL2500170 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/02/20New drug · Class 1 注射用CS5001 · No verified English nameCXSL2500169 Ji Shi Pharma (Suzhou) Co., Ltd. romanized
2025/02/20New drug · Class 1.2 重组破伤风疫苗(大肠埃希菌) · No verified English nameCXSL2500168 Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized; Zhongguo Ren Min Jie Fang Jun Jun Shi Ke College Jun Shi Yi Xue Research Institute romanized
2025/02/20New drug · Class 1 注射用MHB046C · No verified English nameCXSL2500167 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2025/02/20New drug · Class 1 注射用BGB-R046 · No verified English nameCXSL2500166 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2025/02/20New drug · Class 2.2 AX23104口崩片 · No verified English nameCXHL2500207 Beijing Hai Yi Pharma Co., Ltd. romanized
2025/02/20New drug · Class 1 MT2004胶囊 · No verified English nameCXHL2500206 Xian Ao Li Tai Pharmaceuticals Technology Co., Ltd. romanized
2025/02/20New drug · Class 1 MT2004胶囊 · No verified English nameCXHL2500205 Xian Ao Li Tai Pharmaceuticals Technology Co., Ltd. romanized
2025/02/20New drug · Class 1 注射用VB6893 · No verified English nameCXHL2500204 Shenzhen Wei Ke Sen Biopharmaceuticals Technology Co., Ltd. romanized
2025/02/19Generic · Class 3 Multiple Electrolytes and Sodium Acetate InjectionCYHS2500795 Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized
2025/02/19Generic · Class 3 Multiple Electrolytes and Sodium Acetate InjectionCYHS2500794 Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized
2025/02/19Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2500792 Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized
2025/02/19Generic · Class 3 Butorphanol Tartrate InjectionCYHS2500791 Xi Nan Pharma Co., Ltd. romanized
2025/02/19Generic · Class 3 Butorphanol Tartrate InjectionCYHS2500790 Xi Nan Pharma Co., Ltd. romanized
2025/02/19Generic · Class 3 维生素B12注射液 · No verified English nameCYHS2500788 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2025/02/19Generic · Class 3 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2500787 Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanized
2025/02/19Generic · Class 3 Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHL2500046 Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2025/02/19Generic · Class 3 Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHL2500045 Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2025/02/19Generic · Class 3 Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHL2500044 Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2025/02/19Generic · Class 3 Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHL2500043 Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized

55 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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