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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 304 drug applications between 17 February 2025 and 23 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 59 drug names.

2025/02/17 – 2025/02/23

Period
2025/02/17 to 2025/02/23, 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
304
Drugs with new generic filings (by drug name, de-duplicated)
59
Accepted this week, now under review
14

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

304filings, 83 of them generic

By application type

Application typeFilings
Supplement149
Generic83
New drug50
Import15
Import re-registration4
Unspecified3

By drug type

Drug typeFilings
Chemical drug210
TCM49
Therapeutic biologic41
Prophylactic biologic4

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
1Ruxolitinib Phosphate Tablets5327
2Esomeprazole Magnesium for Delayed-release Oral Suspension424
3Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules412
4Brexpiprazole Tablets3231
5盐酸舍曲林口服浓缩液 · No verified English name223
6Multiple Electrolytes and Sodium Acetate Injection214
7多种油脂肪乳注射液(C?~??) · No verified English nameThe source text contains a character that cannot be displayed.210
8氯雷他定口服溶液 · No verified English name213
9Sacubitril Valsartan Sodium Tablets2170
10Nafamostat Mesilate for Injection2138

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

190 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. romanized770
5Hebei Hua Chen Pharma Group Co., Ltd. romanized440
6Shijiazhuang No.4 Pharmaceutical Co., Ltd.444
7Hua Chuan Pharmaceutical Co., Ltd. romanized430
8Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized432
9Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized414
10Nei Menggu Ku Lun Meng Yao 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

100 this week

AcceptedDrugApplicants
2025/02/22Generic · Class 3 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2500823 Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2025/02/22Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2500820 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/02/22Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2500819 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2025/02/22Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2500818 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2025/02/22Generic · Class 3 维生素K滴剂 · No verified English nameCYHS2500817 Hefei Ke Da Bio Technology Co., Ltd. romanized; Anhui Wei Er Man Pharmaceutical Co., Ltd. romanized
2025/02/22Generic · Class 3 Peramivir InjectionCYHS2500816 Anhui Feng Yuan Pharma Co., Ltd. romanized
2025/02/22Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2500814 Hunan Bai Qi He Drug Research and Development Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2025/02/22Generic · Class 3 Nafamostat Mesilate for InjectionCYHL2500050 Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized
2025/02/22Generic · Class 3 Nafamostat Mesilate for InjectionCYHL2500049 Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized
2025/02/22New drug · Class 2.2 伊匹木单抗注射液 · No verified English nameCXSS2500032 Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized; Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/02/22New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSS2500031 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/02/22New drug · Class 1 注射用QLS5132 · No verified English nameCXSL2500173 Qilu Pharmaceutical Co., Ltd.
2025/02/22New drug · Class 2.2; 2.4 优替德隆胶囊 · No verified English nameCXHL2500214 Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized; Beijing Hua Hao Zhong Tian Biopharmaceuticals Co., Ltd. romanized
2025/02/22New drug · Class 2.2 X001 干混悬剂 · No verified English nameCXHL2500213 Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized
2025/02/22New drug · Class 1 TFX06片 · No verified English nameCXHL2500212 Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized
2025/02/22New drug · Class 1 TFX06片 · No verified English nameCXHL2500211 Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized
2025/02/21Import · Class 3.1 Tremelimumab注射液 · No verified English nameJXSS2500016 AstraZeneca AB; Vetter Pharma-Fertigung GmbH & Co. KG; AstraZeneca Global R&D (China) Co. Ltd.
2025/02/21Import · Class 3.1 Tremelimumab注射液 · No verified English nameJXSS2500015 AstraZeneca AB; Vetter Pharma-Fertigung GmbH & Co. KG; AstraZeneca Global R&D (China) Co. Ltd.
2025/02/21Import · Class 3.1 度伐利尤单抗注射液 · No verified English nameJXSS2500014 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/02/21Import · Class 3.1 度伐利尤单抗注射液 · No verified English nameJXSS2500013 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/02/21Generic · Class 3 Acetylcysteine InjectionCYHS2500813 Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized
2025/02/21Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2500812 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2025/02/21Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2500811 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2025/02/21Generic · Class 3 Valganciclovir Hydrochloride Powder For Oral SolutionCYHS2500808 Hubei Wei Sen Pharmaceutical Co., Ltd. romanized
2025/02/21New drug · Class 1 TAEST1901注射液 · No verified English nameCXSL2500172 Xiang Xue Sheng Ming Ke Xue Technology (Guangdong) Co., Ltd. romanized
2025/02/21New drug · Class 2.2 吸附无细胞百白破(组分)b型流感嗜血杆菌(结合)联合疫苗 · No verified English nameCXSL2500171 Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized
2025/02/21New drug · Class 1 Afuresertib片 · No verified English nameCXHL2500210 Lai Kai Pharmaceutical (Ningbo) Co., Ltd. romanized
2025/02/21New drug · Class 1 Afuresertib片 · No verified English nameCXHL2500209 Lai Kai Pharmaceutical (Ningbo) Co., Ltd. romanized
2025/02/21New drug · Class 1 WXSH0493片 · No verified English nameCXHL2500208 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
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

70 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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