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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 279 drug applications between 19 February 2025 and 25 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 54 drug names.

2025/02/19 – 2025/02/25

Period
2025/02/19 to 2025/02/25, 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
279
Drugs with new generic filings (by drug name, de-duplicated)
54
Accepted this week, now under review
11

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

279filings, 67 of them generic

By application type

Application typeFilings
Supplement145
Generic67
New drug33
Import23
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug184
TCM53
Therapeutic biologic35
Biologic3
Prophylactic biologic3
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

54 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules412
2盐酸舍曲林口服浓缩液 · No verified English name223
3Multiple Electrolytes and Sodium Acetate Injection214
4多种油脂肪乳注射液(C?~??) · No verified English nameThe source text contains a character that cannot be displayed.210
5氯雷他定口服溶液 · No verified English name213
6Nafamostat Mesilate for Injection2138
7环硅酸锆钠散 · No verified English name2112
8Isoprenaline Hydrochloride Injection217
9草酸艾司西酞普兰口服溶液 · No verified English name2111
10Dapagliflozin Tablets2184

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
1Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized1690
2Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized14140
3Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized660
4Boehringer Ingelheim International GmbH430
5AstraZeneca AB420
6AstraZeneca UK Limited410
7Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized414
8Baxter Holding B.V.330
9Daiichi Sankyo Inc.320
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

84 this week

AcceptedDrugApplicants
2025/02/25Import · Class 2.2 特泽利尤单抗注射液 · No verified English nameJXSS2500020 AstraZeneca AB; Amgen Manufacturing Limited LLC; AstraZeneca Investment (China) Co. Ltd.
2025/02/25Import · Class 2.2 特泽利尤单抗注射液 · No verified English nameJXSS2500019 AstraZeneca AB; Amgen Manufacturing Limited LLC; AstraZeneca Investment (China) Co. Ltd.
2025/02/25Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSS2500018 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/02/25Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSS2500017 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/02/25Import · Class 1 那米司特片 · No verified English nameJXHS2500030 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/02/25Import · Class 1 那米司特片 · No verified English nameJXHS2500029 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/02/25Generic · Class 3 Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2500844 Hebei Hui De Xu Sheng Pharmaceuticals Technology Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2025/02/25Generic · Class 3 Potassium Chloride Oral SolutionCYHS2500843 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2025/02/25Generic · Class 3 Polaprezinc GranulesCYHS2500839 Yan Tai Wan Run Pharma Co., Ltd. romanized
2025/02/25Generic · Class 3 Paracetamol and Ibuprofen TabletsCYHS2500835 Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/02/25Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2500834 Hubei Min Kang Pharma Group Co., Ltd. romanized; Hubei Mei Lin Pharma Co., Ltd. romanized
2025/02/25Generic · Class 3 卡格列净二甲双胍缓释片 · No verified English nameCYHS2500830 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2025/02/25Generic · Class 3 Desonide OintmentCYHS2500829 Hunan Ming Rui Pharmaceutical Co., Ltd. romanized
2025/02/25Generic · Class 3 贝美前列素涂剂 · No verified English nameCYHL2500051 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/02/25New drug · Class 3.1 二冬汤颗粒 · No verified English nameCXZS2500009 Shanghai Jin Cun Pharmaceutical Co., Ltd. romanized
2025/02/25New drug · Class 2 人细小病毒(B19)核酸检测试剂盒 (PCR-荧光法) · No verified English nameCXSS2500033 Suzhou Hua Yi Mei Bio Technology Co., Ltd. romanized
2025/02/25New drug · Class 1 BNT323 · No verified English nameCXSL2500174 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/02/25New drug · Class 1 X-L177胶囊 · No verified English nameCXHL2500217 Zhongguo Ke College Shanghai Drug Research Institute romanized; Yan Tai Xin Yao Chuang Zhi Shandong Sheng Laboratory romanized
2025/02/25New drug · Class 1 X-L177胶囊 · No verified English nameCXHL2500216 Zhongguo Ke College Shanghai Drug Research Institute romanized; Yan Tai Xin Yao Chuang Zhi Shandong Sheng Laboratory romanized
2025/02/25New drug · Class 1 X-L177胶囊 · No verified English nameCXHL2500215 Zhongguo Ke College Shanghai Drug Research Institute romanized; Yan Tai Xin Yao Chuang Zhi Shandong Sheng Laboratory romanized
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

54 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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