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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 370 drug applications between 12 November 2025 and 18 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 59 drug names.

2025/11/12 – 2025/11/18

Period
2025/11/12 to 2025/11/18, 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
370
Drugs with new generic filings (by drug name, de-duplicated)
59
Accepted this week, now under review
82

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

370filings, 82 of them generic

By application type

Application typeFilings
Supplement200
Generic82
New drug64
Import17
Unspecified5
Import re-registration2

By drug type

Drug typeFilings
Chemical drug225
TCM108
Therapeutic biologic29
Prophylactic biologic7
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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Polyvinyl Alcohol Eye Drops3324
2二甲硅油乳剂 · No verified English name3214
3奥氮平萨米多芬片 · No verified English name310
4Brexpiprazole Tablets3131
5MOVICOL Ready To Take Sachet, Powder For Oral Solution2216
6氧 · No verified English name2215
7Acetylcysteine Oral Solution2111
8依伏卡塞片 · No verified English name219
9Furosemide Oral Solution218
10Ibuprofen Granules213

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

212 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bayer Vital GmbH1410
2Hunan Ke Lun Pharmaceutical Co., Ltd. romanized832
3Sichuan Shu Zhong Pharma Co., Ltd. romanized770
4Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized770
5CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD741
6Qinghai Chun Tian Yao Yong Zi Yuan Technology Co., Ltd. romanized660
7Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized630
8Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized550
9AstraZeneca AB540
10Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized542

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

115 this week

AcceptedDrugApplicants
2025/11/18Import · Class 1 Zasocitinib (TAK-279) 胶囊 · No verified English nameJXHL2500355 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2025/11/18Generic · Class 3 Ketorolac Trometamol TabletsCYHS2503994 Jiangsu He Chen Pharma Co., Ltd. romanized
2025/11/18Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2503992 Wuhan Yi Bo Yuan Pharmaceuticals Technology Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2025/11/18Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2503991 Shanghai Zhao Hui Pharma Co., Ltd. romanized
2025/11/18Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2503990 Hangzhou Min Sheng Drug Research Institute Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized
2025/11/18Generic · Class 3 注射用青霉素钠/氯化钠注射液 · No verified English nameCYHS2503986 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/11/18Generic · Class 3 注射用青霉素钠/氯化钠注射液 · No verified English nameCYHS2503985 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/11/18Generic · Class 3 Ebastine Oral SolutionCYHS2503982 Hangzhou Min Sheng Drug Research Institute Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized
2025/11/18Generic · Class 3 Ibuprofen GranulesCYHS2503977 Jilin Kai Man Pharma Co., Ltd. romanized
2025/11/18Generic · Class 3 Ibuprofen GranulesCYHS2503976 Jilin Kai Man Pharma Co., Ltd. romanized
2025/11/18Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2503975 Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized
2025/11/18Generic · Class 3 Buspirone Hydrochloride TabletsCYHS2503974 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2025/11/18Generic · Class 3 Furosemide Oral SolutionCYHS2503973 Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized
2025/11/18Generic · Class 3 Furosemide Oral SolutionCYHS2503972 Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized
2025/11/18Generic · Class 3 尿素[14C]胶囊 · No verified English nameCYHL2500205 Wuxi Bei Ta Pharmaceuticals Technology Co., Ltd. romanized
2025/11/18New drug · Class 1 RGL-270注射液 · No verified English nameCXSL2500980 Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized; Guangzhou Rui Ling Pharmaceuticals Co., Ltd. romanized
2025/11/18New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500979 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/11/18New drug · Class 1.3 重组带状疱疹ZFA01佐剂疫苗(CHO细胞) · No verified English nameCXSL2500978 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2025/11/18New drug · Class 1 XW003注射液 · No verified English nameCXSL2500977 Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized
2025/11/18New drug · Class 1 XW003注射液 · No verified English nameCXSL2500976 Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized
2025/11/18New drug · Class 1 注射用ZG005 · No verified English nameCXSL2500975 Name not romanized; Name not romanized
2025/11/18New drug · Class 1 TQF3250胶囊 · No verified English nameCXHL2501268 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2025/11/18New drug · Class 1 TQF3250胶囊 · No verified English nameCXHL2501267 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2025/11/18New drug · Class 1 TQF3250胶囊 · No verified English nameCXHL2501266 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2025/11/18New drug · Class 1 IJ-25-362片 · No verified English nameCXHL2501265 Chengdu Yin Chuang Yuan Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2025/11/18New drug · Class 2.2 YKRH00257吸入溶液 · No verified English nameCXHL2501264 Beijing Ying Ke Rui Innovation Drug Research Co., Ltd. romanized
2025/11/17New drug · Class 1 JNJ-95597528注射液 · No verified English nameCXSL2500974 Qiang Sheng (Zhongguo) Investment Co., Ltd. romanized
2025/11/17New drug · Class 1 YKYY032注射液 · No verified English nameCXHL2501263 Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized
2025/11/17New drug · Class 2.1; 2.4 AP-2202片 · No verified English nameCXHL2501262 Hangzhou An Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/15Import · Class 1 EPX-100口服溶液 · No verified English nameJXHL2500354 Epygenix Therapeutics Inc.; Tenacia Biotechnology (Shanghai) Co. Ltd

85 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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