YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 281 drug applications between 29 December 2023 and 4 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 58 drug names.

2023/12/29 – 2024/01/04

Period
2023/12/29 to 2024/01/04, 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
281
Drugs with new generic filings (by drug name, de-duplicated)
58
Accepted this week, now under review
0

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

281filings, 76 of them generic

By application type

Application typeFilings
Supplement132
Generic76
New drug50
Import11
Import re-registration8
Unspecified4

By drug type

Drug typeFilings
Chemical drug207
TCM38
Therapeutic biologic33
Prophylactic biologic3

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

58 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Minoxidil Liniment4252
3Citicoline Injection310
4Levofloxacin Tablets227
5氯化钙注射液 · No verified English name226
6腺苷钴胺胶囊 · No verified English name228
7Lactulose Oral Solution2134
8注射用头孢唑肟钠 · No verified English name214
9Dopamine Hydrochloride Injection213
10Thioctic Acid Tablets214

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

184 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized10100
2Boehringer Ingelheim International GmbH820
3Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized543
4Shandong Xin Shi Dai Pharma Co., Ltd. romanized442
5Nanjing Healthnice Pharmaceutical Technology Co., Ltd430
6Xizang Bang Chen Pharma Group Co., Ltd. romanized420
7Celgene Corporation410
8Jilin San Jiu Jin Fu Kang Pharma Co., Ltd. romanized330
9Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized320
10Kamari Pharma Ltd310

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

87 this week

AcceptedDrugApplicants
2024/01/04Import · Class 2.2 注射用罗特西普 · No verified English nameJXSL2400003 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/01/04Import · Class 2.2 注射用罗特西普 · No verified English nameJXSL2400002 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/01/04Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2400050 Fujian Sheng Yi Long Li Kang Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Wan Run Pharma Co., Ltd. romanized
2024/01/04Generic · Class 3 Minoxidil LinimentCYHS2400046 Hefei Hua Wei Pharma Co., Ltd. romanized
2024/01/04Generic · Class 3 Minoxidil LinimentCYHS2400045 Hefei Hua Wei Pharma Co., Ltd. romanized
2024/01/04Generic · Class 3 Minoxidil LinimentCYHS2400044 Shang Yao Dong Ying (Jiangsu) Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/01/04Generic · Class 3 Minoxidil LinimentCYHS2400043 Shang Yao Dong Ying (Jiangsu) Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/01/04Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2400042 Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized
2024/01/04Generic · Class 3 Polaprezinc GranulesCYHS2400038 Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2024/01/04Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2400037 Kunming Bei Ke Nuo Dun Pharmaceutical Co., Ltd. romanized
2024/01/04Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2400033 Hainan Tao Sheng Pharmaceuticals Technology Research Institute Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanized
2024/01/04Generic · Class 3 Flurbiprofen Axetil InjectionCYHS2400026 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/01/04Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2400025 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/01/04New drug · Class 2.3 湿润烧伤膏 · No verified English nameCXZL2400001 Shan Tou Shi Mei Bao Pharmaceutical Co., Ltd. romanized
2024/01/04New drug · Class 2.2 瑞基奥仑赛注射液 · No verified English nameCXSS2400002 Shanghai Yao Ming Ju Nuo Bio Technology Co., Ltd. romanized; Suzhou Yao Ming Ju Nuo Bio Technology Co., Ltd. romanized
2024/01/04New drug · Class 1 赛立奇单抗注射液 · No verified English nameCXSS2400001 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2024/01/04New drug · Class 1 洛奈利单抗注射液 · No verified English nameCXSL2400008 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/01/04New drug · Class 1.2 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2400007 Ji Nuo Wei (Shanghai) Bio Zhi Pin Co., Ltd. romanized; Beijing Ji Nuo Wei Bio Technology Co., Ltd. romanized; Ji Nuo Wei (Lang Fang Lin Kong Zi Mao Qu) Bio Zhi Pin Co., Ltd. romanized
2024/01/04New drug · Class 2.2 兰索拉唑碳酸氢钠干混悬剂 · No verified English nameCXHL2400009 Nanjing Healthnice Pharmaceutical Technology Co., Ltd
2024/01/04New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2400008 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/01/04New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2400007 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/01/04New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2400006 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/01/04New drug · Class 1 CP0119片 · No verified English nameCXHL2400005 Nan Kai University romanized
2024/01/04New drug · Class 1 CP0119片 · No verified English nameCXHL2400004 Nan Kai University romanized
2024/01/04New drug · Class 2.2 兰索拉唑碳酸氢钠干混悬剂 · No verified English nameCXHL2400003 Nanjing Healthnice Pharmaceutical Technology Co., Ltd
2024/01/04New drug · Class 2.2 艾司奥美拉唑镁碳酸氢钠干混悬剂(Ⅱ) · No verified English nameCXHL2400002 Nanjing Healthnice Pharmaceutical Technology Co., Ltd
2024/01/04New drug · Class 2.2 艾司奥美拉唑镁碳酸氢钠干混悬剂(Ⅰ) · No verified English nameCXHL2400001 Nanjing Healthnice Pharmaceutical Technology Co., Ltd
2024/01/03Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2400001 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2024/01/03Import · Class 1 镥[177Lu]依多曲肽注射液 · No verified English nameJXHL2400001 ITM Solucin GmbH; Grand Pharmaceutical (China) Co. Ltd.
2024/01/03Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2400020 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized

57 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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