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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 281 drug applications between 30 March 2023 and 5 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 59, covering 46 drug names.

2023/03/30 – 2023/04/05

Period
2023/03/30 to 2023/04/05, 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)
46
Accepted this week, now under review
1

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, 59 of them generic

By application type

Application typeFilings
Supplement156
Generic59
Import26
New drug23
Import re-registration10
Unspecified5
Drug-device combination product2

By drug type

Drug typeFilings
Chemical drug202
TCM50
Therapeutic biologic28
Prophylactic 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

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Diprophylline Injection227
2氧(液态) · No verified English name2213
3Oseltamivir Phosphate For Oral Suspension222
4Tadalafil Tablets2123
5Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2123
6Potassium Chloride Granules214
7Thiotepa for Injection210
8注射用头孢唑肟钠 · No verified English name214
9Trimetazidine Dihydrochloride Tablets210
10Dapoxetine Hydrochloride Tablets2120

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

155 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Wuhan Xiang Cao Tang Pharma Co., Ltd. romanized25240
2Shijiazhuang No.4 Pharmaceutical Co., Ltd.643
3Eli Lilly and Company610
4Heilongjiang Hua Xi Biopharmaceuticals Technology Co., Ltd. romanized550
5Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized520
6Celgene Corporation510
7Chu Xiong He Chuang Pharma Co., Ltd. romanized430
8Novo Nordisk A/S420
9Xian Sheng Zai Ming Pharmaceuticals Co., Ltd. romanized420
10Chongqing Rui En Pharmaceuticals Co., Ltd. romanized420

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

61 this week

AcceptedDrugApplicants
2023/04/05Import · Class 1 AMG 451 · No verified English nameJXSL2300064 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2023/04/05Generic · Class 3 Thiotepa for InjectionCYHS2300983 Name not romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2023/04/05Generic · Class 3 Thiotepa for InjectionCYHS2300982 Name not romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2023/04/05Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2300981 Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized
2023/04/05Generic · Class 3 Polyvinyl Alcohol Eye DropsCYHS2300976 Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized
2023/04/05Generic · Class 3 Potassium Chloride GranulesCYHS2300965 Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; Ji Chuan Pharma Group Co., Ltd. romanized
2023/04/05Generic · Class 3 Potassium Chloride GranulesCYHS2300964 Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; Ji Chuan Pharma Group Co., Ltd. romanized
2023/04/05Generic · Class 3 阿巴帕肽注射液 · No verified English nameCYHL2300044 Chengdu Guo Wei Biopharmaceuticals Co., Ltd. romanized
2023/04/05New drug · Class 2.2 舒格利单抗注射液 · No verified English nameCXSS2300016 Hui Rui Investment Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized
2023/04/05New drug · Class 3.2 C1酯酶抑制剂 · No verified English nameCXSL2300226 Hua Run Bo Ya Biopharmaceutical Group Co., Ltd. romanized
2023/04/04Import · Class 2.4 达罗他胺片 · No verified English nameJXHL2300075 Bayer HealthCare Pharmaceuticals Inc.; Bayer Healthcare Company Ltd.
2023/04/04Generic · Class 3 Pentoxifylline InjectionCYHS2300961 Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized
2023/04/04Generic · Class 3 Minoxidil Topical SolutionCYHS2300960 Shenzhen Shi Lang Bo Biopharmaceuticals Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd.
2023/04/04Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2300958 Beijing Si Li An Pharma Co., Ltd. romanized
2023/04/04Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2300956 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/04/04Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2300954 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2023/04/04Generic · Class 3 聚乙二醇钠钾散 · No verified English nameCYHS2300952 Ji Chuan Pharma Group Co., Ltd. romanized
2023/04/04New drug · Class 1 SENL101自体T细胞注射液 · No verified English nameCXSL2300225 Hebei Sen Lang Bio Technology Co., Ltd. romanized
2023/04/04New drug · Class 1 伊鲁阿克片 · No verified English nameCXHS2300042 Qilu Pharmaceutical Co., Ltd.
2023/04/04New drug · Class 1 伊鲁阿克片 · No verified English nameCXHS2300041 Qilu Pharmaceutical Co., Ltd.
2023/04/04New drug · Class 1 CB06-036 · No verified English nameCXHL2300353 Shanghai Zhi Meng Pharmaceuticals Technology Co., Ltd. romanized
2023/04/04New drug · Class 1 CB06-036 · No verified English nameCXHL2300352 Shanghai Zhi Meng Pharmaceuticals Technology Co., Ltd. romanized
2023/04/03Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300951 Hefei Guo Gao Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized
2023/04/03Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300950 Hefei Guo Gao Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized
2023/04/03New drug · Class 1 TQH2929注射液 · No verified English nameCXSL2300224 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/04/01Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2300032 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2023/04/01Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2300031 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2023/04/01Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2300030 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2023/04/01Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2300029 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2023/04/01Generic · Class 3 Pirfenidone TabletsCYHS2300947 Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized

31 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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