YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 232 drug applications between 1 April 2023 and 7 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 40 drug names.

2023/04/01 – 2023/04/07

Period
2023/04/01 to 2023/04/07, 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
232
Drugs with new generic filings (by drug name, de-duplicated)
40
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

232filings, 53 of them generic

By application type

Application typeFilings
Supplement138
Generic53
New drug22
Import11
Import re-registration5
Unspecified2
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug162
TCM46
Therapeutic biologic24

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

40 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1氧(液态) · No verified English name2213
2Oseltamivir Phosphate For Oral Suspension222
3Polyvinyl Alcohol Eye Drops2224
4Tadalafil Tablets2123
5Ozagrel Sodium Injection213
6Levocarnitine Oral Solution219
7Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2123
8Potassium Chloride Granules214
9Thiotepa for Injection210
10注射用头孢唑肟钠 · No verified English name214

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

137 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Wuhan Xiang Cao Tang Pharma Co., Ltd. romanized25240
2Heilongjiang Hua Xi Biopharmaceuticals Technology Co., Ltd. romanized550
3Qilu Pharmaceutical Co., Ltd.520
4Chu Xiong He Chuang Pharma Co., Ltd. romanized430
5Xian Sheng Zai Ming Pharmaceuticals Co., Ltd. romanized420
6Actelion Pharmaceuticals Ltd410
7Pfizer Europe MA EEIG410
8Chongqing Tian Zhi Pharma Co., Ltd. romanized330
9Biocon Pharma Limited310
10Novo Nordisk A/S310

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

54 this week

AcceptedDrugApplicants
2023/04/07Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2300995 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2023/04/07Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2300994 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2023/04/07Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2300993 Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/04/07Generic · Class 3 Polyvinyl Alcohol Eye DropsCYHS2300992 Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/04/07Generic · Class 3 Diprophylline InjectionCYHS2300991 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/04/07Generic · Class 3 Silodosin TabletsCYHS2300990 Beijing Ai Li Jia Pharmaceuticals Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
2023/04/07New drug · Class 1 MG-013人源化单抗注射液 · No verified English nameCXSL2300232 Shanghai Mai Ji Bio Technology Co., Ltd. romanized
2023/04/07New drug · Class 1 MG-013人源化单抗注射液 · No verified English nameCXSL2300231 Shanghai Mai Ji Bio Technology Co., Ltd. romanized
2023/04/07New drug · Class 1 XJ103注射液 · No verified English nameCXSL2300230 Xing Ji Bio (Suzhou) Co., Ltd. romanized
2023/04/07New drug · Class 1 人前脑神经前体细胞注射液 · No verified English nameCXSL2300229 Zhejiang Huo De Bio Gong Cheng Co., Ltd. romanized
2023/04/07New drug · Class 1 注射用重组WNV-HCD86 · No verified English nameCXSL2300228 Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized
2023/04/07New drug · Class 1 SDT-101马来酸盐胶囊 · No verified English nameCXHL2300355 Suzhou Jin Sheng Pharma Co., Ltd. romanized
2023/04/07New drug · Class 1 SDT-101马来酸盐胶囊 · No verified English nameCXHL2300354 Suzhou Jin Sheng Pharma Co., Ltd. romanized
2023/04/06Generic · Class 3 Ozagrel Sodium InjectionCYHS2300985 Beijing Si Huan Ke Bao Pharma Co., Ltd. romanized; Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/04/06Generic · Class 3 Ozagrel Sodium InjectionCYHS2300984 Beijing Si Huan Ke Bao Pharma Co., Ltd. romanized; Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/04/06New drug · Class 1 DS001注射用冻干粉针 · No verified English nameCXSL2300227 Zhongguo Ke College Shanghai Drug Research Institute romanized; Da Shi Pharma (Guangdong) Co., Ltd. romanized
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

24 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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