YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 335 drug applications between 27 February 2025 and 5 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 63 drug names.

2025/02/27 – 2025/03/05

Period
2025/02/27 to 2025/03/05, 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
335
Drugs with new generic filings (by drug name, de-duplicated)
63
Accepted this week, now under review
8

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

335filings, 82 of them generic

By application type

Application typeFilings
Supplement178
Generic82
New drug50
Import14
Import re-registration8
Unspecified3

By drug type

Drug typeFilings
Chemical drug216
TCM74
Therapeutic biologic38
Prophylactic biologic6
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

63 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Polidocanol Injection5223
2Oxaliplatin Injection314
3Mupirocin Ointment2230
4Acetylcysteine Granules214
5Lactulose Oral Solution2134
6Ibrutinib Tablets210
7Procaterol Hydrochloride Solution for Inhalation212
8Baricitinib Tablets2132
9Famotidine Injection218
10Cefuroxime Sodium for Injection218

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

191 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized24220
2Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized820
3Bayer AG810
4Shanghai Min Wei Bio Technology Co., Ltd. romanized810
5Guizhou San Ren Tang Pharma Co., Ltd. romanized770
6Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized550
7Novo Nordisk A/S510
8Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized510
9Heilongjiang Han Hong Pharma Co., Ltd. romanized440
10Pfizer Inc.430

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

107 this week

AcceptedDrugApplicants
2025/03/05Import · Class 1 CagriSema注射液 · No verified English nameJXSL2500034 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd.
2025/03/05Import · Class 1 CagriSema注射液 · No verified English nameJXSL2500033 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2025/03/05Import · Class 1 CagriSema注射液 · No verified English nameJXSL2500032 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2025/03/05Import · Class 1 CagriSema注射液 · No verified English nameJXSL2500031 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2025/03/05Import · Class 1 CagriSema注射液 · No verified English nameJXSL2500030 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2025/03/05Import · Class 1 PF-06821497片 · No verified English nameJXHL2500034 Pfizer Inc.; Pfizer Investment Co. Ltd.
2025/03/05Import · Class 1 PF-06821497片 · No verified English nameJXHL2500033 Pfizer Inc.; Pfizer Investment Co. Ltd.
2025/03/05Generic · Class 3 Terlipressin Acetate InjectionCYHS2500927 Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2025/03/05Generic · Class 3 Fudosteine oral solutionCYHS2500925 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/03/05Generic · Class 3 美洛昔康纳米晶注射液 · No verified English nameCYHS2500924 Yangtze River Pharmaceutical Group Co., Ltd
2025/03/05Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2500923 Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized
2025/03/05Generic · Class 3 聚乙二醇3350散 · No verified English nameCYHS2500920 Hefei Sheng Qin Pharmaceuticals Technology Co., Ltd. romanized; Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized
2025/03/05New drug · Class 1 注射用重组人源化抗BCMA/CD3双特异性抗体 · No verified English nameCXSL2500199 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2025/03/05New drug · Class 2.2 利奥西呱胃滞留缓释胶囊 · No verified English nameCXHL2500250 Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized
2025/03/05New drug · Class 2.2 利奥西呱胃滞留缓释胶囊 · No verified English nameCXHL2500249 Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized
2025/03/05New drug · Class 2.2 利奥西呱胃滞留缓释胶囊 · No verified English nameCXHL2500248 Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized
2025/03/05New drug · Class 2.2 利奥西呱胃滞留缓释胶囊 · No verified English nameCXHL2500247 Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized
2025/03/05New drug · Class 2.2 利奥西呱胃滞留缓释胶囊 · No verified English nameCXHL2500246 Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized
2025/03/05New drug · Class 1 奎斯诺片 · No verified English nameCXHL2500245 Zhong Ke Nanjing Sheng Ming Health Gao Deng Research Institute romanized
2025/03/05New drug · Class 1 HS-10510片 · No verified English nameCXHL2500244 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2025/03/05New drug · Class 1 HS-10510片 · No verified English nameCXHL2500243 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2025/03/04Import · Class 2.2 伊奈利珠单抗注射液 · No verified English nameJXSS2500021 Horizon Therapeutics Ireland DAC; AstraZeneca Nijmegen B.V.; Changzhou Hansoh Pharmaceutical Co. Ltd.
2025/03/04Import · Class 1 PIT565 · No verified English nameJXSL2500029 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/03/04Generic · Class 3 Famotidine InjectionCYHS2500914 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shanxi Pu De Pharma Co., Ltd. romanized
2025/03/04Generic · Class 3 Famotidine InjectionCYHS2500913 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shanxi Pu De Pharma Co., Ltd. romanized
2025/03/04Generic · Class 3 Doxycycline Hyclate TabletsCYHS2500910 TC Pharmaceuticals (Jiangsu) Co., Ltd
2025/03/04Generic · Class 3 Aceclofenac TabletsCYHS2500909 Hefei Ying Tai Pharmaceutical Co., Ltd. romanized
2025/03/04Generic · Class 3 Eltrombopag Lamine For Oral SuspensionCYHS2500908 Hubei Min Kang Pharma Group Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/03/04Generic · Class 3 Sodium Thiosulfate InjectionCYHS2500905 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized
2025/03/04Generic · Class 3 Sodium Thiosulfate InjectionCYHS2500904 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized

77 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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