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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 409 drug applications between 30 August 2025 and 5 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 125, covering 85 drug names.

2025/08/30 – 2025/09/05

Period
2025/08/30 to 2025/09/05, 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
409
Drugs with new generic filings (by drug name, de-duplicated)
85
Accepted this week, now under review
131

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

409filings, 125 of them generic

By application type

Application typeFilings
Supplement162
Generic125
New drug70
Import37
Unspecified9
Import re-registration6

By drug type

Drug typeFilings
Chemical drug278
TCM62
Therapeutic biologic59
Biologic9
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

85 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets9370
2Polidocanol Injection4223
3Dapoxetine Hydrochloride Tablets3220
4Ozagrel Sodium Injection313
5左羟丙哌嗪口服溶液 · No verified English name318
6Brexpiprazole Tablets3131
7Ceftazidime And Avibactam Sodium For Injection2212
8Rivaroxaban Tablets213
9Diclofenac Diethylamine Emulgel2120
10小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English name211

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

236 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized12110
2Eli Lilly and Company1130
3Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized1120
4Topfond Pharmaceutical Co., Ltd.880
5Novo Nordisk A/S730
6Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized534
7Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized525
8Takeda Canada Inc510
9Terumo Corporation Kofu Factory510
10Hubei Ke Lun Pharma Co., Ltd. romanized510

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

153 this week

AcceptedDrugApplicants
2025/09/05Import · Class 3.1 注射用伏索利肽 · No verified English nameJXSS2500121 BioMarin International Limited; Vetter Pharma-Fertigung GmbH & Co. KG; PAREXEL China Co. Ltd
2025/09/05Import · Class 3.1 注射用伏索利肽 · No verified English nameJXSS2500120 BioMarin International Limited; Vetter Pharma-Fertigung GmbH & Co. KG; PAREXEL China Co. Ltd
2025/09/05Import · Class 3.1 注射用伏索利肽 · No verified English nameJXSS2500119 BioMarin International Limited; Vetter Pharma-Fertigung GmbH & Co. KG; PAREXEL China Co. Ltd
2025/09/05Import · Class 1 ACE1831 · No verified English nameJXSL2500168 Acepodia Biotech Inc.; Syneos Health(Beijing)Inc. Ltd.
2025/09/05Import · Class 1 注射用RO7837195 · No verified English nameJXSL2500167 Genentech Inc.
2025/09/05Import · Class 2.4 阿贝西利片 · No verified English nameJXHS2500096 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd
2025/09/05Import · Class 2.4 阿贝西利片 · No verified English nameJXHS2500095 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd
2025/09/05Import · Class 1 Orforglipron片 · No verified English nameJXHL2500262 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/05Import · Class 1 Orforglipron片 · No verified English nameJXHL2500261 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/05Import · Class 1 Orforglipron片 · No verified English nameJXHL2500260 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/05Import · Class 1 Orforglipron片 · No verified English nameJXHL2500259 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/05Import · Class 1 Orforglipron片 · No verified English nameJXHL2500258 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/05Import · Class 1 Orforglipron片 · No verified English nameJXHL2500257 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/05Generic · Class 3 Thioctic Acid TabletsCYHS2503299 Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/09/05Generic · Class 3 中性腹膜透析液(乳酸盐-G1.5%) · No verified English nameCYHS2503298 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/09/05Generic · Class 3 Articaine Hydrochloride And Epinephrine InjectionCYHS2503297 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/09/05Generic · Class 3 Enalapril Maleate Oral SolutionCYHS2503291 Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2025/09/05Generic · Class 3 西诺氨酯片 · No verified English nameCYHS2503286 Yi Si Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2025/09/05Generic · Class 3 Lidocaine Hydrochloride GelCYHS2503285 Fujian Da Pu Biopharmaceuticals Co., Ltd. romanized; Wuhan Wei Ao Pharmaceutical Co., Ltd. romanized
2025/09/05Generic · Class 3 西诺氨酯片 · No verified English nameCYHS2503284 Yi Si Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2025/09/05Generic · Class 3 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2503280 Guangdong Ke Hong Pharma Co., Ltd. romanized
2025/09/05Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2503278 Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized
2025/09/05Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2503277 Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized
2025/09/05Generic · Class 3 左羟丙哌嗪口服溶液 · No verified English nameCYHS2503273 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/09/05Generic · Class 3 左羟丙哌嗪口服溶液 · No verified English nameCYHS2503272 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/09/05Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2503271 Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized
2025/09/05Generic · Class 3 左羟丙哌嗪口服溶液 · No verified English nameCYHS2503270 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/09/05Generic · Class 3 Minoxidil LinimentCYHS2503268 Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized
2025/09/05Generic · Class 3 Fosfomycin Sodium For InjectionCYHS2503267 Beijing Pin Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2025/09/05Generic · Class 3 Minoxidil LinimentCYHS2503266 Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized

123 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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