YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 398 drug applications between 1 September 2025 and 7 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 113, covering 75 drug names.

2025/09/01 – 2025/09/07

Period
2025/09/01 to 2025/09/07, 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
398
Drugs with new generic filings (by drug name, de-duplicated)
75
Accepted this week, now under review
121

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

398filings, 113 of them generic

By application type

Application typeFilings
Supplement167
Generic113
New drug78
Import29
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug262
TCM70
Therapeutic biologic61
Biologic4
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

75 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets8370
2Polidocanol Injection4223
3Ozagrel Sodium Injection313
4左羟丙哌嗪口服溶液 · No verified English name318
5Brexpiprazole Tablets3131
6Pemafibrate Tablets2223
7Ceftazidime And Avibactam Sodium For Injection2212
8Rivaroxaban Tablets213
9Diclofenac Diethylamine Emulgel2120
10复方醋酸钠葡萄糖注射液 · No verified English name218

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

232 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized1120
2Qilu Pharmaceutical Co., Ltd.1052
3Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized970
4Topfond Pharmaceutical Co., Ltd.880
5Eli Lilly and Company820
6Janssen Research & Development LLC620
7Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized550
8Hubei Ke Lun Pharma Co., Ltd. romanized510
9Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized424
10Shanghai Ao Ke Da Pharmaceuticals Technology Co., Ltd. romanized410

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

148 this week

AcceptedDrugApplicants
2025/09/06Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSS2500122 MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2025/09/06Import · Class 1 FUB523注射液 · No verified English nameJXSL2500169 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/09/06Generic · Class 3 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2503313 Shandong Qidu Pharmaceutical Co., Ltd.
2025/09/06Generic · Class 3 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2503312 Shandong Qidu Pharmaceutical Co., Ltd.
2025/09/06Generic · Class 3 Tiopronin TabletsCYHS2503304 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/09/06Generic · Class 3 Relugolix TabletsCYHL2500162 Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized
2025/09/06New drug · Class 1.1 小儿六味湿疹凝胶 · No verified English nameCXZL2500075 Shandong Han Fang Pharmaceutical Co., Ltd. romanized
2025/09/06New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSL2500774 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/09/06New drug · Class 1 TQB2922注射液(皮下注射) · No verified English nameCXSL2500773 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/09/06New drug · Class 1 ESG206注射液 · No verified English nameCXSL2500772 Shanghai Shi Jian Bio Technology Co., Ltd. romanized
2025/09/06New drug · Class 1 注射用间充质干细胞(脐带) · No verified English nameCXSL2500771 Tianjin Ang Sai Xi Bao Ji Yin Gong Cheng Co., Ltd. romanized
2025/09/06New drug · Class 1 HWS117注射液 · No verified English nameCXSL2500770 Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized
2025/09/06New drug · Class 1 注射用ZG006 · No verified English nameCXSL2500769 Name not romanized; Name not romanized
2025/09/06New drug · Class 1 IBI3033 · No verified English nameCXSL2500768 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/09/06New drug · Class 1 IBI3033 · No verified English nameCXSL2500767 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/09/06New drug · Class 1 GW5282片 · No verified English nameCXHL2500970 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2025/09/06New drug · Class 1 GW5282片 · No verified English nameCXHL2500969 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2025/09/06New drug · Class 1 GS3-007a干混悬剂 · No verified English nameCXHL2500968 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/09/06New drug · Class 1 QLS1304片 · No verified English nameCXHL2500967 Qilu Pharmaceutical Co., Ltd.
2025/09/06New drug · Class 1 QLS1304片 · No verified English nameCXHL2500966 Qilu Pharmaceutical Co., Ltd.
2025/09/06New drug · Class 1 QLS1304片 · No verified English nameCXHL2500965 Qilu Pharmaceutical Co., Ltd.
2025/09/06New drug · Class 1 QLC1401片 · No verified English nameCXHL2500964 Qilu Pharmaceutical Co., Ltd.
2025/09/06New drug · Class 2.4 阿贝西利片 · No verified English nameCXHL2500963 Qilu Pharmaceutical Co., Ltd.
2025/09/06New drug · Class 2.4 阿贝西利片 · No verified English nameCXHL2500962 Qilu Pharmaceutical Co., Ltd.
2025/09/06New drug · Class 2.4 阿贝西利片 · No verified English nameCXHL2500961 Qilu Pharmaceutical Co., Ltd.
2025/09/06New drug · Class 1 VSA012注射液 · No verified English nameCXHL2500960 Wei Ya Zhen Bio Technology (Suzhou) Co., Ltd. romanized
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.

118 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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