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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 494 drug applications between 1 July 2026 and 7 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 84, covering 53 drug names.

2026/07/01 – 2026/07/07

Period
2026/07/01 to 2026/07/07, 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
494
Drugs with new generic filings (by drug name, de-duplicated)
53
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

494filings, 84 of them generic

By application type

Application typeFilings
Supplement298
Generic84
New drug64
Import26
Unspecified14
Import re-registration8

By drug type

Drug typeFilings
Chemical drug229
TCM204
Therapeutic biologic54
Biologic6
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

53 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nafamostat Mesilate for Injection6438
2司美格鲁肽注射液 · No verified English name5192
3Adapalene And Benzoyl Peroxide Gel4230
4泊马度胺胶囊 · No verified English name414
5Ambroxol Hydrochloride Oral Solution3346
6Levothyroxine Sodium Oral Solution314
7Dopamine Hydrochloride Injection313
8Edaravone and Dexborneol Concentrated Solution for Injection2234
9Glucosamine Sulfate Capsules2251
10Lactulose Oral Solution2134

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

287 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized24180
2AstraZeneca AB1320
3Lan Yun Zhi He Bio Technology Co., Ltd. romanized880
4Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized870
5Zhong Shan Shi Heng Sheng Pharma Co., Ltd. romanized660
6Hubei Tai Zi Pharma Co., Ltd. romanized550
7Kang Nuo Ya Biopharmaceuticals Technology Co., Ltd. romanized530
8Qilu Pharmaceutical Co., Ltd.532
9Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized515
10Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized440

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

131 this week

AcceptedDrugApplicants
2026/07/07Import · Class 1 LY4257496注射液 · No verified English nameJXHL2600259 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/07/07Import · Class 1 GSK6042981片 · No verified English nameJXHL2600258 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited
2026/07/07Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2601621 Hebei Qiao Zhou Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2026/07/07Generic · Class 3 Azilsartan TabletsCYHS2601617 Jiangxi Shimei Pharmaceutical Co., Ltd
2026/07/07Generic · Class 3 Tizanidine Hydrochloride TabletsCYHS2601613 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized
2026/07/07New drug · Class 1 GenSci148注射液 · No verified English nameCXSL2600711 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/07/07New drug · Class 1 GenSci148注射液 · No verified English nameCXSL2600710 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/07/07New drug · Class 1 GenSci148注射液 · No verified English nameCXSL2600709 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/07/07New drug · Class 1 GD002细胞外囊泡滴鼻液 · No verified English nameCXSL2600708 Guo Dian (Beijing) Pharmaceuticals Technology Co., Ltd. romanized
2026/07/07New drug · Class 1 GD002细胞外囊泡滴鼻液 · No verified English nameCXSL2600707 Guo Dian (Beijing) Pharmaceuticals Technology Co., Ltd. romanized
2026/07/07New drug · Class 1 GD002细胞外囊泡滴鼻液 · No verified English nameCXSL2600706 Guo Dian (Beijing) Pharmaceuticals Technology Co., Ltd. romanized
2026/07/07New drug · Class 1 造血干细胞来源的血小板注射液 · No verified English nameCXSL2600705 Suzhou Xue Ji Bio Technology Co., Ltd. romanized
2026/07/07New drug · Class 1 SYS6077注射液 · No verified English nameCXSL2600704 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized
2026/07/07New drug · Class 1 ADV2104注射液 · No verified English nameCXSL2600703 Ai Di Wei Xin (Suzhou) Biopharmaceutical Co., Ltd. romanized
2026/07/07New drug · Class 1 注射用SHR-4595 · No verified English nameCXSL2600702 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/07/07New drug · Class 2.4 舒沃替尼片 · No verified English nameCXHL2600807 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2026/07/07New drug · Class 2.4 舒沃替尼片 · No verified English nameCXHL2600806 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2026/07/07New drug · Class 1 维卡格雷胶囊 · No verified English nameCXHL2600805 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2026/07/06Import · Class 2.2 注射用维恩妥尤单抗 · No verified English nameJXSS2600058 Astellas Pharma Europe B.V.; Simtra Deutschland GmbH; Astellas (China) Investment Co. Ltd.
2026/07/06Import · Class 2.2 注射用维恩妥尤单抗 · No verified English nameJXSS2600057 Astellas Pharma Europe B.V.; Simtra Deutschland GmbH; Astellas (China) Investment Co Ltd.
2026/07/06Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2601607 Changzhou Pharmaceutical Factory Co., Ltd. romanized
2026/07/06Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2601606 Changzhou Pharmaceutical Factory Co., Ltd. romanized
2026/07/06Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2601605 Changzhou Pharmaceutical Factory Co., Ltd. romanized
2026/07/06Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2601604 Changzhou Pharmaceutical Factory Co., Ltd. romanized
2026/07/06Generic · Class 3 Levothyroxine Sodium Oral SolutionCYHS2601602 Guangdong Luo Si Te Pharmaceutical Co., Ltd. romanized
2026/07/06Generic · Class 3 Levothyroxine Sodium Oral SolutionCYHS2601601 Guangdong Luo Si Te Pharmaceutical Co., Ltd. romanized
2026/07/06Generic · Class 3 Levothyroxine Sodium Oral SolutionCYHS2601600 Guangdong Luo Si Te Pharmaceutical Co., Ltd. romanized
2026/07/06Generic · Class 3 盐酸赛庚啶口服溶液 · No verified English nameCYHS2601597 Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2026/07/06Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2601596 Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2026/07/06Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601594 Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized

101 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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