YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 442 drug applications between 21 August 2026 and 27 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 52 drug names.

2026/08/21 – 2026/08/27

Period
2026/08/21 to 2026/08/27, 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
442
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
256

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

442filings, 73 of them generic

By application type

Application typeFilings
Supplement248
Generic73
New drug62
Import38
Unspecified13
Import re-registration8

By drug type

Drug typeFilings
Chemical drug224
TCM124
Therapeutic biologic79
Prophylactic biologic14
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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dotinurad Tablets4255
2Brivaracetam Tablets3119
3Pregabalin Extended release Tablets3113
4生理氯化钠溶液 · No verified English name2217
5Glucosamine Sulfate Capsules2251
6Orlistat Capsules218
7Ibuprofen Injection218
8琥珀酸地文拉法辛缓释片 · No verified English name213
9甘油灌肠剂 · No verified English name212
10Metformin Hydrochloride Tablets214

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

241 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Gao Miao Pharma Co., Ltd. romanized39350
2Luo Yang Yi Long Pharma Co., Ltd. romanized10100
3Ming Hui Pharmaceuticals (Shanghai) Co., Ltd. romanized740
4Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized640
5Chengdu Brilliant Pharmaceutical Co., Ltd.631
6Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized630
7Eli Lilly Italia S.p.A.610
8Eli Lilly and Company610
9Pfizer Inc.530
10Haerbin Zhong Yao Si Factory 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

128 this week

AcceptedDrugApplicants
2026/08/27Import · Class 3.1 司美格鲁肽片 · No verified English nameJXSS2600082 Novo Nordisk A/S; Novo Nordisk Pharmaceutical Industries LP; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2026/08/27Import · Class 3.1 司美格鲁肽片 · No verified English nameJXSS2600081 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2026/08/27Import · Class 3.1 司美格鲁肽片 · No verified English nameJXSS2600080 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2026/08/27Import · Class 3.1 司美格鲁肽片 · No verified English nameJXSS2600079 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2026/08/27Import · Class 1 注射用VIR-5500 · No verified English nameJXSL2600231 Astellas Pharma Global Development Inc.; Astellas (Beijing) Pharmaceutical R&D Co. Ltd.
2026/08/27Import · Class 2.4 瑞米布替尼片 · No verified English nameJXHL2600367 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/08/27Import · Class 1 Petrelintide注射液 · No verified English nameJXHL2600366 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/27Import · Class 1 Petrelintide注射液 · No verified English nameJXHL2600365 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/27Import · Class 1 Petrelintide注射液 · No verified English nameJXHL2600364 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/27Import · Class 1 Petrelintide注射液 · No verified English nameJXHL2600363 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/27Generic · Class 3 Pregabalin Extended release TabletsCYHS2602149 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/08/27Generic · Class 3 Pregabalin Extended release TabletsCYHS2602148 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/08/27Generic · Class 3 Pregabalin Extended release TabletsCYHS2602147 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/08/27Generic · Class 3 Levothyroxine Sodium Oral SolutionCYHS2602146 Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized
2026/08/27Generic · Class 3 甘油灌肠剂 · No verified English nameCYHS2602139 Heilongjiang Lai Kang Pharmaceutical Co., Ltd. romanized; Yi Chun Kang Er Xin Pharma Co., Ltd. romanized
2026/08/27Generic · Class 3 甘油灌肠剂 · No verified English nameCYHS2602138 Heilongjiang Lai Kang Pharmaceutical Co., Ltd. romanized; Yi Chun Kang Er Xin Pharma Co., Ltd. romanized
2026/08/27Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2602137 Shandong Qidu Pharmaceutical Co., Ltd.
2026/08/27New drug · Class 1.1 麻痛颗粒 · No verified English nameCXZL2600081 Tai Zhou Le Ye Zhi Neng Technology Partnership (Limited Partnership) romanized
2026/08/27New drug · Class 1 CUG279 · No verified English nameCXSL2600925 Shanghai Zheng Yin Da Biopharmaceuticals Co., Ltd. romanized
2026/08/27New drug · Class 1 注射用MRG009 · No verified English nameCXSL2600924 Le Pu Bio Technology Co., Ltd. romanized
2026/08/27New drug · Class 1 BBT002皮下注射液 · No verified English nameCXSL2600923 Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized
2026/08/27New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2600922 Wuhan Han Mi Dun Bio Technology Co., Ltd. romanized
2026/08/27New drug · Class 1 UX-GIP001注射液 · No verified English nameCXSL2600921 Shanghai Yue Sai Bio Technology Co., Ltd. romanized
2026/08/27New drug · Class 1 注射用BNT3210 · No verified English nameCXSL2600920 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/08/27New drug · Class 1 KQB198胶囊 · No verified English nameCXHL2601051 Jin Ju Bio Technology (Shanghai) Co., Ltd. romanized
2026/08/27New drug · Class 1 KQB198胶囊 · No verified English nameCXHL2601050 Jin Ju Bio Technology (Shanghai) Co., Ltd. romanized
2026/08/27New drug · Class 1 AHB-137注射液 · No verified English nameCXHL2601049 Hangzhou Hao Bo Pharmaceuticals Co., Ltd. romanized
2026/08/27New drug · Class 1 PRT-064040鼻喷雾剂 · No verified English nameCXHL2601048 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2026/08/27New drug · Class 1 HW281171片 · No verified English nameCXHL2601047 Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized
2026/08/27New drug · Class 1 HW281171片 · No verified English nameCXHL2601046 Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized

98 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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