YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 427 drug applications between 24 August 2026 and 30 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 52 drug names.

2026/08/24 – 2026/08/30

Period
2026/08/24 to 2026/08/30, 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
427
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
248

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

427filings, 71 of them generic

By application type

Application typeFilings
Supplement247
Generic71
New drug56
Import35
Unspecified12
Import re-registration6

By drug type

Drug typeFilings
Chemical drug220
TCM122
Therapeutic biologic76
Prophylactic biologic9

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
2Dapagliflozin Tablets4284
3Pregabalin Extended release Tablets3113
4Orlistat Capsules218
5Ibuprofen Injection218
6琥珀酸地文拉法辛缓释片 · No verified English name213
7甘油灌肠剂 · No verified English name212
8Metformin Hydrochloride Tablets214
9Phenylephrine Hydrochloride Injection215
10Promethazine Hydrochloride Injection2111

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

238 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Gao Miao Pharma Co., Ltd. romanized36320
2Luo Yang Yi Long Pharma Co., Ltd. romanized10100
3Eli Lilly and Company930
4Ming Hui Pharmaceuticals (Shanghai) Co., Ltd. romanized740
5Eli Lilly Italia S.p.A.610
6AbbVie Inc.530
7Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized530
8Haerbin Zhong Yao Si Factory Co., Ltd. romanized440
9Topfond Pharmaceutical Co., Ltd.440
10Hubei Tong De Tang Pharma 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

116 this week

AcceptedDrugApplicants
2026/08/28Import · Class 3.1 马塔西单抗注射液 · No verified English nameJXSL2600233 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/08/28Import · Class 1 ABBV-901注射用粉末 · No verified English nameJXSL2600232 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/08/28Import · Class 1 PFL-721片 · No verified English nameJXHL2600371 PIERRE FABRE MEDICAMENT; Pierre Fabre (Shanghai) Medical Co. Ltd.
2026/08/28Import · Class 1 PFL-721片 · No verified English nameJXHL2600370 PIERRE FABRE MEDICAMENT; Pierre Fabre (Shanghai) Medical Co. Ltd.
2026/08/28Import · Class 2.4 贝组替凡片 · No verified English nameJXHL2600369 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2026/08/28Import · Class 1 ATL-101鞘内注射液 · No verified English nameJXHL2600368 Atalanta Therapeutics Inc.; Tenacia Biopharmaceuticals (Shanghai) Co. Ltd.
2026/08/28Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2602151 Hubei Wu Shi Pharma Co., Ltd. romanized
2026/08/28Generic · Class 3 Midazolam Nasal SprayCYHL2600092 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/08/28New drug · Class 1 注射用HS-20122 · No verified English nameCXSL2600931 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/08/28New drug · Class 1 ATG-201注射液 · No verified English nameCXSL2600930 De Qi (Hangzhou) Bio Co., Ltd. romanized
2026/08/28New drug · Class 1 ART002g1注射液 · No verified English nameCXSL2600929 Rui Zheng Ji Yin (Suzhou) Co., Ltd. romanized
2026/08/28New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2600928 Guangzhou Bai Ji Ji Yin Technology Co., Ltd. romanized
2026/08/28New drug · Class 1 GenSci161注射液 · No verified English nameCXSL2600927 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/08/28New drug · Class 1 MK-2010注射液 · No verified English nameCXSL2600926 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2026/08/28New drug · Class 1 ZX-8177片 · No verified English nameCXHL2601056 Zheng Xiang Pharmaceuticals (Nanjing) Group Co., Ltd. romanized
2026/08/28New drug · Class 1 ZX-8177片 · No verified English nameCXHL2601055 Zheng Xiang Pharmaceuticals (Nanjing) Group Co., Ltd. romanized
2026/08/28New drug · Class 1 WD-910片 · No verified English nameCXHL2601054 Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized
2026/08/28New drug · Class 1 HRS-9308片 · No verified English nameCXHL2601053 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/08/28New drug · Class 1 HRS-9308片 · No verified English nameCXHL2601052 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
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

86 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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