YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 402 drug applications between 25 August 2026 and 31 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 61, covering 42 drug names.

2026/08/25 – 2026/08/31

Period
2026/08/25 to 2026/08/31, 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
402
Drugs with new generic filings (by drug name, de-duplicated)
42
Accepted this week, now under review
250

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

402filings, 61 of them generic

By application type

Application typeFilings
Supplement247
Generic61
New drug54
Import31
Import re-registration5
Unspecified4

By drug type

Drug typeFilings
Chemical drug185
TCM133
Therapeutic biologic77
Prophylactic biologic7

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

42 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dotinurad Tablets4255
2Dapagliflozin Tablets4284
3二硫化硒洗剂 · No verified English name3214
4Pregabalin Extended release Tablets3113
5Eplerenone Tablets214
6Orlistat Capsules218
7琥珀酸地文拉法辛缓释片 · No verified English name213
8甘油灌肠剂 · No verified English name212
9Metformin Hydrochloride Tablets214
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

224 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Gao Miao Pharma Co., Ltd. romanized17170
2F. Hoffmann-La Roche Ltd1020
3Eli Lilly and Company930
4Novo Nordisk A/S920
5Ming Hui Pharmaceuticals (Shanghai) Co., Ltd. romanized740
6Luo Yang Yi Long Pharma Co., Ltd. romanized660
7Haerbin Zhong Yao Si Factory Co., Ltd. romanized440
8Topfond Pharmaceutical Co., Ltd.440
9Hubei Tong De Tang Pharma Co., Ltd. romanized440
10AbbVie Inc.430

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

106 this week

AcceptedDrugApplicants
2026/08/31Import · Class 1 注射用MK-2750 · No verified English nameJXSL2600235 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/08/31Import · Class 1 FUB523注射液 · No verified English nameJXSL2600234 Novartis Pharma AG
2026/08/31Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600378 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/31Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600377 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/31Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600376 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/31Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600375 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/31Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600374 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/31Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600373 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/31Import · Class 2.4 盐酸阿曲生坦片 · No verified English nameJXHL2600372 Novartis Pharma AG
2026/08/31Generic · Class 3 Ebastine Oral SolutionCYHS2602166 Nanchang Li Jian Pharma Co., Ltd. romanized
2026/08/31Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2602163 Jing Shi (Hangzhou) Pharma Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2026/08/31Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2602162 Jing Shi (Hangzhou) Pharma Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2026/08/31Generic · Class 3 Eplerenone TabletsCYHS2602158 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2026/08/31Generic · Class 3 Eplerenone TabletsCYHS2602157 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2026/08/31New drug · Class 1 JUR-003注射液 · No verified English nameCXSL2600939 Shuo Lei Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/08/31New drug · Class 1 JUR-003注射液 · No verified English nameCXSL2600938 Shuo Lei Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/08/31New drug · Class 1 Cizutamig注射液(皮下注射) · No verified English nameCXSL2600937 Shanghai Tan Di Biopharmaceuticals Technology Co., Ltd. romanized
2026/08/31New drug · Class 1 AZD7003 · No verified English nameCXSL2600936 A Si Li Kang Investment (Zhongguo) Co., Ltd. romanized
2026/08/31New drug · Class 1 沃拉德单抗注射液 · No verified English nameCXSL2600935 Beijing Ke Xin Mei De Biopharmaceuticals Technology Co., Ltd. romanized
2026/08/31New drug · Class 1 沃拉德单抗注射液 · No verified English nameCXSL2600934 Beijing Ke Xin Mei De Biopharmaceuticals Technology Co., Ltd. romanized
2026/08/31New drug · Class 3.3 冻干人用狂犬病疫苗(ZFB-3细胞) · No verified English nameCXSL2600933 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2026/08/31New drug · Class 1 注射用BL-M08D1 · No verified English nameCXSL2600932 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/08/31New drug · Class 1 MWX205注射液 · No verified English nameCXHL2601057 Shanghai Min Wei Bio Technology Co., Ltd. romanized
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

76 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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