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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 426 drug applications between 28 February 2026 and 6 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 52, covering 43 drug names.

2026/02/28 – 2026/03/06

Period
2026/02/28 to 2026/03/06, 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
426
Drugs with new generic filings (by drug name, de-duplicated)
43
Accepted this week, now under review
115

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

426filings, 52 of them generic

By application type

Application typeFilings
Supplement247
New drug79
Generic52
Import32
Unspecified8
Import re-registration8

By drug type

Drug typeFilings
Chemical drug211
TCM107
Therapeutic biologic99
Prophylactic biologic5
Biologic3
In vitro diagnostic reagent1

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

43 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cetitizine Hydrochloride Oral Solution316
2环硅酸锆钠散 · No verified English name2112
3Rosuvastatin Calcium Tablets2118
4Mirogabalin Besilate Tablets2161
5Dapagliflozin Tablets2184
6Acetate And Glucose Electrolytes Injection214
7Gadoteridol Injection213
8Finerenone Tablets2169
9Fluticasone Propionate Cream1112
10Acetylcysteine Injection1153

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

236 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bayer Vital GmbH1610
2Hong Ji Tang Pharmaceutical (Lai Wu Qu) Co., Ltd. romanized14120
3Eli Lilly and Company950
4Amgen Inc.930
5Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized660
6Tianjin Hong Ren Tang Pharma Co., Ltd. romanized660
7Shanxi Huang He Zhong Yao Co., Ltd. romanized550
8Shaanxi Pan Long Pharma Group Co., Ltd. romanized550
9Janssen Research & Development LLC530
10Changchun Jin Sai Pharma Co., Ltd. romanized530

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

127 this week

AcceptedDrugApplicants
2026/03/06Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSS2600020 MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2026/03/06Import · Class 2.4 贝组替凡片 · No verified English nameJXHS2600030 MERCK SHARP & DOHME (UK) LIMITED; MSD INTERNATIONAL GMBH; MSD R&D (China) Co. Ltd
2026/03/06Generic · Class 3 Acetylcysteine TabletsCYHS2600621 Hebei Rui Sen Pharma Co., Ltd. romanized
2026/03/06Generic · Class 3 Cetitizine Hydrochloride Oral SolutionCYHS2600618 Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized
2026/03/06Generic · Class 3 Cetitizine Hydrochloride Oral SolutionCYHS2600617 Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized
2026/03/06Generic · Class 3 Cetitizine Hydrochloride Oral SolutionCYHS2600616 Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized
2026/03/06Generic · Class 3 Acetate And Glucose Electrolytes InjectionCYHS2600615 Chengdu Sai Nuo Lian Chuang Bio Technology Co., Ltd. romanized; Sichuan Tai Ping Yang Pharma Co., Ltd. romanized
2026/03/06Generic · Class 3 Acetate And Glucose Electrolytes InjectionCYHS2600614 Chengdu Sai Nuo Lian Chuang Bio Technology Co., Ltd. romanized; Sichuan Tai Ping Yang Pharma Co., Ltd. romanized
2026/03/06New drug · Class 1.1 小儿健脾消食颗粒 · No verified English nameCXZL2600026 Shandong Han Fang Pharmaceutical Co., Ltd. romanized
2026/03/06New drug · Class 1 SYS6063注射液 · No verified English nameCXSL2600308 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2026/03/06New drug · Class 1 HSK39297片 · No verified English nameCXHS2600039 Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized; Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized
2026/03/06New drug · Class 1 GNTbm-38 2HCl 胶囊 · No verified English nameCXHL2600275 Nuo Wei Tai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/03/06New drug · Class 1 GNTbm-38 2HCl 胶囊 · No verified English nameCXHL2600274 Nuo Wei Tai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/03/06New drug · Class 2.4 TM001 · No verified English nameCXHL2600273 Haerbin Tian Mei Pharma Co., Ltd. romanized
2026/03/05Import · Class 1 Pasritamig注射液 · No verified English nameJXSL2600068 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/03/05Import · Class 1 Pasritamig注射液 · No verified English nameJXSL2600067 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/03/05Import · Class 1 JNJ-87189401 注射液 · No verified English nameJXSL2600066 Janssen Research & Development LLC; Johnson & Johnson (China)Investment Ltd.
2026/03/05Import · Class 1 JNJ-87189401 注射液 · No verified English nameJXSL2600065 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/03/05Generic · Class 3 Gabapentin Oral SolutionCYHS2600612 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized; Shanghai Zhong Hua Pharma Co., Ltd. romanized
2026/03/05New drug · Class 3.1 桃红四物汤颗粒 · No verified English nameCXZS2600016 Shanghai Kai Bao Pharma Co., Ltd. romanized
2026/03/05New drug · Class 3.4 人凝血因子Ⅸ · No verified English nameCXSL2600307 Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized
2026/03/05New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2600306 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/03/05New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2600305 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/03/05New drug · Class 1 注射用SHR-A2009 · No verified English nameCXSL2600304 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/03/05New drug · Class 1 HS-20117注射液 · No verified English nameCXSL2600303 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/03/05New drug · Class 2.4 甲磺酸阿美替尼片 · No verified English nameCXHS2600038 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2026/03/05New drug · Class 1 Alpha-0261片 · No verified English nameCXHL2600272 Shanghai A Er Fa Fen Zi Qi Ye Development Co., Ltd. romanized
2026/03/05New drug · Class 1 Alpha-0261片 · No verified English nameCXHL2600271 Shanghai A Er Fa Fen Zi Qi Ye Development Co., Ltd. romanized
2026/03/04Import · Class 2.2 Mirikizumab注射液 · No verified English nameJXSL2600064 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/04Import · Class 2.2 Mirikizumab注射液 · No verified English nameJXSL2600063 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.

97 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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