YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 295 drug applications between 24 June 2021 and 30 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 40, covering 30 drug names.

2021/06/24 – 2021/06/30

Period
2021/06/24 to 2021/06/30, 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
295
Drugs with new generic filings (by drug name, de-duplicated)
30
Accepted this week, now under review
0

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

295filings, 40 of them generic

By application type

Application typeFilings
Supplement156
New drug48
Generic40
Import33
Unspecified11
Import re-registration7

By drug type

Drug typeFilings
Chemical drug194
Therapeutic biologic58
TCM42
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

30 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Compound Ipratropium Bromide Solution For Inhalation224
2Tenofovir alafenamide Fumarate Tablets220
3Clindamycin Injection214
4Selexipag Tablets2124
5Ipratropium Bromide Inhalation Solution212
6Ornidazole Injection210
7Epinastine Hydrochloride Tablets212
8Ropivacaine hydrochloride injection215
9Ketorolac Tromethamine Injection214
10Desmopressin Acetate Injection210

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

167 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhejiang You Sheng Mei Te Zhong Yao Co., Ltd. romanized31280
2Roche Pharma (Schweiz) Ltd.610
3Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized530
4Boehringer Ingelheim International GmbH520
5Janssen Research & Development LLC520
6Baxalta US Inc.510
7Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized440
8Mao Xiang Group Jilin Pharmaceutical Co., Ltd. romanized440
9Pliva Croatia Ltd.420
10UCB Pharma S.A.410

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

91 this week

AcceptedDrugApplicants
2021/06/30Import · Class 2.2 阿替利珠单抗注射液 · No verified English nameJXSS2101014 Roche Registration GmbH; Roche Diagnostics GmbH; Roche (China) Holding Ltd.
2021/06/30Import · Class 1 RO7030816 · No verified English nameJXSL2101058 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2021/06/30Import · Class 1 RO7030816 · No verified English nameJXSL2101057 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2021/06/30Import · Class 1 avalglucosidase alfa for injection · No verified English nameJXSL2101056 Sanofi-aventis Recherche & Développement; Sanofi (China) investment Co. Ltd
2021/06/30Import · Class 1 NNC0385-0434 片 · No verified English nameJXSL2101054 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2021/06/30Import · Class 1 NNC0385-0434 片 · No verified English nameJXSL2101053 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2021/06/30Import · Class 1 NNC0385-0434 片 · No verified English nameJXSL2101052 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2021/06/30Generic · Class 3 ω-3 鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English nameCYHS2101368 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/06/30New drug · Class 1 TP01HN106 · No verified English nameCXSL2101164 Shenzhen Rui Jian Sheng Ming Ke Xue Research Institute Co., Ltd. romanized
2021/06/30New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2101163 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/06/30New drug · Class 1 注射用BEBT-908 · No verified English nameCXHL2101244 Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized
2021/06/29Import · Class 2.2 纳武利尤单抗注射液 · No verified English nameJXSL2101047 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/06/29Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2101363 Haerbin Sheng Tai Biopharmaceutical Co., Ltd. romanized
2021/06/29Generic · Class 3 Clindamycin InjectionCYHS2101359 Anhui Pioneer Pharmaceutical Co., Ltd
2021/06/29Generic · Class 3 Clindamycin InjectionCYHS2101358 Anhui Pioneer Pharmaceutical Co., Ltd
2021/06/29Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2101356 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2021/06/29New drug · Class 3.3 帕妥珠单抗注射液 · No verified English nameCXSL2101162 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2021/06/29New drug · Class 1.4 20价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2101161 Jiangsu Kun Li Biopharmaceutical Co., Ltd. romanized; Xiamen Wan Tai Cang Hai Bio Technology Co., Ltd. romanized
2021/06/29New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101160 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/06/29New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101159 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/06/29New drug · Class 3.3 德谷胰岛素注射液 · No verified English nameCXSL2101158 Beijing SL Pharmaceutical Co., Ltd.
2021/06/29New drug · Class 3.3 索玛鲁肽注射液 · No verified English nameCXSL2101157 Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized
2021/06/29New drug · Class 3.3 注射用BLB101 · No verified English nameCXSL2101153 Beijing Li Bang Biopharmaceuticals Technology Co., Ltd. romanized
2021/06/29New drug · Class 1 注射用重组人白介素22-Fc融合蛋白 · No verified English nameCXSL2101152 Yi Yi Biopharmaceuticals Kai Fa (Shanghai) Co., Ltd. romanized
2021/06/29New drug · Class 1 CX1440胶囊 · No verified English nameCXHL2101246 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2021/06/29New drug · Class 1 CX1440胶囊 · No verified English nameCXHL2101245 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2021/06/28Import · Class 1 Talquetamab注射液 · No verified English nameJXSL2101051 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2021/06/28Import · Class 1 Talquetamab注射液 · No verified English nameJXSL2101050 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2021/06/28Import · Class 1 BI 1810631 片 · No verified English nameJXHL2101108 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/06/28Import · Class 1 BI 1810631 片 · No verified English nameJXHL2101107 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.

61 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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