YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 173 drug applications between 20 July 2021 and 26 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 27, covering 20 drug names.

2021/07/20 – 2021/07/26

Period
2021/07/20 to 2021/07/26, 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
173
Drugs with new generic filings (by drug name, de-duplicated)
20
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

173filings, 27 of them generic

By application type

Application typeFilings
Supplement98
New drug31
Generic27
Import10
Unspecified4
Import re-registration3

By drug type

Drug typeFilings
Chemical drug121
Therapeutic biologic33
TCM10
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

20 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Neostigmine Methylsulfate Injection314
2Carbetocin Injection226
3Micafungin Sodium for Injection210
4Iodixanol Injection210
5Eldecalcitol Soft Capsules218
6Dapagliflozin Tablets2184
7Limaprost Alfadex Tablets110
8Paracetamol Tablets116
9Levofloxacin Tablets117
10异丙托溴铵吸入气雾剂 · No verified English name112

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

113 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xian Tang Chen Pharmaceutical Co., Ltd. romanized760
2SANOFI PASTEUR420
3Guangzhou Bai Te Medical Yong Pin Co., Ltd. romanized420
4Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized410
5Hefei Li Fang Pharmaceutical Co., Ltd. romanized330
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized330
7Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized330
8Novo Nordisk A/S320
9Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized320
10Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized310

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

48 this week

AcceptedDrugApplicants
2021/07/26Import · Class 1 RO7030816 · No verified English nameJXSL2101073 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2021/07/26Import · Class 1 RO7030816 · No verified English nameJXSL2101072 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2021/07/26Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2101071 Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd.
2021/07/26Import · Class 1 PF-06823859注射液 · No verified English nameJXSL2101070 Pfizer Inc.; Pfizer Investment Co. Ltd.
2021/07/26Import · Class 2.4 Lazertinib片 · No verified English nameJXHL2101140 Janssen-Cilag International NV; Johnson & Johnson (China) Investment Ltd.
2021/07/26Generic · Class 3 Limaprost Alfadex TabletsCYHS2101475 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2021/07/26New drug · Class 1 QX006N注射液 · No verified English nameCXSL2101214 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2021/07/26New drug · Class 1 注射用BC3448 · No verified English nameCXSL2101213 Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized
2021/07/26New drug · Class 2.4 硝羟喹啉片 · No verified English nameCXHL2101329 Jiangsu Ya Hong Pharmaceuticals Technology Co., Ltd. romanized
2021/07/26New drug · Class 1 注射用TB001 · No verified English nameCXHL2101328 Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized
2021/07/26New drug · Class 1 注射用TB001 · No verified English nameCXHL2101327 Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized
2021/07/24Import · Class 1 PF-06863135 · No verified English nameJXSL2101069 Pfizer Inc; Pfizer Investment CO. Ltd.
2021/07/24Import · Class 2.2 Amivantamab注射液 · No verified English nameJXSL2101068 Janssen-Cilag International NV; Johnson & Johnson (China) Investment Ltd.
2021/07/24Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2101471 Chengdu Giantech Hi-technology Development Co., Ltd.; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2021/07/24Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2101470 Chengdu Giantech Hi-technology Development Co., Ltd.; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2021/07/24Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2101469 Chengdu Giantech Hi-technology Development Co., Ltd.; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2021/07/24Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2101468 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2021/07/24Generic · Class 3 Carbetocin InjectionCYHS2101453 Hui Ling Pharmaceutical (Zhongguo) Co., Ltd. romanized
2021/07/24New drug · Class 1 BA1105注射液 · No verified English nameCXSL2101212 Shandong Bo An Bio Technology Co., Ltd. romanized
2021/07/24New drug · Class 1 注射用SSGJ-705 · No verified English nameCXSL2101211 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/07/24New drug · Class 1 AK112注射液 · No verified English nameCXSL2101210 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/07/24New drug · Class 1 AK120注射液 · No verified English nameCXSL2101209 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/07/24New drug · Class 1 依鲁奥克片 · No verified English nameCXHS2101032 Qilu Pharmaceutical Co., Ltd.
2021/07/24New drug · Class 1 依鲁奥克片 · No verified English nameCXHS2101031 Qilu Pharmaceutical Co., Ltd.
2021/07/24New drug · Class 1 NB003片 · No verified English nameCXHL2101323 Ningbo Xin Wan Technology Development Co., Ltd. romanized
2021/07/24New drug · Class 1 NB003片 · No verified English nameCXHL2101322 Ningbo Xin Wan Technology Development Co., Ltd. romanized
2021/07/24New drug · Class 1 NB003片 · No verified English nameCXHL2101321 Ningbo Xin Wan Technology Development Co., Ltd. romanized
2021/07/24New drug · Class 1 苯磺酸克立福替尼片 · No verified English nameCXHL2101317 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/07/24New drug · Class 1 苯磺酸克立福替尼片 · No verified English nameCXHL2101316 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/07/24New drug · Class 1 苯磺酸克立福替尼片 · No verified English nameCXHL2101315 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized

18 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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