YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 162 drug applications between 10 June 2021 and 16 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 29, covering 20 drug names.

2021/06/10 – 2021/06/16

Period
2021/06/10 to 2021/06/16, 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
162
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

162filings, 29 of them generic

By application type

Application typeFilings
Supplement87
New drug30
Generic29
Unspecified8
Import7
Import re-registration1

By drug type

Drug typeFilings
Chemical drug122
Therapeutic biologic23
TCM14
Prophylactic biologic3

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
1Oxcarbazepine Tablets314
2Voriconazole for Injection225
3Ipratropium Bromide Inhalation Solution212
4Sacubitril Valsartan Sodium Tablets2170
5注射用头孢曲松钠/氯化钠注射液 · No verified English name213
6注射用头孢美唑钠/氯化钠注射液 · No verified English name211
7Daptomycin for Injection211
8Epinastine Hydrochloride Granules210
9Propofol Medium And Long Chain Fat Emulsion Injection113
10吸入用七氟烷 · No verified English name110

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

96 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1NAPP PHARMACEUTICALS LIMITED910
2Tong Yong Dian Qi Pharma (Shanghai) Co., Ltd. romanized710
3Shijiazhuang No.4 Pharmaceutical Co., Ltd.643
4Wuhan Fu Xing Bio Pharma Co., Ltd. romanized610
5Lian Cardiovascular Limited510
6Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized430
7Beijing Rui Ye Pharmaceutical Co., Ltd. romanized424
8Nang Kuang Pharmaceutical Co. Ltd410
9Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized410
10Aspen OOS B.V330

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

45 this week

AcceptedDrugApplicants
2021/06/16Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHL2101016 Tai Yang Sheng (Bo Zhou) Biopharmaceuticals Technology Co., Ltd. romanized
2021/06/16New drug · Class 1 AK104注射液 · No verified English nameCXSL2101137 Kang Fang Pharma Co., Ltd. romanized
2021/06/15Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2101041 Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd.
2021/06/15Import · Class 1 Mavacamten胶囊 · No verified English nameJXHL2101091 Lian Cardiovascular Limited; Shanghai LianBio Development Co. Ltd.
2021/06/15Import · Class 1 Mavacamten胶囊 · No verified English nameJXHL2101090 Lian Cardiovascular Limited; Shanghai LianBio Development Co. Ltd.
2021/06/15Import · Class 1 Mavacamten胶囊 · No verified English nameJXHL2101089 Lian Cardiovascular Limited; Shanghai LianBio Development Co. Ltd.
2021/06/15Import · Class 1 Mavacamten胶囊 · No verified English nameJXHL2101088 Lian Cardiovascular Limited; Shanghai LianBio Development Co. Ltd.
2021/06/15Import · Class 1 Mavacamten胶囊 · No verified English nameJXHL2101087 Lian Cardiovascular Limited; Shanghai LianBio Development Co. Ltd.
2021/06/15Generic · Class 3 Pralatrexate InjectionCYHS2101296 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/06/15Generic · Class 3 注射用头孢曲松钠/氯化钠注射液 · No verified English nameCYHS2101249 Beijing Rui Ye Pharmaceutical Co., Ltd. romanized
2021/06/15Generic · Class 3 注射用头孢曲松钠/氯化钠注射液 · No verified English nameCYHS2101248 Beijing Rui Ye Pharmaceutical Co., Ltd. romanized
2021/06/15New drug · Class 1 SHR-1901注射液 · No verified English nameCXSL2101135 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/06/15New drug · Class 1 SG301注射液 · No verified English nameCXSL2101134 Hangzhou Shang Jian Bio Technology Co., Ltd. romanized
2021/06/15New drug · Class 1 注射用SHR-A1912 · No verified English nameCXSL2101133 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/06/15New drug · Class 1 IBI325 · No verified English nameCXSL2101132 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/06/15New drug · Class 1 JSI-1187胶囊 · No verified English nameCXHL2101203 Jie Si Ying Da Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2021/06/15New drug · Class 1 JSI-1187胶囊 · No verified English nameCXHL2101202 Jie Si Ying Da Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2021/06/15New drug · Class 1 Zorifertinib片 · No verified English nameCXHL2101201 Jiangsu Chen Tai Pharmaceuticals Technology Co., Ltd. romanized
2021/06/15New drug · Class 1 Zorifertinib片 · No verified English nameCXHL2101200 Jiangsu Chen Tai Pharmaceuticals Technology Co., Ltd. romanized
2021/06/15New drug · Class 1 LP-128胶囊 · No verified English nameCXHL2101195 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2021/06/15New drug · Class 1 LP-128胶囊 · No verified English nameCXHL2101194 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2021/06/11Generic · Class 3 Epinastine Hydrochloride GranulesCYHS2101293 Jiao Zuo Shi Ming Ren Tian Ran Drug Co., Ltd. romanized
2021/06/11Generic · Class 3 Epinastine Hydrochloride GranulesCYHS2101292 Jiao Zuo Shi Ming Ren Tian Ran Drug Co., Ltd. romanized
2021/06/11Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2101291 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2021/06/11Generic · Class 3 注射用头孢美唑钠/氯化钠注射液 · No verified English nameCYHS2101251 Beijing Rui Ye Pharmaceutical Co., Ltd. romanized
2021/06/11Generic · Class 3 注射用头孢美唑钠/氯化钠注射液 · No verified English nameCYHS2101250 Beijing Rui Ye Pharmaceutical Co., Ltd. romanized
2021/06/11New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2101131 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2021/06/11New drug · Class 3.4 卡介菌纯蛋白衍生物 · No verified English nameCXSL2101114 Chengdu Ke En Bio Technology Co., Ltd. romanized
2021/06/11New drug · Class 1 盐酸安舒法辛缓释片 · No verified English nameCXHS2101024 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2021/06/11New drug · Class 1 盐酸安舒法辛缓释片 · No verified English nameCXHS2101023 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized

15 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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