YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 192 drug applications between 28 February 2021 and 6 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 19, covering 14 drug names.

2021/02/28 – 2021/03/06

Period
2021/02/28 to 2021/03/06, 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
192
Drugs with new generic filings (by drug name, de-duplicated)
14
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

192filings, 19 of them generic

By application type

Application typeFilings
Supplement99
New drug35
Import28
Generic19
Unspecified8
Import re-registration3

By drug type

Drug typeFilings
Chemical drug145
Therapeutic biologic28
TCM15
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

14 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Apremilast Tablets310
2Dexmedetomidine Hydrochloride Injection220
3Atomoxetine Hydrochloride Capsules216
4Memantine Hydrochloride Tablets212
5Tadalafil Tablets1123
6Cefdinir Capsules110
7Olmesartan Medoxomil and Amlodipine Besylate Tablets112
8注射用奥美拉唑钠(静脉滴注) · No verified English name110
9Metformin Hydrochloride Extended-release Tablets1110
10Palonosetron Hydrochloride Injection111

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

111 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized850
2Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized810
3Xian Jing Xi Shuang He Pharma Co., Ltd. romanized610
4Da Lian Tian Shan Pharma Co., Ltd. romanized550
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
6Chengdu Brilliant Pharmaceutical Co., Ltd.420
7Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized410
8Jilin Si Huan Ao Kang Pharma Co., Ltd. romanized410
9Gansu Qi Zheng Zang Yao Co., Ltd. romanized330
10Karyopharm Therapeutics Inc.320

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

63 this week

AcceptedDrugApplicants
2021/03/06New drug · Class 1 YH003注射液 · No verified English nameCXSL2101002 Name not romanized
2021/03/05Import · Class 1 Tanezumab注射液 · No verified English nameJXSL2100037 Pfizer Inc.
2021/03/05Import · Class 2.2 注射用Luspatercept · No verified English nameJXSL2100036 Celgene Corporation
2021/03/05Import · Class 2.2 注射用Luspatercept · No verified English nameJXSL2100035 Celgene Corporation
2021/03/05Import · Class 1 ATG-016片 · No verified English nameJXHL2100082 Karyopharm Therapeutics Inc.
2021/03/05Import · Class 1 ATG-016片 · No verified English nameJXHL2100081 Karyopharm Therapeutics Inc.
2021/03/05Import · Class 1 注射用EC-DG · No verified English nameJXHL2100080 Name not romanized
2021/03/05New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSS2100030 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized
2021/03/05New drug · Class 1 JS103注射液 · No verified English nameCXSL2100083 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/03/05New drug · Class 2.2 盐酸罗哌卡因脂质体混悬注射液 · No verified English nameCXHL2100170 Nanjing Lv Ye Pharmaceutical Co., Ltd. romanized
2021/03/04Import · Class 1 CG0070注射液 · No verified English nameJXSL2100029 CG Oncology Inc.
2021/03/04Import · Class 1 MB-102注射液 · No verified English nameJXHL2100079 MediBeacon Inc.
2021/03/04Import · Class 1 ALG-010133注射液 · No verified English nameJXHL2100075 Aligos Therapeutics Inc.
2021/03/04Import · Class 1 JNJ-67856633 硬胶囊 · No verified English nameJXHL2100074 Janssen Research & Development LLC
2021/03/04Import · Class 1 JNJ-67856633 硬胶囊 · No verified English nameJXHL2100073 Janssen Research & Development LLC
2021/03/04Import · Class 2.4 ATG-010片 · No verified English nameJXHL2100072 Karyopharm Therapeutics Inc.
2021/03/04Import · Class 1 ZN-c3片 · No verified English nameJXHL2100071 Zentera Therapeutics HK Limited
2021/03/04Import · Class 1 ZN-c3片 · No verified English nameJXHL2100070 Zentera Therapeutics HK Limited
2021/03/04Import · Class 1 注射用LY3437943 · No verified English nameJXHL2100069 Eli Lilly and Company
2021/03/04Generic · Class 3 Carbocisteine Oral SolutionCYHS2100254 Guangdong Pin Cheng Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2021/03/04Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2100252 Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2021/03/04New drug · Class 1 AK104注射液 · No verified English nameCXSL2100082 Kang Fang Pharma Co., Ltd. romanized
2021/03/04New drug · Class 1 IBI321 · No verified English nameCXSL2100081 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/03/04New drug · Class 1 甲磺酸贝福替尼胶囊 · No verified English nameCXHS2100009 Bei Da Pharma Co., Ltd. romanized
2021/03/04New drug · Class 1 甲磺酸贝福替尼胶囊 · No verified English nameCXHS2100008 Bei Da Pharma Co., Ltd. romanized
2021/03/04New drug · Class 1 YY-20394片 · No verified English nameCXHL2100169 Shanghai Ying Li Pharma Co., Ltd. romanized
2021/03/04New drug · Class 1 GW117胶囊 · No verified English nameCXHL2100168 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/03/04New drug · Class 1 GW117胶囊 · No verified English nameCXHL2100167 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/03/04New drug · Class 1 GW117胶囊 · No verified English nameCXHL2100166 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/03/04New drug · Class 1 GW117胶囊 · No verified English nameCXHL2100165 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized

33 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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