YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 121 drug applications between 5 September 2021 and 11 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 18, covering 11 drug names.

2021/09/05 – 2021/09/11

Period
2021/09/05 to 2021/09/11, 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
121
Drugs with new generic filings (by drug name, de-duplicated)
11
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

121filings, 18 of them generic

By application type

Application typeFilings
Supplement67
New drug20
Generic18
Import8
Unspecified4
Import re-registration4

By drug type

Drug typeFilings
Chemical drug64
TCM38
Therapeutic biologic16
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

11 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Carfilzomib For Injection310
2烟酸缓释片 · No verified English name310
3Nintedanib Esilate Soft Capsules216
4Pramipexole Dihydrochloride Prolonged-release Tablets210
5Lincomycin Injection211
6Ambroxol Hydrochloride Solution For Inhalation1110
7头孢地尼颗粒 · No verified English name113
8Levofloxacin Tablets117
9泊沙康唑注射液 · No verified English name111
10Oseltamivir Phosphate Capsules1139

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

65 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Ye Zhen Tang Pharma Co., Ltd. romanized22220
2Gansu Fu Ge Zang Yao Co., Ltd. romanized1090
3Novartis Europharm Limited530
4Jiangsu Hao Sen Pharma Group Co., Ltd. romanized525
5Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized330
6Hainan Pu Li Pharmaceutical Co., Ltd. romanized322
7Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized310
8Yi Chang Ren Fu Pharma Co., Ltd. romanized313
9Sun Pharmaceutical Industries Limited220
10Sichuan Sheng Zhong Pharmaceuticals Ke College (Sichuan Sheng Zhong Yao Research Institute) romanized220

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

32 this week

AcceptedDrugApplicants
2021/09/08Import · Class 1 TPX-0022胶囊 · No verified English nameJXHL2101175 Turning Point Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2021/09/08New drug · Class 1 XKH001注射液 · No verified English nameCXSL2101315 Beijing Xin Kang He Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/08New drug · Class 1 IBI397 · No verified English nameCXSL2101314 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/09/08New drug · Class 3.3 门冬胰岛素注射液 · No verified English nameCXSL2101313 Chongqing Chen An Biopharmaceutical Co., Ltd. romanized
2021/09/08New drug · Class 1 LD002注射液 · No verified English nameCXSL2101312 Zhejiang Lan Dun Pharma Co., Ltd. romanized
2021/09/08New drug · Class 1 赛拉瑞韦钾片 · No verified English nameCXHS2101038 Yin Xing Shu Pharma (Suzhou) Co., Ltd. romanized; Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized
2021/09/08New drug · Class 2.4 示踪用盐酸米托蒽醌注射液 · No verified English nameCXHS2101037 Shenzhen Hua Run Jiu Chuang Pharmaceuticals Co., Ltd. romanized; Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized
2021/09/08New drug · Class 1 DT678片 · No verified English nameCXHL2101462 Beijing SL Pharmaceutical Co., Ltd.
2021/09/08New drug · Class 1 AZD4205胶囊 · No verified English nameCXHL2101461 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2021/09/08New drug · Class 1 AZD4205胶囊 · No verified English nameCXHL2101460 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2021/09/08New drug · Class 1 PB-201片 · No verified English nameCXHL2101459 Pai Ge Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2021/09/08New drug · Class 1 PB-201片 · No verified English nameCXHL2101458 Pai Ge Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2021/09/08New drug · Class 1 硫酸舒欣啶注射液 · No verified English nameCXHL2101457 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2021/09/07Import · Class 1 HP558注射液 · No verified English nameJXHL2101173 Hinova Pharmaceuticals (USA) Inc.; Hinova Pharmaceuticals Inc.
2021/09/07Generic · Class 3 烟酸缓释片 · No verified English nameCYHS2101698 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/09/07Generic · Class 3 烟酸缓释片 · No verified English nameCYHS2101697 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/09/07Generic · Class 3 烟酸缓释片 · No verified English nameCYHS2101696 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/09/07Generic · Class 3 Carfilzomib For InjectionCYHS2101695 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/09/07Generic · Class 3 Carfilzomib For InjectionCYHS2101694 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/09/07Generic · Class 3 Carfilzomib For InjectionCYHS2101693 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/09/07Generic · Class 3 Lincomycin InjectionCYHS2101690 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2021/09/07Generic · Class 3 Lincomycin InjectionCYHS2101689 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2021/09/07Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2101686 Shandong Qidu Pharmaceutical Co., Ltd.
2021/09/06Generic · Class 3 头孢地尼颗粒 · No verified English nameCYHS2101687 Guo Yao Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd. romanized
2021/09/06New drug · Class 1.3 马甲子叶 · No verified English nameCXZL2101026 Sichuan Sheng Zhong Pharmaceuticals Ke College (Sichuan Sheng Zhong Yao Research Institute) romanized
2021/09/06New drug · Class 1.3 马甲子胶囊 · No verified English nameCXZL2101025 Sichuan Sheng Zhong Pharmaceuticals Ke College (Sichuan Sheng Zhong Yao Research Institute) romanized
2021/09/06New drug · Class 3.3 地舒单抗注射液 · No verified English nameCXSS2101027 Qilu Pharmaceutical Co., Ltd.
2021/09/06New drug · Class 1 舒格利单抗注射液 · No verified English nameCXSS2101026 Ji Shi Pharma (Suzhou) Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized
2021/09/06New drug · Class 1 重组抗CD20人源化单克隆抗体注射液 · No verified English nameCXSL2101308 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2021/09/06New drug · Class 1 ASC42片 · No verified English nameCXHL2101456 Gan Lai Pharmaceutical Co., Ltd. romanized

2 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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