YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 98 drug applications between 7 August 2023 and 13 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 21, covering 15 drug names.

2023/08/07 – 2023/08/13

Period
2023/08/07 to 2023/08/13, 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
98
Drugs with new generic filings (by drug name, de-duplicated)
15
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

98filings, 21 of them generic

By application type

Application typeFilings
Supplement42
Generic21
Import re-registration18
New drug13
Unspecified4

By drug type

Drug typeFilings
Chemical drug61
TCM18
Therapeutic biologic16
Prophylactic biologic2
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

15 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tacrolimus Sustained-release Capsules216
2Piracetam Injection219
3昂丹司琼口溶膜 · No verified English name212
4Pegaspargase For Injection210
5Nicorandil for Injection211
6Esomeprazole Sodium for Injection211
7二甲双胍恩格列净片(Ⅴ) · No verified English name110
8Formoterol Fumarate Inhalation Solution115
9Peramivir Injection117
10Sildenafil Citrate Oral Disintegrating Tablets118

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

56 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1GE Healthcare AS1410
2Shenyang Qing Gong Pharma Group Co., Ltd. romanized990
3Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized310
4Zhejiang Ya Tai Pharma Co., Ltd. romanized310
5Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized220
6Heng Tuo Group Guangxi Sheng Kang Pharmaceutical Co., Ltd. romanized220
7Amgen Inc.210
8Bard Pharmaceuticals Limited210
9GlaxoSmithKline Biologicals S.A.210
10PIERRE FABRE MEDICAMENT210

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

24 this week

AcceptedDrugApplicants
2023/08/12Generic · Class 3 Piracetam InjectionCYHS2302098 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2023/08/12Generic · Class 3 Piracetam InjectionCYHS2302097 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2023/08/12Generic · Class 3 Regadenoson InjectionCYHS2302096 Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2023/08/12Generic · Class 3 Nicorandil for InjectionCYHS2302095 HAINAN HUALON PHARMACEUTICAL CO.,LTD
2023/08/12Generic · Class 3 Nicorandil for InjectionCYHS2302094 HAINAN HUALON PHARMACEUTICAL CO.,LTD
2023/08/12Generic · Class 3 昂丹司琼口溶膜 · No verified English nameCYHS2302092 Jiangsu He Chen Pharma Co., Ltd. romanized
2023/08/12Generic · Class 3 昂丹司琼口溶膜 · No verified English nameCYHS2302091 Jiangsu He Chen Pharma Co., Ltd. romanized
2023/08/12Generic · Class 3 Pegaspargase For InjectionCYHS2302085 Beijing SL Pharmaceutical Co., Ltd.
2023/08/12Generic · Class 3 Pegaspargase For InjectionCYHS2302083 Beijing SL Pharmaceutical Co., Ltd.
2023/08/12New drug · Class 1 艾帕洛利单抗托沃瑞利单抗注射液 · No verified English nameCXSS2300066 Qilu Pharmaceutical Co., Ltd.
2023/08/12New drug · Class 3.3 乌司奴单抗注射液 · No verified English nameCXSS2300065 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized; Jiangsu Sai Fu Shi Bio Technology Co., Ltd. romanized
2023/08/12New drug · Class 1 QX005N注射液 · No verified English nameCXSL2300540 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2023/08/12New drug · Class 1 RRG001眼内注射液 · No verified English nameCXSL2300539 Shanghai Ding Xin Ji Yin Technology Co., Ltd. romanized
2023/08/12New drug · Class 1 注射用NBL-028 · No verified English nameCXSL2300538 Shanghai Xin Shi Biopharmaceuticals Co., Ltd. romanized
2023/08/12New drug · Class 1 WXFL10203614片 · No verified English nameCXHL2300860 Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized
2023/08/12New drug · Class 1 WXFL10203614片 · No verified English nameCXHL2300859 Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized
2023/08/12New drug · Class 1 XS-03片 · No verified English nameCXHL2300858 Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized
2023/08/12New drug · Class 1 XS-03片 · No verified English nameCXHL2300857 Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized
2023/08/12New drug · Class 1 XS-03片 · No verified English nameCXHL2300856 Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized
2023/08/12New drug · Class 2.4 枸橼酸坦度螺酮胶囊 · No verified English nameCXHL2300855 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2023/08/12New drug · Class 2.4 枸橼酸坦度螺酮胶囊 · No verified English nameCXHL2300854 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2023/08/11Generic · Class 3 Peramivir InjectionCYHS2302082 Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized
2023/08/10Generic · Class 3 Salbutamol Sulfate injectionCYHS2302079 Sichuan Guo Rui Pharma Co., Ltd. romanized
2023/08/10New drug · Class 1 M108单抗注射液 · No verified English nameCXSL2300537 Ming Ji Biopharmaceutical (Beijing) Co., Ltd. romanized

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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