YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 96 drug applications between 2 May 2021 and 8 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 9, covering 8 drug names.

2021/05/02 – 2021/05/08

Period
2021/05/02 to 2021/05/08, 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
96
Drugs with new generic filings (by drug name, de-duplicated)
8
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

96filings, 9 of them generic

By application type

Application typeFilings
Supplement61
New drug15
Generic9
Import6
Import re-registration3
Unspecified2

By drug type

Drug typeFilings
Chemical drug55
TCM28
Therapeutic biologic12
Prophylactic 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

8 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Quetiapine Fumarate Extended-release Tablets210
2Olanzapine Tablets114
3屈螺酮炔雌醇片(Ⅱ) · No verified English name111
4Teprenone Capsules115
5Ambroxol Hydrochloride Injection119
6硫酸特布他林雾化吸入用溶液 · No verified English name111
7Valsartan Film-Coated Tablets110
8Citicoline Sodium Injection113

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

57 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Tian Qi Zhong Meng Pharmaceutical Co., Ltd. romanized25250
2CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD310
3Xi Nan Pharma Co., Ltd. romanized310
4Bright Future Pharmaceuticals Factory220
5Eli Lilly Nederland B.V.210
6Merck Sharp & Dohme Corp.210
7UCB Pharma S.A.210
8Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized210
9Shanghai Han Dou Pharmaceuticals Technology Co., Ltd. romanized210
10Hua Yi Tai Kang Pharma Co., Ltd. romanized212

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

20 this week

AcceptedDrugApplicants
2021/05/08Import · Class 2.2 Benralizumab注射液 · No verified English nameJXSL2101022 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2021/05/08Import · Class 1 U3-1402 · No verified English nameJXSL2101021 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2021/05/08Import · Class 2.2 硫酸阿托品滴眼液 · No verified English nameJXHL2101023 Ocumension (Hong Kong)Limited; Ocumension Therapeutics(Shanghai)Co. Ltd
2021/05/08Generic · Class 3 Citicoline Sodium InjectionCYHS2101123 Guangdong Sai Feng Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2021/05/08New drug · Class 1 派安普利单抗注射液 · No verified English nameCXSL2101056 Zheng Da Tian Qing Kang Fang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized
2021/05/08New drug · Class 1 UB-621注射液 · No verified English nameCXSL2101055 Lian Yao (Shanghai) Bio Technology Co., Ltd. romanized
2021/05/08New drug · Class 1 3D-229注射液 · No verified English nameCXSL2101049 Xu Zhou Si Lu Di Pharma Co., Ltd. romanized
2021/05/07New drug · Class 1 REV001注射液 · No verified English nameCXSL2101053 Shanghai Xing Shen Bio Technology Co., Ltd. romanized
2021/05/07New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHS2101012 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/05/07New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHS2101011 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/05/07New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHS2101010 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/05/07New drug · Class 1 甲磺酸瑞泽替尼胶囊 · No verified English nameCXHS2101009 Shanghai Bei Er Da Pharma Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized
2021/05/07New drug · Class 2.2 卡左双多巴控释片 · No verified English nameCXHL2101104 Shanghai Han Dou Pharmaceuticals Technology Co., Ltd. romanized
2021/05/07New drug · Class 2.2 卡左双多巴控释片 · No verified English nameCXHL2101103 Shanghai Han Dou Pharmaceuticals Technology Co., Ltd. romanized
2021/05/06Import · Class 1 Efgartigimod注射液 · No verified English nameJXSL2101018 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2021/05/06New drug · Class 1 BAT6005注射液 · No verified English nameCXSL2101052 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2021/05/06New drug · Class 1 AZD4205胶囊 · No verified English nameCXHL2101102 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2021/05/06New drug · Class 1 AZD4205胶囊 · No verified English nameCXHL2101101 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2021/05/06New drug · Class 2.2 雷美替胺双释片 · No verified English nameCXHL2101100 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized
2021/05/06New drug · Class 1 注射用硝酮嗪 · No verified English nameCXHL2101099 Guangzhou Xi Que Pharmaceuticals 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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