YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 222 drug applications between 7 May 2021 and 13 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 27, covering 20 drug names.

2021/05/07 – 2021/05/13

Period
2021/05/07 to 2021/05/13, 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
222
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

222filings, 27 of them generic

By application type

Application typeFilings
Supplement119
New drug35
Generic27
Import27
Import re-registration9
Unspecified5

By drug type

Drug typeFilings
Chemical drug151
Therapeutic biologic34
TCM32
Prophylactic biologic4
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

20 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1硫酸特布他林雾化吸入用溶液 · No verified English name321
2Tadalafil Tablets2123
3Quetiapine Fumarate Extended-release Tablets210
4Osimertinib Mesylate Tablets212
5Oseltamivir Phosphate Capsules2139
6Valsartan Film-Coated Tablets210
7Salbutamol Sulfate Inhalation Solution112
8Olmesartan Medoxomil and Amlodipine Besylate Tablets112
9屈螺酮炔雌醇片(Ⅱ) · No verified English name111
10Batroxobin Injection110

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

121 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Tian Qi Zhong Meng Pharmaceutical Co., Ltd. romanized24230
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
3Takeda Development Center Americas Inc.520
4Qilu Pharmaceutical Co., Ltd.520
5AstraZeneca AB430
6Bright Future Pharmaceuticals Factory430
7Takeda Pharma A/S420
8Shanghai Pharmaceuticals Group Co., Ltd. romanized420
9HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.420
10LTL Pharma Co. Ltd.410

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
2021/05/13Import · Class 1 巴替利单抗注射液 · No verified English nameJXSL2101016 Agenus Inc.; Betta Pharmaceuticals Co. Ltd.
2021/05/13Import · Class 1 TAK-935片 · No verified English nameJXHL2101036 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd.
2021/05/13Import · Class 1 TAK-935片 · No verified English nameJXHL2101035 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd.
2021/05/13Import · Class 1 TAK-935片 · No verified English nameJXHL2101034 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd.
2021/05/13Import · Class 1 TAK-935片 · No verified English nameJXHL2101033 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd.
2021/05/13Import · Class 1 GDC-9545 · No verified English nameJXHL2101017 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2021/05/13New drug · Class 1 重组人源化抗Trop2单抗-SN38偶联物 · No verified English nameCXSL2101069 Shanghai Shi Jian Bio Technology Co., Ltd. romanized
2021/05/13New drug · Class 1 PM8003注射液 · No verified English nameCXSL2101066 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2021/05/13New drug · Class 2.4 注射用甲苯磺酸瑞马唑仑 · No verified English nameCXHS2101005 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/05/13New drug · Class 1 苯乙基异硫氰酸酯液体硬胶囊 · No verified English nameCXHL2101120 Wuxi Jie Xi Pharmaceuticals Co., Ltd. romanized
2021/05/13New drug · Class 1 IN10018片 · No verified English nameCXHL2101119 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2021/05/13New drug · Class 1 IN10018片 · No verified English nameCXHL2101118 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2021/05/13New drug · Class 1 SPH3127片 · No verified English nameCXHL2101117 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2021/05/13New drug · Class 1 SPH3127片 · No verified English nameCXHL2101116 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2021/05/13New drug · Class 1 HSK21542注射液 · No verified English nameCXHL2101115 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2021/05/13New drug · Class 1 HTMC0370片 · No verified English nameCXHL2101112 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2021/05/13New drug · Class 1 HTMC0370片 · No verified English nameCXHL2101111 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2021/05/13New drug · Class 1 SBK001注射液 · No verified English nameCXHL2101105 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized
2021/05/12Import · Class 2.2 注射用维得利珠单抗 · No verified English nameJXSL2101026 Takeda Development Center Americas Inc.
2021/05/12Import · Class 1 Efgartigimod浓缩注射液 · No verified English nameJXSL2101024 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2021/05/12Import · Class 1 Efgartigimod注射液 · No verified English nameJXSL2101023 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2021/05/12Import · Class 1 NMS-03305293胶囊 · No verified English nameJXHL2101032 Nerviano Medical Sciences S.r.l.; PPC China Corporation Limited
2021/05/12Import · Class 1 Lerociclib片 · No verified English nameJXHL2101031 G1 Therapeutics Inc.; Genor Biopharma Co. Ltd
2021/05/12Import · Class 1 NMS-03305293胶囊 · No verified English nameJXHL2101030 Nerviano Medical Sciences S.r.l.; PPC China Corporation Limited
2021/05/12Import · Class 1 Lerociclib片 · No verified English nameJXHL2101029 G1 Therapeutics Inc.; Genor Biopharma Co. Ltd
2021/05/12Import · Class 2.4 BYL719 · No verified English nameJXHL2101028 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2021/05/12Import · Class 2.4 BYL719 · No verified English nameJXHL2101027 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2021/05/12Import · Class 2.4 BYL719 · No verified English nameJXHL2101026 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2021/05/12Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2101143 Haerbin Shi Kang Long Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2021/05/12Generic · Class 3 Metoprolol Tartrate InjectionCYHS2101142 Zhejiang You Sheng Mei Te Zhong Yao 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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