YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 215 drug applications between 6 May 2021 and 12 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 23, covering 18 drug names.

2021/05/06 – 2021/05/12

Period
2021/05/06 to 2021/05/12, 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
215
Drugs with new generic filings (by drug name, de-duplicated)
18
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

215filings, 23 of them generic

By application type

Application typeFilings
Supplement130
New drug28
Generic23
Import20
Import re-registration8
Unspecified6

By drug type

Drug typeFilings
Chemical drug132
TCM44
Therapeutic biologic34
Prophylactic biologic5

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

18 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Valsartan Film-Coated Tablets320
2Quetiapine Fumarate Extended-release Tablets210
3Osimertinib Mesylate Tablets212
4Oseltamivir Phosphate Capsules2139
5Salbutamol Sulfate Inhalation Solution112
6Olanzapine Tablets114
7Olmesartan Medoxomil and Amlodipine Besylate Tablets112
8屈螺酮炔雌醇片(Ⅱ) · No verified English name111
9Batroxobin Injection110
10Teprenone Capsules115

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

117 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Tian Qi Zhong Meng Pharmaceutical Co., Ltd. romanized37360
2AstraZeneca AB430
3Bright Future Pharmaceuticals Factory430
4Takeda Pharma A/S420
5HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.420
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
7LTL Pharma Co. Ltd.410
8argenx BV320
9Bayer HealthCare LLC310
10Merck Sharp & Dohme Corp.310

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

51 this week

AcceptedDrugApplicants
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
2021/05/12New drug · Class 1.1 颅通胶囊 · No verified English nameCXZL2101007 Shanghai Lv Gu Sheng Ming Yuan Pharmaceuticals Co., Ltd. romanized
2021/05/12New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2101067 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2021/05/12New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101065 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/05/12New drug · Class 1 SPH5030片 · No verified English nameCXHL2101114 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2021/05/12New drug · Class 1 SPH5030片 · No verified English nameCXHL2101113 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2021/05/11Generic · Class 3 Batroxobin InjectionCYHL2101007 Hainan Xian Sheng Pharma Co., Ltd. romanized
2021/05/11New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2101060 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2021/05/11New drug · Class 1 Ociperlimab注射液 · No verified English nameCXSL2101059 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2021/05/11New drug · Class 1 HY-072808软膏 · No verified English nameCXHL2101110 Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized
2021/05/11New drug · Class 1 注射用HRS3797 · No verified English nameCXHL2101109 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2021/05/10Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2101006 Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2021/05/10Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2101005 Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2021/05/10Import · Class 2.2 硫酸阿托品微量眼用溶液 · No verified English nameJXHL2101025 Arctic Vision (Hong Kong) Limited; Arctic Vision (Shanghai) Biotechnology Co Ltd
2021/05/10Import · Class 2.2 硫酸阿托品微量眼用溶液 · No verified English nameJXHL2101024 Arctic Vision (Hong Kong) Limited; Arctic Vision (Shanghai) Biotechnology Co Ltd
2021/05/10Generic · Class 3 Glycerol Fructose And Sodium Chloride InjectionCYHS2101134 CISEN PHARMACEUTICAL CO., LTD.
2021/05/10New drug · Class 1 泽贝妥单抗注射液 · No verified English nameCXSL2101057 Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized
2021/05/10New drug · Class 1 NTQ1062片 · No verified English nameCXHL2101108 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2021/05/10New drug · Class 1 NTQ1062片 · No verified English nameCXHL2101107 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.

21 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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