YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 243 drug applications between 14 May 2021 and 20 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 25 drug names.

2021/05/14 – 2021/05/20

Period
2021/05/14 to 2021/05/20, 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
243
Drugs with new generic filings (by drug name, de-duplicated)
25
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

243filings, 35 of them generic

By application type

Application typeFilings
Supplement114
New drug57
Generic35
Import26
Unspecified7
Import re-registration4

By drug type

Drug typeFilings
Chemical drug180
Therapeutic biologic43
TCM14
Prophylactic biologic4
In vitro diagnostic reagent1
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

25 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Propofol Medium And Long Chain Fat Emulsion Injection313
2Clindamycin Injection314
3Brexpiprazole Tablets3131
4阿普斯特片 · No verified English name310
5Tadalafil Tablets2223
6Ambroxol Hydrochloride Injection229
7Sodium Valproate Concentrated Solution for Injection110
8Linagliptin Tablets112
9Pimecrolimus Cream115
10地氯雷他定口服溶液 · No verified English name1126

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

154 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.15100
2AstraZeneca AB530
3Xian Li Bang Pharmaceutical Co., Ltd. romanized523
4Shandong Luo Xin Pharma Group Co., Ltd. romanized420
5N.V.Organon410
6Sichuan Bai Li Pharma Co., Ltd. romanized410
7Wei Shi Pharma (Ru Gao) Co., Ltd. romanized410
8Bayer AG320
9Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized320
10Jiangsu Hao Sen Pharma Group Co., Ltd. romanized320

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

93 this week

AcceptedDrugApplicants
2021/05/20Import · Class 1 泽弗利单抗注射液 · No verified English nameJXSL2101030 Agenus Inc.; Betta Pharmaceuticals Co. Ltd.
2021/05/20Import · Class 1 Capivasertib · No verified English nameJXHL2101051 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2021/05/20Import · Class 1 Capivasertib · No verified English nameJXHL2101050 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2021/05/20Import · Class 2.4 Selumetinib胶囊 · No verified English nameJXHL2101049 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2021/05/20Import · Class 2.4 Selumetinib胶囊 · No verified English nameJXHL2101048 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2021/05/20Import · Class 2.4 达罗他胺片 · No verified English nameJXHL2101047 Bayer HealthCare Pharmaceuticals Inc.; Bayer Healthcare Company Ltd.
2021/05/20Import · Class 2.4 Tucatinib片 · No verified English nameJXHL2101046 Seagen Inc.; MSD R&D (China) Co. Ltd.
2021/05/20Import · Class 2.4 Tucatinib片 · No verified English nameJXHL2101045 Seagen Inc.; MSD R&D (China) Co. Ltd.
2021/05/20New drug · Class 1.1 参远片 · No verified English nameCXZL2101010 Zhongguo Yi Xue Ke College Yao Yong Zhi Wu Research Institute romanized
2021/05/20New drug · Class 1 HR17031注射液 · No verified English nameCXSL2101090 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/05/20New drug · Class 1 全人源抗CD19和CD22自体T细胞注射液 · No verified English nameCXSL2101089 Nanjing Xun Lu Medical Technology Co., Ltd. romanized
2021/05/20New drug · Class 1 全人源抗CD19和CD22自体T细胞注射液 · No verified English nameCXSL2101088 Nanjing Xun Lu Medical Technology Co., Ltd. romanized
2021/05/20New drug · Class 1 SI-B001双特异性抗体注射液 · No verified English nameCXSL2101085 Sichuan Bai Li Pharma Co., Ltd. romanized
2021/05/20New drug · Class 2.4 甲磺酸阿美替尼片 · No verified English nameCXHS2101017 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/05/20New drug · Class 1 复方ACC007片 · No verified English nameCXHS2101016 Jiangsu Ai Di Pharma Co., Ltd. romanized
2021/05/20New drug · Class 1 LDS片 · No verified English nameCXHL2101144 Shanghai Li Dao Pharmaceuticals Technology Co., Ltd. romanized
2021/05/20New drug · Class 1 LDS片 · No verified English nameCXHL2101143 Shanghai Li Dao Pharmaceuticals Technology Co., Ltd. romanized
2021/05/20New drug · Class 1 IMP5471-CA胶囊 · No verified English nameCXHL2101142 Shanghai Ying Pai Pharma Co., Ltd. romanized
2021/05/20New drug · Class 1 IMP5471-CA胶囊 · No verified English nameCXHL2101141 Shanghai Ying Pai Pharma Co., Ltd. romanized
2021/05/19Import · Class 1 BR55 · No verified English nameJXHL2101044 Bracco International B.V.; Bracco Imaging Medical Technologies(Shanghai) Co. Ltd.
2021/05/19Import · Class 2.4 注射用依拉环素 · No verified English nameJXHL2101043 Everest Medicines (US) Limited; EverID Medicines (Beijing) Limited
2021/05/19Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2101179 Changchun Hai Yue Pharma Co., Ltd. romanized
2021/05/19Generic · Class 3 Olprinone Hydrochloride InjectionCYHS2101178 Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized
2021/05/19Generic · Class 3 Leflunomide TabletsCYHS2101172 Mei Luo Pharma Co., Ltd. romanized
2021/05/19Generic · Class 3 聚普瑞锌颗粒? · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2101166 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2021/05/19New drug · Class 1 PA3-17注射液 · No verified English nameCXSL2101087 Bo Sheng Ji Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2021/05/19New drug · Class 1 SI-B001双特异性抗体注射液 · No verified English nameCXSL2101086 Sichuan Bai Li Pharma Co., Ltd. romanized
2021/05/19New drug · Class 1 SI-B001双特异性抗体注射液 · No verified English nameCXSL2101083 Sichuan Bai Li Pharma Co., Ltd. romanized
2021/05/19New drug · Class 2.4 注射用培尿酸酶 · No verified English nameCXSL2101071 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2021/05/19New drug · Class 1 全人源抗CD19和CD22自体T细胞注射液 · No verified English nameCXSL2101070 Nanjing Xun Lu Medical Technology Co., Ltd. romanized

63 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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