YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 279 drug applications between 3 August 2021 and 9 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 43, covering 32 drug names.

2021/08/03 – 2021/08/09

Period
2021/08/03 to 2021/08/09, 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
279
Drugs with new generic filings (by drug name, de-duplicated)
32
Accepted this week, now under review
1

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

279filings, 43 of them generic

By application type

Application typeFilings
Supplement123
New drug65
Generic43
Import re-registration21
Import19
Unspecified8

By drug type

Drug typeFilings
Chemical drug189
TCM44
Therapeutic biologic44
In vitro diagnostic reagent1
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

32 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Carbamazepine Extended-release Tablets310
2Alanyl Glutamine Injection214
3Enoxaparin Sodium Injection2116
4Carbazochrome Sodium Sulfonate Injection211
5Torsemide Injection211
6Tranexamic Acid Injection2111
7Trimetazidine Dihydrochloride Tablets210
8Fosphenytoin Sodium Injection215
9Oseltamivir Phosphate Capsules2139
10Febuxostat Tablets2112

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
1Shanxi Fu Ren Heng Feng Pharma Co., Ltd. romanized20200
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized1360
3Shandong Er Ye Pharmaceutical Co., Ltd. romanized1130
4Shaanxi An Yuan Tang Pharma Co., Ltd. romanized660
5Novartis Pharma Schweiz AG620
6Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized620
7Eli Lilly and Company610
8Fresenius Kabi Deutschland GmbH610
9Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized440
10San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized420

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

103 this week

AcceptedDrugApplicants
2021/08/09Import · Class 1 ES104 · No verified English nameJXSL2101090 Elpiscience Biopharmaceuticals Co. Limited; Elpiscience (Suzhou) Biopharma Ltd.
2021/08/09Import · Class 2.4 环硅酸锆钠散 · No verified English nameJXHL2101157 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2021/08/09Import · Class 2.4 环硅酸锆钠散 · No verified English nameJXHL2101156 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2021/08/09Import · Class 1 CPI-818片 · No verified English nameJXHL2101155 Corvus Pharmaceuticals Inc.; Angel Pharmaceuticals
2021/08/09Import · Class 1 CPI-818片 · No verified English nameJXHL2101154 Corvus Pharmaceuticals Inc.; Angel Pharmaceuticals
2021/08/09Import · Class 1 BI 1701963片 · No verified English nameJXHL2101153 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/08/09Import · Class 1 BI 1701963片 · No verified English nameJXHL2101152 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/08/09Import · Class 1 TAK-981 注射液 · No verified English nameJXHL2101151 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2021/08/09Generic · Class 3 非洛地平片 · No verified English nameCYHS2101538 Hunan Jiudian Pharmaceutical Co., Ltd
2021/08/09Generic · Class 3 Torsemide InjectionCYHS2101536 Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized
2021/08/09Generic · Class 3 Torsemide InjectionCYHS2101533 Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized
2021/08/09Generic · Class 3 Zoledronic Acid InjectionCYHS2101520 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2021/08/09Generic · Class 3 Lidocaine and Tetracaine CreamCYHL2101021 Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized
2021/08/09Generic · Class 3 丙酸氟替卡松吸入粉雾剂 · No verified English nameCYHL2101020 Run Sheng Pharma Co., Ltd. romanized
2021/08/09New drug · Class 1.1 柏金颗粒 · No verified English nameCXZL2101022 Zhong Nan Min Zu University romanized
2021/08/09New drug · Class 1 THZ0104注射液 · No verified English nameCXSL2101245 Tian Jing Bio Technology (Hangzhou) Co., Ltd. romanized
2021/08/09New drug · Class 2.2 注射用卡瑞利珠单抗 · No verified English nameCXSL2101244 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/08/09New drug · Class 3.3 注射用HZBio2 · No verified English nameCXSL2101243 Hangzhou Yuan Da Biopharmaceutical Co., Ltd. romanized
2021/08/09New drug · Class 1 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2101242 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2021/08/09New drug · Class 1 CX1440胶囊 · No verified English nameCXHL2101383 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2021/08/09New drug · Class 1 CX1440胶囊 · No verified English nameCXHL2101382 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2021/08/09New drug · Class 1 CX1440胶囊 · No verified English nameCXHL2101381 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2021/08/09New drug · Class 1 CX1440胶囊 · No verified English nameCXHL2101380 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2021/08/09New drug · Class 2.2 HL231吸入溶液 · No verified English nameCXHL2101379 Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
2021/08/09New drug · Class 2.2 HL231吸入溶液 · No verified English nameCXHL2101378 Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
2021/08/09New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2101377 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2021/08/09New drug · Class 1 苹果酸法米替尼胶囊 · No verified English nameCXHL2101376 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/08/09New drug · Class 1 苹果酸法米替尼胶囊 · No verified English nameCXHL2101375 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/08/09New drug · Class 1 苹果酸法米替尼胶囊 · No verified English nameCXHL2101374 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/08/09New drug · Class 1 注射用罗替戈汀山嵛酸酯缓释微球 · No verified English nameCXHL2101373 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized

73 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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