YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 241 drug applications between 31 December 2020 and 6 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 29, covering 25 drug names.

2020/12/31 – 2021/01/06

Period
2020/12/31 to 2021/01/06, 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

The daily national snapshot started on 2026/10/22; the earlier days of this week have no complete acceptance-list snapshot yet, so this week's counts may be lower than the national total.

New acceptances this week
241
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

241filings, 29 of them generic

By application type

Application typeFilings
Supplement136
New drug40
Generic29
Unspecified19
Import14
Import re-registration3

By drug type

Drug typeFilings
Chemical drug168
Therapeutic biologic45
TCM19
Prophylactic biologic8
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
1Pramipexole Dihydrochloride Prolonged-release Tablets310
2Empagliflozin Tablets2118
3Ropivacaine hydrochloride injection215
4Ambroxol Hydrochloride Solution For Inhalation1110
5Diquafosol Sodium Eye Drops115
6Ibuprofen Suspension1114
7Dutasteride Soft Capsules110
8Emtricitabine and tenofovir disoproxil fumarate tablets110
9Torsemide Injection111
10泊沙康唑注射液 · No verified English name111

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

140 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bard Pharmaceuticals Ltd.1180
2F. Hoffmann-La Roche Ltd810
3CSPC OUYI PHARMACEUTICAL CO., LTD.634
4Novartis Pharma Schweiz AG620
5Hua Lan Bio Gong Cheng Co., Ltd. romanized610
6Boehringer Ingelheim International GmbH510
7Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized430
8BAXTER S.A.S420
9Merck Sharp & Dohme Limited420
10Haikou Shi Pharmaceutical Factory 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

53 this week

AcceptedDrugApplicants
2021/01/06Import · Class 2.2 阿替利珠单抗注射液 · No verified English nameJXSL2100001 F.Hoffmann-La Roche Ltd
2021/01/06Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2100007 Suzhou Hong Sen Pharma Co., Ltd. romanized
2021/01/06Generic · Class 3 Aripiprazole Oral SolutionCYHS2100005 Changzhou Si Yao Pharmaceutical Co., Ltd. romanized
2021/01/06New drug · Class 1.3 广防风胶囊 · No verified English nameCXZL2000031 Shanghai Yao Gang Bio Technology Co., Ltd. romanized
2021/01/06New drug · Class 1.3 广防风根 · No verified English nameCXZL2000030 Shanghai Yao Gang Bio Technology Co., Ltd. romanized
2021/01/06New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2100004 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2021/01/06New drug · Class 3.3 重组抗RANKL全人源单克隆抗体注射液 · No verified English nameCXSL2100003 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2021/01/06New drug · Class 3.4 注射用A型肉毒毒素 · No verified English nameCXSL2100002 Lanzhou Bio Technology Kai Fa Co., Ltd. romanized
2021/01/06New drug · Class 3.4 注射用A型肉毒毒素 · No verified English nameCXSL2100001 Lanzhou Bio Technology Kai Fa Co., Ltd. romanized
2021/01/06New drug · Class 2.2 组分无细胞百白破联合疫苗 · No verified English nameCXSL2000386 Zhongguo Yi Xue Ke College Yi Xue Bio Xue Research Institute romanized
2021/01/06New drug · Class 1 注射用GQ1001冻干粉针剂 · No verified English nameCXSL2000385 Qi De Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2021/01/06New drug · Class 1 NH102盐酸盐片 · No verified English nameCXHL2100005 Jiangsu En Hua Pharma Co., Ltd. romanized
2021/01/06New drug · Class 1 NH102盐酸盐片 · No verified English nameCXHL2100004 Jiangsu En Hua Pharma Co., Ltd. romanized
2021/01/06New drug · Class 1 NH102盐酸盐片 · No verified English nameCXHL2100003 Jiangsu En Hua Pharma Co., Ltd. romanized
2021/01/06New drug · Class 1 YZJ-3058片 · No verified English nameCXHL2100002 Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized
2021/01/06New drug · Class 1 YZJ-3058片 · No verified English nameCXHL2100001 Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized
2021/01/06New drug · Class 1 LP-168片 · No verified English nameCXHL2000689 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2021/01/06New drug · Class 1 LP-168片 · No verified English nameCXHL2000688 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2021/01/05Import · Class 3.1 贝伐珠单抗注射液 · No verified English nameJXSS2000068 Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH
2021/01/05Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2000360 Boehringer Ingelheim International GmbH
2021/01/05Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2000359 Boehringer Ingelheim International GmbH
2021/01/05Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2000358 Boehringer Ingelheim International GmbH
2021/01/05Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2000357 Boehringer Ingelheim International GmbH
2021/01/05Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2000356 Boehringer Ingelheim International GmbH
2021/01/05Generic · Class 3 泊沙康唑注射液 · No verified English nameCYHS2100002 Jiangxi Qing Feng Pharma Co., Ltd. romanized
2021/01/05New drug · Class 1.1 芩味胶囊 · No verified English nameCXZL2000032 Sichuan Sheng Zhong Pharmaceuticals Ke College romanized
2021/01/05New drug · Class 1.2 注射用B4 · No verified English nameCXZL2000029 Jiangxi Zhong Pharmaceuticals University romanized
2021/01/05New drug · Class 1.2 白头翁皂苷B4 · No verified English nameCXZL2000028 Jiangxi Zhong Pharmaceuticals University romanized; Guangxi Xin Hai Pharma Technology Co., Ltd. romanized
2021/01/05New drug · Class 1.1 生肌止痛烧伤膏 · No verified English nameCXZL2000027 Guangdong Song De Pharmaceutical Co., Ltd. romanized
2021/01/05New drug · Class 1.1 静脉炎颗粒 · No verified English nameCXZL2000026 Shanghai Tu Feng Pharmaceuticals Technology Co., Ltd., Jiangsu Kang Yuan Pharma Co., Ltd. romanized

23 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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