YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 220 drug applications between 2 January 2021 and 8 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 25, covering 21 drug names.

2021/01/02 – 2021/01/08

Period
2021/01/02 to 2021/01/08, 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
220
Drugs with new generic filings (by drug name, de-duplicated)
21
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

220filings, 25 of them generic

By application type

Application typeFilings
Supplement128
New drug33
Generic25
Import23
Unspecified7
Import re-registration4

By drug type

Drug typeFilings
Chemical drug142
Therapeutic biologic55
TCM18
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

21 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Pramipexole Dihydrochloride Prolonged-release Tablets310
2Ornidazole Injection210
3Empagliflozin Tablets2118
4Rivaroxaban Tablets113
5Risperidone Oral Solution116
6Ambroxol Hydrochloride Solution For Inhalation1110
7Diquafosol Sodium Eye Drops115
8Ibuprofen Suspension1114
9Dutasteride Soft Capsules110
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

138 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1BIOTON S.A.730
2Hua Lan Bio Gong Cheng Co., Ltd. romanized610
3Boehringer Ingelheim International GmbH510
4AstraZeneca AB420
5BAXTER S.A.S420
6Les Laboratoires Servier420
7CSPC OUYI PHARMACEUTICAL CO., LTD.424
8Fresenius Kabi Austria GmbH410
9Qilu Pharmaceutical Co., Ltd.332
10Merz Pharmaceuticals GmbH320

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

52 this week

AcceptedDrugApplicants
2021/01/08Import · Class 3.1 注射用A型肉毒毒素(150KD,不含复合蛋白) · No verified English nameJXSS2100002 Merz Pharmaceuticals GmbH; Merz Pharma GmbH & Co. KGaA
2021/01/08Import · Class 3.1 注射用A型肉毒毒素(150KD,不含复合蛋白) · No verified English nameJXSS2100001 Merz Pharmaceuticals GmbH; Merz Pharma GmbH & Co. KGaA
2021/01/08Import · Class 1 注射用TAK-755 · No verified English nameJXSL2100004 Baxalta Innovations GmbH
2021/01/08Import · Class 1 注射用TAK-755 · No verified English nameJXSL2100003 Baxalta Innovations GmbH
2021/01/08Import · Class 2.4 ATG-010片 · No verified English nameJXHL2100001 Karyopharm Therapeutics Inc.
2021/01/08Generic · Class 3 Adenosine InjectionCYHS2100016 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
2021/01/08Generic · Class 3 Ornidazole InjectionCYHS2100004 Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2021/01/08Generic · Class 3 Ornidazole InjectionCYHS2100003 Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2021/01/08New drug · Class 1 CBP-201注射液 · No verified English nameCXSL2100006 Suzhou Kang Nai De Biopharmaceuticals Co., Ltd. romanized
2021/01/08New drug · Class 1 杰洛利单抗注射液 · No verified English nameCXSL2100005 Jia He Bio Pharma Co., Ltd. romanized
2021/01/08New drug · Class 1 西奥罗尼胶囊 · No verified English nameCXHL2100010 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2021/01/08New drug · Class 1 VVN001滴眼液 · No verified English nameCXHL2100008 Wei Mou Bio Technology (Shanghai) Co., Ltd. romanized
2021/01/08New drug · Class 1 VVN001滴眼液 · No verified English nameCXHL2100007 Wei Mou Bio Technology (Shanghai) Co., Ltd. romanized
2021/01/08New drug · Class 1 吸入用TQC3721混悬液 · No verified English nameCXHL2100006 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/01/07Import · Class 2.2 DS-8201a · No verified English nameJXSL2100002 Daiichi Sankyo Inc.
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

22 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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