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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 110 drug applications between 26 December 2020 and 1 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 10, covering 9 drug names.

2020/12/26 – 2021/01/01

Period
2020/12/26 to 2021/01/01, 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
110
Drugs with new generic filings (by drug name, de-duplicated)
9
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

110filings, 10 of them generic

By application type

Application typeFilings
Supplement70
Unspecified14
New drug13
Generic10
Import3

By drug type

Drug typeFilings
Chemical drug85
Therapeutic biologic19
Prophylactic biologic3
TCM2
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

9 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ropivacaine hydrochloride injection215
2Emtricitabine and tenofovir disoproxil fumarate tablets110
3Torsemide Injection111
4Sodium Hyaluronate Eye Drops1130
5Ambroxol Hydrochloride Injection119
6Moxifloxacin Hydrochloride And Sodium Chloride Injection1110
7Rocuronium Bromide Injection111
8Sugammadex Sodium Injection116
9Apixaban Tablets113

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

63 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bard Pharmaceuticals Ltd.1180
2F. Hoffmann-La Roche Ltd810
3Novartis Pharma Schweiz AG620
4Merck Sharp & Dohme Limited420
5Bristol-Myers Squibb Pharma EEIG410
6Jiangsu Huai An Shuang He Pharma Co., Ltd. romanized410
7SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED330
8Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.320
9Pfizer Inc.310
10Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized220

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

16 this week

AcceptedDrugApplicants
2021/01/01Import · Class 1 PM1016注射液 · No verified English nameJXSL2000238 TILT Biotherapeutics Ltd.
2021/01/01Import · Class 2.2 DS-8201a · No verified English nameJXSL2000237 Daiichi Sankyo Inc.
2021/01/01Generic · Class 3 Torsemide InjectionCYHS2000959 Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized; Yangtze River Pharmaceutical Group Co., Ltd
2021/01/01New drug · Class 1.1 坤怡宁颗粒 · No verified English nameCXZS2000010 Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized
2021/01/01New drug · Class 1.1 安心颗粒 · No verified English nameCXZL2000025 Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized
2021/01/01New drug · Class 1 SGN1 · No verified English nameCXSL2000388 Guangzhou Hua Jin Pharmaceuticals Technology Co., Ltd. romanized
2021/01/01New drug · Class 1 BC006单抗注射液 · No verified English nameCXSL2000387 Bao Chuan Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2021/01/01New drug · Class 1 CM326注射液 · No verified English nameCXSL2000384 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2021/01/01New 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 nameCXSL2000379 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2021/01/01New drug · Class 1 SYHX1901片 · No verified English nameCXHL2000679 CSPC OUYI PHARMACEUTICAL CO., LTD.
2021/01/01New drug · Class 1 SYHX1901片 · No verified English nameCXHL2000678 CSPC OUYI PHARMACEUTICAL CO., LTD.
2021/01/01New drug · Class 1 LM-061片 · No verified English nameCXHL2000677 Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized
2021/01/01New drug · Class 1 LM-061片 · No verified English nameCXHL2000676 Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized
2021/01/01New drug · Class 1 注射用CX13-608 · No verified English nameCXHL2000675 Ningbo Sheng Jian Biopharmaceuticals Technology Co., Ltd. romanized
2021/01/01New drug · Class 2.2; 2.4 醋酸阿比特龙片(I) · No verified English nameCXHL2000674 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/01/01New drug · Class 2.4 氟唑帕利胶囊 · No verified English nameCXHL2000673 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized

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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