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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 381 drug applications between 19 September 2024 and 25 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 122, covering 83 drug names.

2024/09/19 – 2024/09/25

Period
2024/09/19 to 2024/09/25, 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
381
Drugs with new generic filings (by drug name, de-duplicated)
83
Accepted this week, now under review
6

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

381filings, 122 of them generic

By application type

Application typeFilings
Supplement132
Generic122
New drug59
Import33
Unspecified22
Import re-registration12
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug244
TCM64
Therapeutic biologic46
Biologic20
Prophylactic biologic7

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

83 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Fentanyl Citrate Buccal Tablets610
2Cefoperazone Sodium and Sulbactam Sodium for Injection6114
3Ambroxol Hydrochloride Oral Solution4146
4Polymyxin B sulfate for Injection336
5Dapagliflozin Tablets3284
6Carbamazepine Sustained-Release Tablets(II)310
7Brexpiprazole Orally Disintegrating Tablets3110
8Brexpiprazole Tablets3131
9Amoxicillin Sodium and Sulbactam Sodium for Injection317
10Metoclopramide Hydrochloride Injection226

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

230 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1230
2Amgen Inc.920
3Yi Chang Ren Fu Pharma Co., Ltd. romanized929
4Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized880
5Janssen-Cilag International NV620
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
7Baxalta Manufacturing Sàrl610
8Shandong Jing Hui Bio Technology Co., Ltd. romanized616
9Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized550
10AbbVie Inc.530

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

141 this week

AcceptedDrugApplicants
2024/09/25Import · Class 2.1 埃万妥单抗注射液(皮下注射) · No verified English nameJXSS2400078 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.
2024/09/25Import · Class 2.1 埃万妥单抗注射液(皮下注射) · No verified English nameJXSS2400077 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.
2024/09/25Import · Class 2.1 埃万妥单抗注射液(皮下注射) · No verified English nameJXSS2400076 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.
2024/09/25Import · Class 2.1 埃万妥单抗注射液(皮下注射) · No verified English nameJXSS2400075 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.
2024/09/25Import · Class 1 ABBV-706注射用冻干粉 · No verified English nameJXSL2400179 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/09/25Import · Class 1 MEDI5752 · No verified English nameJXSL2400178 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/25Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2400177 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/09/25Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2400176 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/09/25Import · Class 1 DS-7300a · No verified English nameJXSL2400175 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD
2024/09/25Import · Class 1 AZD2936 · No verified English nameJXSL2400174 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/25Import · Class 1 AZD2936 · No verified English nameJXSL2400173 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/25Import · Class 2.4 Sotorasib 片 · No verified English nameJXHL2400234 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2024/09/25Import · Class 1 AMG 193 · No verified English nameJXHL2400233 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/09/25Import · Class 1 AMG 193 · No verified English nameJXHL2400232 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/09/25Import · Class 1 AMG 193 · No verified English nameJXHL2400231 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/09/25Import · Class 1 AMG 193 · No verified English nameJXHL2400230 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/09/25Import · Class 2.4 Lazertinib片 · No verified English nameJXHL2400229 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/09/25Import · Class 1 AMG 193 · No verified English nameJXHL2400228 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/09/25Import · Class 1 AMG 193 · No verified English nameJXHL2400227 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/09/25Import · Class 1 GDC-0077 · No verified English nameJXHL2400226 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2024/09/25Import · Class 1 GDC-0077 · No verified English nameJXHL2400225 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2024/09/25Import · Class 1 AMG 193 · No verified English nameJXHL2400224 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/09/25Import · Class 1 AMG 193 · No verified English nameJXHL2400223 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/09/25Generic · Class 3 Risedronate Sodium TabletsCYHS2403229 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2024/09/25Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2403223 Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized
2024/09/25Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2403218 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/09/25Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2403217 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/09/25Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2403216 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/09/25Generic · Class 3 Amikacin Sulfate injectionCYHS2403213 Kang Pu Pharma Co., Ltd. romanized
2024/09/25Generic · Class 3 Cycloserine CapsulesCYHS2403212 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized

111 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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