YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 386 drug applications between 7 December 2023 and 13 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 56 drug names.

2023/12/07 – 2023/12/13

Period
2023/12/07 to 2023/12/13, 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
386
Drugs with new generic filings (by drug name, de-duplicated)
56
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

386filings, 80 of them generic

By application type

Application typeFilings
Supplement208
Generic80
New drug61
Import28
Import re-registration6
Unspecified3

By drug type

Drug typeFilings
Chemical drug226
TCM85
Therapeutic biologic68
Biologic3
Prophylactic biologic3
In vitro diagnostic reagent1

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

56 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1地氯雷他定口服溶液 · No verified English name3326
2Levocarnitine Oral Solution329
3Minoxidil Liniment3252
4Diprophylline Injection227
5Morinidazole and Sodium Chloride Injection229
6Ceftazidime And Avibactam Sodium For Injection2212
7Methocarbamol Injection223
8Agomelatine Tablets228
9Acetylcysteine Oral Solution2111
10Bisoprolol Fumarate Tablets216

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

206 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Lan Yun Zhi He Bio Technology Co., Ltd. romanized43340
2Novo Nordisk A/S1510
3Tai Ji Group Sichuan Tian Cheng Pharmaceutical Co., Ltd. romanized880
4Fresenius Kabi Austria GmbH610
5Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized610
6Karuna Therapeutics Inc.510
7GlaxoSmithKline (Ireland) Limited430
8ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.432
9F. Hoffmann-La Roche Ltd420
10Janssen Research & Development LLC420

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

124 this week

AcceptedDrugApplicants
2023/12/13Import · Class 1 CagriSema注射液 · No verified English nameJXSL2300225 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2023/12/13Import · Class 1 CagriSema注射液 · No verified English nameJXSL2300224 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2023/12/13Import · Class 1 CagriSema注射液 · No verified English nameJXSL2300223 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2023/12/13Import · Class 1 CagriSema注射液 · No verified English nameJXSL2300222 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2023/12/13Import · Class 1 CagriSema注射液 · No verified English nameJXSL2300221 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2023/12/13Generic · Class 3 Acetylcysteine Oral SolutionCYHS2303448 Nanjing Ai De Jia Biopharmaceutical Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/12/13Generic · Class 3 Acetylcysteine Oral SolutionCYHS2303447 Nanjing Ai De Jia Biopharmaceutical Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/12/13Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2303445 Nanjing Hai Ke Rui Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Su Zhong Pharma Group Biopharmaceutical Co., Ltd. romanized
2023/12/13Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2303444 Nanjing Hai Ke Rui Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Su Zhong Pharma Group Biopharmaceutical Co., Ltd. romanized
2023/12/13New drug · Class 1 GC012F注射液 · No verified English nameCXSL2300855 Suzhou Gen Xi Bio Technology Co., Ltd. romanized; Gen Xi Bio Technology (Shanghai) Co., Ltd. romanized
2023/12/13New drug · Class 1 YFQLXB-UC01注射液 · No verified English nameCXSL2300854 Shandong Sheng Qi Lu Xi Bao Zhi Liao Gong Cheng Technology Co., Ltd. romanized
2023/12/13New drug · Class 2.2 盐酸多奈哌齐口溶膜 · No verified English nameCXHL2301386 Shanxi Huang Cheng Xiang Fu Pharma Co., Ltd. romanized
2023/12/13New drug · Class 1 DA-302168S片 · No verified English nameCXHL2301385 Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized
2023/12/13New drug · Class 1 DA-302168S片 · No verified English nameCXHL2301384 Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized
2023/12/13New drug · Class 1 DA-302168S片 · No verified English nameCXHL2301383 Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized
2023/12/13New drug · Class 1 DA-302168S片 · No verified English nameCXHL2301382 Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized
2023/12/13New drug · Class 1 DA-302168S片 · No verified English nameCXHL2301381 Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized
2023/12/13New drug · Class 1 DA-302168S片 · No verified English nameCXHL2301380 Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized
2023/12/12Import · Class 3.1 艾沙妥昔单抗注射液 · No verified English nameJXSS2300091 Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH; Sanofi (China) Investment Co. Ltd.
2023/12/12Import · Class 3.1 艾沙妥昔单抗注射液 · No verified English nameJXSS2300090 Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH; Sanofi (China) Investment Co. Ltd.
2023/12/12Import · Class 3.1 注射用德曲妥珠单抗 · No verified English nameJXSS2300089 Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2023/12/12Generic · Class 3 注射用头孢唑林钠/氯化钠注射液 · No verified English nameCYHS2303443 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/12/12Generic · Class 3 Fludeoxyglucose[18F] InjectionCYHS2303442 Guangdong Gao Shang Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Hui Xuan Pharmaceuticals Technology Co., Ltd. romanized
2023/12/12Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2303441 Guangdong Ke Hong Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2023/12/12Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2303440 Guangdong Ke Hong Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2023/12/12Generic · Class 3 Adenosine InjectionCYHS2303438 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2023/12/12Generic · Class 3 Adenosine InjectionCYHS2303437 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2023/12/12Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2303435 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2023/12/12Generic · Class 3 Calcium Gluconate InjectionCYHS2303434 Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized
2023/12/12Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2303428 Shandong Jian Dao Pharmaceutical Co., Ltd. romanized

94 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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