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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 394 drug applications between 6 January 2024 and 12 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 138, covering 106 drug names.

2024/01/06 – 2024/01/12

Period
2024/01/06 to 2024/01/12, 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
394
Drugs with new generic filings (by drug name, de-duplicated)
106
Accepted this week, now under review
1

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

394filings, 138 of them generic

By application type

Application typeFilings
Supplement140
Generic138
New drug77
Import26
Import re-registration10
Unspecified3

By drug type

Drug typeFilings
Chemical drug304
Therapeutic biologic49
TCM33
Prophylactic biologic6
Biologic2

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

106 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1注射用头孢唑肟钠 · No verified English name424
2Acetylcysteine Injection3353
3Levofloxacin Injection321
4Sitagliptin and Metformin Hydrochloride Extended-release Tablets3212
5Levofloxacin and Sodium Chloride Injection3114
6Diprophylline Injection227
7吸入用丙酸倍氯米松混悬液 · No verified English name223
8Levodopa and Benserazide Hydrochloride Tablets222
9Potassium Chloride Oral Solution2211
10Dobutamine Hydrochloride Injection223

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

242 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB850
2Novartis Pharma AG830
3Sanofi-Aventis Recherche & Developpement610
4Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized610
5Shijiazhuang No.4 Pharmaceutical Co., Ltd.555
6Sanofi-Aventis Recherche & Développement530
7Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized510
8ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.433
9Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized420
10Boehringer Ingelheim International GmbH410

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

156 this week

AcceptedDrugApplicants
2024/01/12Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400018 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400017 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400016 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400015 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400014 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400013 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Generic · Class 3 Potassium Chloride GranulesCYHS2400193 Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/01/12Generic · Class 3 Potassium Chloride GranulesCYHS2400192 Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/01/12Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2400188 Zhejiang AngLiKang Pharmaceutical CO.,LTD.
2024/01/12Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2400187 Hubei Min Kang Pharma Group Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2024/01/12Generic · Class 3 Epinephrine InjectionCYHS2400186 Wuhan Jiu An Pharma Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized
2024/01/12Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2400185 Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized
2024/01/12Generic · Class 3 Haloperidol TabletsCYHS2400177 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2024/01/12Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2400176 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized
2024/01/12Generic · Class 3 Diprophylline InjectionCYHS2400174 Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized
2024/01/12New drug · Class 3.1 二冬颗粒 · No verified English nameCXZS2400003 Jiangxi Yao Dou Zhang Shu Pharmaceutical Co., Ltd. romanized
2024/01/12New drug · Class 1 注射用RGL-2102 · No verified English nameCXSL2400028 Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized
2024/01/12New drug · Class 1 注射用SHR-A1904 · No verified English nameCXSL2400027 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/01/12New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2400026 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/01/12New drug · Class 1 TST001注射液 · No verified English nameCXSL2400025 Suzhou Chuang Sheng Pharmaceuticals Group Co., Ltd. romanized
2024/01/12New drug · Class 1 TGI-5注射液 · No verified English nameCXSL2400024 Hefei Tian Gang Mian Yi Drug Co., Ltd. romanized
2024/01/12New drug · Class 2.2; 2.4 MTS004口崩片 · No verified English nameCXHL2400065 Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized
2024/01/12New drug · Class 2.4; 2.2 PDX-02 · No verified English nameCXHL2400064 Hunan Jiudian Pharmaceutical Co., Ltd
2024/01/12New drug · Class 2.4; 2.2 PDX-02 · No verified English nameCXHL2400063 Hunan Jiudian Pharmaceutical Co., Ltd
2024/01/12New drug · Class 2.4; 2.2 PDX-02 · No verified English nameCXHL2400062 Hunan Jiudian Pharmaceutical Co., Ltd
2024/01/12New drug · Class 1 HMPL-506片 · No verified English nameCXHL2400061 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2024/01/12New drug · Class 1 HMPL-506片 · No verified English nameCXHL2400060 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2024/01/11Import · Class 2.4 LNP023胶囊 · No verified English nameJXHL2400012 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/01/11Import · Class 2.4 布地奈德富马酸福莫特罗吸入气雾剂 · No verified English nameJXHL2400011 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2024/01/11Import · Class 1 PF-07220060 · No verified English nameJXHL2400010 Pfizer Inc.; Pfizer Investment CO. Ltd

126 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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