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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 427 drug applications between 4 January 2024 and 10 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 139, covering 99 drug names.

2024/01/04 – 2024/01/10

Period
2024/01/04 to 2024/01/10, 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
427
Drugs with new generic filings (by drug name, de-duplicated)
99
Accepted this week, now under review
3

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

427filings, 139 of them generic

By application type

Application typeFilings
Supplement177
Generic139
New drug73
Import25
Import re-registration8
Unspecified5

By drug type

Drug typeFilings
Chemical drug338
Therapeutic biologic44
TCM41
Prophylactic biologic4

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

99 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Minoxidil Liniment4252
3腺苷钴胺胶囊 · No verified English name338
4Lactulose Oral Solution3234
5Levofloxacin and Sodium Chloride Injection3114
6Citicoline Injection310
7Acetylcysteine Injection2253
8吸入用丙酸倍氯米松混悬液 · No verified English name223
9Dobutamine Hydrochloride Injection223
10Mesalazine Enteric-coated Tablets221

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

252 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB950
2Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized810
3Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized770
4Boehringer Ingelheim International GmbH720
5Novartis Pharma AG720
6Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized610
7Shijiazhuang No.4 Pharmaceutical Co., Ltd.543
8Sanofi-Aventis Recherche & Développement530
9Yi Chang Ren Fu Pharma Co., Ltd. romanized533
10Bei Da Pharma Co., Ltd. romanized520

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

149 this week

AcceptedDrugApplicants
2024/01/10Import · Class 1 AZD7789 · No verified English nameJXSL2400012 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/01/10Import · Class 2.2 DS-8201a · No verified English nameJXSL2400011 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2024/01/10Import · Class 1 Ziltivekimab 注射液 · No verified English nameJXSL2400010 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2024/01/10Import · Class 2.1 Risankizumab注射液 · No verified English nameJXSL2400009 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/01/10Import · Class 1 JDQ443片 · No verified English nameJXHL2400009 Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd
2024/01/10Import · Class 1 Baxdrostat片 · No verified English nameJXHL2400008 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/01/10Import · Class 1 Baxdrostat片 · No verified English nameJXHL2400007 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/01/10Import · Class 2.4 琥珀酸瑞波西利片 · No verified English nameJXHL2400006 Novartis Pharma Schweiz AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/01/10Generic · Class 3 Famotidine InjectionCYHS2400147 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2024/01/10Generic · Class 3 Amikacin Sulfate injectionCYHS2400146 Jinan Chen Xin Pharmaceuticals Technology Co., Ltd. romanized; CISEN PHARMACEUTICAL CO., LTD.
2024/01/10Generic · Class 3 Oxazepam TabletsCYHS2400144 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2024/01/10Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2400143 Guangzhou Hui Feng De Bio Technology Co., Ltd. romanized; Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2024/01/10Generic · Class 3 Potassium Phosphates InjectionCYHS2400139 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/01/10Generic · Class 3 Methocarbamol InjectionCYHS2400129 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2024/01/10Generic · Class 3 Baclofen Oral SolutionCYHS2400124 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2024/01/10Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2400123 Fujian Xin Di Pharmaceuticals Technology Co., Ltd. romanized; Hubei Wei Sen Pharmaceutical Co., Ltd. romanized
2024/01/10Generic · Class 3 Lidocaine and Tetracaine CreamCYHL2400014 Zhejiang Fu Nuo Pharmaceuticals Co., Ltd. romanized
2024/01/10New drug · Class 3.1 枇杷清肺饮颗粒 · No verified English nameCXZS2400002 Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized
2024/01/10New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2400023 Jilin Sheng Tuo Hua Bio Technology Co., Ltd. romanized
2024/01/10New drug · Class 1 SHR-4597吸入剂 · No verified English nameCXSL2400022 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/01/10New drug · Class 1 CS-101注射液 · No verified English nameCXSL2400021 Zheng Xu (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized
2024/01/10New drug · Class 1 SHR-4597吸入剂 · No verified English nameCXSL2400020 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/01/10New drug · Class 3.4 人凝血酶原复合物 · No verified English nameCXSL2400019 Guo Yao Group Wuhan Biopharmaceutical Co., Ltd. romanized
2024/01/10New drug · Class 2.2 人干扰素α2b阴道泡腾片 · No verified English nameCXSL2400018 Beijing Kai Yin Technology Co., Ltd. romanized
2024/01/10New drug · Class 2.2 KEM2104凝胶贴膏 · No verified English nameCXHL2400050 Changsha Jing Yi Pharmaceuticals Technology Co., Ltd. romanized
2024/01/10New drug · Class 2.2 KEM2104凝胶贴膏 · No verified English nameCXHL2400049 Changsha Jing Yi Pharmaceuticals Technology Co., Ltd. romanized
2024/01/10New drug · Class 1 RLA-23174片 · No verified English nameCXHL2400048 Shanghai Ying Li Pharma Co., Ltd. romanized
2024/01/10New drug · Class 1 RLA-23174片 · No verified English nameCXHL2400047 Shanghai Ying Li Pharma Co., Ltd. romanized
2024/01/10New drug · Class 1 HSK16149胶囊 · No verified English nameCXHL2400046 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2024/01/10New drug · Class 2.4 Neratinib Maleate TabletsCXHL2400045 Fu Kang (Shanghai) Health Technology Co., Ltd. romanized; Zhejiang Fu Kang Pharmaceutical Co., Ltd. romanized

119 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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