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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 416 drug applications between 5 January 2024 and 11 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 137, covering 104 drug names.

2024/01/05 – 2024/01/11

Period
2024/01/05 to 2024/01/11, 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
416
Drugs with new generic filings (by drug name, de-duplicated)
104
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

416filings, 137 of them generic

By application type

Application typeFilings
Supplement164
Generic137
New drug77
Import24
Import re-registration10
Unspecified4

By drug type

Drug typeFilings
Chemical drug332
Therapeutic biologic43
TCM38
Prophylactic biologic3

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

104 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Injection3353
2Levofloxacin Injection321
3Levofloxacin and Sodium Chloride Injection3114
4Diprophylline Injection227
5吸入用丙酸倍氯米松混悬液 · No verified English name223
6Potassium Chloride Oral Solution2211
7Dobutamine Hydrochloride Injection223
8Glucosamine Sulfate Capsules2251
9Mesalazine Enteric-coated Tablets221
10Norepinephrine Bitartrate Injection229

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

245 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB850
2Novartis Pharma AG830
3Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized810
4Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized770
5Shijiazhuang No.4 Pharmaceutical Co., Ltd.654
6Bei Da Pharma Co., Ltd. romanized630
7Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized610
8Sanofi-Aventis Recherche & Développement530
9Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized510
10AbbVie Inc.430

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

155 this week

AcceptedDrugApplicants
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
2024/01/11Generic · Class 3 Diprophylline InjectionCYHS2400173 Hunan Bai Qi He Drug Research and Development Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized
2024/01/11Generic · Class 3 Cycloserine CapsulesCYHS2400170 Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2024/01/11Generic · Class 3 Levofloxacin InjectionCYHS2400169 Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hubei Ke Lun Pharma Co., Ltd. romanized
2024/01/11Generic · Class 3 Levofloxacin InjectionCYHS2400168 Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hubei Ke Lun Pharma Co., Ltd. romanized
2024/01/11Generic · Class 3 Potassium Chloride Oral SolutionCYHS2400166 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/01/11Generic · Class 3 Acetylcysteine InjectionCYHS2400165 TC Pharmaceuticals (Jiangsu) Co., Ltd
2024/01/11Generic · Class 3 Potassium Chloride Oral SolutionCYHS2400164 Shenyang Tian Bang Pharma Co., Ltd. romanized
2024/01/11Generic · Class 3 Potassium Aspartate InjectionCYHS2400162 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/01/11Generic · Class 3 Levofloxacin InjectionCYHS2400160 Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized
2024/01/11Generic · Class 3 水合氯醛灌肠剂 · No verified English nameCYHS2400155 Guangdong Luo Si Te Pharmaceutical Co., Ltd. romanized
2024/01/11Generic · Class 3 Sodium Bicarbonate InjectionCYHS2400150 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2024/01/11Generic · Class 3 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2400148 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/01/11New drug · Class 1 怡培生长激素注射液 · No verified English nameCXSS2400008 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2024/01/11New drug · Class 1 怡培生长激素注射液 · No verified English nameCXSS2400007 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2024/01/11New drug · Class 1 怡培生长激素注射液 · No verified English nameCXSS2400006 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2024/01/11New drug · Class 1 怡培生长激素注射液 · No verified English nameCXSS2400005 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2024/01/11New drug · Class 1 怡培生长激素注射液 · No verified English nameCXSS2400004 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2024/01/11New drug · Class 1 醋酸索乐匹尼布片 · No verified English nameCXHS2400004 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; He Ji Huang Pu Pharmaceuticals (Suzhou) Co., Ltd. romanized
2024/01/11New drug · Class 1 焦谷氨酸荣格列净胶囊 · No verified English nameCXHS2400003 Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2024/01/11New drug · Class 1 焦谷氨酸荣格列净胶囊 · No verified English nameCXHS2400002 Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2024/01/11New drug · Class 1 瑞美吡嗪注射液 · No verified English nameCXHS2400001 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2024/01/11New drug · Class 1 HRS-9231注射液 · No verified English nameCXHL2400059 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/01/11New drug · Class 1 HSK39297片 · No verified English nameCXHL2400058 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/01/11New drug · Class 1 HSK39297片 · No verified English nameCXHL2400057 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/01/11New drug · Class 1 FHND1002颗粒 · No verified English nameCXHL2400056 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2024/01/11New drug · Class 1 FHND1002颗粒 · No verified English nameCXHL2400055 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2024/01/11New drug · Class 1 NH103草酸盐片 · No verified English nameCXHL2400054 Jiangsu En Hua Pharma Co., Ltd. romanized

125 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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