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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 406 drug applications between 5 December 2024 and 11 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 121, covering 76 drug names.

2024/12/05 – 2024/12/11

Period
2024/12/05 to 2024/12/11, 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
406
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
7

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

406filings, 121 of them generic

By application type

Application typeFilings
Supplement178
Generic121
New drug73
Import17
Unspecified11
Import re-registration5
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug261
TCM71
Therapeutic biologic57
Biologic8
Prophylactic biologic7
In vitro diagnostic reagent2

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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets14760
2Lactulose Oral Solution5134
3Ambroxol Hydrochloride Oral Solution4146
4Isavuconazonium Sulfate for Injection3315
5Sodium Bicarbonate Injection3210
6Oxcarbazepine Extended-release Tablets310
7Upadacitinib Sustained-release Tablets2243
8Levocarnitine Oral Solution229
9Mupirocin Ointment2230
10Progesterone Injection225

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

248 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangxi Qing Feng Pharma Co., Ltd. romanized760
2Ren He Yi Kang Group Co., Ltd. romanized732
3Ya Bao Pharma Group Co., Ltd. romanized660
4Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized660
5Novo Nordisk A/S530
6Shaanxi Xing Bang Pharma Co., Ltd. romanized515
7Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized440
8Tong Hua Zheng Yuan Pharma Co., Ltd. romanized440
9SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED431
10Hainan Sai Li Ke Pharma Co., Ltd. romanized430

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

119 this week

AcceptedDrugApplicants
2024/12/11Generic · Class 3 Sodium Bicarbonate InjectionCYHS2404303 Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2024/12/11Generic · Class 3 Atropine Sulfate InjectionCYHS2404301 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2024/12/11Generic · Class 3 Famotidine InjectionCYHS2404291 Hangzhou Min Sheng Drug Research Institute Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd
2024/12/11Generic · Class 3 Potassium Phosphates InjectionCYHS2404290 Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2024/12/11Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2404289 Suzhou Lang Yi Biopharmaceuticals Research Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized
2024/12/11New drug · Class 2.3 淫羊藿总黄酮胶囊 · No verified English nameCXZL2400088 Jiangsu Kang Yuan Yang Guang Pharma Co., Ltd. romanized
2024/12/11New drug · Class 1.1 固本消疹颗粒 · No verified English nameCXZL2400087 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2024/12/11New drug · Class 1.2 冻干呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2400850 Suzhou Ai Bo Bio Technology Co., Ltd. romanized; Ai Bo Bio Technology (Shanghai) Co., Ltd. romanized
2024/12/11New drug · Class 1.2 冻干呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2400849 Suzhou Ai Bo Bio Technology Co., Ltd. romanized; Ai Bo Bio Technology (Shanghai) Co., Ltd. romanized
2024/12/11New drug · Class 1.2 冻干呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2400848 Suzhou Ai Bo Bio Technology Co., Ltd. romanized; Ai Bo Bio Technology (Shanghai) Co., Ltd. romanized
2024/12/11New drug · Class 1.2 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2400847 Beijing Ji Nuo Wei Bio Technology Co., Ltd. romanized; Ji Nuo Wei (Hebei) Bio Technology Co., Ltd. romanized; Ji Nuo Wei (Lang Fang Lin Kong Zi Mao Qu) Bio Zhi Pin Co., Ltd. romanized
2024/12/11New drug · Class 2.2 人干扰素α2b喷雾剂 · No verified English nameCXSL2400846 Tianjin Wei Ming Biopharmaceuticals Co., Ltd. romanized
2024/12/11New drug · Class 2.2 人干扰素α2b喷雾剂 · No verified English nameCXSL2400845 Tianjin Wei Ming Biopharmaceuticals Co., Ltd. romanized
2024/12/11New drug · Class 1 重组人源化抗Trop2单抗-SN38偶联物 · No verified English nameCXSL2400844 Shanghai Shi Jian Bio Technology Co., Ltd. romanized
2024/12/11New drug · Class 2.2 BN021208H · No verified English nameCXHL2401356 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized
2024/12/11New drug · Class 1 AP306片 · No verified English nameCXHL2401355 Shanghai Li Bang Pharmaceuticals Technology Co., Ltd. romanized
2024/12/11New drug · Class 1 AP306片 · No verified English nameCXHL2401354 Shanghai Li Bang Pharmaceuticals Technology Co., Ltd. romanized
2024/12/11New drug · Class 1 AP306片 · No verified English nameCXHL2401353 Shanghai Li Bang Pharmaceuticals Technology Co., Ltd. romanized
2024/12/11New drug · Class 1 AP306片 · No verified English nameCXHL2401352 Shanghai Li Bang Pharmaceuticals Technology Co., Ltd. romanized
2024/12/11New drug · Class 1 HS-10561胶囊 · No verified English nameCXHL2401351 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/11New drug · Class 1 HS-10561胶囊 · No verified English nameCXHL2401350 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/11New drug · Class 1 HS-10561胶囊 · No verified English nameCXHL2401349 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/11New drug · Class 1 IN10018片 · No verified English nameCXHL2401348 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2024/12/11New drug · Class 1 IN10018片 · No verified English nameCXHL2401347 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2024/12/11New drug · Class 1 JK0001片 · No verified English nameCXHL2401346 Shenzhen Jia Ke Bio Technology Co., Ltd. romanized
2024/12/11New drug · Class 1 JK0001片 · No verified English nameCXHL2401345 Shenzhen Jia Ke Bio Technology Co., Ltd. romanized
2024/12/11New drug · Class 1 SBK013片 · No verified English nameCXHL2401344 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/10Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2400235 Merck Sharp & Dohme LLC; MSD R&D(China) Co. Ltd
2024/12/10Generic · Class 3 Ferrous Succinate TabletsCYHS2404279 Chi Feng Gu De Pharma Co., Ltd. romanized; Zhejiang Nord Pharmaceutical Co., Ltd
2024/12/10Generic · Class 3 Ketamine Hydrochloride InjectionCYHS2404278 Guo Yao Group Gong Ye Co., Ltd. Lang Fang Branch romanized

89 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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