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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 400 drug applications between 8 July 2023 and 14 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 62 drug names.

2023/07/08 – 2023/07/14

Period
2023/07/08 to 2023/07/14, 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
400
Drugs with new generic filings (by drug name, de-duplicated)
62
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

400filings, 78 of them generic

By application type

Application typeFilings
Supplement208
Generic78
New drug64
Import27
Import re-registration19
Unspecified4

By drug type

Drug typeFilings
Chemical drug303
Therapeutic biologic48
TCM39
Prophylactic biologic9
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

62 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Oral Solution3211
2Lidocaine and Prilocaine Cream2224
3Acetylcysteine Granules214
4Ethyl Iosapentate Capsules2127
5Carbazochrome Sodium Sulfonate Injection211
6复方奥美拉唑干混悬剂 · No verified English name210
7Oxcarbazepine Tablets214
8泊马度胺胶囊 · No verified English name214
9注射用头孢唑肟钠 · No verified English name214
10Oxacillin Sodium for Injection2113

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

217 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized32240
2Hainan Brilliant Pharmaceutical Co., Ltd.1530
3AstraZeneca AB1460
4Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized660
5Upjohn Manufacturing Ireland Unlimited Company610
6Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized532
7Intas Pharmaceuticals. Ltd.510
8Shanghai Xin Yi Jin Zhu Pharma Co., Ltd. romanized440
9An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized440
10Li Zhu Group Li Zhu Pharmaceutical Factory romanized433

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

114 this week

AcceptedDrugApplicants
2023/07/14Import · Class 2.2 法瑞西单抗注射液 · No verified English nameJXSS2300058 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG
2023/07/14Import · Class 1 IMG-020注射液 · No verified English nameJXSL2300129 INMAGENE PTE. LTD.; Inmagene Biopharmaceuticals (Hangzhou) Co. Ltd.
2023/07/14Import · Class 1 RO7435846片 · No verified English nameJXHL2300161 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/07/14Import · Class 1 RO7435846片 · No verified English nameJXHL2300160 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/07/14Import · Class 1 RO7435846片 · No verified English nameJXHL2300159 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/07/14Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2301904 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/07/14Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2301902 Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized
2023/07/14Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2301901 Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized
2023/07/14Generic · Class 3 Desonide CreamCYHS2301899 Jiangsu Ziyond Pharmaceutical Co., Ltd.
2023/07/14Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2301894 Sheng Jia (Bin Hai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2023/07/14New drug · Class 1 注射用ASKG315 · No verified English nameCXSL2300481 Jiangsu Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized
2023/07/14New drug · Class 1.2 自复制RNA带状疱疹疫苗(JCXH-105注射液) · No verified English nameCXSL2300480 Jia Chen Xi Hai (Hangzhou) Bio Technology Co., Ltd. romanized
2023/07/14New drug · Class 1 重组人源抗狂犬病病毒单克隆抗体注射液 · No verified English nameCXSL2300479 Lanzhou Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/07/14New drug · Class 1 QR059349片 · No verified English nameCXHL2300782 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/07/14New drug · Class 1 QR059349片 · No verified English nameCXHL2300781 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/07/14New drug · Class 1 JYP0035胶囊 · No verified English nameCXHL2300780 Jia Yue (Chengdu) Pharmaceuticals Technology Co., Ltd. romanized
2023/07/14New drug · Class 1 JYP0035胶囊 · No verified English nameCXHL2300779 Jia Yue (Chengdu) Pharmaceuticals Technology Co., Ltd. romanized
2023/07/13Import · Class 3.1 注射用泰朗妥昔单抗 · No verified English nameJXSS2300057 ADC Therapeutics SA; BSP Pharmaceuticals S.p.A.; Overland Pharmaceuticals (Shanghai) Co. Ltd.
2023/07/13Import · Class 1 Lu AF82422 注射液 · No verified English nameJXSL2300128 H. Lundbeck A/S
2023/07/13Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2301892 Hainan He Rui Pharmaceutical Co., Ltd. romanized
2023/07/13Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301889 Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2023/07/13Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301888 Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2023/07/13Generic · Class 3 Famotidine InjectionCYHS2301883 Yunnan Xian Shi Pharma Co., Ltd. romanized; Jiangsu Shen Long Pharma Co., Ltd. romanized
2023/07/13Generic · Class 3 Sodium Nitroprusside InjectionCYHS2301878 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized
2023/07/13Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2300087 Jiangsu En Hua Pharma Co., Ltd. romanized
2023/07/13Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2300086 Jiangsu En Hua Pharma Co., Ltd. romanized
2023/07/13Generic · Class 3 Nelarabine injectionCYHL2300085 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/07/13New drug · Class 1.1 六黄止渴颗粒 · No verified English nameCXZL2300047 Guangdong Kai Zhong Bio Technology Co., Ltd. romanized
2023/07/13New drug · Class 1.2 复制缺陷型猴痘疫苗 · No verified English nameCXSL2300478 Beijing Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/07/13New drug · Class 3.3 QL2107注射液 · No verified English nameCXSL2300477 Qilu Pharmaceutical Co., Ltd.

84 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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