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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 329 drug applications between 14 April 2023 and 20 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 51 drug names.

2023/04/14 – 2023/04/20

Period
2023/04/14 to 2023/04/20, 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
329
Drugs with new generic filings (by drug name, de-duplicated)
51
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

329filings, 64 of them generic

By application type

Application typeFilings
Supplement176
Generic64
New drug62
Import15
Unspecified7
Import re-registration4
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug227
TCM58
Therapeutic biologic37
Prophylactic biologic3
Biologic2
Drug-device combination1
Drug-device combination1

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

51 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution3234
2Diprophylline Injection227
3Acetylcysteine Solution For Inhalation224
4Pregabalin Oral Solution225
5Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
6Lacosamide Injection210
7注射用头孢唑肟钠 · No verified English name214
8Lurasidone Hydrochloride Tablets212
9Azilsartan Medoxomil Potassium Tablets2135
10Ketorolac Tromethamine Injection214

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

187 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized23230
2Changsha Ai Bei Gao Pharma Co., Ltd. romanized15150
3Heilongjiang Hua Xi Biopharmaceuticals Technology Co., Ltd. romanized990
4Eli Lilly and Company510
5Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized510
6Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized510
7Henan Lan Tian Pharma Co., Ltd. romanized440
8Da Lian Tian Shan Pharma Co., Ltd. romanized430
9UCB Pharma SA410
10Shanghai Pu You Biopharmaceuticals Co., Ltd. romanized410

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

107 this week

AcceptedDrugApplicants
2023/04/20Import · Class 2.2 萨特利珠单抗注射液 · No verified English nameJXSL2300071 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/04/20Import · Class 2.2 注射用戈沙妥珠单抗 · No verified English nameJXSL2300070 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2023/04/20Import · Class 1 STC314注射液 · No verified English nameJXHL2300088 Grand Medical Pty Ltd.; Name not romanized
2023/04/20Generic · Class 3 Oxytocin InjectionCYHS2301105 Anhui Bai Ao Pharma Co., Ltd. romanized; Chengdu Li Er Pharma Co., Ltd. romanized
2023/04/20Generic · Class 3 醋酸维持液(含葡萄糖) · No verified English nameCYHS2301104 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/04/20Generic · Class 3 醋酸维持液(含葡萄糖) · No verified English nameCYHS2301103 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/04/20Generic · Class 3 复方氨基酸(16AA)/葡萄糖(12.6%)电解质注射液 · No verified English nameCYHS2301098 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/04/20Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2301095 Sichuan Nuo Fei Te Bio Pharma Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/04/20Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2301094 Sichuan Nuo Fei Te Bio Pharma Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/04/20Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2301093 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/04/20New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300279 Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized
2023/04/20New drug · Class 1 JMT203注射液 · No verified English nameCXSL2300278 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2023/04/20New drug · Class 1 重组抗NKG2A人源化单克隆抗体注射液 · No verified English nameCXSL2300277 Shanghai Huai Yue Bio Technology Co., Ltd. romanized
2023/04/20New drug · Class 1 TQB2928注射液 · No verified English nameCXSL2300276 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/04/20New drug · Class 1 FT-004注射液 · No verified English nameCXSL2300275 Fang Tuo Bio Technology (Suzhou) Co., Ltd. romanized
2023/04/20New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300274 Hui Sheng Biopharmaceutical Co., Ltd. romanized
2023/04/20New drug · Class 1 HS-10518胶囊 · No verified English nameCXHL2300398 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/04/20New drug · Class 1 卟硒啉片 · No verified English nameCXHL2300397 Shanghai Yuan Xi Pharmaceuticals Technology Co., Ltd. romanized
2023/04/20New drug · Class 1 卟硒啉片 · No verified English nameCXHL2300396 Shanghai Yuan Xi Pharmaceuticals Technology Co., Ltd. romanized
2023/04/20New drug · Class 1 卟硒啉片 · No verified English nameCXHL2300395 Shanghai Yuan Xi Pharmaceuticals Technology Co., Ltd. romanized
2023/04/20New drug · Class 1 妥拉美替尼胶囊 · No verified English nameCXHL2300394 Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized
2023/04/20New drug · Class 1 妥拉美替尼胶囊 · No verified English nameCXHL2300393 Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized
2023/04/20New drug · Class 1 HRS-4357注射液 · No verified English nameCXHL2300392 Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/04/19Import · Class 1 Tiragolumab注射液 · No verified English nameJXSL2300069 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd
2023/04/19Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2301092 Hubei Min Kang Pharma Group Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2023/04/19Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2301089 Hunan Xian Shi Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/04/19Generic · Class 3 Diprophylline InjectionCYHS2301086 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2023/04/19Generic · Class 3 Ketotifen Fumarate Nasal SprayCYHS2301084 Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/04/19Generic · Class 3 Pregabalin Oral SolutionCYHS2301083 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2023/04/19Generic · Class 3 Pregabalin Oral SolutionCYHS2301082 Zhong Huan Pharmaceuticals Co., Ltd. romanized; Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized

77 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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