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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 338 drug applications between 15 April 2023 and 21 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 57 drug names.

2023/04/15 – 2023/04/21

Period
2023/04/15 to 2023/04/21, 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
338
Drugs with new generic filings (by drug name, de-duplicated)
57
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

338filings, 69 of them generic

By application type

Application typeFilings
Supplement178
Generic69
New drug66
Import11
Unspecified8
Import re-registration5
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug238
TCM55
Therapeutic biologic39
Prophylactic biologic3
Biologic1
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

57 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution3234
2Diprophylline Injection227
3Pregabalin Oral Solution225
4Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
5Progesterone Injection225
6Lacosamide Injection210
7注射用头孢唑肟钠 · No verified English name214
8Lurasidone Hydrochloride Tablets212
9Ketorolac Tromethamine Injection214
10醋酸维持液(含葡萄糖) · No verified English name210

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

190 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
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
5Shandong Luo Xin Pharma Group Co., Ltd. romanized520
6Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized510
7Da Lian Tian Shan Pharma Co., Ltd. romanized430
8Shanghai Xian Bo Bio Technology Co., Ltd. romanized420
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

112 this week

AcceptedDrugApplicants
2023/04/21Import · Class 3.4 达雷妥尤单抗注射液 · No verified English nameJXSL2300072 Janssen-Cilag AG; Johnson & Johnson (China) Investment Ltd.
2023/04/21Generic · Class 3 Fudosteine oral solutionCYHS2301118 Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/04/21Generic · Class 3 Pentoxifylline InjectionCYHS2301115 Anhui Mei Lai Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized
2023/04/21Generic · Class 3 Temozolomide For InjectionCYHS2301114 Beijing SL Pharmaceutical Co., Ltd.
2023/04/21Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2301113 Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized
2023/04/21Generic · Class 3 Progesterone InjectionCYHS2301111 Li Zhu Group Li Min Pharmaceutical Factory romanized
2023/04/21Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2301110 Shanghai Bao Long Bio Technology Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2023/04/21Generic · Class 3 Dexketoprofen Trometamol TabletsCYHS2301107 Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2023/04/21New drug · Class 1 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液 · No verified English nameCXSL2300282 Shanghai Xian Bo Bio Technology Co., Ltd. romanized
2023/04/21New drug · Class 1 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液 · No verified English nameCXSL2300281 Shanghai Xian Bo Bio Technology Co., Ltd. romanized
2023/04/21New drug · Class 1 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液 · No verified English nameCXSL2300280 Shanghai Xian Bo Bio Technology Co., Ltd. romanized
2023/04/21New drug · Class 1 NH300231片 · No verified English nameCXHL2300408 Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized
2023/04/21New drug · Class 1 NH300231片 · No verified English nameCXHL2300407 Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized
2023/04/21New drug · Class 1 NH300231片 · No verified English nameCXHL2300406 Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized
2023/04/21New drug · Class 2.4 布比卡因脂质体注射液 · No verified English nameCXHL2300405 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/04/21New drug · Class 2.4 布比卡因脂质体注射液 · No verified English nameCXHL2300404 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/04/21New drug · Class 1 TY-4028胶囊 · No verified English nameCXHL2300403 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2023/04/21New drug · Class 1 TY-4028胶囊 · No verified English nameCXHL2300402 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2023/04/21New drug · Class 1 D3S-002片 · No verified English nameCXHL2300401 Name not romanized
2023/04/21New drug · Class 1 D3S-002片 · No verified English nameCXHL2300400 Name not romanized
2023/04/21New drug · Class 1 D3S-002片 · No verified English nameCXHL2300399 Name not romanized
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

82 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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