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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 235 drug applications between 9 August 2023 and 15 August 2023 (data as of 14 November 2026 06:00). Of these, generic applications numbered 59, covering 42 drug names.

2023/08/09 – 2023/08/15

Period
2023/08/09 to 2023/08/15, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
235
Drugs with new generic filings (by drug name, de-duplicated)
42
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

235filings, 59 of them generic

By application type

Application typeFilings
Supplement113
Generic59
New drug35
Import re-registration18
Import6
Unspecified4

By drug type

Drug typeFilings
Chemical drug151
TCM54
Therapeutic biologic27
Prophylactic biologic2
Biologic1

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

42 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Aminophylline Injection323
2Peramivir Injection227
3氧 · No verified English name2215
4Lactulose Oral Solution2134
5Tacrolimus Sustained-release Capsules216
6Piracetam Injection219
7Procaterol Hydrochloride Solution for Inhalation212
8Brivaracetam Tablets2119
9昂丹司琼口溶膜 · No verified English name212
10Pegaspargase For Injection210

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

138 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1GE Healthcare AS1410
2Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized990
3Shenyang Qing Gong Pharma Group Co., Ltd. romanized990
4Changsha Ai Bei Gao Pharma Co., Ltd. romanized660
5Jiangsu Vanguard Pharmaceutical Co., Ltd.434
6Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized410
7An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized330
8Ren He Yi Kang Group Co., Ltd. romanized323
9Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized320
10Nichi-Iko Pharmaceutical Co. Ltd.310

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

66 this week

AcceptedDrugApplicants
2023/08/15Import · Class 2.2 注射用tisotumab vedotin · No verified English nameJXSL2300151 Seagen Inc.; Zai Lab (Shanghai) CO. Ltd
2023/08/15Import · Class 1 MEDI3506注射液 · No verified English nameJXSL2300150 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/08/15Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2302133 Liao Cheng Gao Xin Bio Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2023/08/15Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2302132 Liao Cheng Gao Xin Bio Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2023/08/15Generic · Class 3 头孢克肟颗粒 · No verified English nameCYHS2302131 Chongqing Ji Si Rui Pharmaceutical Co., Ltd. romanized; Sichuan He Xin Pharma Co., Ltd. romanized
2023/08/15Generic · Class 3 Aminophylline InjectionCYHS2302129 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/08/15Generic · Class 3 Potassium Phosphates InjectionCYHS2302126 Hubei Ke Lun Pharma Co., Ltd. romanized
2023/08/15Generic · Class 3 Acetylcysteine InjectionCYHS2302124 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2023/08/15Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302123 Hai Men Pu Shi Pharmaceuticals Co., Ltd. romanized
2023/08/15Generic · Class 3 Peramivir InjectionCYHS2302122 Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2023/08/15Generic · Class 3 Nitroglycerin InjectionCYHS2302118 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2023/08/15Generic · Class 3 Nitroglycerin InjectionCYHS2302117 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2023/08/15Generic · Class 3 Sodium Bicarbonate InjectionCYHS2302115 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/08/15Generic · Class 3 Famotidine InjectionCYHS2302113 Suzhou Hai Jing Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Shen Long Pharma Co., Ltd. romanized
2023/08/15Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2302111 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/08/15Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2302110 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/08/15Generic · Class 3 Brivaracetam TabletsCYHL2300098 Chengdu Ao Bang Pharma Co., Ltd. romanized
2023/08/15Generic · Class 3 Brivaracetam TabletsCYHL2300097 Chengdu Ao Bang Pharma Co., Ltd. romanized
2023/08/15New drug · Class 1 FT-002注射液 · No verified English nameCXSL2300545 Fang Tuo Bio Technology (Suzhou) Co., Ltd. romanized
2023/08/15New drug · Class 1 BA2101注射液 · No verified English nameCXSL2300544 Shandong Bo An Bio Technology Co., Ltd. romanized
2023/08/15New drug · Class 1 VG2062 · No verified English nameCXSL2300543 Shanghai Fu Nuo Jian Bio Technology Co., Ltd. romanized; Shenzhen Fu Nuo Jian Bio Technology Co., Ltd. romanized; Fu Nuo Jian Bio Technology (Nan Tong) Co., Ltd. romanized
2023/08/15New drug · Class 1 注射用LM-108 · No verified English nameCXSL2300542 Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized
2023/08/15New drug · Class 1 JS015注射液 · No verified English nameCXSL2300541 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2023/08/15New drug · Class 1 英强布韦片 · No verified English nameCXHS2300069 Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2023/08/15New drug · Class 1 TGRX-814片 · No verified English nameCXHL2300876 Shenzhen Shi Ta Ji Rui Biopharmaceuticals Co., Ltd. romanized
2023/08/15New drug · Class 1 TGRX-814片 · No verified English nameCXHL2300875 Shenzhen Shi Ta Ji Rui Biopharmaceuticals Co., Ltd. romanized
2023/08/15New drug · Class 1 TGRX-814片 · No verified English nameCXHL2300874 Shenzhen Shi Ta Ji Rui Biopharmaceuticals Co., Ltd. romanized
2023/08/15New drug · Class 1 XY0206片 · No verified English nameCXHL2300873 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2023/08/15New drug · Class 1 XY0206片 · No verified English nameCXHL2300872 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2023/08/15New drug · Class 1 XY0206片 · No verified English nameCXHL2300871 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized

36 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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