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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 348 drug applications between 28 August 2023 and 3 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 67 drug names.

2023/08/28 – 2023/09/03

Period
2023/08/28 to 2023/09/03, 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
348
Drugs with new generic filings (by drug name, de-duplicated)
67
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

348filings, 93 of them generic

By application type

Application typeFilings
Supplement183
Generic93
New drug54
Import13
Import re-registration3
Unspecified2

By drug type

Drug typeFilings
Chemical drug234
TCM69
Therapeutic biologic37
Prophylactic biologic6
In vitro diagnostic reagent1
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

67 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets4223
2Nicorandil for Injection321
3Etoricoxib Tablets318
4Quetiapine Fumarate Tablets310
5Lidocaine and Prilocaine Cream2224
6Potassium Chloride Injection2210
7Lornoxicam for Injection222
8Moxifloxacin Hydrochloride Tablets2211
9腺苷钴胺胶囊 · No verified English name228
10Phloroglucinol Injection222

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

208 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized19150
2Guizhou Rui He Pharmaceutical Co., Ltd. romanized18180
3Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized880
4Celgene Corporation610
5Pfizer Europe MA EEIG520
6AstraZeneca AB430
7Merck Sharp & Dohme LLC420
8Hainan Brilliant Pharmaceutical Co., Ltd.421
9Rui Yang Pharmaceutical Co., Ltd. romanized420
10Organon Pharma (UK) Limited410

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

95 this week

AcceptedDrugApplicants
2023/09/02Generic · Class 3 Potassium Chloride InjectionCYHS2302366 Hainan Ou Ruo La Bio Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/09/02Generic · Class 3 Indobufen TabletsCYHS2302365 Shenzhen Shi Lang Bo Biopharmaceuticals Co., Ltd. romanized; Ya Bao Pharma Tai Yuan Pharmaceutical Co., Ltd. romanized
2023/09/02Generic · Class 3 Indobufen TabletsCYHS2302364 Shenzhen Shi Lang Bo Biopharmaceuticals Co., Ltd. romanized; Ya Bao Pharma Tai Yuan Pharmaceutical Co., Ltd. romanized
2023/09/02Generic · Class 3 Famotidine InjectionCYHS2302358 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2023/09/02Generic · Class 3 Cisplatin InjectionCYHS2302357 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2023/09/02New drug · Class 2.1 清喉咽含片 · No verified English nameCXZS2300018 Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized; Suzhou Wu Song Jiang Pharmaceutical Co., Ltd. romanized
2023/09/02New drug · Class 1.2 洋常春藤叶口服液 · No verified English nameCXZL2300058 Zhejiang Kang En Bei Zhong Yao Co., Ltd. romanized
2023/09/02New drug · Class 1.2 洋常春藤叶提取物 · No verified English nameCXZL2300057 Zhejiang Kang En Bei Zhong Yao Co., Ltd. romanized
2023/09/02New drug · Class 3.4 人凝血因子IX · No verified English nameCXSL2300595 Hua Lan Bio Gong Cheng Co., Ltd. romanized
2023/09/02New drug · Class 2.2 大流行流感全病毒灭活疫苗(H5N1) · No verified English nameCXSL2300594 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized; Lanzhou Bai Ling Bio Technology Co., Ltd. romanized
2023/09/02New drug · Class 3.4 人纤维蛋白原 · No verified English nameCXSL2300593 Guangdong Dan Xia Biopharmaceutical Co., Ltd. romanized
2023/09/02New drug · Class 3.4 人纤维蛋白原 · No verified English nameCXSL2300592 Guangdong Dan Xia Biopharmaceutical Co., Ltd. romanized
2023/09/02New drug · Class 1 177Lu-LNC1003 注射液 · No verified English nameCXHL2300945 Yan Tai Lan Na Cheng Bio Technology Co., Ltd. romanized
2023/09/02New drug · Class 2.2 氢溴酸伏硫西汀口崩片 · No verified English nameCXHL2300944 Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized
2023/09/02New drug · Class 2.2 氢溴酸伏硫西汀口崩片 · No verified English nameCXHL2300943 Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized
2023/09/02New drug · Class 1 YR001软膏 · No verified English nameCXHL2300942 Hangzhou Yi Rui Pharmaceuticals Technology Co., Ltd. romanized
2023/09/02New drug · Class 1 YR001软膏 · No verified English nameCXHL2300941 Hangzhou Yi Rui Pharmaceuticals Technology Co., Ltd. romanized
2023/09/01Import · Class 1 BI 765049 输注用粉末 · No verified English nameJXSL2300162 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/01Import · Class 1 AUP1602-C · No verified English nameJXSL2300161 Aurealis Therapeutics AG; Shenzhen Xbiome Biotech Co. Ltd.
2023/09/01Import · Class 2.2 Anifrolumab注射液 · No verified English nameJXSL2300160 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2023/09/01Generic · Class 3 Bumetanide InjectionCYHS2302349 Name not romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/09/01Generic · Class 3 Potassium Chloride InjectionCYHS2302346 Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2023/09/01Generic · Class 3 Salbutamol Sulfate injectionCYHS2302342 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/09/01Generic · Class 3 Revefenacin inhalation solutionCYHL2300111 Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized
2023/09/01New drug · Class 1 注射用RC108 · No verified English nameCXSL2300591 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/09/01New drug · Class 1 HB0025注射液 · No verified English nameCXSL2300590 Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/09/01New drug · Class 1 HB0025注射液 · No verified English nameCXSL2300589 Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/09/01New drug · Class 2.2 布地奈德福莫特罗吸入粉雾剂(胶囊型) · No verified English nameCXHL2300939 Zhuhai Rui Si Pu Li Pharmaceuticals Technology Co., Ltd. romanized
2023/09/01New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHL2300938 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/09/01New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHL2300937 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized

65 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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