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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 257 drug applications between 10 March 2023 and 16 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 61, covering 42 drug names.

2023/03/10 – 2023/03/16

Period
2023/03/10 to 2023/03/16, 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
257
Drugs with new generic filings (by drug name, de-duplicated)
42
Accepted this week, now under review
10

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

257filings, 61 of them generic

By application type

Application typeFilings
Supplement116
Generic61
New drug47
Import20
Import re-registration8
Unspecified5

By drug type

Drug typeFilings
Chemical drug182
Therapeutic biologic42
TCM26
Biologic5
Prophylactic biologic2

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
1Glucosamine Sulfate Capsules4451
2Amiodarone Hydrochloride Injection310
3Lactulose Oral Solution2234
4Famotidine Injection228
5Rivastigmine transdermal system211
6Obeticholic Acid Tablets210
7Dimethyl Fumarate Delayed-release Capsules210
8Empagliflozin And Linagliptin Tablets210
9Amlodipine Besylate and Atorvastatin Calcium Tablets212
10氯雷他定糖浆 · No verified English name217

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

163 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Tianjin He Zhi Pharma Group Co., Ltd. romanized990
2Shandong Run Ze Pharmaceutical Co., Ltd. romanized610
3Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized550
4Jin He Zang Yao Co., Ltd. romanized430
5MSD Pharma (Singapore) Pte. Ltd420
6Qilu Pharmaceutical (Hainan) Co., Ltd424
7Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized410
8Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized330
9Guangxi Ji Min Tang Pharma Co., Ltd. romanized330
10Guangxi Yu Yuan Pharma Co., Ltd. romanized330

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

88 this week

AcceptedDrugApplicants
2023/03/16Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2300808 Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/03/16Generic · Class 3 Carbocisteine Oral SolutionCYHS2300805 Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/03/16Generic · Class 3 Carbocisteine Oral SolutionCYHS2300804 Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/03/16Generic · Class 3 Pentoxifylline InjectionCYHS2300803 Henan Xin Tai Pharma Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2023/03/16Generic · Class 3 Levetiracetam extended-release tabletsCYHS2300802 Hunan Dong Ting Pharma Co., Ltd. romanized
2023/03/16Generic · Class 3 Latamoxef Sodium for InjectionCYHS2300800 Shandong Lan Jing Bio Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized
2023/03/16Generic · Class 3 Latamoxef Sodium for InjectionCYHS2300799 Shandong Lan Jing Bio Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized
2023/03/16New drug · Class 1.1 金玄安脉颗粒 · No verified English nameCXZL2300017 Zhongguo Zhong Pharmaceuticals Technology Development Center (Guo Jia Zhong Pharmaceuticals Management Ju Ren Cai Jiao Liu Center) romanized
2023/03/16New drug · Class 3.3 13价肺炎球菌多糖结合疫苗 · No verified English nameCXSS2300013 Lanzhou Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/03/16New drug · Class 1 EMB-07注射液 · No verified English nameCXSL2300198 An Mai Bio Technology (Suzhou) Co., Ltd. romanized
2023/03/16New drug · Class 1 注射用RC108 · No verified English nameCXSL2300197 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/03/16New drug · Class 1 SW0715 注射液 · No verified English nameCXSL2300196 Si Wei (Shanghai) Bio Technology Co., Ltd. romanized
2023/03/16New drug · Class 1 重组全人抗LAG-3单克隆抗体注射液 · No verified English nameCXSL2300195 Guangzhou Yu Heng Bio Technology Co., Ltd. romanized
2023/03/16New drug · Class 1 9MW3811注射液 · No verified English nameCXSL2300194 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2023/03/16New drug · Class 1 9MW3811注射液 · No verified English nameCXSL2300193 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2023/03/15Import · Class 1 Tarlatamab · No verified English nameJXSL2300054 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2023/03/15Import · Class 1 Tarlatamab · No verified English nameJXSL2300053 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2023/03/15Import · Class 1 Tarlatamab · No verified English nameJXSL2300052 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2023/03/15Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2300792 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/03/15Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2300791 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/03/15New drug · Class 1 FP002注射液 · No verified English nameCXSL2300192 Guangdong Fei Peng Pharmaceutical Co., Ltd. romanized
2023/03/15New drug · Class 1 MWN101注射液 · No verified English nameCXSL2300191 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2023/03/15New drug · Class 1 MWN101注射液 · No verified English nameCXSL2300190 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2023/03/15New drug · Class 3.3 BR201注射液 · No verified English nameCXSL2300189 Hai Zheng Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized
2023/03/15New drug · Class 2.2 赛帕利单抗注射液 · No verified English nameCXSL2300188 Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/03/15New drug · Class 1 Domvanalimab注射液 · No verified English nameCXSL2300187 Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/03/15New drug · Class 1 TNM006注射液 · No verified English nameCXSL2300186 Shenzhen Shi Zhi Xin Bio Technology Co., Ltd. romanized
2023/03/15New drug · Class 1 PB-718注射液 · No verified English nameCXHL2300314 Pai Ge Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2023/03/15New drug · Class 1 HS336片 · No verified English nameCXHL2300313 Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2023/03/15New drug · Class 1 HS336片 · No verified English nameCXHL2300312 Zhejiang Hai Zheng Pharma Co., Ltd. romanized

58 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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