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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 452 drug applications between 8 December 2023 and 14 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 71 drug names.

2023/12/08 – 2023/12/14

Period
2023/12/08 to 2023/12/14, 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
452
Drugs with new generic filings (by drug name, de-duplicated)
71
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

452filings, 97 of them generic

By application type

Application typeFilings
Supplement242
Generic97
New drug64
Import31
Unspecified10
Import re-registration8

By drug type

Drug typeFilings
Chemical drug268
TCM107
Therapeutic biologic70
Biologic4
Prophylactic biologic2
In vitro diagnostic reagent1

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

71 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1地氯雷他定口服溶液 · No verified English name4426
2Morinidazole and Sodium Chloride Injection339
3Minoxidil Liniment3252
4Tapentadol Hydrochloride Tablets310
5二甲双胍恩格列净片(I) · No verified English name222
6Diquafosol Sodium Eye Drops225
7Ceftazidime And Avibactam Sodium For Injection2212
8Norepinephrine Bitartrate Injection229
9Acetylcysteine Oral Solution2111
10Quetiapine Fumarate Extended-release Tablets210

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

239 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Lan Yun Zhi He Bio Technology Co., Ltd. romanized49380
2Novo Nordisk A/S1010
3Tai Ji Group Sichuan Tian Cheng Pharmaceutical Co., Ltd. romanized880
4Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized820
5Boehringer Ingelheim International GmbH630
6Fresenius Kabi Austria GmbH610
7ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.543
8Hunan Ke Lun Pharmaceutical Co., Ltd. romanized544
9F. Hoffmann-La Roche Ltd530
10Kang Zhi Pharma Co., Ltd. romanized530

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

136 this week

AcceptedDrugApplicants
2023/12/14Import · Class 1 Cevostamab · No verified English nameJXSL2300228 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2023/12/14Import · Class 2.2 Pozelimab注射液 · No verified English nameJXSL2300227 Regeneron Pharmaceuticals Inc.; Zai Lab (Shanghai) Co. Ltd.
2023/12/14Import · Class 2.2 Pozelimab注射液 · No verified English nameJXSL2300226 Regeneron Pharmaceuticals Inc.; Zai Lab (Shanghai) Co. Ltd.
2023/12/14Import · Class 1 Cemdisiran注射液 · No verified English nameJXHL2300314 Regeneron Pharmaceuticals Inc.; Zai Lab (Shanghai) Co. Ltd.
2023/12/14Import · Class 1 Cemdisiran注射液 · No verified English nameJXHL2300313 Regeneron Pharmaceuticals Inc.; Zai Lab (Shanghai) Co. Ltd
2023/12/14Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2303473 Hubei Kai Na Pharma Co., Ltd. romanized; Hubei Mei Si Chuang Pharma Co., Ltd. romanized
2023/12/14Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2303469 Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized; Bao Ding Ai Hui Pharma Co., Ltd. romanized
2023/12/14Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2303468 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2023/12/14Generic · Class 3 Nefopam Hydrochloride InjectionCYHS2303467 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2023/12/14Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2303464 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2023/12/14Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2303463 Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized
2023/12/14Generic · Class 3 丁酸氯维地平乳状注射液 · No verified English nameCYHS2303461 Yangtze River Pharmaceutical Group Co., Ltd
2023/12/14Generic · Class 3 Tapentadol Hydrochloride TabletsCYHS2303460 Jiangsu En Hua Pharma Co., Ltd. romanized
2023/12/14Generic · Class 3 Tapentadol Hydrochloride TabletsCYHS2303459 Jiangsu En Hua Pharma Co., Ltd. romanized
2023/12/14Generic · Class 3 Tapentadol Hydrochloride TabletsCYHS2303458 Jiangsu En Hua Pharma Co., Ltd. romanized
2023/12/14Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2303453 Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Jiangxi Yin Tao Pharma Co., Ltd. romanized
2023/12/14Generic · Class 3 Potassium Aspartate InjectionCYHS2303451 Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/12/14Generic · Class 3 Abiraterone Acetate TabletsCYHL2300152 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/12/14Generic · Class 3 尿素[13C]呼气试验药盒 · No verified English nameCYHL2300151 Shenzhen Shi Zhong He Hai De Wei Bio Technology Co., Ltd. romanized
2023/12/14New drug · Class 1 注射用重组(酵母分泌型)人血清白蛋白-人粒细胞集落刺激因子(I)融合蛋白 · No verified English nameCXSS2300099 Jiangsu Tai Kang Biopharmaceuticals Co., Ltd. romanized
2023/12/14New drug · Class 1 润达基奥仑赛注射液(拟定) · No verified English nameCXSS2300098 Shanghai Heng Run Da Sheng Bio Technology Co., Ltd. romanized; Shanghai Heng Run Da Sheng Biopharmaceutical Co., Ltd. romanized
2023/12/14New drug · Class 3.4 注射用重组人凝血因子VIIa · No verified English nameCXSS2300097 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/12/14New drug · Class 1 QX007N注射液 · No verified English nameCXSL2300860 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2023/12/14New drug · Class 1 注射用BC001 · No verified English nameCXSL2300858 Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized
2023/12/14New drug · Class 1 人脂肪间充质干细胞注射液 · No verified English nameCXSL2300857 Beijing Ai Ge Gan Xi Bao Technology Co., Ltd. romanized
2023/12/14New drug · Class 1 注射用AMT-562 · No verified English nameCXSL2300856 Pu Zhong Fa Xian Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/12/14New drug · Class 2.4 替戈拉生片 · No verified English nameCXHS2300114 Shandong Luo Xin Pharma Group Co., Ltd. romanized
2023/12/14New drug · Class 1 注射用HR20013 · No verified English nameCXHS2300113 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/12/14New drug · Class 1 HTMC0435片 · No verified English nameCXHL2301389 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2023/12/14New drug · Class 1 HTMC0435片 · No verified English nameCXHL2301388 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized

106 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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