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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 351 drug applications between 14 November 2023 and 20 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 53 drug names.

2023/11/14 – 2023/11/20

Period
2023/11/14 to 2023/11/20, 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
351
Drugs with new generic filings (by drug name, de-duplicated)
53
Accepted this week, now under review
4

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

351filings, 68 of them generic

By application type

Application typeFilings
Supplement204
Generic68
New drug44
Import23
Import re-registration7
Unspecified5

By drug type

Drug typeFilings
Chemical drug239
TCM69
Therapeutic biologic39
Biologic2
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

53 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Granules424
2Dabigatran Etexilate Capsules312
3Gabapentin Capsules210
4Perindopril arginine and amlodipine besylate tablets213
5Vonoprazan Fumarate Tablets2160
6Famotidine Injection218
7注射用头孢哌酮钠舒巴坦钠(2:1) · No verified English name212
8Neostigmine Methylsulfate Injection214
9Minoxidil Liniment2152
10Eldecalcitol Soft Capsules218

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

204 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Shuang Yan Pharma Co., Ltd. romanized27260
2AstraZeneca AB1050
3Jiu Hua Hua Yuan Pharma Co., Ltd. romanized880
4CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD810
5Bao Guang Pharma (Chengdu) Co., Ltd. romanized550
6Shandong Er Ye Pharmaceutical Co., Ltd. romanized520
7Novo Nordisk A/S510
8Pfizer Europe MA EEIG420
9Guangzhou Yin Nuo Pharmaceuticals Group Co., Ltd. romanized410
10Xiu Zheng Pharma Group Tian Han 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

91 this week

AcceptedDrugApplicants
2023/11/20Import · Class 1 AZD3470薄膜衣片 · No verified English nameJXHL2300292 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/11/20Import · Class 1 AZD3470薄膜衣片 · No verified English nameJXHL2300291 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/11/20Generic · Class 3 Acetate And Glucose Electrolytes InjectionCYHS2303177 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/11/20Generic · Class 3 Acetate And Glucose Electrolytes InjectionCYHS2303176 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/11/20Generic · Class 3 Pregabalin Oral SolutionCYHS2303172 Beijing Suo Pu Xing Da Pharmaceuticals Research Co., Ltd. romanized; Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized
2023/11/20Generic · Class 3 Fexofenadine Hydrochloride Oral SuspensionCYHS2303171 Zhejiang Pu Li Pharma Co., Ltd. romanized
2023/11/20New drug · Class 3.1 桃红四物汤颗粒 · No verified English nameCXZS2300023 Hainan Kang Mao Xin Pharmaceuticals Technology Co., Ltd. romanized; Guo Yao Group De Zhong (Fo Shan) Pharma Co., Ltd. romanized
2023/11/20New drug · Class 1.1 四仙颗粒 · No verified English nameCXZL2300071 Sichuan Sheng Zhong Pharmaceuticals Ke College romanized
2023/11/20New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2300794 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/11/20New drug · Class 1 TQB2223 注射液 · No verified English nameCXSL2300793 Zheng Da Tian Qing (Guangzhou) Pharmaceuticals Co., Ltd. romanized
2023/11/20New drug · Class 1 IMC001注射液 · No verified English nameCXSL2300792 Chengdu Yi Mu Feng Bio Technology Co., Ltd. romanized; Suzhou Yi Mu Feng Bio Technology Co., Ltd. romanized
2023/11/20New drug · Class 2.4 镥[177Lu]氧奥曲肽注射液 · No verified English nameCXHL2301284 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized
2023/11/18Generic · Class 3 Arbidol Hydrochloride TabletsCYHS2303169 Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized
2023/11/18Generic · Class 3 Cimetidine InjectionCYHS2303168 Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized
2023/11/18New drug · Class 2.3 小儿热速清口服液 · No verified English nameCXZL2300070 Jilin Yi Zheng Pharma Group Co., Ltd. romanized
2023/11/18New drug · Class 1 BW-20507注射液 · No verified English nameCXHL2301283 Hangzhou Bo Lin Pharmaceuticals Technology Co., Ltd. romanized
2023/11/18New drug · Class 2.1; 2.2; 2.4 盐酸(R)-氯胺酮鼻喷雾剂 · No verified English nameCXHL2301282 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2023/11/18New drug · Class 2.1; 2.2; 2.4 盐酸(R)-氯胺酮鼻喷雾剂 · No verified English nameCXHL2301281 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2023/11/17Import · Class 2.3 Aztreonam and Avibactam Sodium for InjectionJXHS2300103 Pfizer Europe MA EEIG; Hospira Australia Pty Ltd; Pfizer Investment Co. Ltd.
2023/11/17Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2303156 Lang Tian Pharmaceuticals Technology (Wuhan) Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized
2023/11/17Generic · Class 3 Polyvinyl Alcohol Eye DropsCYHS2303155 Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/11/17Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2303150 Hebei Ke Yuan Pharma Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/11/17Generic · Class 3 美洛昔康纳米晶注射液 · No verified English nameCYHL2300139 Jiangsu Hui Ju Pharma Co., Ltd. romanized
2023/11/17New drug · Class 2.3 八宝丹胶囊 · No verified English nameCXZL2300069 Xiamen Zhong Pharmaceutical Factory Co., Ltd. romanized
2023/11/17New drug · Class 1 ZVS203e 注射液 · No verified English nameCXSL2300790 Beijing Zhong Yin Pharmaceutical Co., Ltd. romanized
2023/11/17New drug · Class 1 注射用重组酰化胰高血糖素样肽2类似物 · No verified English nameCXSL2300789 Chongqing Pai Jin Bio Technology Co., Ltd. romanized
2023/11/17New 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 nameCXSL2300788 Shanghai Xian Bo Bio Technology Co., Ltd. romanized
2023/11/17New 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 nameCXSL2300787 Shanghai Xian Bo Bio Technology Co., Ltd. romanized
2023/11/17New 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 nameCXSL2300786 Shanghai Xian Bo Bio Technology Co., Ltd. romanized
2023/11/17New drug · Class 1 ZHB103注射液 · No verified English nameCXSL2300785 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized

61 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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