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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 351 drug applications between 15 November 2023 and 21 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 59 drug names.

2023/11/15 – 2023/11/21

Period
2023/11/15 to 2023/11/21, 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)
59
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, 79 of them generic

By application type

Application typeFilings
Supplement190
Generic79
New drug44
Import21
Unspecified12
Import re-registration5

By drug type

Drug typeFilings
Chemical drug249
TCM63
Therapeutic biologic31
Biologic7
Prophylactic 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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Brivaracetam Tablets4119
2Famotidine Injection328
3Dabigatran Etexilate Capsules312
4Levodopa and Benserazide Hydrochloride Tablets222
5Metoclopramide Hydrochloride Injection226
6Tacrolimus Sustained-release Capsules216
7Gabapentin Capsules210
8Perindopril arginine and amlodipine besylate tablets213
9Vonoprazan Fumarate Tablets2160
10Neostigmine Methylsulfate Injection214

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

216 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Shuang Yan Pharma Co., Ltd. romanized15150
2AstraZeneca AB940
3CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD810
4Bao Guang Pharma (Chengdu) Co., Ltd. romanized550
5Shandong Er Ye Pharmaceutical Co., Ltd. romanized520
6ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.525
7Eli Lilly and Company510
8Novo Nordisk A/S510
9Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized440
10Pfizer Europe MA EEIG420

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
2023/11/21Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2303200 Jiangxi Yi You Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized
2023/11/21Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2303190 Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/11/21Generic · Class 3 Famotidine InjectionCYHS2303189 Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2023/11/21Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2303184 Guangdong Sai Kang Pharmaceutical Factory Co., Ltd. romanized
2023/11/21Generic · Class 3 Magnesium Sulfate InjectionCYHS2303181 Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized
2023/11/21Generic · Class 3 Drotaverine Hydrochloride TabletsCYHS2303180 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2023/11/21Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2303179 An Sheng Pharma Co., Ltd. romanized; Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized
2023/11/21Generic · Class 3 Brivaracetam TabletsCYHL2300143 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2023/11/21Generic · Class 3 Brivaracetam TabletsCYHL2300142 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2023/11/21Generic · Class 3 Brivaracetam TabletsCYHL2300141 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2023/11/21Generic · Class 3 Brivaracetam TabletsCYHL2300140 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2023/11/21New drug · Class 1 FCN-437c胶囊 · No verified English nameCXHS2300103 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2023/11/21New drug · Class 1 FCN-437c胶囊 · No verified English nameCXHS2300102 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2023/11/21New drug · Class 1 177Lu-NYM032注射液 · No verified English nameCXHL2301288 Wuxi Nuo Yu Pharmaceuticals Technology Co., Ltd. romanized
2023/11/21New drug · Class 1 KX-826酊 · No verified English nameCXHL2301287 Suzhou Kai Tuo Pharma Co., Ltd. romanized
2023/11/21New drug · Class 1 KX-826酊 · No verified English nameCXHL2301286 Suzhou Kai Tuo Pharma Co., Ltd. romanized
2023/11/21New drug · Class 2.2 OPL-058迟释片 · No verified English nameCXHL2301285 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized
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

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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