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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 341 drug applications between 16 November 2023 and 22 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 60 drug names.

2023/11/16 – 2023/11/22

Period
2023/11/16 to 2023/11/22, 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
341
Drugs with new generic filings (by drug name, de-duplicated)
60
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

341filings, 81 of them generic

By application type

Application typeFilings
Supplement187
Generic81
New drug46
Import12
Unspecified11
Import re-registration4

By drug type

Drug typeFilings
Chemical drug240
TCM57
Therapeutic biologic35
Biologic7
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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Brivaracetam Tablets4119
2Iohexol Injection315
3Dabigatran Etexilate Capsules312
4Metoclopramide Hydrochloride Injection226
5Esmolol Hydrochloride Injection223
6Tacrolimus Sustained-release Capsules216
7Gabapentin Capsules210
8Perindopril arginine and amlodipine besylate tablets213
9Vonoprazan Fumarate Tablets2160
10Bupivacaine Hydrochloride 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

226 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized660
2Shandong Er Ye Pharmaceutical Co., Ltd. romanized520
3Eli Lilly and Company510
4GUERBET510
5Novo Nordisk A/S510
6Pfizer Europe MA EEIG420
7Guangzhou Yin Nuo Pharmaceuticals Group Co., Ltd. romanized410
8ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.414
9Ferring GmbH330
10Jiangsu Xiu Zheng Pharmaceutical 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

82 this week

AcceptedDrugApplicants
2023/11/22Import · Class 1 HRO761 · No verified English nameJXHL2300295 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/11/22Import · Class 1 HRO761 · No verified English nameJXHL2300294 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/11/22Import · Class 1 LNP023胶囊 · No verified English nameJXHL2300293 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/11/22Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2303214 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2023/11/22Generic · Class 3 Piperacillin Sodium for InjectionCYHS2303212 Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized
2023/11/22Generic · Class 3 Nefopam Hydrochloride InjectionCYHS2303211 Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/11/22Generic · Class 3 Levetiracetam in Sodium Chloride InjectionCYHS2303210 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Name not romanized
2023/11/22Generic · Class 3 Nicorandil for InjectionCYHS2303209 Chengdu Di Ao Jiu Hong Pharmaceutical Factory romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2023/11/22Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2303207 Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized
2023/11/22Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2303206 Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized
2023/11/22New drug · Class 1 注射用MHB039A · No verified English nameCXSL2300799 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2023/11/22New drug · Class 1 重组抗CD20人源化单克隆抗体皮下注射液 · No verified English nameCXSL2300798 Shanghai Shang Yao Jiao Lian Pharmaceuticals Technology Co., Ltd. romanized
2023/11/22New drug · Class 1 JMB2004注射液 · No verified English nameCXSL2300797 Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized
2023/11/22New drug · Class 1.2 重组脊髓灰质炎疫苗(汉逊酵母) · No verified English nameCXSL2300796 Guo Yao Zhong Sheng Bio Technology Research Institute Co., Ltd. romanized; Beijing Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/11/22New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300795 Zhejiang Quan Sheng Bio Technology Co., Ltd. romanized
2023/11/22New drug · Class 1 泰莱替尼胶囊 · No verified English nameCXHS2300104 Bao Yuan Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2023/11/22New drug · Class 1 SBK007片 · No verified English nameCXHL2301295 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/22New drug · Class 1 NHWD-870 HCl片 · No verified English nameCXHL2301294 Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized; Hunan Heng Ya Pharmaceuticals Technology Co., Ltd. romanized
2023/11/22New drug · Class 1 NHWD-870 HCl片 · No verified English nameCXHL2301293 Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized; Hunan Heng Ya Pharmaceuticals Technology Co., Ltd. romanized
2023/11/22New drug · Class 1 FZ007-119片 · No verified English nameCXHL2301292 Guangzhou Fei Mi Zi Technology Co., Ltd. romanized
2023/11/22New drug · Class 1 FZ007-119片 · No verified English nameCXHL2301291 Guangzhou Fei Mi Zi Technology Co., Ltd. romanized
2023/11/22New drug · Class 1 YK1001MY片 · No verified English nameCXHL2301290 Yao Kang Zhong Tuo (Beijing) Pharmaceuticals Technology Co., Ltd. romanized
2023/11/22New drug · Class 1 YK1001MY片 · No verified English nameCXHL2301289 Yao Kang Zhong Tuo (Beijing) Pharmaceuticals Technology Co., Ltd. romanized
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

52 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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