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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 368 drug applications between 12 June 2024 and 18 June 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 69 drug names.

2024/06/12 – 2024/06/18

Period
2024/06/12 to 2024/06/18, 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
368
Drugs with new generic filings (by drug name, de-duplicated)
69
Accepted this week, now under review
3

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

368filings, 90 of them generic

By application type

Application typeFilings
Supplement189
Generic90
New drug60
Import13
Unspecified10
Import re-registration6

By drug type

Drug typeFilings
Chemical drug248
TCM60
Therapeutic biologic49
Prophylactic biologic6
Biologic5

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

69 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Penicillin G Sodium For Injection512
2Amisulpride Injection321
3二甲双胍恩格列净片(Ⅰ) · No verified English name227
4Nicardipine Hydrochloride Injection2213
5Sitagliptin and Metformin Hydrochloride Extended-release Tablets2212
6西甲硅油乳剂 · No verified English name223
7丁酸氯维地平注射用乳剂 · No verified English name210
8Tacrolimus Capsules212
9头孢呋辛酯干混悬剂 · No verified English name215
10Bisoprolol Fumarate Tablets216

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

210 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bracco Imaging S.P.A.2410
2Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized872
3Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized740
4Novartis Pharma Schweiz AG730
5Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized720
6Boehringer Ingelheim International GmbH710
7Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized550
8Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized550
9Xizang Jin Yue Pharmaceuticals Co., Ltd. romanized515
10Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized440

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

116 this week

AcceptedDrugApplicants
2024/06/18Import · Class 1 BRII-179注射液 · No verified English nameJXSL2400115 Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited
2024/06/18Import · Class 2.2 注射用戈沙妥珠单抗 · No verified English nameJXSL2400114 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2024/06/18Import · Class 1 BRII-835 (VIR-2218) 注射液 · No verified English nameJXHL2400142 Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited
2024/06/18Generic · Class 3 Trimebutine Maleate TabletsCYHS2401822 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2024/06/18Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2401819 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2024/06/18Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2401815 Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2024/06/18Generic · Class 3 枸橼酸苯海拉明布洛芬片 · No verified English nameCYHS2401813 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized
2024/06/18Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2401812 Changzhou Pharmaceutical Factory Co., Ltd. romanized
2024/06/18Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2401811 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2024/06/18Generic · Class 3 Deoxycholic Acid InjectionCYHL2400113 Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized
2024/06/18New drug · Class 2.3 白脉软膏 · No verified English nameCXZL2400034 Xizang Qi Zheng Zang Yao Co., Ltd. romanized
2024/06/18New drug · Class 3.2 注射用重组人促甲状腺激素 · No verified English nameCXSS2400060 Name not romanized
2024/06/18New drug · Class 1 HRS-5635注射液 · No verified English nameCXHL2400609 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/06/18New drug · Class 2.2 HY22005I片 · No verified English nameCXHL2400608 Changchun Hai Yue Pharma Co., Ltd. romanized
2024/06/17New drug · Class 1.2 SCTV04C注射液 · No verified English nameCXSL2400397 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2024/06/17New drug · Class 1.2 SCTV04C注射液 · No verified English nameCXSL2400396 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2024/06/17New drug · Class 1 SYSA1801注射液 · No verified English nameCXSL2400395 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/06/17New drug · Class 1 PG-033片 · No verified English nameCXHL2400607 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2024/06/17New drug · Class 1 PG-033片 · No verified English nameCXHL2400606 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2024/06/17New drug · Class 1 TY751注射液 · No verified English nameCXHL2400605 Tianjin Drug Research Institute Co., Ltd. romanized
2024/06/15Import · Class 1 BAY 2927088片 · No verified English nameJXHL2400140 Bayer AG; Bayer Healthcare Company Ltd.
2024/06/15Import · Class 2.4 Capivasertib片 · No verified English nameJXHL2400139 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2024/06/15Import · Class 2.4 Capivasertib片 · No verified English nameJXHL2400138 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2024/06/15Import · Class 1 AZD9833片 · No verified English nameJXHL2400137 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2024/06/15Generic · Class 3 Ondansetron Hydrochloride TabletsCYHS2401808 Chengdu Tong De Pharma Co., Ltd. romanized
2024/06/15Generic · Class 3 Minoxidil LinimentCYHS2401807 Guizhou Rui He Pharmaceutical Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/06/15Generic · Class 3 Minoxidil LinimentCYHS2401806 Guizhou Rui He Pharmaceutical Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/06/15Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2401805 Sichuan Xin Tuo Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/06/15New drug · Class 3.1 五味消毒饮颗粒 · No verified English nameCXZS2400022 Rui Yang Pharmaceutical Co., Ltd. romanized
2024/06/15New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400394 Hui Sheng Biopharmaceutical Co., Ltd. romanized

86 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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