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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 368 drug applications between 14 December 2024 and 20 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 100, covering 78 drug names.

2024/12/14 – 2024/12/20

Period
2024/12/14 to 2024/12/20, 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
368
Drugs with new generic filings (by drug name, de-duplicated)
78
Accepted this week, now under review
5

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, 100 of them generic

By application type

Application typeFilings
Supplement153
Generic100
New drug80
Import24
Import re-registration7
Unspecified4

By drug type

Drug typeFilings
Chemical drug233
TCM68
Therapeutic biologic62
Prophylactic biologic3
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

78 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Bromhexine Hydrochloride Oral Solution4222
2Procaterol Hydrochloride Solution for Inhalation322
3Nafamostat Mesilate for Injection3238
4Safinamide Methansulfonate Tablets3220
5阿贝西利片 · No verified English name312
6Fusidic Acid Cream2215
7Rosuvastatin Calcium and Ezetimibe Tablets (I)229
8Nicardipine Hydrochloride Injection2213
9Vonoprazan Fumarate Tablets2160
10Nimodipine Oral Solution214

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

234 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized12100
2Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized920
3Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized660
4Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized550
5AstraZeneca AB530
6Novartis Pharma AG520
7Jiangxi Cheng Zhi Yong Feng Pharma Co., Ltd. romanized440
8Shijiazhuang No.4 Pharmaceutical Co., Ltd.443
9Novartis Europharm Limited420
10Jing Hua Pharmaceutical Group Co., Ltd. romanized420

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

142 this week

AcceptedDrugApplicants
2024/12/20Import · Class 1 AZD8630 · No verified English nameJXSL2400245 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/12/20Import · Class 1 AZD8630 · No verified English nameJXSL2400244 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/12/20Import · Class 1 AZD8630 · No verified English nameJXSL2400243 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/12/20Generic · Class 3 Nimodipine Oral SolutionCYHS2404433 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2024/12/20Generic · Class 3 Nimodipine Oral SolutionCYHS2404430 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2024/12/20Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2404429 Hebei Hui De Xu Sheng Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanized
2024/12/20Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2404428 Hebei Hui De Xu Sheng Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanized
2024/12/20Generic · Class 3 双氯芬酸依泊胺贴 · No verified English nameCYHS2404427 Hangzhou Duan Ben Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/12/20Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2404422 Guangdong Tai Sen De Pharmaceutical Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/12/20Generic · Class 3 盐酸赛庚啶口服溶液 · No verified English nameCYHS2404421 Suzhou Hua Jian Rui Da Pharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2024/12/20Generic · Class 3 盐酸他喷他多口服溶液 · No verified English nameCYHL2400265 Jiangsu En Hua Pharma Co., Ltd. romanized
2024/12/20New drug · Class 1 POC101胶囊 · No verified English nameCXHL2401415 Changchun Zhang Cheng Pharmaceuticals Technology Co., Ltd. romanized
2024/12/20New drug · Class 1 HC016脂质复合物注射液 · No verified English nameCXHL2401413 Zhejiang Hai Chang Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/20New drug · Class 1 GT919胶囊 · No verified English nameCXHL2401412 Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/12/20New drug · Class 1 GT919胶囊 · No verified English nameCXHL2401410 Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/12/20New drug · Class 2.2 BCM235双释干混悬剂 · No verified English nameCXHL2401409 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2024/12/20New drug · Class 2.2 BCM235双释干混悬剂 · No verified English nameCXHL2401408 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2024/12/20New drug · Class 1 WJ01024片 · No verified English nameCXHL2401407 Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/20New drug · Class 1 ABSK131胶囊 · No verified English nameCXHL2401406 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/20New drug · Class 1 ABSK131胶囊 · No verified English nameCXHL2401405 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/19Import · Class 1 DS-3939a · No verified English nameJXSL2400242 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/12/19Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2404418 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2024/12/19Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2404417 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2024/12/19Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2404416 Zhejiang Shang Ke Biopharmaceuticals Co., Ltd. romanized
2024/12/19Generic · Class 3 Magnesium Sulfate InjectionCYHS2404413 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2024/12/19Generic · Class 3 Magnesium Sulfate InjectionCYHS2404412 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2024/12/19Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2404411 Henan Li Hua Pharmaceutical Co., Ltd. romanized; Henan Run Hong Pharmaceutical Co., Ltd. romanized
2024/12/19Generic · Class 3 头孢克肟颗粒 · No verified English nameCYHS2404410 Guangdong Hua Nan Pharma Group Co., Ltd. romanized; Jin Hong Pharma Co., Ltd. romanized
2024/12/19Generic · Class 3 Bumetanide InjectionCYHS2404407 Yunnan Hua Pai Pharmaceuticals Technology Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2024/12/19Generic · Class 3 环索奈德吸入气雾剂 · No verified English nameCYHS2404405 Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized

112 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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