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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 372 drug applications between 13 December 2024 and 19 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 75 drug names.

2024/12/13 – 2024/12/19

Period
2024/12/13 to 2024/12/19, 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
372
Drugs with new generic filings (by drug name, de-duplicated)
75
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

372filings, 96 of them generic

By application type

Application typeFilings
Supplement166
Generic96
New drug79
Import22
Import re-registration7
Unspecified2

By drug type

Drug typeFilings
Chemical drug224
TCM81
Therapeutic biologic62
Prophylactic 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

75 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride Oral Solution5146
2Nafamostat Mesilate for Injection4338
3Procaterol Hydrochloride Solution for Inhalation322
4阿贝西利片 · No verified English name312
5Fusidic Acid Cream2215
6氟比洛芬凝胶贴膏 · No verified English name2216
7Rosuvastatin Calcium and Ezetimibe Tablets (I)229
8Vonoprazan Fumarate Tablets2160
9Metformin Hydrochloride And Empagliflozin Extended Release Tablets2112
10Topiramate Tablets210

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

236 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
4Fu Yuan Pharma Co., Ltd. romanized552
5Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized550
6Novartis Pharma AG520
7Hainan Si Da Pharmaceutical Co., Ltd. romanized515
8Jiangxi Cheng Zhi Yong Feng Pharma Co., Ltd. romanized440
9Shijiazhuang No.4 Pharmaceutical Co., Ltd.443
10Janssen Research & Development LLC430

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

134 this week

AcceptedDrugApplicants
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
2024/12/19Generic · Class 3 Bepotastine Besilate Orally Disintegrating TabletsCYHS2404404 Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2024/12/19New drug · Class 1.1 小儿苓龙早熟颗粒 · No verified English nameCXZL2400094 Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized
2024/12/19New drug · Class 1 OVV-01 注射液 · No verified English nameCXSL2400887 Shanghai Rong Rui Pharmaceuticals Technology Co., Ltd. romanized
2024/12/19New drug · Class 1 OVV-01 注射液 · No verified English nameCXSL2400886 Shanghai Rong Rui Pharmaceuticals Technology Co., Ltd. romanized
2024/12/19New drug · Class 1 注射用BR111 · No verified English nameCXSL2400885 Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized; Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized
2024/12/19New drug · Class 1 IBI3007 · No verified English nameCXSL2400884 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/12/19New drug · Class 1 FT-003注射液 · No verified English nameCXSL2400883 Fang Tuo Bio Technology (Suzhou) Co., Ltd. romanized
2024/12/19New drug · Class 1 同种异体脂肪间充质基质细胞注射液 · No verified English nameCXSL2400882 Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized
2024/12/19New drug · Class 3.2 Catumaxomab注射液(卡妥索单抗注射液) · No verified English nameCXSL2400881 Guangzhou Ling Teng Biopharmaceuticals Co., Ltd. romanized
2024/12/19New drug · Class 3.2 Catumaxomab注射液(卡妥索单抗注射液) · No verified English nameCXSL2400880 Guangzhou Ling Teng Biopharmaceuticals Co., Ltd. romanized
2024/12/19New drug · Class 1 HTMC0658片 · No verified English nameCXHL2401404 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2024/12/19New drug · Class 1 HTMC0658片 · No verified English nameCXHL2401403 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2024/12/19New drug · Class 1 TT-00420片 · No verified English nameCXHL2401402 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2024/12/19New drug · Class 1 TT-00420片 · No verified English nameCXHL2401401 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2024/12/19New drug · Class 1 TT-00420片 · No verified English nameCXHL2401400 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2024/12/19New drug · Class 2.2 注射用BJ007(皮下注射) · No verified English nameCXHL2401399 Shanghai Bao Ji Pharma Co., Ltd. romanized
2024/12/19New drug · Class 2.4 Esketamine Hydrochloride InjectionCXHL2401398 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/12/18Import · Class 1 AZD4360 · No verified English nameJXSL2400241 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/12/18Import · Class 2.4 硫酸瑞美吉泮口崩片 · No verified English nameJXHL2400296 Pfizer Inc.; Pfizer Investment CO. Ltd.
2024/12/18Import · Class 1 KFA115 · No verified English nameJXHL2400295 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.

104 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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