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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 524 drug applications between 3 January 2025 and 9 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 204, covering 145 drug names.

2025/01/03 – 2025/01/09

Period
2025/01/03 to 2025/01/09, 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
524
Drugs with new generic filings (by drug name, de-duplicated)
145
Accepted this week, now under review
19

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

524filings, 204 of them generic

By application type

Application typeFilings
Generic204
Supplement204
New drug88
Import17
Unspecified5
Import re-registration5
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug384
TCM69
Therapeutic biologic61
Prophylactic biologic8
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

145 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Metformin Hydrochloride And Empagliflozin Extended Release Tablets5212
2Rosuvastatin Calcium and Ezetimibe Tablets (I)449
3Vonoprazan Fumarate Tablets4360
4Tacrolimus Ointment426
5Azilsartan Medoxomil Potassium Tablets4235
6苯磺酸左氨氯地平片 · No verified English name4245
7Lidocaine and Prilocaine Cream3224
8Bromfenac Sodium Eye Drops327
9盐酸特比萘芬喷雾剂 · No verified English name327
10Mivacurium Chloride Injection323

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

303 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized20180
2ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.868
3Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized710
4Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized660
5Qilu Pharmaceutical Co., Ltd.541
6Beijing Foyou Pharma CO.,LTD535
7Pfizer Europe MA EEIG520
8Nan Tong Lian Ya Pharma Co., Ltd. romanized525
9Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized520
10Jiangxi Ke Rui Pharma Co., Ltd. romanized523

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

180 this week

AcceptedDrugApplicants
2025/01/09Import · Class 1 AZD2936 · No verified English nameJXSL2500006 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/01/09Import · Class 2.2 Tremelimumab · No verified English nameJXSL2500005 MedImmune LLC; AstraZeneca Global R&D (China) Co. Ltd.
2025/01/09Import · Class 2.2 Tremelimumab · No verified English nameJXSL2500004 MedImmune LLC; AstraZeneca Global R&D (China) Co. Ltd.
2025/01/09Generic · Class 3 Aztreonam For InjectionCYHS2500196 Shaanxi Hai Hui Pharmaceuticals Technology Co., Ltd. romanized; Haikou Shi Pharmaceutical Factory Co., Ltd. romanized
2025/01/09Generic · Class 3 Aztreonam For InjectionCYHS2500195 Shaanxi Hai Hui Pharmaceuticals Technology Co., Ltd. romanized; Haikou Shi Pharmaceutical Factory Co., Ltd. romanized
2025/01/09Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2500186 Bao Li Hua (Nanjing) Pharmaceutical Co., Ltd. romanized; Shanghai Mei You Pharmaceutical Co., Ltd. romanized
2025/01/09Generic · Class 3 Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2500185 Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized; Le Pu Pharmaceutical Technology Co., Ltd. romanized
2025/01/09Generic · Class 3 Sodium Bicarbonate InjectionCYHS2500184 Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/01/09Generic · Class 3 Sodium Bicarbonate InjectionCYHS2500183 Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/01/09Generic · Class 3 Calcium Gluconate InjectionCYHS2500182 Henan Xin Tai Pharma Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/01/09Generic · Class 3 Chloral Hydrate SuppositoriesCYHS2500180 Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized
2025/01/09Generic · Class 3 Indobufen TabletsCYHS2500177 Mu Bang (Beijing) Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Yong An Pharmaceutical Co., Ltd. romanized
2025/01/09Generic · Class 3 Levothyroxine Sodium Oral SolutionCYHS2500173 Po Nuo (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2025/01/09Generic · Class 3 氨基酸(15)腹膜透析液 · No verified English nameCYHS2500163 Qingdao Li Teng Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2025/01/09Generic · Class 3 Epalrestat TabletsCYHS2500153 Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized
2025/01/09Generic · Class 3 Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2500152 Hefei Kang Hui Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/01/09Generic · Class 3 Mesalazine Sustained-release GranulesCYHS2500150 Ji Chuan Pharma Group Co., Ltd. romanized
2025/01/09Generic · Class 3 Bempedoic Acid TabletsCYHL2500010 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/01/09Generic · Class 3 丙酸倍氯米松吸入气雾剂 · No verified English nameCYHL2500009 Hefei Li Cheng Pharma Co., Ltd. romanized
2025/01/09Generic · Class 3 Mannitol-S InjectionCYHL2500008 Hunan Xian Shi Pharmaceutical Co., Ltd. romanized
2025/01/09Generic · Class 3 Ketoprofen PatchesCYHL2500006 Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2025/01/09New drug · Class 2.3 乌灵胶囊 · No verified English nameCXZL2500002 Zhejiang Zuo Li Pharma Co., Ltd. romanized
2025/01/09New drug · Class 1 QLP2117注射液 · No verified English nameCXSL2500029 Qilu Pharmaceutical Co., Ltd.
2025/01/09New drug · Class 2.2 QL2107注射液 · No verified English nameCXSL2500028 Qilu Pharmaceutical Co., Ltd.
2025/01/09New drug · Class 1 JSKN016注射液 · No verified English nameCXSL2500027 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2025/01/09New drug · Class 1 注射用SHR-9803 · No verified English nameCXSL2500026 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Mai Jin Biopharmaceuticals Technology Co., Ltd. romanized
2025/01/09New drug · Class 1 注射用ZL-1310 · No verified English nameCXSL2500025 Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized
2025/01/09New drug · Class 1 SSGJ-627注射液 · No verified English nameCXSL2500024 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2025/01/09New drug · Class 1 注射用JS212 · No verified English nameCXSL2500023 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2025/01/09New drug · Class 1 枸橼酸伏维西利胶囊 · No verified English nameCXHS2500006 Jin Zhou Ao Hong Pharma Co., Ltd. romanized

150 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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