YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 386 drug applications between 1 January 2025 and 7 January 2025 (data as of 14 November 2026 06:00). Of these, generic applications numbered 131, covering 93 drug names.

2025/01/01 – 2025/01/07

Period
2025/01/01 to 2025/01/07, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
386
Drugs with new generic filings (by drug name, de-duplicated)
93
Accepted this week, now under review
12

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

386filings, 131 of them generic

By application type

Application typeFilings
Supplement168
Generic131
New drug66
Import15
Unspecified3
Import re-registration3

By drug type

Drug typeFilings
Chemical drug280
TCM50
Therapeutic biologic49
Prophylactic biologic7

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

93 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets5358
2Metformin Hydrochloride And Empagliflozin Extended Release Tablets5212
3Tacrolimus Ointment426
4Lidocaine and Prilocaine Cream3224
5帕拉米韦氯化钠注射液 · No verified English name3217
6Mivacurium Chloride Injection323
7Tadalafil Tablets3123
8Topiroxostat Tablets310
9Lactulose Oral Solution2234
10Fusidic Acid Cream2214

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

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

130 this week

AcceptedDrugApplicants
2025/01/07Generic · Class 3 Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2500098 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/01/07Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2500095 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2025/01/07Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2500094 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/01/07Generic · Class 3 Diprophylline InjectionCYHS2500092 Shanghai Bao Long Bio Technology Co., Ltd. romanized; Xu Chang Wei Lai Pharmaceutical Co., Ltd. romanized
2025/01/07Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2500089 Anhui Xin Run Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/01/07Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2500086 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2025/01/07Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2500085 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2025/01/07Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2500084 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2025/01/07Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2500083 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2025/01/07Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2500082 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2025/01/07Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2500081 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2025/01/07Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2500080 Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized
2025/01/07Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2500079 Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized
2025/01/07Generic · Class 3 Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2500073 Hunan Jin Pu Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/01/07Generic · Class 3 美沙拉秦肠溶缓释胶囊 · No verified English nameCYHS2500072 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2025/01/07Generic · Class 3 Bifonazole SolutionCYHS2500071 Jewim Pharmaceutical (Shandong) Co., Ltd.
2025/01/07New drug · Class 1 DS010注射液 · No verified English nameCXSL2500018 Da Shi Pharma (Guangdong) Co., Ltd. romanized
2025/01/07New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2500017 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized
2025/01/07New drug · Class 1 SYS6040 · No verified English nameCXSL2500016 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/01/07New drug · Class 1 PM8002注射液 · No verified English nameCXSL2500015 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/01/07New drug · Class 2.1; 2.2 泰它西普注射液 · No verified English nameCXSL2500014 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/01/07New drug · Class 2.1 泰它西普注射液 · No verified English nameCXSL2500013 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/01/07New drug · Class 3.4 抗蝮蛇毒血清 · No verified English nameCXSL2500012 Jiangxi Bio Zhi Pin Research Institute Co., Ltd. romanized
2025/01/07New drug · Class 1 JYP0035胶囊 · No verified English nameCXHL2500021 Jia Yue (Chengdu) Pharmaceuticals Technology Co., Ltd. romanized
2025/01/07New drug · Class 1 JYP0035胶囊 · No verified English nameCXHL2500020 Jia Yue (Chengdu) Pharmaceuticals Technology Co., Ltd. romanized
2025/01/07New drug · Class 1 JYP0035胶囊 · No verified English nameCXHL2500019 Jia Yue (Chengdu) Pharmaceuticals Technology Co., Ltd. romanized
2025/01/07New drug · Class 1 JYP0035胶囊 · No verified English nameCXHL2500018 Jia Yue (Chengdu) Pharmaceuticals Technology Co., Ltd. romanized
2025/01/07New drug · Class 1 SKB107注射液 · No verified English nameCXHL2500017 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2025/01/07New drug · Class 2.2 JX004P搽剂 · No verified English nameCXHL2500016 Shaanxi Dong Ke Pharmaceutical Co., Ltd. romanized
2025/01/07New drug · Class 1 ETS-006片 · No verified English nameCXHL2500015 Wuxi Yi Tuo Pharmaceuticals Technology Co., Ltd. romanized

100 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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