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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 436 drug applications between 27 July 2025 and 2 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 102, covering 76 drug names.

2025/07/27 – 2025/08/02

Period
2025/07/27 to 2025/08/02, 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
436
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
85

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

436filings, 102 of them generic

By application type

Application typeFilings
Supplement204
Generic102
New drug80
Import28
Import re-registration16
Unspecified4
Drug-device combination product2

By drug type

Drug typeFilings
Chemical drug265
TCM98
Therapeutic biologic67
Unspecified3
Prophylactic biologic2
Biologic1

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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets4270
2Finerenone Tablets4269
3Cefditoren Pivoxil Granules3218
4Dapagliflozin Tablets3284
5Brexpiprazole Tablets3131
6Omega-3-acid ethyl ester 90 Soft Capsules2211
7Pemafibrate Tablets2223
8双氯芬酸钠盐酸利多卡因注射液 · No verified English name228
9Morinidazole and Sodium Chloride Injection229
10头孢克肟干混悬剂 · No verified English name223

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

269 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Kelun Pharmaceutical Co., Ltd.1551
2Shanxi Hua Kang Pharma Co., Ltd. romanized12120
3Qilu Pharmaceutical Co., Ltd.841
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized730
5Amgen Inc.630
6Novo Nordisk A/S620
7Henan Xin Xiang Hua Xing Pharmaceutical Factory romanized620
8AstraZeneca UK Limited610
9Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized550
10Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized530

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

123 this week

AcceptedDrugApplicants
2025/08/02Import · Class 2.1 Onasemnogene abeparvovec鞘内注射液 · No verified English nameJXSS2500106 Novartis Pharma Schweiz AG; Novartis Gene Therapies Inc.; Beijing Novartis Pharma Co. Ltd.
2025/08/02Import · Class 1 ABBV-400注射用粉末 · No verified English nameJXSL2500137 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/08/02Generic · Class 3 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2502797 Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2025/08/02Generic · Class 3 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2502796 Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2025/08/02Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2502785 Guangdong Fang Sheng Jian Meng Pharma Co., Ltd. romanized; Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized
2025/08/02Generic · Class 3 维生素B??注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2502772 Hainan Jun Hua Medical Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized
2025/08/02Generic · Class 3 Relugolix TabletsCYHL2500136 Guangdong Fang Sheng Jian Meng Pharma Co., Ltd. romanized
2025/08/02New drug · Class 1.1 益气升脉颗粒 · No verified English nameCXZL2500059 Rui Yang Pharmaceutical Co., Ltd. romanized
2025/08/02New drug · Class 1 VPD/FC01002 注射液 · No verified English nameCXSL2500652 Wei Neng Sheng Ming Technology Group Co., Ltd. romanized
2025/08/02New drug · Class 1 VUM02注射液 · No verified English nameCXSL2500651 Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized
2025/08/02New drug · Class 1 HTB-C042鼻喷雾剂 · No verified English nameCXSL2500650 Shanghai Hui Dun Yin Tai Bio Technology Co., Ltd. romanized; Shanghai Hui Dun Bio Technology Co., Ltd. romanized
2025/08/02New drug · Class 1 注射用JSKN003 · No verified English nameCXSL2500649 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2025/08/02New drug · Class 1 注射用JSKN022 · No verified English nameCXSL2500648 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2025/08/02New drug · Class 1 SNC115注射液 · No verified English nameCXSL2500647 Shanghai Xian Bo Bio Technology Co., Ltd. romanized
2025/08/02New drug · Class 1 HS-20117-2 注射液 · No verified English nameCXSL2500646 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2025/08/02New drug · Class 1 TQB2868注射液 · No verified English nameCXSL2500645 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/08/02New drug · Class 2.2 注射用瑞康曲妥珠单抗 · No verified English nameCXSL2500644 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/08/02New drug · Class 1 玛氘诺沙韦片 · No verified English nameCXHS2500089 Jia Xing An Di Kang Bio Technology Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized
2025/08/02New drug · Class 1 APH03621片 · No verified English nameCXHL2500803 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2025/08/02New drug · Class 1 APH03621片 · No verified English nameCXHL2500802 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2025/08/02New drug · Class 2.4 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2500801 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2025/08/02New drug · Class 1 羧胺三唑软胶囊 · No verified English nameCXHL2500800 Guangdong Yin Zhu Pharmaceuticals Technology Co., Ltd. romanized
2025/08/02New drug · Class 1 羧胺三唑软胶囊 · No verified English nameCXHL2500799 Guangdong Yin Zhu Pharmaceuticals Technology Co., Ltd. romanized
2025/08/02New drug · Class 1 GSBR-1001290 L-精氨酸片 · No verified English nameCXHL2500798 Shanghai Shuo Di Bio Technology Co., Ltd. romanized
2025/08/02New drug · Class 1 GSBR-1001290 L-精氨酸片 · No verified English nameCXHL2500797 Shanghai Shuo Di Bio Technology Co., Ltd. romanized
2025/08/02New drug · Class 1 GSBR-1001290 L-精氨酸片 · No verified English nameCXHL2500796 Shanghai Shuo Di Bio Technology Co., Ltd. romanized
2025/08/02New drug · Class 1 GSBR-1001290 L-精氨酸片 · No verified English nameCXHL2500795 Shanghai Shuo Di Bio Technology Co., Ltd. romanized
2025/08/02New drug · Class 1 GSBR-1001290 L-精氨酸片 · No verified English nameCXHL2500794 Shanghai Shuo Di Bio Technology Co., Ltd. romanized
2025/08/02New drug · Class 1 QHRD110胶囊 · No verified English nameCXHL2500793 Changzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanized
2025/08/02New drug · Class 1 QHRD110胶囊 · No verified English nameCXHL2500792 Changzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanized

93 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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