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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 286 drug applications between 13 February 2025 and 19 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 91, covering 64 drug names.

2025/02/13 – 2025/02/19

Period
2025/02/13 to 2025/02/19, 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
286
Drugs with new generic filings (by drug name, de-duplicated)
64
Accepted this week, now under review
18

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

286filings, 91 of them generic

By application type

Application typeFilings
Supplement134
Generic91
New drug46
Import9
Unspecified5
Import re-registration1

By drug type

Drug typeFilings
Chemical drug193
Therapeutic biologic46
TCM42
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

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ruxolitinib Phosphate Tablets5327
2Esomeprazole Magnesium for Delayed-release Oral Suspension424
3Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules412
4Potassium Phosphates Injection222
5Polymyxin B sulfate for Injection226
6Diclofenac Sodium Sustained Release Tablets2110
7Multiple Electrolytes and Sodium Acetate Injection214
8Oxcarbazepine Tablets214
9Brexpiprazole Tablets2131
10Topiroxostat 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

180 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Janssen-Cilag International NV1240
2Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized880
3Henan Ying Feng Pharmaceuticals Co., Ltd. romanized840
4Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized770
5Hua Chuan Pharmaceutical Co., Ltd. romanized540
6CSPC OUYI PHARMACEUTICAL CO., LTD.523
7Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized432
8Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized414
9Xian Li Bang Pharmaceutical Co., Ltd. romanized410
10Shanxi Zheng Lai Pharmaceutical Co., Ltd. romanized330

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

98 this week

AcceptedDrugApplicants
2025/02/19Generic · Class 3 Multiple Electrolytes and Sodium Acetate InjectionCYHS2500795 Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized
2025/02/19Generic · Class 3 Multiple Electrolytes and Sodium Acetate InjectionCYHS2500794 Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized
2025/02/19Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2500792 Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized
2025/02/19Generic · Class 3 Butorphanol Tartrate InjectionCYHS2500791 Xi Nan Pharma Co., Ltd. romanized
2025/02/19Generic · Class 3 Butorphanol Tartrate InjectionCYHS2500790 Xi Nan Pharma Co., Ltd. romanized
2025/02/19Generic · Class 3 维生素B12注射液 · No verified English nameCYHS2500788 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2025/02/19Generic · Class 3 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2500787 Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanized
2025/02/19Generic · Class 3 Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHL2500046 Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2025/02/19Generic · Class 3 Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHL2500045 Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2025/02/19Generic · Class 3 Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHL2500044 Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2025/02/19Generic · Class 3 Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHL2500043 Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2025/02/19New drug · Class 3.3 冻干A群C群脑膜炎球菌多糖结合疫苗 · No verified English nameCXSS2500029 Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized
2025/02/19New drug · Class 3.2 静注人免疫球蛋白 · No verified English nameCXSL2500165 Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized
2025/02/19New drug · Class 1 PM8002注射液 · No verified English nameCXSL2500164 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/02/19New drug · Class 1 伏欣奇拜单抗注射液 · No verified English nameCXSL2500163 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/02/19New drug · Class 1 BBM-P002注射液 · No verified English nameCXSL2500162 Xin Zhong Pharmaceuticals Technology (Beijing) Co., Ltd. romanized; Shanghai Xin Zhi Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Mian Yi Bio Technology Co., Ltd. romanized
2025/02/18Generic · Class 3 Lansoprazole For InjectionCYHS2500783 Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized
2025/02/18Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2500780 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2025/02/18Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2500776 Anhui Chang Jiang Pharma Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized
2025/02/18Generic · Class 3 聚乙二醇4000散 · No verified English nameCYHS2500775 Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized; Hangzhou Qian Yuan Bao Ling Pharma Co., Ltd. romanized
2025/02/18Generic · Class 3 盐酸非索非那定干混悬剂 · No verified English nameCYHS2500774 Chen Guang (Tianjin) Pharmaceutical Co., Ltd. romanized; Tianjin Drug Research Institute Pharma Co., Ltd. romanized
2025/02/18Generic · Class 3 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2500767 Beijing Ren Zhong Pharma Co., Ltd. romanized; Anhui Fu Bang Pharma Co., Ltd. romanized
2025/02/18Generic · Class 3 Potassium Phosphates InjectionCYHS2500765 Hua Ren Pharma (Ri Zhao) Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/02/18Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2500764 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/02/18Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2500763 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/02/18Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2500762 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/02/18Generic · Class 3 Relugolix TabletsCYHL2500042 Chengdu Brilliant Pharmaceutical Co., Ltd.
2025/02/18New drug · Class 1.1 活血消异颗粒 · No verified English nameCXZL2500013 Zhu Zhou Qian Jin Pharma Co., Ltd. romanized
2025/02/18New drug · Class 1.2 美蠊复新液 · No verified English nameCXZL2500012 Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized
2025/02/18New drug · Class 1.2 美蠊复新液 · No verified English nameCXZL2500011 Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized

68 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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