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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 401 drug applications between 2 January 2025 and 8 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 147, covering 106 drug names.

2025/01/02 – 2025/01/08

Period
2025/01/02 to 2025/01/08, 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
401
Drugs with new generic filings (by drug name, de-duplicated)
106
Accepted this week, now under review
17

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

401filings, 147 of them generic

By application type

Application typeFilings
Supplement168
Generic147
New drug67
Import11
Import re-registration4
Unspecified3
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug291
TCM56
Therapeutic biologic47
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

106 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Metformin Hydrochloride And Empagliflozin Extended Release Tablets5212
2Tacrolimus Ointment426
3Rosuvastatin Calcium and Ezetimibe Tablets (I)339
4Lidocaine and Prilocaine Cream3224
5Vonoprazan Fumarate Tablets3260
6Mivacurium Chloride Injection323
7Tadalafil Tablets3123
8Topiroxostat Tablets310
9阿贝西利片 · No verified English name312
10Lactulose Oral Solution2234

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

237 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

138 this week

AcceptedDrugApplicants
2025/01/08Import · Class 2.4 达罗他胺片 · No verified English nameJXHS2500001 Bayer HealthCare Pharmaceuticals Inc.; Orion Corporation,Orion Pharma,Espoo; Bayer Healthcare Company Ltd.
2025/01/08Import · Class 1 TAK-279胶囊 · No verified English nameJXHL2500005 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2025/01/08Import · Class 1 TAK-279胶囊 · No verified English nameJXHL2500004 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2025/01/08Generic · Class 3 Butorphanol Tartrate InjectionCYHS2500133 Yangtze River Pharmaceutical Group Co., Ltd
2025/01/08Generic · Class 3 Butorphanol Tartrate InjectionCYHS2500132 Yangtze River Pharmaceutical Group Co., Ltd
2025/01/08Generic · Class 3 吡格列酮二甲双胍片(15mg/500mg) · No verified English nameCYHS2500131 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2025/01/08Generic · Class 3 Raltitrexed for InjectionCYHS2500130 Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized
2025/01/08Generic · Class 3 阿仑膦酸钠泡腾片 · No verified English nameCYHS2500123 Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized
2025/01/08Generic · Class 3 Perospirone Hydrochloride TabletsCYHS2500119 Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2025/01/08Generic · Class 3 Perospirone Hydrochloride TabletsCYHS2500118 Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2025/01/08Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2500117 Beijing Foyou Pharma CO.,LTD
2025/01/08Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2500116 Beijing Foyou Pharma CO.,LTD
2025/01/08Generic · Class 3 Clindamycin Palmitate Hydrochloride GranulesCYHS2500115 Shandong Qidu Pharmaceutical Co., Ltd.; Jewim Pharmaceutical (Shandong) Co., Ltd.
2025/01/08Generic · Class 3 Diprophylline InjectionCYHS2500114 Hefei Sheng Qin Pharmaceuticals Technology Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2025/01/08Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2500113 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2025/01/08Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2500112 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2025/01/08Generic · Class 3 Sodium Nitroprusside InjectionCYHS2500111 Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized
2025/01/08Generic · Class 3 Allopurinol TabletsCYHS2500108 Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanized
2025/01/08Generic · Class 3 复方匹可硫酸钠颗粒 · No verified English nameCYHS2500107 Hainan Tong Yong San Yang Pharma Co., Ltd. romanized
2025/01/08Generic · Class 3 Sulpiride TabletsCYHS2500105 Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2025/01/08Generic · Class 3 Nitroglycerin InjectionCYHS2500101 Kang Pu Pharma Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2025/01/08New drug · Class 1 注射用菲泽妥单抗 · No verified English nameCXSS2500003 Tian Jing Bio Technology (Hangzhou) Co., Ltd. romanized
2025/01/08New drug · Class 1 注射用博度曲妥珠单抗 · No verified English nameCXSS2500002 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2025/01/08New drug · Class 3.2 静注人免疫球蛋白(10%) · No verified English nameCXSL2500022 Guangdong Shuang Lin Biopharmaceutical Co., Ltd. romanized
2025/01/08New drug · Class 1 ZT006片 · No verified English nameCXSL2500021 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized
2025/01/08New drug · Class 1 ZT006片 · No verified English nameCXSL2500020 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized
2025/01/08New drug · Class 1 ZT006片 · No verified English nameCXSL2500019 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized
2025/01/08New drug · Class 1 ABSK061胶囊装微片 · No verified English nameCXHL2500039 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2025/01/08New drug · Class 1 ABSK061胶囊装微片 · No verified English nameCXHL2500038 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2025/01/08New drug · Class 1 ABSK061胶囊装微片 · No verified English nameCXHL2500037 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized

108 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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