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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 420 drug applications between 4 December 2025 and 10 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 66 drug names.

2025/12/04 – 2025/12/10

Period
2025/12/04 to 2025/12/10, 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
420
Drugs with new generic filings (by drug name, de-duplicated)
66
Accepted this week, now under review
121

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

420filings, 90 of them generic

By application type

Application typeFilings
Supplement182
Generic90
New drug88
Import28
Unspecified16
Import re-registration16

By drug type

Drug typeFilings
Chemical drug250
TCM93
Therapeutic biologic54
Biologic13
Prophylactic biologic6
In vitro diagnostic reagent4

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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Finerenone Tablets5369
2Minoxidil Liniment3252
3Norepinephrine Bitartrate Injection329
4Riociguat Tablets314
5Metformin Hydrochloride And Empagliflozin Extended Release Tablets3112
6Emedastine Difumarate Eye Drops229
7多种微量元素注射液(IV) · No verified English name214
8奥洛他定莫米松鼻喷雾剂 · No verified English name211
9左羟丙哌嗪糖浆 · No verified English name210
10帕拉米韦氯化钠注射液 · No verified English name2117

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

249 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fu Song Xian Zhong Yao Co., Ltd. romanized13130
2Eli Lilly and Company1210
3AstraZeneca AB840
4Ai Min Pharma Group Co., Ltd. romanized660
5Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized540
6Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized535
7Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized530
8Bayer AG520
9Terumo Corporation Kofu Factory510
10Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized510

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

150 this week

AcceptedDrugApplicants
2025/12/10Import · Class 2.2 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500150 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/12/10Import · Class 2.2 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500149 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/12/10Generic · Class 3 Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2504249 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2025/12/10Generic · Class 3 Progesterone InjectionCYHS2504239 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2025/12/10Generic · Class 3 Progesterone InjectionCYHS2504238 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2025/12/10Generic · Class 3 托吡酯口服溶液 · No verified English nameCYHS2504237 Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized
2025/12/10New drug · Class 1 阴道用乳杆菌二联活菌胶囊 · No verified English nameCXSS2500137 Guangdong Long Chuang Ji Pharma Co., Ltd. romanized
2025/12/10New drug · Class 1.1 发热伴血小板减少综合征灭活疫苗(Vero细胞) · No verified English nameCXSL2501069 Guo Yao Zhong Sheng Bio Technology Research Institute Co., Ltd. romanized
2025/12/10New drug · Class 3.2 人凝血因子IX · No verified English nameCXSL2501068 Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized
2025/12/10New drug · Class 1 WGc-043注射液 · No verified English nameCXSL2501067 Chengdu Wei Si Jin Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/10New drug · Class 1 WGc-043注射液 · No verified English nameCXSL2501066 Chengdu Wei Si Jin Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/10New drug · Class 1 KSD-101注射液 · No verified English nameCXSL2501064 Zhong Shan Heng Sai Bio Technology Co., Ltd. romanized
2025/12/10New drug · Class 1 KL0011034注射液 · No verified English nameCXHL2501370 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized; Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized
2025/12/10New drug · Class 2.2 TH202266胶束注射液 · No verified English nameCXHL2501363 Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized
2025/12/10New drug · Class 1 PSTB100片 · No verified English nameCXHL2501362 Pu Luo Si Te (Nanjing) Bio Technology Co., Ltd. romanized
2025/12/10New drug · Class 1 PSTB100片 · No verified English nameCXHL2501361 Pu Luo Si Te (Nanjing) Bio Technology Co., Ltd. romanized
2025/12/10New drug · Class 1 PSTB100片 · No verified English nameCXHL2501360 Pu Luo Si Te (Nanjing) Bio Technology Co., Ltd. romanized
2025/12/10New drug · Class 1 GT919胶囊 · No verified English nameCXHL2501359 Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/12/10New drug · Class 1 GT919胶囊 · No verified English nameCXHL2501358 Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/12/10New drug · Class 1 GT919胶囊 · No verified English nameCXHL2501357 Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/12/10New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2501356 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/12/10New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2501355 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/12/10New drug · Class 1 ADX-324注射液 · No verified English nameCXHL2501354 Yuan Yi Bio Technology (Shanghai) Co., Ltd. romanized
2025/12/10New drug · Class 1 LWP779片 · No verified English nameCXHL2501353 Yuan Sen Pharmaceutical (Hangzhou) Co., Ltd. romanized
2025/12/10New drug · Class 1 LWP779片 · No verified English nameCXHL2501352 Yuan Sen Pharmaceutical (Hangzhou) Co., Ltd. romanized
2025/12/10New drug · Class 2.4 GEN-725片 · No verified English nameCXHL2501351 Henan Zhen Shi Bio Technology Co., Ltd. romanized
2025/12/10New drug · Class 2.4 GEN-725片 · No verified English nameCXHL2501350 Henan Zhen Shi Bio Technology Co., Ltd. romanized
2025/12/10New drug · Class 1 注射用莱古比星 · No verified English nameCXHL2501349 Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/09Import · Class 3.1 ACYW群脑膜炎球菌多糖结合疫苗 · No verified English nameJXSL2500237 Sanofi Pasteur Inc.; Shenzhen Sanofi Pasteur Biological Products Co. Ltd.
2025/12/09Generic · Class 3 Protamine Sulfate InjectionCYHS2504227 Nanjing Hai Chen Pharma Co., Ltd. romanized

120 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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