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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 416 drug applications between 3 December 2025 and 9 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 67 drug names.

2025/12/03 – 2025/12/09

Period
2025/12/03 to 2025/12/09, 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
416
Drugs with new generic filings (by drug name, de-duplicated)
67
Accepted this week, now under review
120

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

416filings, 95 of them generic

By application type

Application typeFilings
Supplement183
Generic95
New drug83
Import25
Unspecified15
Import re-registration15

By drug type

Drug typeFilings
Chemical drug233
TCM104
Therapeutic biologic58
Biologic13
In vitro diagnostic reagent4
Prophylactic biologic4

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

67 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
7Ilaprazole Enteric-coated Tablets2226
8Tadalafil Tablets2123
9多种微量元素注射液(IV) · No verified English name214
10奥洛他定莫米松鼻喷雾剂 · No verified English name211

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

242 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fu Song Xian Zhong Yao Co., Ltd. romanized30300
2Eli Lilly and Company1210
3Ai Min Pharma Group Co., Ltd. romanized660
4Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized540
5Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized535
6Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized530
7Terumo Corporation Kofu Factory510
8Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized510
9Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized510
10Shanghai Ke Hua Bio Gong Cheng Co., Ltd. romanized440

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

146 this week

AcceptedDrugApplicants
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
2025/12/09Generic · Class 3 Indobufen TabletsCYHS2504226 Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized
2025/12/09Generic · Class 3 头孢克肟干混悬剂 · No verified English nameCYHS2504225 Zhejiang Pu Luo Ju Tai Pharma Co., Ltd. romanized
2025/12/09Generic · Class 3 Minoxidil LinimentCYHS2504222 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanized
2025/12/09Generic · Class 3 Minoxidil LinimentCYHS2504221 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanized
2025/12/09Generic · Class 3 头孢克肟胶囊 · No verified English nameCYHS2504217 Shandong Cheng Kang Pharma Co., Ltd. romanized; Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized
2025/12/09Generic · Class 3 Bucladesine Sodium InjectionCYHL2500218 Hunan Ming Rui Pharmaceutical Co., Ltd. romanized
2025/12/09Generic · Class 3 Methylergonovine Maleate InjectionCYHL2500217 Chengdu Brilliant Pharmaceutical Co., Ltd.
2025/12/09New drug · Class 1.1 苏辛通窍颗粒 · No verified English nameCXZS2500051 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2025/12/09New drug · Class 3.2 人抗凝血酶III · No verified English nameCXSS2500136 Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized
2025/12/09New drug · Class 1 YOLT-203注射液 · No verified English nameCXSL2501065 Shanghai Yao Tang Bio Technology Co., Ltd. romanized
2025/12/09New drug · Class 1 IMM0306 · No verified English nameCXSL2501063 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/12/09New drug · Class 2.2 托莱西单抗注射液 · No verified English nameCXSL2501062 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/12/09New drug · Class 2.2 IBI310 · No verified English nameCXSL2501061 Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2025/12/09New drug · Class 1 sbk002片 · No verified English nameCXHS2500153 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized; HAINAN HUALON PHARMACEUTICAL CO.,LTD
2025/12/09New drug · Class 1 JAB-23E73片 · No verified English nameCXHL2501348 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2025/12/09New drug · Class 1 JAB-23E73片 · No verified English nameCXHL2501347 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2025/12/09New drug · Class 1 JAB-23E73片 · No verified English nameCXHL2501346 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2025/12/08Generic · Class 3 左羟丙哌嗪糖浆 · No verified English nameCYHS2504213 Hubei Wei Sen Pharmaceutical Co., Ltd. romanized
2025/12/08Generic · Class 3 左羟丙哌嗪糖浆 · No verified English nameCYHS2504212 Hubei Wei Sen Pharmaceutical Co., Ltd. romanized
2025/12/08Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2504211 Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2025/12/08New drug · Class 3.1 温经汤颗粒 · No verified English nameCXZS2500050 Shandong Run Zhong Pharma Co., Ltd. romanized
2025/12/08New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSL2501060 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/12/08New drug · Class 1 靶向BCMA的嵌合抗原受体T细胞注射液 · No verified English nameCXSL2501059 Shenzhen Pu Rui Jin Bio Pharma Co., Ltd. romanized
2025/12/08New drug · Class 3.3 重组抗CD38全人单克隆抗体注射液-皮下注射 · No verified English nameCXSL2501058 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2025/12/08New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2501057 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/12/08New drug · Class 1 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2501056 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2025/12/08New drug · Class 1 SYS6023 · No verified English nameCXSL2501055 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/12/08New drug · Class 1 MRG006A · No verified English nameCXSL2501054 Le Pu Bio Technology Co., Ltd. romanized

116 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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