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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 438 drug applications between 6 February 2025 and 12 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 156, covering 106 drug names.

2025/02/06 – 2025/02/12

Period
2025/02/06 to 2025/02/12, 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
438
Drugs with new generic filings (by drug name, de-duplicated)
106
Accepted this week, now under review
19

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

438filings, 156 of them generic

By application type

Application typeFilings
Generic156
Supplement135
New drug98
Import29
Import re-registration14
Unspecified6

By drug type

Drug typeFilings
Chemical drug324
Therapeutic biologic73
TCM34
Prophylactic biologic5
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

106 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets9660
2Brexpiprazole Tablets8331
3Tacrolimus Capsules422
4Sodium Hyaluronate Eye Drops4230
5盐酸纳美芬注射液 · No verified English name321
6Azilsartan Medoxomil Potassium Tablets3235
7Polidocanol Injection3123
8Levofloxacin Eye Drops2216
9Tofacitinib Citrate Extended Release tablets222
10Sacubitril Valsartan Sodium Tablets2270

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

262 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Hao Sen Pharma Group Co., Ltd. romanized1130
2Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized930
3Novartis Pharma AG640
4CSPC OUYI PHARMACEUTICAL CO., LTD.643
5Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized550
6Sichuan Kelun Pharmaceutical Co., Ltd.532
7Jiangsu Kang Yuan Pharma Co., Ltd. romanized535
8Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized535
9Novo Nordisk A/S510
10Beijing Hua Shen Pharmaceutical 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

173 this week

AcceptedDrugApplicants
2025/02/12Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2500011 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd
2025/02/12Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2500010 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd
2025/02/12Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2500009 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd
2025/02/12Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2500008 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd
2025/02/12Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2500007 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd
2025/02/12Import · Class 2.1 Mosunetuzumab Injection (Subcutaneous Injection) · No verified English nameJXSL2500024 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2025/02/12Import · Class 2.1 Mosunetuzumab Injection (Subcutaneous Injection) · No verified English nameJXSL2500023 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2025/02/12Generic · Class 3 Nitroglycerin InjectionCYHS2500714 Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2025/02/12Generic · Class 3 Nitroglycerin InjectionCYHS2500713 Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2025/02/12Generic · Class 3 Amisulpride Oral SolutionCYHS2500712 Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Ji Cui Ji Ding Pharmaceuticals Co., Ltd. romanized
2025/02/12Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2500708 Jinan Dong Fang Kai Yuan Pharmaceuticals Xin Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/02/12Generic · Class 3 Ornidazole InjectionCYHS2500706 Si Huan Pharmaceuticals (Zhengzhou) Co., Ltd. romanized
2025/02/12Generic · Class 3 Ornidazole InjectionCYHS2500705 Si Huan Pharmaceuticals (Zhengzhou) Co., Ltd. romanized
2025/02/12Generic · Class 3 Bumetanide InjectionCYHS2500702 Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2025/02/12Generic · Class 3 Bumetanide InjectionCYHS2500701 Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2025/02/12Generic · Class 3 Eltrombopag Lamine For Oral SuspensionCYHS2500700 Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized
2025/02/12Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2500699 Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2025/02/12Generic · Class 3 铜[64Cu]氧奥曲肽注射液 · No verified English nameCYHL2500038 Jiangsu Hua Yi Technology Co., Ltd. romanized
2025/02/12New drug · Class 3.1 当归六黄颗粒 · No verified English nameCXZS2500005 Shandong Hong Ji Tang Pharmaceutical Group Co., Ltd. romanized
2025/02/12New drug · Class 3.3 乌司奴单抗注射液(静脉输注) · No verified English nameCXSS2500028 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized; Jiangsu Sai Fu Shi Bio Technology Co., Ltd. romanized
2025/02/12New drug · Class 1.3 重组人乳头瘤病毒九价疫苗(汉逊酵母)(BFA58佐剂) · No verified English nameCXSL2500139 Jiangsu Rui Ke Bio Technology Co., Ltd. romanized; Beijing An Bai Sheng Bio Technology Co., Ltd. romanized
2025/02/12New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2500138 Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized
2025/02/12New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2500137 Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized
2025/02/12New drug · Class 1 TQB2210注射液 · No verified English nameCXSL2500136 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/02/12New drug · Class 2.2 注射用卡瑞利珠单抗 · No verified English nameCXSL2500135 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/02/12New drug · Class 1 GZR102 · No verified English nameCXSL2500134 Gan Li Pharma Shandong Co., Ltd. romanized
2025/02/12New drug · Class 2.2 注射用RS202227 · No verified English nameCXHL2500194 Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized
2025/02/12New drug · Class 1 AHB-137注射液 · No verified English nameCXHL2500193 Hangzhou Hao Bo Pharmaceuticals Co., Ltd. romanized
2025/02/11Import · Class 2.2 美泊利珠单抗注射液 · No verified English nameJXSS2500006 GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited
2025/02/11Import · Class 2.2 美泊利珠单抗注射液 · No verified English nameJXSS2500005 GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited

143 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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