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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 248 drug applications between 2 February 2025 and 8 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 88, covering 65 drug names.

2025/02/02 – 2025/02/08

Period
2025/02/02 to 2025/02/08, 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
248
Drugs with new generic filings (by drug name, de-duplicated)
65
Accepted this week, now under review
10

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

248filings, 88 of them generic

By application type

Application typeFilings
Generic88
Supplement79
New drug57
Import re-registration11
Import9
Unspecified4

By drug type

Drug typeFilings
Chemical drug183
Therapeutic biologic43
TCM19
Biologic2
Prophylactic biologic1

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

65 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets9660
2Brexpiprazole Tablets3131
3Polidocanol Injection3123
4Cetrorelix Acetate for Injection224
5Tadalafil Tablets2123
6Voglibose Tablets210
7Perampanel Tablets212
8Procaterol Hydrochloride Solution for Inhalation212
9Sodium Hyaluronate Eye Drops2130
10Imatinib Mesylate Tablets215

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

163 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized930
2Jiangsu Hao Sen Pharma Group Co., Ltd. romanized920
3Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized420
4Jinan Gao Hua Pharmaceutical Co., Ltd. romanized424
5Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized420
6Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized420
7Bristol-Myers Squibb Pharma EEIG410
8Pfizer Europe MA EEIG410
9Beijing Hua Shen Pharmaceutical Co., Ltd. romanized330
10Wuhan Jiu An Pharma 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

92 this week

AcceptedDrugApplicants
2025/02/08Import · Class 2.2 Tezepelumab注射液 · No verified English nameJXSL2500021 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/02/08Import · Class 1 TAK-279胶囊 · No verified English nameJXHL2500018 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2025/02/08Generic · Class 3 Indocyaninegreen for InjectionCYHS2500640 Hainan Brilliant Pharmaceutical Co., Ltd.
2025/02/08Generic · Class 3 微量元素注射液4-I · No verified English nameCYHS2500635 Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/02/08Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2500632 Fujian Sheng Fu Kang Pharma Co., Ltd. romanized; Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2025/02/08Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2500631 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2025/02/08Generic · Class 3 尿素[13C]呼气试验药盒 · No verified English nameCYHS2500629 Shenzhen Shi Zhong He Hai De Wei Bio Technology Co., Ltd. romanized
2025/02/08New drug · Class 3.3 司库奇尤单抗注射液 · No verified English nameCXSS2500024 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2025/02/08New drug · Class 3.3 司库奇尤单抗注射液 · No verified English nameCXSS2500023 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2025/02/08New drug · Class 1 注射用ZG006 · No verified English nameCXSL2500122 Name not romanized
2025/02/08New drug · Class 1 XS228细胞注射液 · No verified English nameCXSL2500121 Shi Ze Biopharmaceuticals (Suzhou) Co., Ltd. romanized; Shi Ze Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2025/02/08New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2500120 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/02/08New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2500119 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/02/08New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2500118 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/02/08New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2500117 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/02/08New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2500116 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/02/08New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2500115 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/02/08New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2500114 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/02/08New drug · Class 1 LBL-007注射液 · No verified English nameCXSL2500113 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized
2025/02/08New drug · Class 1 注射用LBL-024 · No verified English nameCXSL2500112 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized
2025/02/08New drug · Class 1 SHR-4849注射液 · No verified English nameCXSL2500111 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/02/08New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2500110 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/02/08New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500109 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/02/08New drug · Class 1 注射用RC108 · No verified English nameCXSL2500108 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/02/08New drug · Class 1 注射用LBL-024 · No verified English nameCXSL2500107 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized
2025/02/08New drug · Class 1 注射用LBL-024 · No verified English nameCXSL2500106 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized
2025/02/08New drug · Class 1 注射用BL-M11D1 · No verified English nameCXSL2500105 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/02/08New drug · Class 2.2; 2.4 洛索洛芬钠滴眼液 · No verified English nameCXHS2500016 Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized
2025/02/08New drug · Class 1 UA026片 · No verified English nameCXHL2500176 Name not romanized
2025/02/08New drug · Class 1 UA026片 · No verified English nameCXHL2500175 Name not romanized

62 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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