YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 393 drug applications between 28 November 2025 and 4 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 66 drug names.

2025/11/28 – 2025/12/04

Period
2025/11/28 to 2025/12/04, 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
393
Drugs with new generic filings (by drug name, de-duplicated)
66
Accepted this week, now under review
100

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

393filings, 83 of them generic

By application type

Application typeFilings
Supplement210
Generic83
New drug53
Import34
Unspecified7
Import re-registration6

By drug type

Drug typeFilings
Chemical drug226
TCM109
Therapeutic biologic54
Biologic2
Prophylactic 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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Crisaborole Ointment2226
2瑞维那新吸入溶液 · No verified English name2253
3Mupirocin Ointment2230
4Tadalafil Tablets2123
5奥洛他定莫米松鼻喷雾剂 · No verified English name211
6Levonorgestrel Tablets215
7Teneligliptin Hydrobromide Hydrate Tablets2110
8生理氯化钠溶液 · No verified English name2117
9Levocetirizine dihydrochloride Oral Solution215
10Clopidogrel Hydrogen Sulphate Tablets216

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

229 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fu Song Xian Zhong Yao Co., Ltd. romanized19190
2Eli Lilly and Company1210
3Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized660
4AstraZeneca AB650
5Amgen Inc.620
6Hunan Ke Lun Pharmaceutical Co., Ltd. romanized610
7Xian Le Xi Medical Technology Co., Ltd. romanized550
8Beijing Sai Er Bio Pharma Co., Ltd. romanized545
9Merck Sharp & Dohme B.V.530
10Zhong Shan Kang Fang Biopharmaceuticals 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

108 this week

AcceptedDrugApplicants
2025/12/04Import · Class 3.1 帕博利珠单抗注射液 · No verified English nameJXSS2500148 MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2025/12/04Import · Class 1 BI 764532 输注用浓缩粉末 · No verified English nameJXSL2500236 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/12/04Import · Class 1 RO7790121注射液 · No verified English nameJXSL2500235 F. Hoffmann-La Roche Ltd.
2025/12/04Import · Class 1 AZD2936 · No verified English nameJXSL2500234 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/12/04Import · Class 1 AZD8205 · No verified English nameJXSL2500233 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/12/04Import · Class 1 Cevostamab · No verified English nameJXSL2500232 Genentech Inc.; Roche(China)Holding Ltd.
2025/12/04Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2500387 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2025/12/04Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2500386 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2025/12/04Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2500385 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2025/12/04Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2500384 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2025/12/04Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2500383 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2025/12/04Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2500382 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2025/12/04Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2500381 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2025/12/04Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2500380 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2025/12/04Import · Class 1 AZD9574 · No verified English nameJXHL2500379 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/12/04Import · Class 1 AZD9574 · No verified English nameJXHL2500378 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/12/04Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2500377 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2025/12/04Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2500376 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2025/12/04Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2500375 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2025/12/04Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2500374 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2025/12/04Import · Class 1 RO7435846片 · No verified English nameJXHL2500373 F. Hoffmann-La Roche Ltd
2025/12/04Import · Class 1 RO7435846片 · No verified English nameJXHL2500372 F. Hoffmann-La Roche Ltd
2025/12/04Import · Class 1 RO7435846片 · No verified English nameJXHL2500371 F. Hoffmann-La Roche Ltd
2025/12/04Generic · Class 3 Indocyaninegreen for InjectionCYHS2504164 Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2025/12/04Generic · Class 3 乳酸维持液含葡萄糖10% · No verified English nameCYHS2504161 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized
2025/12/04Generic · Class 3 Esflurbiprofen PatchesCYHL2500213 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/12/04New drug · Class 1 HB0056注射液 · No verified English nameCXSL2501039 Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/12/04New drug · Class 1 注射用SSS50 · No verified English nameCXSL2501038 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/12/04New drug · Class 1 地尼法司他片 · No verified English nameCXHS2500147 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized; Ge Li Pharma (Zhejiang) Co., Ltd. romanized
2025/12/03Generic · Class 3 Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2504156 Jiangsu Chang Jiang Pharma Co., Ltd. romanized

78 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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