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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 398 drug applications between 27 November 2025 and 3 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 66 drug names.

2025/11/27 – 2025/12/03

Period
2025/11/27 to 2025/12/03, 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
398
Drugs with new generic filings (by drug name, de-duplicated)
66
Accepted this week, now under review
98

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

398filings, 82 of them generic

By application type

Application typeFilings
Supplement211
Generic82
New drug69
Import21
Unspecified10
Import re-registration5

By drug type

Drug typeFilings
Chemical drug231
TCM103
Therapeutic biologic59
Biologic3
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
1Pemafibrate Tablets2223
2Crisaborole Ointment2226
3Mupirocin Ointment2230
4Tadalafil Tablets2123
5复方电解质醋酸钠葡萄糖注射液 · No verified English name2122
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

230 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fu Song Xian Zhong Yao Co., Ltd. romanized17170
2Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized990
3Novo Nordisk A/S920
4Hunan Ke Lun Pharmaceutical Co., Ltd. romanized721
5Merck Sharp & Dohme LLC650
6Amgen Inc.620
7Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized620
8Xian Le Xi Medical Technology Co., Ltd. romanized550
9Beijing Sai Er Bio Pharma Co., Ltd. romanized545
10Merck Sharp & Dohme B.V.530

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

115 this week

AcceptedDrugApplicants
2025/12/03Generic · Class 3 Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2504156 Jiangsu Chang Jiang Pharma Co., Ltd. romanized
2025/12/03Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2504148 Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2025/12/03Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2504147 Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2025/12/03Generic · Class 3 Hydrotalcite SuspensionCYHS2504146 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Hua Run San Jiu (Tang Shan) Pharma Co., Ltd. romanized
2025/12/03Generic · Class 3 Heparin Sodium InjectionCYHS2504145 Suzhou Erye Pharmaceutical Co., Ltd
2025/12/03Generic · Class 3 维生素B12注射液 · No verified English nameCYHS2504142 Name not romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2025/12/03Generic · Class 3 酮洛芬凝胶贴膏 · No verified English nameCYHL2500212 Shaanxi Pan Long Pharma Group Co., Ltd. romanized
2025/12/03New drug · Class 3.3 地舒单抗注射液 · No verified English nameCXSS2500128 Fu Xing Han Lin (Shenzhen) Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2025/12/03New drug · Class 3.3 地舒单抗注射液 · No verified English nameCXSS2500127 Fu Xing Han Lin (Shenzhen) Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2025/12/03New drug · Class 2.2 注射用MK-2870 · No verified English nameCXSL2501037 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2025/12/03New drug · Class 2.2 注射用MK-2870 · No verified English nameCXSL2501036 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2025/12/03New drug · Class 1 GKL-006Allo注射液 · No verified English nameCXSL2501035 Beijing Ji Yin Qi Ming Bio Technology Co., Ltd. romanized
2025/12/03New drug · Class 2.1 卡度尼利单抗注射液(皮下注射) · No verified English nameCXSL2501034 Kang Fang Pharma Co., Ltd. romanized
2025/12/03New drug · Class 1 脐带血巨核细胞注射液 · No verified English nameCXSL2501033 Suzhou Xue Ji Bio Technology Co., Ltd. romanized
2025/12/03New drug · Class 1 XTYW007片 · No verified English nameCXHL2501328 Xian Xin Tong Drug Research Co., Ltd. romanized
2025/12/03New drug · Class 1 XTYW007片 · No verified English nameCXHL2501327 Xian Xin Tong Drug Research Co., Ltd. romanized
2025/12/03New drug · Class 1 XTYW007片 · No verified English nameCXHL2501326 Xian Xin Tong Drug Research Co., Ltd. romanized
2025/12/03New drug · Class 2.2 SYH9089注射液 · No verified English nameCXHL2501325 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/12/03New drug · Class 1 SY-9453胶囊 · No verified English nameCXHL2501324 Shou Yao Holding (Beijing) Co., Ltd. romanized
2025/12/03New drug · Class 1 SY-9453胶囊 · No verified English nameCXHL2501323 Shou Yao Holding (Beijing) Co., Ltd. romanized
2025/12/03New drug · Class 1 XW014片 · No verified English nameCXHL2501322 Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized
2025/12/03New drug · Class 1 XW014片 · No verified English nameCXHL2501321 Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized
2025/12/03New drug · Class 1 ANS014004片 · No verified English nameCXHL2501320 Beijing An Shi Bio Technology Co., Ltd. romanized
2025/12/03New drug · Class 1 ANS014004片 · No verified English nameCXHL2501319 Beijing An Shi Bio Technology Co., Ltd. romanized
2025/12/02Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2504138 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/12/02Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2504126 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2025/12/02Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2504125 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2025/12/02Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2504121 Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized
2025/12/02Generic · Class 3 Nafamostat Mesilate for InjectionCYHL2500211 Tianjin Hong Ri Pharma Co., Ltd. romanized
2025/12/02New drug · Class 1.1 疏肝解郁颗粒 · No verified English nameCXZS2500048 Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized; Kang Mei Bao Ning (Sichuan) Pharmaceutical Co., Ltd. romanized

85 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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