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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 357 drug applications between 21 March 2025 and 27 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 62 drug names.

2025/03/21 – 2025/03/27

Period
2025/03/21 to 2025/03/27, 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
357
Drugs with new generic filings (by drug name, de-duplicated)
62
Accepted this week, now under review
25

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

357filings, 83 of them generic

By application type

Application typeFilings
Supplement183
Generic83
New drug48
Import30
Import re-registration8
Unspecified5

By drug type

Drug typeFilings
Chemical drug239
Therapeutic biologic58
TCM53
Prophylactic biologic7

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

62 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sodium Nitroprusside Injection3315
2Glucosamine Sulfate Capsules3351
3Sacubitril Valsartan Sodium Tablets3170
4Mupirocin Ointment3130
5Diquafosol Sodium Eye Drops225
6Ferrous Succinate Tablets2220
7Apalutamide Tablets2218
8Calcitriol Injection220
9Canagliflozin Tablets218
10Diclofenac Diethylamine Emulgel2120

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

219 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized990
2Amgen Inc.820
3Roche Pharma(Schweiz)AG810
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
5Jilin Sheng Qi Ke Pharma Co., Ltd. romanized550
6Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized550
7Hubei Wu Shi Pharma Co., Ltd. romanized535
8Sanofi Winthrop Industrie520
9Sichuan Kelun Pharmaceutical Co., Ltd.510
10Xian Da Heng 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

103 this week

AcceptedDrugApplicants
2025/03/27Import · Class 2.1 仑卡奈单抗注射液(皮下注射) · No verified English nameJXSL2500046 Eisai Co. Ltd.; Eisai China Inc.
2025/03/27Import · Class 1 TPST-1120片 · No verified English nameJXHL2500058 Tempest Therapeutics Inc.; Novotech Clinical Services (Shanghai) Co. Ltd.
2025/03/27Import · Class 2.4 Megestrol Acetate Oral SuspensionJXHL2500056 TWi Pharmaceuticals Inc.; Changchun GeneScience Pharmaceuticals Co. Ltd.
2025/03/27Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2501201 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2025/03/27Generic · Class 3 Ferrous Succinate TabletsCYHS2501200 Shanxi Tong Da Pharma Co., Ltd. romanized
2025/03/27Generic · Class 3 Ferrous Succinate TabletsCYHS2501199 Shanghai Jin Bu Huan Lan Kao Pharmaceutical Co., Ltd. romanized
2025/03/27Generic · Class 3 Bumetanide InjectionCYHS2501196 Chongqing Bo Teng Pharma Co., Ltd. romanized
2025/03/27Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2501195 Shanghai Qing Ping Pharma Co., Ltd. romanized
2025/03/27New drug · Class 3.1 桃核承气汤颗粒 · No verified English nameCXZS2500012 Hefei Hua Run Shen Lu Pharma Co., Ltd. romanized
2025/03/27New drug · Class 2.3 肺热咳喘颗粒 · No verified English nameCXZL2500020 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2025/03/27New drug · Class 1 注射用JS207 · No verified English nameCXSL2500252 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2025/03/27New drug · Class 1 HD006细胞 · No verified English nameCXSL2500251 Hua Dao (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2025/03/27New drug · Class 3.3 吸附破伤风疫苗 · No verified English nameCXSL2500250 Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized
2025/03/27New drug · Class 1 Cizutamig注射液 · No verified English nameCXSL2500249 Shanghai Tan Di Biopharmaceuticals Technology Co., Ltd. romanized
2025/03/27New drug · Class 1 注射用人白介素-2(高亲和型复合物) · No verified English nameCXSL2500248 Beijing Liang Yuan Biopharmaceuticals Research Co., Ltd. romanized
2025/03/27New drug · Class 1 BW-40202注射液 · No verified English nameCXHL2500338 Shanghai Bo Wang Pharmaceutical Co., Ltd. romanized
2025/03/27New drug · Class 1 CPI-818片 · No verified English nameCXHL2500332 Jia Xing He Ji Pharma Co., Ltd. romanized
2025/03/27New drug · Class 1 CPI-818片 · No verified English nameCXHL2500331 Jia Xing He Ji Pharma Co., Ltd. romanized
2025/03/27New drug · Class 1 WJ47156片 · No verified English nameCXHL2500330 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2025/03/27New drug · Class 1 WJ47156片 · No verified English nameCXHL2500329 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2025/03/27New drug · Class 2.2 ZL-0018 · No verified English nameCXHL2500328 Shandong Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized
2025/03/27New drug · Class 1 JKN2301干混悬剂 · No verified English nameCXHL2500327 Health Yuan Pharma Group Co., Ltd. romanized
2025/03/26Import · Class 1 DS-1062a · No verified English nameJXSL2500045 ASTRAZENECA AB; AstraZeneca Investment (China) Co. Limited
2025/03/26Import · Class 1 AZD2936 · No verified English nameJXSL2500044 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/03/26Generic · Class 3 罗沙司他片 · No verified English nameCYHS2501188 Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized
2025/03/26Generic · Class 3 盐酸伊立替康脂质体注射液 · No verified English nameCYHS2501187 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/03/26Generic · Class 3 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2501182 Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized
2025/03/26Generic · Class 3 Sodium Nitroprusside InjectionCYHS2501180 Zhong Run Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2025/03/26Generic · Class 3 Sodium Nitroprusside InjectionCYHS2501176 Shanxi Jiu Kang Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2025/03/26Generic · Class 3 Ketoprofen PatchesCYHL2500071 Beijing Foyou Pharma CO.,LTD

73 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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