YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 328 drug applications between 20 March 2025 and 26 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 69 drug names.

2025/03/20 – 2025/03/26

Period
2025/03/20 to 2025/03/26, 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
328
Drugs with new generic filings (by drug name, de-duplicated)
69
Accepted this week, now under review
23

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

328filings, 92 of them generic

By application type

Application typeFilings
Supplement160
Generic92
New drug35
Import25
Unspecified8
Import re-registration8

By drug type

Drug typeFilings
Chemical drug224
TCM49
Therapeutic biologic49
Prophylactic biologic6

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

69 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sodium Nitroprusside Injection3315
2Sacubitril Valsartan Sodium Tablets3170
3Mupirocin Ointment3130
4Diquafosol Sodium Eye Drops225
5氧(气态) · No verified English name221
6Glucosamine Sulfate Capsules2251
7Sodium Iodide[131I] Oral Solution222
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

205 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Amgen Inc.1020
2Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized990
3Roche Pharma(Schweiz)AG810
4Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized630
5Hubei Wu Shi Pharma Co., Ltd. romanized535
6Sanofi Winthrop Industrie520
7Sichuan Kelun Pharmaceutical Co., Ltd.510
8Xian Da Heng Pharmaceutical Co., Ltd. romanized440
9Celgene Corporation410
10Roche Pharma (Schweiz) AG410

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

93 this week

AcceptedDrugApplicants
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
2025/03/26Generic · Class 3 Ketoprofen PatchesCYHL2500070 Beijing Foyou Pharma CO.,LTD
2025/03/26Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2500067 Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized
2025/03/26Generic · Class 3 米诺地尔泡沫剂 · No verified English nameCYHL2500066 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/03/26New drug · Class 1 注射用SSGJ-705 · No verified English nameCXSL2500247 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/03/26New drug · Class 2.4 注射用重组A型肉毒毒素 · No verified English nameCXSL2500246 Beijing Bo Te Wei Ke Bio Technology Co., Ltd. romanized
2025/03/26New drug · Class 1 注射用BC2027 · No verified English nameCXSL2500245 Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized
2025/03/26New drug · Class 2.2; 2.4 硫酸镁无菌溶液 · No verified English nameCXHL2500326 Guangdong Mai Heng Pharmaceuticals Research and Development Co., Ltd. romanized
2025/03/26New drug · Class 1 RO7673396薄膜包衣片 · No verified English nameCXHL2500325 Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized
2025/03/26New drug · Class 1 RO7673396薄膜包衣片 · No verified English nameCXHL2500324 Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized
2025/03/26New drug · Class 1 RO7673396薄膜包衣片 · No verified English nameCXHL2500323 Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized
2025/03/26New drug · Class 1 WSD0922-FU片 · No verified English nameCXHL2500322 Hangzhou Wei Rui Bao Biopharmaceuticals Co., Ltd. romanized
2025/03/26New drug · Class 1 WSD0922-FU 片 · No verified English nameCXHL2500321 Hangzhou Wei Rui Bao Biopharmaceuticals Co., Ltd. romanized
2025/03/26New drug · Class 1 JZ-14胶囊 · No verified English nameCXHL2500320 Yun Bai Yao Zheng Wu Technology (Shanghai) Co., Ltd. romanized
2025/03/26New drug · Class 1 JZ-14胶囊 · No verified English nameCXHL2500319 Yun Bai Yao Zheng Wu Technology (Shanghai) Co., Ltd. romanized
2025/03/26New drug · Class 1 SVHRSP注射液 · No verified English nameCXHL2500318 Shenyang Wan Jin Pharmaceuticals Technology Co., Ltd. romanized
2025/03/25Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2500043 Merck Sharp & Dohme LLC; MSD R&D(China) Co. Ltd
2025/03/25Import · Class 1 AZD2936 · No verified English nameJXSL2500042 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/03/25Import · Class 2.2 Tarlatamab · No verified English nameJXSL2500041 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2025/03/25Import · Class 2.2 Tarlatamab · No verified English nameJXSL2500040 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2025/03/25Import · Class 2.2 Tarlatamab · No verified English nameJXSL2500039 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2025/03/25Generic · Class 3 Hydrotalcite SuspensionCYHS2501173 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/03/25Generic · Class 3 盐酸精氨酸注射液 · No verified English nameCYHS2501162 Sichuan Miao Ji Biopharmaceuticals Technology Co., Ltd. romanized; Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized

63 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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