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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 301 drug applications between 19 March 2025 and 25 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 60 drug names.

2025/03/19 – 2025/03/25

Period
2025/03/19 to 2025/03/25, 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
301
Drugs with new generic filings (by drug name, de-duplicated)
60
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

301filings, 77 of them generic

By application type

Application typeFilings
Supplement149
Generic77
New drug35
Import23
Unspecified10
Import re-registration7

By drug type

Drug typeFilings
Chemical drug205
TCM45
Therapeutic biologic45
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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Progesterone Soft Capsules322
3Mupirocin Ointment3130
4氧(气态) · No verified English name221
5Sodium Iodide[131I] Oral Solution222
6Canagliflozin Tablets218
7Diclofenac Diethylamine Emulgel2120
8Loxoprofen Sodium Patches2130
9Buspirone Hydrochloride Tablets215
10Bupivacaine Hydrochloride Injection214

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

185 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized12120
2Roche Pharma(Schweiz)AG810
3Amgen Inc.720
4Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized630
5Sanofi Winthrop Industrie610
6Hubei Wu Shi Pharma Co., Ltd. romanized535
7Sichuan Kelun Pharmaceutical Co., Ltd.510
8Li Bang Pharma (Shanghai) Co., Ltd. romanized510
9Xian Da Heng Pharmaceutical Co., Ltd. romanized440
10Celgene Corporation410

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

88 this week

AcceptedDrugApplicants
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
2025/03/25Generic · Class 3 Sodium Bicarbonate InjectionCYHS2501161 Anhui Shuang He Pharma Co., Ltd. romanized
2025/03/25Generic · Class 3 Indocyaninegreen for InjectionCYHS2501160 Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized
2025/03/25Generic · Class 3 Sodium Nitroprusside InjectionCYHS2501159 Hainan Hai He Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2025/03/25Generic · Class 3 Bilastine Oral SolutionCYHS2501158 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/03/25Generic · Class 3 Buspirone Hydrochloride TabletsCYHS2501157 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2025/03/25Generic · Class 3 Buspirone Hydrochloride TabletsCYHS2501156 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2025/03/25Generic · Class 3 山梨醇甘露醇冲洗剂 · No verified English nameCYHS2501155 Xian Jing Xi Shuang He Pharma Co., Ltd. romanized
2025/03/25Generic · Class 3 双氯芬酸依泊胺贴 · No verified English nameCYHL2500065 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/03/25New drug · Class 3.4 破伤风人免疫球蛋白 · No verified English nameCXSS2500038 Zhejiang Hai Kang Bio Zhi Pin Co., Ltd. romanized
2025/03/25New drug · Class 2.2 注射用MK-2870 · No verified English nameCXSL2500244 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2025/03/25New drug · Class 3.3 流感病毒裂解疫苗 · No verified English nameCXSL2500243 Shaanxi Kun Qin Bio Technology Co., Ltd. romanized
2025/03/25New drug · Class 1 AZD0901 · No verified English nameCXSL2500242 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized
2025/03/25New drug · Class 1 注射用TQB2102 · No verified English nameCXSL2500241 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/03/25New drug · Class 2.4 注射用甲苯磺酸瑞马唑仑 · No verified English nameCXHL2500317 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/03/24Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2500055 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/03/24Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2500054 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/03/24Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2500053 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/03/24Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2500052 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/03/24New drug · Class 1 Alpha-0261片 · No verified English nameCXHL2500316 Shenzhen A Er Fa Fen Zi Technology Co., Ltd. romanized
2025/03/24New drug · Class 1 Alpha-0261片 · No verified English nameCXHL2500315 Shenzhen A Er Fa Fen Zi Technology Co., Ltd. romanized
2025/03/22Import · Class 2.2 利妥昔单抗注射液 · No verified English nameJXSS2500036 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 2.2 利妥昔单抗注射液 · No verified English nameJXSS2500035 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 2.2 利妥昔单抗注射液 · No verified English nameJXSS2500034 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH

58 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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