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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 372 drug applications between 9 May 2025 and 15 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 108, covering 75 drug names.

2025/05/09 – 2025/05/15

Period
2025/05/09 to 2025/05/15, 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
372
Drugs with new generic filings (by drug name, de-duplicated)
75
Accepted this week, now under review
50

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

372filings, 108 of them generic

By application type

Application typeFilings
Supplement169
Generic108
New drug64
Import20
Unspecified7
Import re-registration4

By drug type

Drug typeFilings
Chemical drug243
TCM63
Therapeutic biologic62
Prophylactic biologic3
Biologic1

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

75 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Minoxidil Liniment4252
2Risperidone Oral Solution416
3Calcium Acetate Oral Solution411
4Aripiprazole Oral Solution414
5Metoclopramide Hydrochloride Injection336
6Riociguat Tablets314
7Brexpiprazole Tablets3131
8Nintedanib Esilate Soft Capsules216
9Carboplatin Injection2110
10复方电解质醋酸钠葡萄糖注射液 · No verified English name2122

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

214 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenyang Dong Xin Pharma Co., Ltd. romanized13130
2Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized13413
3Jiangxi Qing Feng Pharma Co., Ltd. romanized1090
4AstraZeneca AB760
5Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized650
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized620
7Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
8Sanofi Winthrop Industrie610
9Shaanxi Pan Long Pharma Group Co., Ltd. romanized550
10Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized530

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

128 this week

AcceptedDrugApplicants
2025/05/15Import · Class 1 那米司特片 · No verified English nameJXHS2500058 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/05/15Import · Class 1 那米司特片 · No verified English nameJXHS2500057 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/05/15Import · Class 1 Cenerimod片 · No verified English nameJXHL2500111 Idorsia Pharmaceuticals Ltd; Viatris Pharmaceuticals Co. Ltd.
2025/05/15Import · Class 2.2 CHF1535-II · No verified English nameJXHL2500110 CHIESI FARMACEUTICI SPA; Chiesi Pharmaceutical Consulting (Shanghai) Co. Ltd.
2025/05/15Generic · Class 3 Clindamycin Palmitate Hydrochloride GranulesCYHS2501776 Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 维生素B12注射液 · No verified English nameCYHS2501770 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2501769 Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2501766 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2501765 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/05/15Generic · Class 3 Aripiprazole Oral SolutionCYHS2501763 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 Aripiprazole Oral SolutionCYHS2501762 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 Aripiprazole Oral SolutionCYHS2501761 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 Aripiprazole Oral SolutionCYHS2501760 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 磷酸奥司他韦干糖浆 · No verified English nameCYHS2501759 Zhejiang Hua Hai Pharmaceutical Technology Co., Ltd. romanized
2025/05/15Generic · Class 3 维生素D口服溶液 · No verified English nameCYHS2501755 Kunming Bang Yu Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 Calcium Acetate Oral SolutionCYHS2501753 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 Calcium Acetate Oral SolutionCYHS2501752 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2501751 Dong Guan Shi Pu Ji Pharma Co., Ltd. romanized
2025/05/15Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2501750 Dong Guan Shi Pu Ji Pharma Co., Ltd. romanized
2025/05/15Generic · Class 3 Calcium Acetate Oral SolutionCYHS2501749 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 Calcium Acetate Oral SolutionCYHS2501748 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/15New drug · Class 2.3 金丹附延颗粒 · No verified English nameCXZL2500029 Jiangxi Hua Tai Pharma Co., Ltd. romanized
2025/05/15New drug · Class 1 TQB2825注射液(皮下注射) · No verified English nameCXSL2500384 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/05/15New drug · Class 1 TQB2825注射液(皮下注射) · No verified English nameCXSL2500383 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/05/15New drug · Class 1 SENL103自体T细胞注射液 · No verified English nameCXSL2500382 Hebei Sen Lang Bio Technology Co., Ltd. romanized
2025/05/15New drug · Class 2.2 SBK017口服溶液 · No verified English nameCXHL2500477 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/15New drug · Class 2.3 TQC3302吸入喷雾剂 · No verified English nameCXHL2500476 Zheng Da Tian Qing (Guangzhou) Pharmaceuticals Co., Ltd. romanized
2025/05/15New drug · Class 2.3 TQC3302吸入喷雾剂 · No verified English nameCXHL2500475 Zheng Da Tian Qing (Guangzhou) Pharmaceuticals Co., Ltd. romanized
2025/05/15New drug · Class 2.3 TQC3302吸入喷雾剂 · No verified English nameCXHL2500474 Zheng Da Tian Qing (Guangzhou) Pharmaceuticals Co., Ltd. romanized
2025/05/14Import · Class 3.1 达雷妥尤单抗注射液(皮下注射) · No verified English nameJXSS2500061 Janssen-Cilag International NV; Cilag AG; Johnson & Johnson Pharmaceutical Ltd.

98 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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