YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 547 drug applications between 24 December 2025 and 30 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 139, covering 86 drug names.

2025/12/24 – 2025/12/30

Period
2025/12/24 to 2025/12/30, 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
547
Drugs with new generic filings (by drug name, de-duplicated)
86
Accepted this week, now under review
143

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

547filings, 139 of them generic

By application type

Application typeFilings
Supplement233
Generic139
New drug124
Import20
Import re-registration18
Unspecified13

By drug type

Drug typeFilings
Chemical drug336
TCM112
Therapeutic biologic89
Prophylactic biologic7
Biologic2
In vitro diagnostic reagent1

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

86 drugs with new generic filings; top 10 listed

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

315 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Da Tang Pharma Co., Ltd. romanized21190
2Amgen Inc.1530
3Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized12120
4AstraZeneca AB960
5medac Gesellschaft für klinische Spezialpr?parate mbH810
6Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized660
7Chongqing Zhang Xin Pharmaceutical Co., Ltd. romanized550
8Hunan Jiudian Pharmaceutical Co., Ltd541
9Merck Sharp & Dohme LLC530
10Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized532

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

183 this week

AcceptedDrugApplicants
2025/12/30Generic · Class 3 Tolvaptan Orally Disintegrating TabletsCYHS2504488 Hebei Long Hai Pharma Co., Ltd. romanized
2025/12/30Generic · Class 3 Phloroglucinol Orally Disintegrating TabletsCYHS2504486 Yan Tai Lu Yin Pharma Co., Ltd. romanized
2025/12/30Generic · Class 3 盐酸丙卡特罗吸入溶液 · No verified English nameCYHS2504475 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized; Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized
2025/12/30Generic · Class 3 盐酸丙卡特罗吸入溶液 · No verified English nameCYHS2504474 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized; Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized
2025/12/30Generic · Class 3 Entecavir oral solutionCYHS2504473 Shanghai Hai Hong Industrial (Group) Chao Hu Jin Chen Pharma Co., Ltd. romanized
2025/12/30Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2504472 Suzhou Erye Pharmaceutical Co., Ltd
2025/12/30Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2504471 Suzhou Erye Pharmaceutical Co., Ltd
2025/12/30Generic · Class 3 利多卡因丙胺卡因气雾剂 · No verified English nameCYHS2504465 Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized; Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized
2025/12/30Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2500236 Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized
2025/12/30Generic · Class 3 达普司他片 · No verified English nameCYHL2500235 Anhui Hong Ye Pharma Co., Ltd. romanized
2025/12/30Generic · Class 3 达普司他片 · No verified English nameCYHL2500234 Anhui Hong Ye Pharma Co., Ltd. romanized
2025/12/30New drug · Class 3.1 芍药甘草汤颗粒 · No verified English nameCXZS2500053 Hua Run Jiang Zhong Pharma Co., Ltd. romanized
2025/12/30New drug · Class 3.1 一贯煎颗粒 · No verified English nameCXZS2500052 Hua Run Jiang Zhong Pharma Co., Ltd. romanized
2025/12/30New drug · Class 1.1 麻桂退热贴 · No verified English nameCXZL2500136 Zhongguo Zhong Yi Ke College Zhong Yao Research Institute romanized
2025/12/30New drug · Class 1 注射用QLS5308 · No verified English nameCXSL2501169 Qilu Pharmaceutical Co., Ltd.
2025/12/30New drug · Class 1 JL19001注射液 · No verified English nameCXSL2501163 Jie Ku (Shanghai) Biopharmaceuticals Research Co., Ltd. romanized; Jie Ke (Tianjin) Biopharmaceuticals Co., Ltd. romanized
2025/12/30New drug · Class 1 IBR854细胞注射液 · No verified English nameCXSL2501162 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2025/12/30New drug · Class 1 IBR854细胞注射液 · No verified English nameCXSL2501161 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2025/12/30New drug · Class 1 Pumitamig注射液 · No verified English nameCXSL2501160 Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/12/30New drug · Class 1 JY47注射液 · No verified English nameCXSL2501159 Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized
2025/12/30New drug · Class 1 重组抗EGFR人源化单克隆抗体注射液 · No verified English nameCXSL2501158 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2025/12/30New drug · Class 1 LC-1016注射液 · No verified English nameCXHL2501510 Chengdu Xin Zheng He Pharmaceuticals Technology Co., Ltd. romanized
2025/12/30New drug · Class 1 YD6390片 · No verified English nameCXHL2501509 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/12/30New drug · Class 1 YD6390片 · No verified English nameCXHL2501508 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/12/30New drug · Class 1 YD6390片 · No verified English nameCXHL2501507 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/12/30New drug · Class 1 SYH2059吸入粉雾剂 · No verified English nameCXHL2501506 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2025/12/30New drug · Class 1 SYH2059吸入粉雾剂 · No verified English nameCXHL2501505 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2025/12/30New drug · Class 1 SYH2059吸入粉雾剂 · No verified English nameCXHL2501504 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2025/12/30New drug · Class 1 SYH2059吸入粉雾剂 · No verified English nameCXHL2501503 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2025/12/30New drug · Class 1 AOB01-0036胶囊 · No verified English nameCXHL2501502 Shuang Yi Yuan Chuang (Shanghai) Pharmaceuticals Co., Ltd. romanized

153 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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