YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 341 drug applications between 28 October 2025 and 3 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 52 drug names.

2025/10/28 – 2025/11/03

Period
2025/10/28 to 2025/11/03, 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
341
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
79

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

341filings, 64 of them generic

By application type

Application typeFilings
Supplement185
Generic64
New drug59
Import re-registration12
Unspecified11
Import10

By drug type

Drug typeFilings
Chemical drug233
TCM72
Therapeutic biologic31
Biologic3
Prophylactic biologic2

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

52 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

222 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xinjiang Hua Shi Dan Pharma Co., Ltd. romanized710
2Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized550
3Bayer Vital GmbH520
4Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized520
5Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized510
6Shi Yao Group En Bi Pu Pharma Co., Ltd. romanized510
7Ferring GmbH440
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized440
9Eli Lilly and Company430
10Novartis Pharma Schweiz AG430

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

86 this week

AcceptedDrugApplicants
2025/11/03Import · Class 1 Solbinsiran注射液 · No verified English nameJXHL2500336 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/11/01Generic · Class 3 Potassium Chloride GranulesCYHS2503852 Fujian Rui Tai Lai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Jia He Pharma Co., Ltd. romanized
2025/11/01Generic · Class 3 Sucralfate Oral SuspensionCYHS2503851 Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2025/11/01Generic · Class 3 Lanthanum Carbonate Hydrate GranulesCYHS2503849 Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized
2025/11/01New drug · Class 1.2 FS2303分散片 · No verified English nameCXZL2500107 Da Lian Fu Sheng Tian Ran Drug Kai Fa Co., Ltd. romanized
2025/11/01New drug · Class 1 阴道用卷曲乳杆菌活菌胶囊 · No verified English nameCXSS2500117 Suzhou Ou Sai Wei Ke Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/01New drug · Class 2.2 兰索拉唑碳酸氢钠干混悬剂 · No verified English nameCXHS2500135 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/11/01New drug · Class 2.2 CB446 · No verified English nameCXHL2501201 Hangzhou Cheng Bang Pharmaceuticals Technology Co., Ltd. romanized
2025/11/01New drug · Class 2.2 ASECG肠溶干混悬剂 · No verified English nameCXHL2501200 Beijing Tian Heng Drug Research Institute Co., Ltd. romanized
2025/10/31Import · Class 2.4 宗艾替尼片 · No verified English nameJXHS2500124 Boehringer Ingelheim International GmbH; Hovione Farmaciencia S.A.; Boehringer Ingelheim (China) Investment Co. Ltd
2025/10/31Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2503846 Henan Zhong Jie Pharma Co., Ltd. romanized
2025/10/31Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2503845 Henan Zhong Jie Pharma Co., Ltd. romanized
2025/10/31Generic · Class 3 Clindamycin Palmitate Hydrochloride GranulesCYHS2503842 Shandong Rui Yi Pharmaceuticals Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/10/31Generic · Class 3 复方聚乙二醇(3350)电解质维C散 · No verified English nameCYHS2503841 Hefei Sheng Qin Pharmaceuticals Technology Co., Ltd. romanized; Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized
2025/10/31Generic · Class 3 Galanthamine Hydrobromide Oral SolutionCYHS2503839 Shanghai Bao Long Bio Technology Co., Ltd. romanized; Shanghai Mei You Pharmaceutical Co., Ltd. romanized
2025/10/31Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2503835 Hubei Bang Ze Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2025/10/31Generic · Class 3 Regadenoson InjectionCYHL2500195 Hebei Sai Pu Yi Hui Pharmaceuticals Technology Co., Ltd. romanized
2025/10/31New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2500935 Hua Lan Bio Yi Miao Co., Ltd. romanized
2025/10/31New drug · Class 1 NWRD18 · No verified English nameCXHL2501199 Nuo Wei Bio Technology (Wuxi) Co., Ltd. romanized; Nuo Wei Technology (Beijing) Co., Ltd. romanized; Nuo Wei Bio Technology (Tianjin) Co., Ltd. romanized
2025/10/31New drug · Class 2.2; 2.4 SY-606滴眼液 · No verified English nameCXHL2501198 Beijing Yin Gu Pharmaceuticals Technology Co., Ltd. romanized
2025/10/31New drug · Class 2.2; 2.4 SY-606滴眼液 · No verified English nameCXHL2501197 Beijing Yin Gu Pharmaceuticals Technology Co., Ltd. romanized
2025/10/31New drug · Class 2.2; 2.4 SY-606滴眼液 · No verified English nameCXHL2501196 Beijing Yin Gu Pharmaceuticals Technology Co., Ltd. romanized
2025/10/31New drug · Class 2.2; 2.4 SY-606滴眼液 · No verified English nameCXHL2501195 Beijing Yin Gu Pharmaceuticals Technology Co., Ltd. romanized
2025/10/30Import · Class 3.1 Nemolizumab注射液 · No verified English nameJXSL2500208 Galderma SA; Q-Med International Trading (Shanghai) Co. Ltd
2025/10/30Import · Class 1 GSK6042981片 · No verified English nameJXHL2500334 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited
2025/10/30New drug · Class 1.2 栀子西红花酸提取物(C2235) · No verified English nameCXZL2500106 Zhejiang Jian Feng Pharma Co., Ltd. romanized
2025/10/30New drug · Class 1 柯美奇拜单抗注射液 · No verified English nameCXSS2500116 Shanghai Mai Ji Pharmaceuticals Co., Ltd. romanized; Ding Kang (Wuhan) Biopharmaceuticals Co., Ltd. romanized
2025/10/30New drug · Class 1 注射用QLS5316 · No verified English nameCXSL2500934 Qilu Pharmaceutical Co., Ltd.
2025/10/30New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2500133 Gansu Pu An Pharmaceutical Co., Ltd. romanized
2025/10/30New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2500132 Gansu Pu An Pharmaceutical Co., Ltd. romanized

56 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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