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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 304 drug applications between 29 October 2025 and 4 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 38 drug names.

2025/10/29 – 2025/11/04

Period
2025/10/29 to 2025/11/04, 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
304
Drugs with new generic filings (by drug name, de-duplicated)
38
Accepted this week, now under review
61

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

304filings, 44 of them generic

By application type

Application typeFilings
Supplement180
Generic44
New drug40
Unspecified18
Import re-registration14
Import8

By drug type

Drug typeFilings
Chemical drug182
TCM81
Therapeutic biologic28
Biologic11
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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Crisaborole Ointment2226
2Vonoprazan Fumarate Tablets2160
3Pregabalin Capsules2112
4注射用托伐普坦磷酸钠 · No verified English name2115
5Sitagliptin and Metformin Hydrochloride Extended-release Tablets2112
6Finerenone Tablets2169
7Upadacitinib Sustained-release Tablets1143
8Tafluprost Eye Drops113
9Pemafibrate Tablets1123
10Carbidopa and Levodopa Sustained-release Tablets112

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

195 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bao Long Pharma Co., Ltd. romanized550
2Novartis Pharma Schweiz AG540
3Bayer Vital GmbH520
4Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized510
5Eli Lilly and Company430
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized420
7Biogen Netherlands B.V.410
8GUERBET410
9Beijing Yin Gu Pharmaceuticals Technology Co., Ltd. romanized410
10Ferring GmbH330

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

63 this week

AcceptedDrugApplicants
2025/11/04Import · Class 2.4 镥[177Lu] 特昔维匹肽注射液 · No verified English nameJXHS2500125 Novartis Pharma Schweiz AG; Advanced Accelerator Applications (Italy) S.R.L.; Beijing Novartis Pharma Co. Ltd.
2025/11/04Generic · Class 3 Furosemide Oral SolutionCYHS2503859 Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2025/11/04Generic · Class 3 Ketorolac Trometamol TabletsCYHS2503856 Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized
2025/11/04Generic · Class 3 氟[1?F]贝他苯注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2503855 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Xian Tong Fen Zi Ying Xiang Technology Co., Ltd. romanized; Jiangsu Xian Tong Fen Zi Ying Xiang Technology Co., Ltd. romanized; Beijing Shan Wei Zheng Zi Pharmaceuticals Technology Co., Ltd. romanized
2025/11/04New drug · Class 1 重组人IL12/15单纯疱疹I型双调控溶瘤病毒注射液(Vero细胞) · No verified English nameCXSL2500942 Shanghai Fu Nuo Jian Bio Technology Co., Ltd. romanized
2025/11/04New drug · Class 1 自体NK细胞注射液 · No verified English nameCXSL2500941 Guangxi Tai Mei Ren Sheng Bio Technology Co., Ltd. romanized
2025/11/04New drug · Class 2.2 依沃西单抗注射液 · No verified English nameCXSL2500940 Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized
2025/11/04New drug · Class 1 注射用SHR-9839(sc) · No verified English nameCXSL2500939 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/11/04New drug · Class 1 IMM2510 · No verified English nameCXSL2500938 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/11/04New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2500937 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2025/11/04New drug · Class 1 IMM01 · No verified English nameCXSL2500936 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/11/04New drug · Class 1 HRS-4642注射液 · No verified English nameCXHL2501205 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/11/04New drug · Class 1 HRS-4642注射液 · No verified English nameCXHL2501204 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/11/04New drug · Class 1 KR23335片 · No verified English nameCXHL2501203 Shanghai Qing Run Pharmaceuticals Technology Co., Ltd. romanized
2025/11/04New drug · Class 1 KR23335片 · No verified English nameCXHL2501202 Shanghai Qing Run Pharmaceuticals Technology Co., Ltd. romanized
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

33 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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