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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 307 drug applications between 30 October 2025 and 5 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 41 drug names.

2025/10/30 – 2025/11/05

Period
2025/10/30 to 2025/11/05, 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
307
Drugs with new generic filings (by drug name, de-duplicated)
41
Accepted this week, now under review
64

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

307filings, 44 of them generic

By application type

Application typeFilings
Supplement179
Generic44
New drug41
Import15
Unspecified14
Import re-registration14

By drug type

Drug typeFilings
Chemical drug186
TCM78
Therapeutic biologic31
Biologic10
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

41 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1注射用头孢曲松钠/氯化钠注射液 · No verified English name213
2Minoxidil Liniment2152
3Sitagliptin and Metformin Hydrochloride Extended-release Tablets2112
4中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English name117
5Upadacitinib Sustained-release Tablets1143
6Acetylcysteine Injection1153
7Tafluprost Eye Drops113
8Pemafibrate Tablets1123
9Crisaborole Ointment1126
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

191 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bao Long Pharma Co., Ltd. romanized550
2Bayer Vital GmbH520
3Eisai Co. Ltd.510
4Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized510
5Novartis Pharma Schweiz AG430
6Sanofi Winthrop Industrie420
7Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized420
8Biogen Netherlands B.V.410
9Eli Lilly Nederland B.V.410
10GUERBET410

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

72 this week

AcceptedDrugApplicants
2025/11/05Import · Class 2.2 注射用德曲妥珠单抗 · No verified English nameJXSS2500136 Daiichi Sankyo Europe GmbH; Simtra Deutschland GmbH; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2025/11/05Import · Class 1 BIIB115注射液 · No verified English nameJXHL2500343 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2025/11/05Import · Class 1 E2086 · No verified English nameJXHL2500342 Eisai Co. Ltd.; Eisai China Inc.
2025/11/05Import · Class 1 E2086 · No verified English nameJXHL2500341 Eisai Co. Ltd.; Eisai China Inc.
2025/11/05Import · Class 1 E2086 · No verified English nameJXHL2500340 Eisai Co. Ltd.; Eisai China Inc.
2025/11/05Import · Class 1 E2086 · No verified English nameJXHL2500339 Eisai Co. Ltd.; Eisai China Inc.
2025/11/05Import · Class 1 E2086 · No verified English nameJXHL2500338 Eisai Co. Ltd.; Eisai China Inc.
2025/11/05Import · Class 1 SAR443122 硬胶囊 · No verified English nameJXHL2500337 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/11/05Generic · Class 3 Minoxidil LinimentCYHS2503869 Jiangsu Xi Er Sheng Pharma Co., Ltd. romanized; Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2025/11/05Generic · Class 3 Minoxidil LinimentCYHS2503868 Jiangsu Xi Er Sheng Pharma Co., Ltd. romanized; Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2025/11/05Generic · Class 3 Benazepril Hydrochloride and Hydrochlorothiazide TabletsCYHS2503864 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2025/11/05Generic · Class 3 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2503862 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/11/05Generic · Class 3 Bilastine Oral SolutionCYHS2503861 Sichuan Sen Ke Pharmaceutical Co., Ltd. romanized
2025/11/05New drug · Class 3.3 注射用曲妥珠单抗 · No verified English nameCXSS2500118 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2025/11/05New drug · Class 1 Pumitamig注射液 · No verified English nameCXSL2500944 Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/11/05New drug · Class 1 宫血间充质干细胞注射液 · No verified English nameCXSL2500943 Zhejiang Sheng Chuang Jing Zhun Medical Technology Co., Ltd. romanized
2025/11/05New drug · Class 1 TRC003注射液 · No verified English nameCXHL2501210 Tong Rui Biopharmaceutical (Chengdu) Co., Ltd. romanized
2025/11/05New drug · Class 1 VV913胶囊 · No verified English nameCXHL2501209 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized
2025/11/05New drug · Class 1 VV913胶囊 · No verified English nameCXHL2501208 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized
2025/11/05New drug · Class 1 VV913胶囊 · No verified English nameCXHL2501207 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized
2025/11/05New drug · Class 1 伊匹乌肽散剂 · No verified English nameCXHL2501206 Yi Cheng Kang Tai (Xiamen) Bio Technology Co., Ltd. romanized
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

42 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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