YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 435 drug applications between 29 November 2025 and 5 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 73 drug names.

2025/11/29 – 2025/12/05

Period
2025/11/29 to 2025/12/05, 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
435
Drugs with new generic filings (by drug name, de-duplicated)
73
Accepted this week, now under review
106

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

435filings, 93 of them generic

By application type

Application typeFilings
Supplement226
Generic93
New drug71
Import29
Unspecified8
Import re-registration8

By drug type

Drug typeFilings
Chemical drug249
TCM121
Therapeutic biologic60
Biologic4
Prophylactic 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

73 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Riociguat Tablets314
2Mupirocin Ointment2230
3Tadalafil Tablets2123
4奥洛他定莫米松鼻喷雾剂 · No verified English name211
5恩曲替尼胶囊 · No verified English name216
6Lafutidine Tablets212
7Teneligliptin Hydrobromide Hydrate Tablets2110
8生理氯化钠溶液 · No verified English name2117
9甲氧氯普胺片 · No verified English name213
10Levocetirizine dihydrochloride Oral Solution215

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

247 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fu Song Xian Zhong Yao Co., Ltd. romanized29290
2Eli Lilly and Company1210
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
4Hunan Ke Lun Pharmaceutical Co., Ltd. romanized610
5Ai Min Pharma Group Co., Ltd. romanized550
6Beijing Sai Er Bio Pharma Co., Ltd. romanized545
7Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized540
8Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized510
9Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized510
10Guangzhou Bai Yun Shan Hua Cheng Pharma Co., Ltd. romanized440

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

129 this week

AcceptedDrugApplicants
2025/12/05Generic · Class 3 甲氧氯普胺片 · No verified English nameCYHS2504187 Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized
2025/12/05Generic · Class 3 甲氧氯普胺片 · No verified English nameCYHS2504186 Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized
2025/12/05Generic · Class 3 Lafutidine TabletsCYHS2504181 Su Zhong Pharma Group Co., Ltd. romanized
2025/12/05Generic · Class 3 Lafutidine TabletsCYHS2504180 Su Zhong Pharma Group Co., Ltd. romanized
2025/12/05Generic · Class 3 盐酸精氨酸注射液 · No verified English nameCYHS2504175 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/12/05Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2504172 Shaanxi Xin Feng Hua Bio Technology Co., Ltd. romanized; Shaanxi Han Jiang Pharma Group Co., Ltd. romanized
2025/12/05Generic · Class 3 Minoxidil LinimentCYHS2504171 Hunan Jiudian Pharmaceutical Co., Ltd; Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized
2025/12/05Generic · Class 3 Isosulfan Blue InjectionCYHL2500216 HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2025/12/05New drug · Class 1 HS-20117注射液 · No verified English nameCXSL2501050 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2025/12/05New drug · Class 1 注射用HS-20122 · No verified English nameCXSL2501049 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2025/12/05New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2501048 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/12/05New drug · Class 1 注射用SHR-1826 · No verified English nameCXSL2501047 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/12/05New drug · Class 1 注射用SHR-A2009 · No verified English nameCXSL2501046 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/12/05New drug · Class 1 注射用ZHB130 · No verified English nameCXSL2501045 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2025/12/05New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2501044 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/12/05New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2501043 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/12/05New drug · Class 1 注射用MK-1045 · No verified English nameCXSL2501042 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2025/12/05New drug · Class 1 注射用MK-1045 · No verified English nameCXSL2501041 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2025/12/05New drug · Class 1 PA3-17注射液 · No verified English nameCXSL2501040 Bo Sheng Ji An Ke Xi Bao Technology Co., Ltd. romanized; Bo Sheng Ji Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2025/12/05New drug · Class 1 HS-10504片 · No verified English nameCXHL2501339 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/05New drug · Class 1 HS-10504片 · No verified English nameCXHL2501338 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/05New drug · Class 2.2 司美格鲁肽片 · No verified English nameCXHL2501337 Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/05New drug · Class 2.2 司美格鲁肽片 · No verified English nameCXHL2501336 Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/05New drug · Class 2.2 司美格鲁肽片 · No verified English nameCXHL2501335 Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/05New drug · Class 2.2 司美格鲁肽片 · No verified English nameCXHL2501334 Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/05New drug · Class 2.2 司美格鲁肽片 · No verified English nameCXHL2501333 Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/05New drug · Class 1 GSBR-5746片 · No verified English nameCXHL2501332 Shanghai Shuo Di Bio Technology Co., Ltd. romanized
2025/12/05New drug · Class 1 GSBR-5746片 · No verified English nameCXHL2501331 Shanghai Shuo Di Bio Technology Co., Ltd. romanized
2025/12/05New drug · Class 1 GSBR-5746片 · No verified English nameCXHL2501330 Shanghai Shuo Di Bio Technology Co., Ltd. romanized
2025/12/05New drug · Class 1 GSBR-5746片 · No verified English nameCXHL2501329 Shanghai Shuo Di Bio Technology Co., Ltd. romanized

99 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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