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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 528 drug applications between 26 December 2024 and 1 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 167, covering 122 drug names.

2024/12/26 – 2025/01/01

Period
2024/12/26 to 2025/01/01, 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
528
Drugs with new generic filings (by drug name, de-duplicated)
122
Accepted this week, now under review
16

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

528filings, 167 of them generic

By application type

Application typeFilings
Supplement192
Generic167
New drug121
Import27
Unspecified16
Import re-registration5

By drug type

Drug typeFilings
Chemical drug385
TCM76
Therapeutic biologic65
Biologic1
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

122 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Safinamide Methansulfonate Tablets7420
2Lactulose Oral Solution4234
3Vonoprazan Fumarate Tablets4260
4甲氧氯普胺片 · No verified English name323
5Minoxidil Liniment3252
6Paliperidone Palmitate Injection318
7Mirogabalin Besilate Tablets3161
8Ibrutinib Capsules229
9Formoterol Fumarate Inhalation Solution225
10Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223

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

324 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized11110
2AstraZeneca AB850
3Shijiazhuang No.4 Pharmaceutical Co., Ltd.753
4Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized730
5Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized660
6Bracco Imaging S.P.A.610
7Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized610
8Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized610
9Chengdu Easton Biopharmaceuticals Co.,Ltd.523
10Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized520

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

208 this week

AcceptedDrugApplicants
2025/01/01Import · Class 1 德莫奇单抗注射液 · No verified English nameJXSS2400114 GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Limited trading as Glaxo Wellcome Operations; GlaxoSmithKline (China) Investment Co. Ltd.
2025/01/01Import · Class 1 德莫奇单抗注射液 · No verified English nameJXSS2400113 GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Limited trading as Glaxo Wellcome Operations; GlaxoSmithKline (China) Investment Co. Ltd.
2025/01/01Import · Class 2.4 放射性药物镓[68Ga]oxodotreotide注射液配制用药盒 · No verified English nameJXHL2400308 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/01/01Import · Class 2.4 镥[177Lu]oxodotreotide注射液 · No verified English nameJXHL2400307 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/01/01Generic · Class 3 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2404663 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/01/01Generic · Class 3 Metronidazole Vaginal GelCYHS2404662 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized
2025/01/01Generic · Class 3 Minoxidil LinimentCYHS2404653 Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized; Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized
2025/01/01Generic · Class 3 Minoxidil LinimentCYHS2404652 Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized; Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized
2025/01/01Generic · Class 3 Ibuprofen Soft CapsulesCYHS2404651 Ren Fu Pu Ke Pharma (Hainan) Co., Ltd. romanized; Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized
2025/01/01Generic · Class 3 氢溴酸加兰他敏口崩片 · No verified English nameCYHS2404649 Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized
2025/01/01Generic · Class 3 氢溴酸加兰他敏口崩片 · No verified English nameCYHS2404648 Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized
2025/01/01Generic · Class 3 达普司他片 · No verified English nameCYHL2400287 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized
2025/01/01Generic · Class 3 达普司他片 · No verified English nameCYHL2400286 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized
2025/01/01Generic · Class 3 Landiolol Hydrochloride for InjectionCYHL2400285 Tianjin Hong Ri Pharma Co., Ltd. romanized
2025/01/01New drug · Class 3.1 大建中膏 · No verified English nameCXZS2400041 Hua Run San Jiu (Ya An) Pharma Co., Ltd. romanized
2025/01/01New drug · Class 1.1 金桔余甘含片 · No verified English nameCXZL2400101 Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized
2025/01/01New drug · Class 2.4 注射用重组A型肉毒毒素 · No verified English nameCXSS2400144 Chongqing Yu Yan Pharmaceutical Co., Ltd. romanized
2025/01/01New drug · Class 1 GFS202A注射液 · No verified English nameCXSL2400937 Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/01/01New drug · Class 1 IBI363 · No verified English nameCXSL2400936 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/01/01New drug · Class 1 IBI363 · No verified English nameCXSL2400935 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/01/01New drug · Class 1 VUM03注射液 · No verified English nameCXSL2400934 Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized
2025/01/01New drug · Class 1 DNTH103注射液 · No verified English nameCXSL2400933 Yuan Yi Bio Technology (Shanghai) Co., Ltd. romanized
2025/01/01New drug · Class 1 RDc001片 · No verified English nameCXHL2401511 Henan Sheng Rui Da Pharmaceuticals Technology Co., Ltd. romanized
2025/01/01New drug · Class 1 RDc001片 · No verified English nameCXHL2401510 Henan Sheng Rui Da Pharmaceuticals Technology Co., Ltd. romanized
2025/01/01New drug · Class 1 RDc001片 · No verified English nameCXHL2401509 Henan Sheng Rui Da Pharmaceuticals Technology Co., Ltd. romanized
2025/01/01New drug · Class 1 HS-10380片 · No verified English nameCXHL2401508 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2025/01/01New drug · Class 1 K-13片 · No verified English nameCXHL2401507 Shanghai Yi Feng Bio Technology Co., Ltd. romanized
2025/01/01New drug · Class 1 K-13片 · No verified English nameCXHL2401506 Shanghai Yi Feng Bio Technology Co., Ltd. romanized
2025/01/01New drug · Class 1 K-13片 · No verified English nameCXHL2401505 Shanghai Yi Feng Bio Technology Co., Ltd. romanized
2025/01/01New drug · Class 1 RAG-1C眼内注射液 · No verified English nameCXHL2401504 Zhong Mei Rui Kang He Suan Technology (Nan Tong) Research Institute Co., Ltd. romanized

178 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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