YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 527 drug applications between 21 December 2024 and 27 December 2024 (data as of 14 November 2026 06:00). Of these, generic applications numbered 169, covering 114 drug names.

2024/12/21 – 2024/12/27

Period
2024/12/21 to 2024/12/27, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
527
Drugs with new generic filings (by drug name, de-duplicated)
114
Accepted this week, now under review
9

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

527filings, 169 of them generic

By application type

Application typeFilings
Supplement216
Generic169
New drug96
Import29
Unspecified11
Import re-registration6

By drug type

Drug typeFilings
Chemical drug380
TCM79
Therapeutic biologic65
Biologic2
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

114 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Safinamide Methansulfonate Tablets8520
2Lactulose Oral Solution6334
3Vonoprazan Fumarate Tablets4258
4Roxadustat Capsules4213
5Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3323
6Bumetanide Injection3213
7Minoxidil Liniment3252
8Tadalafil Tablets3123
9Lidocaine and Prilocaine Cream3124
10Sildenafil Citrate Tablets3112

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

318 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB850
2Shandong Qidu Pharmaceutical Co., Ltd.830
3Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized660
4Shijiazhuang No.4 Pharmaceutical Co., Ltd.642
5Shandong Er Ye Pharmaceutical Co., Ltd. romanized630
6Bracco Imaging S.P.A.610
7Nei Menggu Da Tang Pharma Co., Ltd. romanized550
8Pfizer Inc.530
9Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized531
10ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.521

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

187 this week

AcceptedDrugApplicants
2024/12/27Import · Class 2.2 注射用德曲妥珠单抗 · No verified English nameJXSL2400255 Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2024/12/27Import · Class 1 MEDI5752 · No verified English nameJXSL2400254 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/12/27Import · Class 3.1 尘螨变应原舌下片 · No verified English nameJXSL2400253 ALK-Abelló A/S
2024/12/27Import · Class 1 HRO761 · No verified English nameJXHL2400305 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/12/27Import · Class 1 HRO761 · No verified English nameJXHL2400304 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/12/27Generic · Class 3 Sodium Thiosulfate InjectionCYHS2404589 Chengdu Yao Yi Li Kang Pharmaceuticals Technology Co., Ltd. romanized; Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized
2024/12/27Generic · Class 3 托吡酯口服溶液 · No verified English nameCYHS2404585 Hangzhou He Kang Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/12/27Generic · Class 3 Bumetanide InjectionCYHS2404578 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/12/27Generic · Class 3 Bumetanide InjectionCYHS2404577 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/12/27Generic · Class 3 Minoxidil LinimentCYHS2404576 Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized
2024/12/27Generic · Class 3 Propafenone Hydrochloride InjectionCYHS2404572 Hebei Qiao Zhou Pharmaceuticals Technology Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2024/12/27Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2404568 Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized
2024/12/27Generic · Class 3 Paracetamol TabletsCYHS2404564 YaoPharma Co., Ltd.
2024/12/27Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2404560 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2024/12/27Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2404559 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2024/12/27Generic · Class 3 Benzbromarone TabletsCYHS2404558 Beijing Foyou Pharma CO.,LTD
2024/12/27Generic · Class 3 Lidocaine and Tetracaine CreamCYHL2400278 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2024/12/27Generic · Class 3 Ramelteon TabletsCYHL2400276 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2024/12/27New drug · Class 1 HS-20117注射液 · No verified English nameCXSL2400917 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2024/12/27New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2400916 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2024/12/27New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2400915 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/12/27New drug · Class 1 BBM-A101注射液 · No verified English nameCXSL2400914 Xin Zhong Pharmaceuticals Technology (Beijing) Co., Ltd. romanized; Shanghai Xin Zhi Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Mian Yi Bio Technology Co., Ltd. romanized
2024/12/27New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2400913 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/12/27New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2400912 Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized; Chuang Zhi Xing (Guangzhou) Bio Technology Co., Ltd. romanized
2024/12/27New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2400911 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/12/27New drug · Class 3.4 注射用重组改构人肿瘤坏死因子 · No verified English nameCXSL2400910 Guangdong Tai He Bio Pharma Co., Ltd. romanized
2024/12/27New drug · Class 1 SNA02-48注射液 · No verified English nameCXSL2400909 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized; Xing Meng Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2024/12/27New drug · Class 2.2 FL-0011 · No verified English nameCXHL2401468 Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized
2024/12/27New drug · Class 2.2 FL-0011 · No verified English nameCXHL2401467 Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized
2024/12/27New drug · Class 2.2 KLA514-2片 · No verified English nameCXHL2401466 Sichuan Kelun Pharmaceutical Co., Ltd.

157 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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