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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 442 drug applications between 9 December 2024 and 15 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 119, covering 87 drug names.

2024/12/09 – 2024/12/15

Period
2024/12/09 to 2024/12/15, 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
442
Drugs with new generic filings (by drug name, de-duplicated)
87
Accepted this week, now under review
6

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

442filings, 119 of them generic

By application type

Application typeFilings
Supplement195
Generic119
New drug94
Import20
Unspecified10
Import re-registration3
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug301
TCM68
Therapeutic biologic56
Prophylactic biologic9
Biologic7
In vitro diagnostic reagent1

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

87 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets14760
2Ambroxol Hydrochloride Oral Solution5146
3醋酸兰瑞肽缓释注射液(预充式) · No verified English name310
4Upadacitinib Sustained-release Tablets2243
5Rosuvastatin Calcium and Ezetimibe Tablets (I)229
6Ezetimibe and Atorvastatin Calcium Trihydrate Tablets214
7利伐沙班口崩片 · No verified English name214
8Diclofenac Diethylamine Emulgel2120
9布比卡因脂质体注射液 · No verified English name217
10Empagliflozin Tablets2118

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

288 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Hao Sen Pharma Group Co., Ltd. romanized920
2Novo Nordisk A/S720
3Ya Bao Pharma Group Co., Ltd. romanized660
4Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized610
5Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized550
6Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized550
7Hainan Si Da Pharmaceutical Co., Ltd. romanized515
8Fu Yuan Pharma Co., Ltd. romanized441
9Tong Hua Zheng Yuan Pharma Co., Ltd. romanized440
10Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized432

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

147 this week

AcceptedDrugApplicants
2024/12/14Import · Class 1 Amycretin注射液 · No verified English nameJXSL2400237 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2024/12/14Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2400111 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/12/14Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2400110 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/12/14Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2400109 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/12/14Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2400108 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/12/14Generic · Class 3 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2404359 Wuhan Jiu An Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2024/12/14Generic · Class 3 头孢泊肟酯干混悬剂 · No verified English nameCYHS2404352 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/12/14Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2404350 Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized
2024/12/14Generic · Class 3 复方聚乙二醇电解质散(II) · No verified English nameCYHS2404347 Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2024/12/14Generic · Class 3 Azilsartan and Amlodipine TabletsCYHL2400259 Beijing Bai Ao Pharma Co., Ltd. romanized
2024/12/14New drug · Class 2.2 吸附无细胞百(三组分)白破联合疫苗 · No verified English nameCXSS2400139 Kang Xi Nuo Bio Shareholding Company romanized
2024/12/14New drug · Class 3.3 阿达木单抗注射液 · No verified English nameCXSS2400138 Zhejiang Hua Hai Bio Technology Co., Ltd. romanized
2024/12/14New drug · Class 1 注射用DXC008 · No verified English nameCXSL2400868 Hangzhou Duo Xi Bio Technology Co., Ltd. romanized
2024/12/14New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2400867 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/12/14New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2400866 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/12/14New drug · Class 1 注射用SHR-4602 · No verified English nameCXSL2400865 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/12/14New drug · Class 1 注射用KKD001 · No verified English nameCXSL2400864 Shang Rao Shi Kang Ke De Bio Technology Co., Ltd. romanized
2024/12/14New drug · Class 1 注射用KKD001 · No verified English nameCXSL2400863 Shang Rao Shi Kang Ke De Bio Technology Co., Ltd. romanized
2024/12/14New drug · Class 1 IMM01 · No verified English nameCXSL2400862 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/12/14New drug · Class 1 IMM2510 · No verified English nameCXSL2400861 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/12/14New drug · Class 1.2 冻干二价呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2400860 Wuhan Rui Ji Bio Technology Co., Ltd. romanized; Shenzhen Rui Ji Bio Technology Co., Ltd. romanized
2024/12/14New drug · Class 1 人骨髓间充质干细胞注射液 · No verified English nameCXSL2400859 Jiu Zhi Tang Mei Ke (Beijing) Xi Bao Technology Co., Ltd. romanized
2024/12/14New drug · Class 1 JMT108注射液 · No verified English nameCXSL2400858 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2024/12/14New drug · Class 1 JYP0015片 · No verified English nameCXHL2401384 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2024/12/14New drug · Class 1 JYP0015片 · No verified English nameCXHL2401383 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2024/12/14New drug · Class 1 JYP0015片 · No verified English nameCXHL2401382 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2024/12/14New drug · Class 1 JYP0015片 · No verified English nameCXHL2401381 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2024/12/14New drug · Class 1 JYP0015片 · No verified English nameCXHL2401380 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2024/12/14New drug · Class 1 JYP0015片 · No verified English nameCXHL2401379 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2024/12/14New drug · Class 1 CXJM-66注射液 · No verified English nameCXHL2401378 Yi Chang Ren Fu Pharma Co., Ltd. romanized

117 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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