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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 395 drug applications between 19 December 2024 and 25 December 2024 (data as of 14 November 2026 06:00). Of these, generic applications numbered 120, covering 79 drug names.

2024/12/19 – 2024/12/25

Period
2024/12/19 to 2024/12/25, 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
395
Drugs with new generic filings (by drug name, de-duplicated)
79
Accepted this week, now under review
5

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

395filings, 120 of them generic

By application type

Application typeFilings
Supplement168
Generic120
New drug71
Import19
Unspecified12
Import re-registration5

By drug type

Drug typeFilings
Chemical drug281
Therapeutic biologic55
TCM54
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

79 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Safinamide Methansulfonate Tablets6320
2Vonoprazan Fumarate Tablets4258
3Roxadustat Capsules4213
4Tadalafil Tablets3123
5Lidocaine and Prilocaine Cream3124
6Sildenafil Citrate Tablets3112
7Alfacalcidol Soft Capsules319
8Diquafosol Sodium Eye Drops225
9Bumetanide Injection2213
10Bisoprolol Fumarate and Amlodipine Besylate Tablets229

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

241 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Qidu Pharmaceutical Co., Ltd.930
2Shandong Er Ye Pharmaceutical Co., Ltd. romanized630
3Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized530
4ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.521
5Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized440
6Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized440
7Jiangsu Hao Sen Pharma Group Co., Ltd. romanized430
8AstraZeneca AB420
9Novartis Pharma Schweiz AG420
10Pfizer Inc.420

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

141 this week

AcceptedDrugApplicants
2024/12/25Import · Class 1 BMS-986489(BMS-986012 + Nivolumab固定剂量复方)注射液 · No verified English nameJXSL2400250 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2024/12/25Import · Class 2.2 Tremelimumab注射液 · No verified English nameJXSL2400249 MedImmune LLC; AstraZeneca Investment (China) Co. Ltd
2024/12/25Import · Class 2.2 特立妥单抗注射液 · No verified English nameJXSL2400248 Stichting European Myeloma Network; Hangzhou Tigermed Consulting Co. Ltd.
2024/12/25Import · Class 2.2 特立妥单抗注射液 · No verified English nameJXSL2400247 Stichting European Myeloma Network; Hangzhou Tigermed Consulting Co. Ltd.
2024/12/25Generic · Class 3 Potassium Chloride InjectionCYHS2404518 Henan Pu Rui Pharma Co., Ltd. romanized
2024/12/25Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2404517 Shandong Jian Dao Pharmaceutical Co., Ltd. romanized
2024/12/25Generic · Class 3 Potassium Chloride InjectionCYHS2404516 Henan Pu Rui Pharma Co., Ltd. romanized
2024/12/25Generic · Class 3 维生素K滴剂 · No verified English nameCYHS2404515 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2024/12/25Generic · Class 3 Betahistine Dihydrochloride TabletsCYHS2404514 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2024/12/25Generic · Class 3 Diphenhydramine Hydrochloride InjectionCYHS2404513 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized
2024/12/25Generic · Class 3 Diphenhydramine Hydrochloride InjectionCYHS2404512 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized
2024/12/25Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2404511 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized
2024/12/25Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2404510 Hebei Long Hai Pharma Co., Ltd. romanized
2024/12/25Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2404509 Hebei Long Hai Pharma Co., Ltd. romanized
2024/12/25Generic · Class 3 Sodium Thiosulfate InjectionCYHS2404508 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shuo De Pharma Co., Ltd. romanized
2024/12/25Generic · Class 3 Succinylcholine Chloride InjectionCYHS2404503 Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2024/12/25Generic · Class 3 Succinylcholine Chloride InjectionCYHS2404502 Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2024/12/25Generic · Class 3 Cimetidine InjectionCYHS2404501 Ze Tian (Shandong) Pharma Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
2024/12/25Generic · Class 3 复方电解质注射液(V) · No verified English nameCYHS2404500 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/12/25Generic · Class 3 Rifamycin Sodium InjectionCYHS2404499 Guangdong Sunho Pharmaceutical Co., Ltd.
2024/12/25Generic · Class 3 Rifamycin Sodium InjectionCYHS2404498 Guangdong Sunho Pharmaceutical Co., Ltd.
2024/12/25Generic · Class 3 Vitamin K1 InjectionCYHS2404497 Yan Tai Lu Yin Pharma Co., Ltd. romanized
2024/12/25Generic · Class 3 Vitamin K1 InjectionCYHS2404496 Yan Tai Lu Yin Pharma Co., Ltd. romanized
2024/12/25Generic · Class 3 Acetylcysteine Oral SolutionCYHS2404478 Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Chengdu Shuo De Pharma Co., Ltd. romanized
2024/12/25Generic · Class 3 艾地骨化醇片 · No verified English nameCYHL2400270 Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized
2024/12/25Generic · Class 3 甲苯磺酸卢美哌隆胶囊 · No verified English nameCYHL2400269 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/12/25New drug · Class 3.1 济川煎颗粒 · No verified English nameCXZS2400038 Hefei Hua Run Shen Lu Pharma Co., Ltd. romanized
2024/12/25New drug · Class 1.2 百蕊提取物颗粒 · No verified English nameCXZL2400097 Yue Kang Pharma Group Co., Ltd. romanized
2024/12/25New drug · Class 1.2 百蕊提取物 · No verified English nameCXZL2400096 Yue Kang Pharma Group Co., Ltd. romanized
2024/12/25New drug · Class 1 JV101注射液 · No verified English nameCXSL2400898 Shanghai Yu Fang Bio Technology Co., Ltd. romanized; Nanjing Yu Fang Bio Technology Co., Ltd. romanized

111 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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