YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 398 drug applications between 17 December 2024 and 23 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 79 drug names.

2024/12/17 – 2024/12/23

Period
2024/12/17 to 2024/12/23, 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
398
Drugs with new generic filings (by drug name, de-duplicated)
79
Accepted this week, now under review
3

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

398filings, 109 of them generic

By application type

Application typeFilings
Supplement173
Generic109
New drug75
Import22
Unspecified11
Import re-registration8

By drug type

Drug typeFilings
Chemical drug259
TCM78
Therapeutic biologic55
Biologic4
Prophylactic biologic2

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
2Bromhexine Hydrochloride Oral Solution4222
3Procaterol Hydrochloride Solution for Inhalation322
4Tadalafil Tablets3123
5Sildenafil Citrate Tablets3112
6Alfacalcidol Soft Capsules319
7阿贝西利片 · No verified English name312
8Fusidic Acid Cream2215
9Bisoprolol Fumarate and Amlodipine Besylate Tablets229
10Nicardipine Hydrochloride Injection2213

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

245 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized12100
2AstraZeneca AB530
3Pfizer Inc.530
4Novartis Pharma AG520
5ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.521
6Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized440
7Jiangxi Cheng Zhi Yong Feng Pharma Co., Ltd. romanized440
8Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized440
9Shijiazhuang No.4 Pharmaceutical Co., Ltd.433
10Novartis Europharm Limited420

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

135 this week

AcceptedDrugApplicants
2024/12/23Generic · Class 3 Metaraminol Tartrate InjectionCYHS2404463 Henan Qun Yi Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized
2024/12/23Generic · Class 3 Pregabalin Oral SolutionCYHS2404462 Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized
2024/12/23New drug · Class 1 IBR854细胞注射液 · No verified English nameCXSL2400891 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2024/12/23New drug · Class 1 IBR854细胞注射液 · No verified English nameCXSL2400890 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2024/12/23New drug · Class 1 HL-1186片 · No verified English nameCXHL2401429 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2024/12/22New drug · Class 1 JX2201胶囊 · No verified English nameCXHL2401428 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2024/12/22New drug · Class 1 JX2201胶囊 · No verified English nameCXHL2401427 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2024/12/22New drug · Class 1 JX2201胶囊 · No verified English nameCXHL2401426 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2024/12/22New drug · Class 1 JX2201胶囊 · No verified English nameCXHL2401425 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2024/12/21Import · Class 2.2 布西珠单抗注射液 · No verified English nameJXSS2400112 Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd.
2024/12/21Import · Class 2.2 布西珠单抗注射液 · No verified English nameJXSS2400111 Novartis Pharma Schweiz AG; Alcon-Couvreur N.V.; Beijing Novartis Pharma Co. Ltd.
2024/12/21Import · Class 1 PF-07220060 · No verified English nameJXHL2400299 Pfizer Inc.; Pfizer Investment CO. Ltd.
2024/12/21Import · Class 1 PF-07220060 · No verified English nameJXHL2400298 Pfizer Inc.; Pfizer Investment CO. Ltd.
2024/12/21Import · Class 1 PF-07220060 · No verified English nameJXHL2400297 Pfizer Inc.; Pfizer Investment CO. Ltd.
2024/12/21Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2404453 Jiangxi Yuan Chao Pharmaceuticals Technology Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized
2024/12/21Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2404450 Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2024/12/21Generic · Class 3 Potassium Phosphates InjectionCYHS2404445 Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2024/12/21Generic · Class 3 Sodium Iodide[131I] Oral SolutionCYHS2404438 Guangdong Jun Qi Pharmaceuticals Technology Co., Ltd. romanized
2024/12/21New drug · Class 1 PT886 · No verified English nameCXSL2400889 Fan En Shi Pharmaceutical (Beijing) Co., Ltd. romanized
2024/12/21New drug · Class 1 注射用T320 · No verified English nameCXSL2400888 Shanxi Na An Bio Technology Co., Ltd. romanized
2024/12/21New drug · Class 2.1; 2.2; 2.4 注射用LX22001 · No verified English nameCXHL2401424 Shandong Luo Xin Pharma Group Co., Ltd. romanized; Luo Xin Pharma (Shanghai) Co., Ltd. romanized
2024/12/21New drug · Class 2.1; 2.2; 2.4 注射用LX22001 · No verified English nameCXHL2401423 Shandong Luo Xin Pharma Group Co., Ltd. romanized; Luo Xin Pharma (Shanghai) Co., Ltd. romanized
2024/12/21New drug · Class 2.2 注射用BSY001 · No verified English nameCXHL2401422 Beijing Bei Sheng Yan Pharmaceuticals Technology Co., Ltd. romanized
2024/12/21New drug · Class 1 D-2570片 · No verified English nameCXHL2401421 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized
2024/12/21New drug · Class 1 LIT0922胶囊 · No verified English nameCXHL2401420 Li Di (Hangzhou) Pharmaceuticals Technology Co., Ltd. romanized
2024/12/21New drug · Class 1 LIT0922胶囊 · No verified English nameCXHL2401419 Li Di (Hangzhou) Pharmaceuticals Technology Co., Ltd. romanized
2024/12/21New drug · Class 1 FNX020片 · No verified English nameCXHL2401418 Chengdu Fan Nuo Xi Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/21New drug · Class 1 FNX020片 · No verified English nameCXHL2401417 Chengdu Fan Nuo Xi Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/21New drug · Class 1 POC101胶囊 · No verified English nameCXHL2401416 Changchun Zhang Cheng Pharmaceuticals Technology Co., Ltd. romanized
2024/12/21New drug · Class 1 POC101胶囊 · No verified English nameCXHL2401414 Changchun Zhang Cheng Pharmaceuticals Technology Co., Ltd. romanized

105 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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