YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 256 drug applications between 17 March 2023 and 23 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 62, covering 47 drug names.

2023/03/17 – 2023/03/23

Period
2023/03/17 to 2023/03/23, 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
256
Drugs with new generic filings (by drug name, de-duplicated)
47
Accepted this week, now under review
1

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

256filings, 62 of them generic

By application type

Application typeFilings
Supplement107
Generic62
Import re-registration30
New drug28
Unspecified16
Import13

By drug type

Drug typeFilings
Chemical drug199
TCM29
Therapeutic biologic19
Biologic8
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

47 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cefalexin Granules for Oral Suspension310
2Ampicillin Sodium and Sulbactam Sodium for Injection3113
3Norepinephrine Bitartrate Injection229
4Sodium Valproate Concentrated Solution for Injection210
5Tacrolimus Ointment216
6Lansoprazole Enteric Capsules213
7Orlistat Capsules218
8Acetaminophen Injection211
9Levocarnitine Injection214
10氯雷他定糖浆 · No verified English name217

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

154 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bracco Imaging Italia S.r.L.2410
2Zhu Zhou Qian Jin Pharma Co., Ltd. romanized650
3Eli Lilly and Company610
4Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized440
5Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized430
6AstraZeneca AB320
7Janssen-Cilag AG320
8Beijing Foyou Pharma CO.,LTD323
9Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized320
10CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD320

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

59 this week

AcceptedDrugApplicants
2023/03/23Import · Class 2.4 Upadacitinib片 · No verified English nameJXHL2300056 AbbVie Inc.
2023/03/23Import · Class 2.4 Upadacitinib片 · No verified English nameJXHL2300055 AbbVie Inc.
2023/03/23Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2300872 Yunnan Xian Shi Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/03/23Generic · Class 3 Latamoxef Sodium for InjectionCYHS2300871 Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized
2023/03/23Generic · Class 3 Sodium Phenylacetate and Sodium Benzoate InjectionCYHS2300868 Anhui Wo Tai Biopharmaceuticals Co., Ltd. romanized
2023/03/23Generic · Class 3 注射用西罗莫司(白蛋白结合型) · No verified English nameCYHL2300037 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/03/23New drug · Class 1.2 马钱子碱 · No verified English nameCXZL2300021 Hainan Sai Li Ke Pharma Co., Ltd. romanized
2023/03/23New drug · Class 1.2 马钱子碱凝胶贴膏 · No verified English nameCXZL2300020 Hainan Sai Li Ke Pharma Co., Ltd. romanized
2023/03/23New drug · Class 2.2 四价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2300207 Zhejiang Tian Yuan Bio Pharma Co., Ltd. romanized; Lanzhou Bai Ling Bio Technology Co., Ltd. romanized; Xi Bei Min Zu University romanized
2023/03/23New drug · Class 1 德恩鲁胺软胶囊 · No verified English nameCXHS2300040 Hai Chuang Pharma Co., Ltd. romanized; Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized
2023/03/23New drug · Class 2.2 BCM344口溶膜 · No verified English nameCXHL2300326 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2023/03/23New drug · Class 2.2 BCM344口溶膜 · No verified English nameCXHL2300325 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2023/03/22Import · Class 1 Garetosmab注射液 · No verified English nameJXSL2300057 Regeneron Pharmaceuticals Inc.; ICON Clinical Research (Beijing No. 2) Co. Ltd.
2023/03/22Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300054 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/03/22Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300053 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/03/22Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300052 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/03/22Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300051 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/03/22Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300050 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/03/22Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300049 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/03/22New drug · Class 1 BD001细胞注射液 · No verified English nameCXSL2300206 Shenzhen Bin De Bio Technology Co., Ltd. romanized
2023/03/22New drug · Class 1 注射用MT1002 · No verified English nameCXHL2300324 Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized
2023/03/22New drug · Class 1 注射用MT1002 · No verified English nameCXHL2300323 Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized
2023/03/21Import · Class 2.2 注射用戈沙妥珠单抗 · No verified English nameJXSL2300056 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2023/03/21Import · Class 1 注射用Abelacimab · No verified English nameJXSL2300055 Anthos Therapeutics Inc.; Labcorp Pharmaceutical Research and Development (Beijing) Co. Ltd.
2023/03/21Generic · Class 3 Acetaminophen InjectionCYHS2300856 Jilin Si Huan Pharmaceutical Co., Ltd. romanized; Jilin Si Zhang Pharmaceutical Co., Ltd. romanized
2023/03/21Generic · Class 3 Acetaminophen InjectionCYHS2300855 Jilin Si Huan Pharmaceutical Co., Ltd. romanized; Jilin Si Zhang Pharmaceutical Co., Ltd. romanized
2023/03/21Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2300854 Topfond Pharmaceutical Co., Ltd.
2023/03/21Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2300853 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/03/21Generic · Class 3 Formoterol Fumarate Inhalation SolutionCYHS2300852 Jiangsu Zhang Tai Pharma Co., Ltd. romanized
2023/03/21Generic · Class 3 Minoxidil Topical SolutionCYHS2300850 Ren Xi Pharmaceuticals Technology Hebei Co., Ltd. romanized; Hua Bei Pharmaceutical Hebei Hua Nuo Co., Ltd. romanized

29 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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