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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 156 drug applications between 18 September 2024 and 24 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 29 drug names.

2024/09/18 – 2024/09/24

Period
2024/09/18 to 2024/09/24, 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
156
Drugs with new generic filings (by drug name, de-duplicated)
29
Accepted this week, now under review
2

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

156filings, 38 of them generic

By application type

Application typeFilings
Supplement63
Generic38
New drug30
Import9
Import re-registration8
Unspecified7
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug103
TCM26
Therapeutic biologic16
Biologic8
Prophylactic biologic3

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

29 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride Oral Solution4146
2Brexpiprazole Tablets3131
3盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212
4Sulindac Tablets215
5Beraprost Sodium Tablets210
6Phenoxymethylpenicillin Potassium Tablets212
7ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液 · No verified English name110
8Fluticasone Propionate Nebuliser Suspension118
9Diquafosol Sodium Eye Drops115
10Perindopril Arginine and Amlodipine Besylate Tablets(III)114

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

107 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S730
2Guangdong Ke Hong Pharma Co., Ltd. romanized510
3AbbVie Inc.420
4Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized414
5Ma Ying Long Pharma Group Co., Ltd. romanized410
6Dr. Willmar Schwabe GmbH & Co. KG320
7Shandong Dan Hong Pharmaceutical Co., Ltd. romanized310
8Shandong An Xin Pharmaceutical Co., Ltd. romanized310
9Zhejiang Pu Li Pharma Co., Ltd. romanized313
10Te Ke Luo Bio Technology (Chengdu) Co., Ltd. romanized310

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

50 this week

AcceptedDrugApplicants
2024/09/23New drug · Class 1 HSK21542注射液 · No verified English nameCXHS2400097 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/09/21Import · Class 1 NNC0519-0130注射液 · No verified English nameJXHL2400222 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2024/09/21Import · Class 2.4 Acalabrutinib Maleate片 · No verified English nameJXHL2400221 AstraZeneca Pty Ltd; AstraZeneca Investment (China) Co. Ltd.
2024/09/21Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2403145 Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized
2024/09/21New drug · Class 3.3 达雷妥尤单抗注射液 · No verified English nameCXSL2400635 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/09/21New drug · Class 1 注射用DM005 · No verified English nameCXSL2400634 Duo Ma Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2024/09/20Import · Class 1 AZD2936 · No verified English nameJXSL2400172 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/20Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2403139 Chongqing Zhong Chuang Ke Pharmaceuticals Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/09/20Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2403138 Chongqing Zhong Chuang Ke Pharmaceuticals Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/09/20Generic · Class 3 Esketamine Hydrochloride InjectionCYHS2403135 Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2024/09/20Generic · Class 3 ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液 · No verified English nameCYHS2403133 Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized
2024/09/20Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2403129 Shanghai Bao Long Bio Technology Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2024/09/20Generic · Class 3 水合氯醛灌肠剂 · No verified English nameCYHS2403128 Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2024/09/20New drug · Class 1.1 MYL软膏 · No verified English nameCXZL2400059 Ma Ying Long Pharma Group Co., Ltd. romanized
2024/09/20New drug · Class 1.1 MYL软膏 · No verified English nameCXZL2400058 Ma Ying Long Pharma Group Co., Ltd. romanized
2024/09/20New drug · Class 1.1 MYL软膏 · No verified English nameCXZL2400057 Ma Ying Long Pharma Group Co., Ltd. romanized
2024/09/20New drug · Class 1.1 MYL软膏 · No verified English nameCXZL2400056 Ma Ying Long Pharma Group Co., Ltd. romanized
2024/09/20New drug · Class 1 瑞拉芙普-α注射液 · No verified English nameCXSS2400101 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/09/20New drug · Class 3.4 注射用重组人B型利钠肽 · No verified English nameCXSL2400633 Jiangsu Jing Ze Biopharmaceutical Co., Ltd. romanized
2024/09/19Import · Class 1 Volixibat胶囊 · No verified English nameJXHL2400220 Mirum Pharmaceuticals Inc.; Syneos Health(Beijing)Inc. Ltd.
2024/09/19Import · Class 1 Volixibat胶囊 · No verified English nameJXHL2400219 Mirum Pharmaceuticals Inc.; Syneos Health(Beijing)Inc. Ltd.
2024/09/19Generic · Class 3 Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2403122 Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2024/09/19Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2403117 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2024/09/19Generic · Class 3 Sulindac TabletsCYHS2403116 Gan Zheng (Hainan) Bio Pharma Co., Ltd. romanized; Hainan Ke Jin Biopharmaceutical Co., Ltd. romanized
2024/09/19Generic · Class 3 Sulindac TabletsCYHS2403115 Gan Zheng (Hainan) Bio Pharma Co., Ltd. romanized; Hainan Ke Jin Biopharmaceutical Co., Ltd. romanized
2024/09/19Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2403113 Qilu Pharmaceutical (Hainan) Co., Ltd
2024/09/19Generic · Class 3 Relugolix TabletsCYHL2400191 Qilu Pharmaceutical Co., Ltd.
2024/09/19Generic · Class 3 米诺地尔泡沫剂 · No verified English nameCYHL2400190 Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized
2024/09/19Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2400189 Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized
2024/09/19New drug · Class 3.1 桃红四物颗粒 · No verified English nameCXZS2400031 Zhu Zhou Qian Jin Pharma Co., Ltd. romanized

20 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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