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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 523 drug applications between 22 September 2024 and 28 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 156, covering 108 drug names.

2024/09/22 – 2024/09/28

Period
2024/09/22 to 2024/09/28, 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
523
Drugs with new generic filings (by drug name, de-duplicated)
108
Accepted this week, now under review
12

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

523filings, 156 of them generic

By application type

Application typeFilings
Supplement201
Generic156
New drug89
Import38
Unspecified27
Import re-registration11
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug333
TCM81
Therapeutic biologic80
Biologic21
Prophylactic biologic8

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

108 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Fentanyl Citrate Buccal Tablets610
2Cefoperazone Sodium and Sulbactam Sodium for Injection6114
3Brexpiprazole Tablets4231
4Dapagliflozin Tablets3284
5Carbamazepine Sustained-Release Tablets(II)310
6Brexpiprazole Orally Disintegrating Tablets3110
7Amoxicillin Sodium and Sulbactam Sodium for Injection317
8Procaterol Hydrochloride Granules312
9盐酸左沙丁胺醇雾化吸入溶液 · No verified English name312
10Ethyl Iosapentate Capsules2227

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

311 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S950
2Amgen Inc.920
3Yi Chang Ren Fu Pharma Co., Ltd. romanized929
4Janssen-Cilag International NV730
5Guo Yao Group Kunming Xue Ye Zhi Pin Co., Ltd. romanized730
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
7Zhejiang Wo Wu Bio Technology Co., Ltd. romanized710
8Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized660
9AstraZeneca AB630
10Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized630

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

193 this week

AcceptedDrugApplicants
2024/09/28Import · Class 2.4 英克司兰钠注射液 · No verified English nameJXHL2400240 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2024/09/28Import · Class 2.4 英克司兰钠注射液 · No verified English nameJXHL2400239 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2024/09/28Generic · Class 3 Potassium Chloride GranulesCYHS2403295 Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2024/09/28Generic · Class 3 Nitroglycerin InjectionCYHS2403294 Hubei Sheng He Kang Da Pharmaceuticals Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/09/28Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2403292 Jinan Jing Sheng Technology Co., Ltd. romanized; Luo Xin An Ruo Wei Ta Pharma (Chengdu) Co., Ltd. romanized
2024/09/28Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2403291 Jinan Jing Sheng Technology Co., Ltd. romanized; Luo Xin An Ruo Wei Ta Pharma (Chengdu) Co., Ltd. romanized
2024/09/28Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2403290 Jinan Jing Sheng Technology Co., Ltd. romanized; Luo Xin An Ruo Wei Ta Pharma (Chengdu) Co., Ltd. romanized
2024/09/28Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2403283 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2024/09/28Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2403282 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2024/09/28Generic · Class 3 Mannitol-S InjectionCYHL2400198 Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized
2024/09/28Generic · Class 3 Lasmiditan TabletsCYHL2400197 Jiangxi Ke Rui Pharma Co., Ltd. romanized
2024/09/28Generic · Class 3 Lasmiditan TabletsCYHL2400196 Jiangxi Ke Rui Pharma Co., Ltd. romanized
2024/09/28New drug · Class 1.1 感咳颗粒 · No verified English nameCXZL2400061 Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized
2024/09/28New drug · Class 1 人羊膜间充质干细胞注射液 · No verified English nameCXSL2400674 Yuan Pin Xi Bao Bio Technology Group Co., Ltd. romanized
2024/09/28New drug · Class 1 UX-DA001注射液(人中脑多巴胺能神经前体细胞注射液) · No verified English nameCXSL2400673 Shanghai Yue Sai Bio Technology Co., Ltd. romanized
2024/09/28New drug · Class 2.4 Dexamethasone Palmitate InjectionCXHL2401026 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2024/09/28New drug · Class 1 GenSci122片 · No verified English nameCXHL2401025 Changchun Jin Sai Pharma Co., Ltd. romanized
2024/09/28New drug · Class 1 GenSci122片 · No verified English nameCXHL2401024 Changchun Jin Sai Pharma Co., Ltd. romanized
2024/09/28New drug · Class 1 GP-2102乳膏 · No verified English nameCXHL2401023 Nanjing Ji Qun Pharmaceuticals Technology Co., Ltd. romanized
2024/09/28New drug · Class 1 GP-2102乳膏 · No verified English nameCXHL2401022 Nanjing Ji Qun Pharmaceuticals Technology Co., Ltd. romanized
2024/09/28New drug · Class 2.2 甲磺酸雷沙吉兰透皮贴剂 · No verified English nameCXHL2401021 Guizhou Shi Ling Pharmaceutical Co., Ltd. romanized; Shanghai Shi Ling Pharmaceutical Co., Ltd. romanized
2024/09/28New drug · Class 2.2 甲磺酸雷沙吉兰透皮贴剂 · No verified English nameCXHL2401020 Guizhou Shi Ling Pharmaceutical Co., Ltd. romanized; Shanghai Shi Ling Pharmaceutical Co., Ltd. romanized
2024/09/27Import · Class 1 MEDI5752 · No verified English nameJXSL2400185 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/27Import · Class 1 AZD2936 · No verified English nameJXSL2400184 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/27Import · Class 2.2 DS-8201a · No verified English nameJXSL2400183 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2024/09/27Import · Class 1 镥[177Lu]依多曲肽注射液 · No verified English nameJXHL2400238 ITM Solucin GmbH; Grand Pharmaceutical (China) Co. Ltd.
2024/09/27Generic · Class 3 Sodium Acetate Ringer's InjectionCYHS2403272 Xian Jing Xi Shuang He Pharma Co., Ltd. romanized
2024/09/27Generic · Class 3 奥美拉唑碳酸氢钠干混悬剂(I) · No verified English nameCYHS2403271 Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized
2024/09/27Generic · Class 3 Vardenafil Hydrochloride Orally disintegrating TabletsCYHS2403265 Jiangxi Shimei Pharmaceutical Co., Ltd
2024/09/27Generic · Class 3 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2403264 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized

163 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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