YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 268 drug applications between 29 October 2022 and 4 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 47, covering 37 drug names.

2022/10/29 – 2022/11/04

Period
2022/10/29 to 2022/11/04, 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
268
Drugs with new generic filings (by drug name, de-duplicated)
37
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

268filings, 47 of them generic

By application type

Application typeFilings
Supplement128
Generic47
New drug41
Import26
Import re-registration18
Unspecified8

By drug type

Drug typeFilings
Chemical drug191
Therapeutic biologic40
TCM36
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

37 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Piperacillin Sodium for Injection2216
2Piracetam Injection219
3Olaparib Tablets210
4Empagliflozin Tablets2118
5Urapidil Hydrochloride Injection216
6Magnesium Sulfate Injection217
7羟乙基淀粉130/0.4氯化钠注射液 · No verified English name210
8Esomeprazole Magnesium Enteric-Coated Capsules214
9Dapagliflozin Tablets2184
10Norepinephrine Bitartrate Injection219

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

147 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1020
2Guangdong Dong Yang Guang Pharma Co., Ltd. romanized910
3Annora Pharma Private Limited830
4Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized810
5Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized660
6Jilin Sheng Yi Pu Bio Technology Co., Ltd. romanized550
7Shandong Han Fang Pharmaceutical Co., Ltd. romanized550
8Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized535
9Anhui Mei Yu Pharmaceutical Co., Ltd. romanized530
10Qilu Pharmaceutical Co., Ltd.532

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

80 this week

AcceptedDrugApplicants
2022/11/04Import · Class 1 Omecamtiv Mecarbil缓释片 · No verified English nameJXHS2200102 Cytokinetics Incorporated; Patheon Inc.; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2022/11/04Import · Class 1 Omecamtiv Mecarbil缓释片 · No verified English nameJXHS2200101 Cytokinetics Incorporated; Patheon Inc.; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2022/11/04Import · Class 1 Omecamtiv Mecarbil缓释片 · No verified English nameJXHS2200100 Cytokinetics Incorporated; Patheon Inc.; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2022/11/04Import · Class 2.2 诺西那生钠注射液 · No verified English nameJXHL2200330 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2022/11/04Import · Class 2.2 诺西那生钠注射液 · No verified English nameJXHL2200329 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2022/11/04Generic · Class 3 Piperacillin Sodium for InjectionCYHS2201894 Hebei Dong Sheng Ke Yu Pharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2022/11/04Generic · Class 3 Esketamine Hydrochloride InjectionCYHS2201893 Yangtze River Pharmaceutical Group Co., Ltd
2022/11/04Generic · Class 3 Sildenafil Sitrate For Oral SuspensionCYHS2201889 Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2022/11/04Generic · Class 3 Piracetam InjectionCYHS2201888 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2022/11/04Generic · Class 3 Piracetam InjectionCYHS2201887 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2022/11/04New drug · Class 1 PE0116注射液 · No verified English nameCXSL2200558 Shanghai Huai Yue Bio Technology Co., Ltd. romanized
2022/11/04New drug · Class 3.3 德谷门冬双胰岛素注射液 · No verified English nameCXSL2200557 Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized; Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2022/11/04New drug · Class 2.4 ASC10片 · No verified English nameCXHL2200867 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized
2022/11/04New drug · Class 2.4; 2.1 ASC10片 · No verified English nameCXHL2200866 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized
2022/11/03Generic · Class 3 Nimodipine Oral SolutionCYHS2201882 Shanghai Ao Quan Biopharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2022/11/03New drug · Class 2.3 阿利沙坦酯氨氯地平片 · No verified English nameCXHS2200061 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/11/03New drug · Class 1 BPI-452080 片 · No verified English nameCXHL2200865 Bei Da Pharma Co., Ltd. romanized
2022/11/03New drug · Class 1 BPI-452080 片 · No verified English nameCXHL2200864 Bei Da Pharma Co., Ltd. romanized
2022/11/02Import · Class 2.4 亮丙瑞林注射乳剂 · No verified English nameJXHL2200328 Foresee Pharmaceuticals Co. Ltd; Changchun GeneScience Pharmaceuticals Co. Ltd.
2022/11/02Import · Class 2.2; 2.4 CBT-001眼用乳液 · No verified English nameJXHL2200327 Cloudbreak Therapeutics LLC; Cloudbreak Bio-Pharmaceutical Science and Technology(Guangzhou)Co. Ltd
2022/11/02Import · Class 2.2; 2.4 CBT-001眼用乳液 · No verified English nameJXHL2200326 Cloudbreak Therapeutics LLC; Cloudbreak Bio-Pharmaceutical Science and Technology(Guangzhou)Co. Ltd
2022/11/02Import · Class 1 SAR443122 硬胶囊 · No verified English nameJXHL2200325 Sanofi-Aventis Recherche & Développement
2022/11/02Import · Class 1 SAR443122 硬胶囊 · No verified English nameJXHL2200324 Sanofi-Aventis Recherche & Développement
2022/11/02Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2201876 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2022/11/02New drug · Class 2.2 重组人血小板生成素注射液 · No verified English nameCXSS2200089 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2022/11/02New drug · Class 2.2 重组人血小板生成素注射液 · No verified English nameCXSS2200088 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2022/11/02New drug · Class 1 注射用SHR-A1921 · No verified English nameCXSL2200556 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2022/11/02New drug · Class 1 阿得贝利单抗注射液 · No verified English nameCXSL2200555 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/11/02New drug · Class 1 注射用SHR-A1811 · No verified English nameCXSL2200554 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2022/11/02New drug · Class 1 注射用间充质干细胞(脐带) · No verified English nameCXSL2200553 Tianjin Ang Sai Xi Bao Ji Yin Gong Cheng Co., Ltd. romanized

50 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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