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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 427 drug applications between 10 February 2023 and 16 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 112, covering 76 drug names.

2023/02/10 – 2023/02/16

Period
2023/02/10 to 2023/02/16, 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
427
Drugs with new generic filings (by drug name, de-duplicated)
76
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

427filings, 112 of them generic

By application type

Application typeFilings
Supplement175
Generic112
New drug70
Import re-registration31
Import21
Unspecified18

By drug type

Drug typeFilings
Chemical drug330
TCM47
Therapeutic biologic44
Prophylactic biologic5
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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Gadoteric Acid Meglumine Salt Injection511
2Oxycodone Hydrochloride and Naloxone Hydrochloride Prolonged-release Tablets413
3Empagliflozin Tablets3218
4Urapidil Hydrochloride Injection326
5Piperacillin Sodium And Tazobactam Sodium For Injection315
6Metoprolol Succinate Extended-release Capsules314
7Sitagliptin Phosphate Tablets312
8Diquafosol Sodium Eye Drops225
9地氯雷他定口服溶液 · No verified English name2226
10复方匹可硫酸钠颗粒 · No verified English name224

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

257 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Name not romanized970
2NAPP PHARMACEUTICALS LIMITED910
3Shandong Xin Shi Dai Pharma Co., Ltd. romanized535
4CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD530
5Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A510
6Hainan Pu Li Pharmaceutical Co., Ltd. romanized515
7Shijiazhuang Yu Ze Tang Pharmaceutical Co., Ltd. romanized440
8Wu Hu Dao Run Pharma Co., Ltd. romanized440
9Shijiazhuang No.4 Pharmaceutical Co., Ltd.431
10Name not romanized430

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

113 this week

AcceptedDrugApplicants
2023/02/16Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2300537 Sichuan He Zong Ze Hui Pharmaceuticals Technology Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd
2023/02/16Generic · Class 3 Mannitol-S InjectionCYHS2300536 Hubei Xin Ze Fei Pharma Co., Ltd. romanized; Hubei Hua Ren Tong Ji Pharma Co., Ltd. romanized
2023/02/16Generic · Class 3 Ornidazole InjectionCYHS2300531 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2023/02/16Generic · Class 3 Ornidazole InjectionCYHS2300530 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2023/02/16Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2300526 Zhejiang Nord Pharmaceutical Co., Ltd
2023/02/16New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2300136 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2023/02/16New drug · Class 1 注射用MR001双特异性抗体 · No verified English nameCXSL2300135 Shenzhen Shi Mai Jia Rui Bio Technology Co., Ltd. romanized
2023/02/16New drug · Class 1 注射用PRO1160 · No verified English nameCXSL2300134 Pu Fang Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/02/16New drug · Class 1 PG-011凝胶 · No verified English nameCXHL2300226 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2023/02/15Import · Class 2.4 Inclisiran注射液 · No verified English nameJXHL2300023 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2023/02/15Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2300525 Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2023/02/15Generic · Class 3 Metaraminol Tartrate InjectionCYHS2300524 Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized
2023/02/15New drug · Class 3.4 治疗用卡介苗 · No verified English nameCXSL2300133 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2023/02/15New drug · Class 1 AL-001眼用注射液 · No verified English nameCXSL2300132 Beijing An Long Biopharmaceuticals Co., Ltd. romanized
2023/02/15New drug · Class 1 注射用重组病毒巨噬细胞炎性蛋白 · No verified English nameCXSL2300131 Guangzhou Hong Run Bio Technology Co., Ltd. romanized
2023/02/15New drug · Class 2.4 结核菌素纯蛋白衍生物 · No verified English nameCXSL2300130 Chengdu Ke En Bio Technology Co., Ltd. romanized
2023/02/15New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300129 Beijing Bei Lai Bio Technology Co., Ltd. romanized; Beijing Bei Lai Pharma Co., Ltd. romanized
2023/02/15New drug · Class 1 DDCI-01胶囊 · No verified English nameCXHL2300225 Chongqing Di Kang Er Le Pharmaceutical Co., Ltd. romanized
2023/02/15New drug · Class 1 DDCI-01胶囊 · No verified English nameCXHL2300224 Chongqing Di Kang Er Le Pharmaceutical Co., Ltd. romanized
2023/02/15New drug · Class 1 注射用RNK05047 · No verified English nameCXHL2300223 Name not romanized
2023/02/15New drug · Class 2.2 利拉鲁肽注射液 · No verified English nameCXHL2300222 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized
2023/02/15New drug · Class 2.2 利拉鲁肽注射液 · No verified English nameCXHL2300221 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized
2023/02/14Import · Class 3.1 Ropeginterferon alfa-2b(P1101)注射液 · No verified English nameJXSS2300016 PharmaEssentia Corporation; PharmaEssentia Corporation Taichung Plant; PharmaEssentia Biotechnology (Beijing) Company limited
2023/02/14Generic · Class 3 复方匹可硫酸钠颗粒 · No verified English nameCYHS2300519 Suzhou Erye Pharmaceutical Co., Ltd
2023/02/14Generic · Class 3 Ibuprofen GranulesCYHS2300517 Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized
2023/02/14Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2300512 Yan Tai Lu Yin Pharma Co., Ltd. romanized
2023/02/14Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2300511 Yan Tai Lu Yin Pharma Co., Ltd. romanized
2023/02/14Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2300510 Yan Tai Lu Yin Pharma Co., Ltd. romanized
2023/02/14Generic · Class 3 Vancomycin Hydrochloride For Oral SolutionCYHS2300506 Jiangxi Qing Feng Pharma Co., Ltd. romanized; Jiangxi Ke Rui Pharma Co., Ltd. romanized
2023/02/14Generic · Class 3 Vancomycin Hydrochloride For Oral SolutionCYHS2300505 Jiangxi Qing Feng Pharma Co., Ltd. romanized; Jiangxi Ke Rui Pharma Co., Ltd. romanized

83 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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