YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 273 drug applications between 3 July 2021 and 9 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 28 drug names.

2021/07/03 – 2021/07/09

Period
2021/07/03 to 2021/07/09, 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
273
Drugs with new generic filings (by drug name, de-duplicated)
28
Accepted this week, now under review
0

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

273filings, 44 of them generic

By application type

Application typeFilings
Supplement150
Generic44
New drug41
Import32
Import re-registration5
Unspecified1

By drug type

Drug typeFilings
Chemical drug211
TCM30
Therapeutic biologic28
In vitro diagnostic reagent2
Prophylactic biologic2

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

28 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets5223
2Ceftriaxone Sodium for Injection319
3Acetylcysteine Granules224
4Tacrolimus Ointment226
5Perindopril tert-Butylamine Tablets215
6Levetiracetam Tablets216
7Ceftazidime for Injection214
8Procaterol Hydrochloride Oral Solution2112
9Minoxidil Topical Solution210
10Sugammadex Sodium Injection216

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

137 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized29220
2Yang Zi Jiang Pharma Group Jiangsu Long Feng Tang Zhong Yao Co., Ltd. romanized12110
3AstraZeneca AB940
4Novartis Pharma Schweiz AG630
5Zhejiang Hui Di Sen Pharma Co., Ltd. romanized620
6Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized525
7Fo Shan De Rui Ke Pharmaceutical Co., Ltd. romanized510
8Merck Sharp & Dohme B.V.430
9Novartis Europharm Ltd.420
10MINGHUI PHARMACEUTICAL PTY LTD410

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

81 this week

AcceptedDrugApplicants
2021/07/09Import · Class 2.4 Copanlisib 注射用冻干制剂 · No verified English nameJXHS2101025 Bayer HealthCare Pharmaceuticals Inc.; Bayer AG; Bayer Healthcare Company Ltd.
2021/07/09Import · Class 2.4 Trametinib TabletsJXHL2101131 Novartis Europharm Ltd.; Beijing Novartis Pharmaceutical Co. Ltd.
2021/07/09Import · Class 2.4 Trametinib TabletsJXHL2101130 Novartis Europharm Ltd.; Beijing Novartis Pharmaceutical Co. Ltd.
2021/07/09Import · Class 2.4 Dabrafenib mesylate CapsulesJXHL2101129 Novartis Europharm Ltd.; Beijing Novartis Pharmaceutical Co. Ltd.
2021/07/09Import · Class 2.4 Dabrafenib mesylate CapsulesJXHL2101128 Novartis Europharm Ltd.; Beijing Novartis Pharmaceutical Co. Ltd.
2021/07/09Import · Class 1 BAY 2586116鼻喷雾剂 · No verified English nameJXHL2101127 Bayer AG; Bayer Healthcare Company Ltd.
2021/07/09Generic · Class 3 Olprinone Hydrochloride InjectionCYHS2101425 TC Pharmaceuticals (Jiangsu) Co., Ltd
2021/07/09Generic · 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 nameCYHL2101018 Sichuan Kelun Pharmaceutical Co., Ltd.
2021/07/09New drug · Class 1 C-4-29细胞制剂 · No verified English nameCXSL2101182 Chongqing Jing Zhun Bio Technology Co., Ltd. romanized
2021/07/09New drug · Class 1 AK112注射液 · No verified English nameCXSL2101177 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/07/09New drug · Class 1 TNP-2092胶囊 · No verified English nameCXHL2101278 Dan Nuo Pharmaceuticals (Suzhou) Co., Ltd. romanized
2021/07/09New drug · Class 2.2 阿哌沙班多释片 · No verified English nameCXHL2101277 Tai Zhou Yue Yang Pharmaceuticals Kai Fa Co., Ltd. romanized
2021/07/09New drug · Class 1 HMPL-453酒石酸盐片 · No verified English nameCXHL2101276 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2021/07/09New drug · Class 1 HMPL-453酒石酸盐片 · No verified English nameCXHL2101275 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2021/07/09New drug · Class 1 HMPL-453酒石酸盐片 · No verified English nameCXHL2101274 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2021/07/08Import · Class 1 NM21-1480注射液 · No verified English nameJXSL2101066 Numab Therapeutics AG; CStone Pharmaceuticals (Suzhou) Co. Ltd.
2021/07/08Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2101055 Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd.
2021/07/08Import · Class 2.4 环硅酸锆钠散 · No verified English nameJXHL2101125 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2021/07/08Import · Class 2.4 环硅酸锆钠散 · No verified English nameJXHL2101124 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2021/07/08Import · Class 2.4 环硅酸锆钠散 · No verified English nameJXHL2101123 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2021/07/08Import · Class 2.4 环硅酸锆钠散 · No verified English nameJXHL2101122 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2021/07/08Import · Class 2.2; 2.4 曲安奈德脉络膜上腔注射混悬液 · No verified English nameJXHL2101121 Arctic Vision (Hong Kong) Limited; Arctic Vision (Shanghai) Biotechnology Co Ltd.
2021/07/08Generic · Class 3 硫酸氢氯吡格雷阿司匹林片 · No verified English nameCYHS2101422 Le Pu Pharma Co., Ltd. romanized
2021/07/08Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2101416 Hainan Brilliant Pharmaceutical Co., Ltd.
2021/07/08Generic · Class 3 Ceftriaxone Sodium for InjectionCYHS2101415 Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized
2021/07/08Generic · Class 3 Ceftriaxone Sodium for InjectionCYHS2101414 Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized
2021/07/08Generic · Class 3 Ceftriaxone Sodium for InjectionCYHS2101413 Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized
2021/07/08Generic · Class 3 Minoxidil Topical SolutionCYHS2101405 Jewim Pharmaceutical (Shandong) Co., Ltd.
2021/07/08Generic · Class 3 Minoxidil Topical SolutionCYHS2101404 Jewim Pharmaceutical (Shandong) Co., Ltd.
2021/07/08Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2101383 Kang Pu Pharma Co., Ltd. romanized

51 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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