YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 256 drug applications between 2 July 2021 and 8 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 45, covering 27 drug names.

2021/07/02 – 2021/07/08

Period
2021/07/02 to 2021/07/08, 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
256
Drugs with new generic filings (by drug name, de-duplicated)
27
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

256filings, 45 of them generic

By application type

Application typeFilings
Supplement131
Generic45
New drug42
Import29
Import re-registration5
Unspecified4

By drug type

Drug typeFilings
Chemical drug200
Therapeutic biologic30
TCM20
Prophylactic biologic4
In vitro diagnostic reagent2

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

27 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets7323
2Ceftriaxone Sodium for Injection319
3Acetylcysteine Granules224
4Tacrolimus Ointment226
5Perindopril tert-Butylamine Tablets215
6Levetiracetam Tablets216
7Ceftazidime for Injection214
8Procaterol Hydrochloride Oral Solution2112
9Lidocaine Hydrochloride Injection216
10Minoxidil Topical Solution210

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

138 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized1590
2AstraZeneca AB1040
3Jiangsu Guang Cheng Pharma Co., Ltd. romanized660
4Zhejiang Hui Di Sen Pharma Co., Ltd. romanized620
5Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized525
6Fo Shan De Rui Ke Pharmaceutical Co., Ltd. romanized510
7Merck Sharp & Dohme B.V.430
8Novartis Pharma Schweiz AG420
9GlaxoSmithKline Biologicals SA410
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

80 this week

AcceptedDrugApplicants
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
2021/07/08New drug · Class 1.1 芹槐胶囊 · No verified English nameCXZL2101018 Jilin Tian Heng Pharma Co., Ltd. romanized
2021/07/08New drug · Class 1.1 补肾和脉颗粒 · No verified English nameCXZL2101017 Rui Yang Pharmaceutical Co., Ltd. romanized
2021/07/08New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSS2101009 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized; Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2021/07/08New drug · Class 1 QLP31907注射液 · No verified English nameCXSL2101176 Qilu Pharmaceutical Co., Ltd.
2021/07/08New drug · Class 1 TST002注射液 · No verified English nameCXSL2101175 Hangzhou Yi An Ji Shi Bio Pharma Co., Ltd. romanized
2021/07/08New drug · Class 1 PM1003注射液 · No verified English nameCXSL2101174 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2021/07/08New drug · Class 1 HBM4003注射液 · No verified English nameCXSL2101173 He Bo Pharmaceuticals (Suzhou) Co., Ltd. romanized
2021/07/08New drug · Class 1 HBM4003注射液 · No verified English nameCXSL2101169 He Bo Pharmaceuticals (Suzhou) Co., Ltd. romanized
2021/07/08New drug · Class 1 羧胺三唑软胶囊 · No verified English nameCXHS2101027 Guangdong Yin Zhu Pharmaceuticals Technology Co., Ltd. romanized; Beijing Chang Cheng Pharmaceutical Co., Ltd. romanized
2021/07/08New drug · Class 2.2 噻托溴铵吸入粉雾剂 · No verified English nameCXHL2101273 Run Sheng Pharma Co., Ltd. romanized
2021/07/08New drug · Class 1 YL-15293 片 · No verified English nameCXHL2101272 Shanghai Ying Li Pharma Co., Ltd. romanized
2021/07/08New drug · Class 1 YL-15293 片 · No verified English nameCXHL2101271 Shanghai Ying Li Pharma Co., Ltd. romanized
2021/07/08New drug · Class 1 注射用DN1508052-01 · No verified English nameCXHL2101270 Shanghai Di Nuo Pharmaceuticals Technology Co., Ltd. romanized
2021/07/08New drug · Class 1 EVER206 for injection · No verified English nameCXHL2101269 Yun Ding Xin Yao Pharmaceuticals Technology Co., Ltd. romanized
2021/07/08New drug · Class 1 SIR1-365片 · No verified English nameCXHL2101268 Wei Tai Rui Long (Beijing) Bio Technology 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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