YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 256 drug applications between 30 July 2021 and 5 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 39, covering 28 drug names.

2021/07/30 – 2021/08/05

Period
2021/07/30 to 2021/08/05, 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)
28
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

256filings, 39 of them generic

By application type

Application typeFilings
Supplement120
New drug54
Generic39
Import re-registration20
Import16
Unspecified7

By drug type

Drug typeFilings
Chemical drug166
TCM46
Therapeutic biologic42
In vitro diagnostic reagent1
Prophylactic 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

28 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Carbamazepine Extended-release Tablets310
2Alanyl Glutamine Injection214
3Enoxaparin Sodium Injection2116
4Carbazochrome Sodium Sulfonate Injection211
5Tranexamic Acid Injection2111
6Caspofungin Acetate for Injection218
7Trimetazidine Dihydrochloride Tablets210
8Fosphenytoin Sodium Injection215
9Oseltamivir Phosphate Capsules2139
10Febuxostat Tablets2112

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

144 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Fu Ren Heng Feng Pharma Co., Ltd. romanized20200
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized1260
3Shaanxi An Yuan Tang Pharma Co., Ltd. romanized660
4CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD630
5Eli Lilly and Company610
6Fresenius Kabi Deutschland GmbH610
7San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized520
8Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized440
9Novartis Pharma Schweiz AG420
10Shijiazhuang No.4 Pharmaceutical Co., Ltd.330

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
2021/08/05Import · Class 2.2 司美格鲁肽注射液 · No verified English nameJXSL2101089 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2021/08/05Import · Class 1 GT90001C注射液 · No verified English nameJXSL2101088 Kintor Pharmaceuticals Hong Kong Limited; Suzhou Kintor Pharmaceticals Inc.
2021/08/05Import · Class 2.2 注射用Loncastuximab tesirine · No verified English nameJXSL2101087 ADC Therapeutics SA; Overland Pharmaceuticals (Shanghai) Co. Ltd.
2021/08/05Import · Class 1 QM1114 · No verified English nameJXSL2101084 IPSEN Biopharm Limited; Q-Med International Trading (Shanghai) Co. Ltd
2021/08/05Import · Class 1 NNC0480-0389注射液 · No verified English nameJXHL2101150 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2021/08/05Generic · Class 3 Tranexamic Acid InjectionCYHS2101531 Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2021/08/05Generic · Class 3 Tranexamic Acid InjectionCYHS2101530 Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2021/08/05Generic · Class 3 Fosphenytoin Sodium InjectionCYHS2101527 Xian Ge Lan Xin Tong Pharmaceutical Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2021/08/05Generic · Class 3 Fosphenytoin Sodium InjectionCYHS2101526 Xian Ge Lan Xin Tong Pharmaceutical Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2021/08/05Generic · Class 3 Potassium Chloride Oral SolutionCYHS2101523 Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2021/08/05New drug · Class 1 派安普利单抗注射液 · No verified English nameCXSS2101020 Zheng Da Tian Qing Kang Fang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/08/05New drug · Class 3.3 注射用曲妥珠单抗 · No verified English nameCXSS2101019 Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized
2021/08/05New drug · Class 1 GB5005嵌合抗原受体T细胞注射液 · No verified English nameCXSL2101240 Shanghai Ji Bei Bio Technology Co., Ltd. romanized
2021/08/05New drug · Class 1 TQB2450注射液 · No verified English nameCXSL2101239 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/08/05New drug · Class 1 注射用LM-302 · No verified English nameCXSL2101238 Li Xin Pharmaceuticals (Zhejiang) Co., Ltd. romanized
2021/08/05New drug · Class 1 重组全人源抗RANKL单克隆抗体注射液 · No verified English nameCXSL2101237 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2021/08/05New drug · Class 2.2 RHYK2001 · No verified English nameCXHL2101367 Ren He Yi Kang Group Co., Ltd. romanized
2021/08/03Import · Class 2.2 DS-8201a · No verified English nameJXSL2101086 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2021/08/03Import · Class 1 BI 905711输注用粉末 · No verified English nameJXSL2101085 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/08/03Import · Class 1 NIS793 · No verified English nameJXSL2101079 Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd
2021/08/03Import · Class 1 AR882胶囊 · No verified English nameJXHL2101149 Arthrosi Therapeutics INC; Hangzhou Tigermed Consulting Co. Ltd.
2021/08/03Import · Class 1 Elinzanetant 软胶囊 · No verified English nameJXHL2101148 Bayer AG; Bayer Healthcare Company Ltd.
2021/08/03Generic · Class 3 Bromhexine Hydrochloride Solution For InhalationCYHS2101521 Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2021/08/03Generic · Class 3 Carbamazepine Extended-release TabletsCYHS2101519 Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2021/08/03Generic · Class 3 Carbamazepine Extended-release TabletsCYHS2101518 Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2021/08/03Generic · Class 3 Carbamazepine Extended-release TabletsCYHS2101517 Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2021/08/03Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2101510 Kang Pu Pharma Co., Ltd. romanized
2021/08/03Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2101509 Kang Pu Pharma Co., Ltd. romanized
2021/08/03Generic · Class 3 Calcitriol Oral SolutionCYHS2101503 Xinjiang Te Feng Pharma Co., Ltd. romanized
2021/08/03Generic · Class 3 Famciclovir TabletsCYHS2101501 Di Sha Pharma Group 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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