YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 326 drug applications between 21 October 2021 and 27 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 38 drug names.

2021/10/21 – 2021/10/27

Period
2021/10/21 to 2021/10/27, 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
326
Drugs with new generic filings (by drug name, de-duplicated)
38
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

326filings, 50 of them generic

By application type

Application typeFilings
Supplement169
New drug59
Generic50
Import27
Import re-registration14
Unspecified7

By drug type

Drug typeFilings
Chemical drug217
TCM51
Therapeutic biologic48
Prophylactic biologic7
Biologic3

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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Moxifloxacin Hydrochloride And Sodium Chloride Injection3310
2Levofloxacin Eye Drops2116
3Torsemide Injection211
4Pregabalin Capsules2112
5Tranexamic Acid Injection2111
6Sodium Hyaluronate Eye Drops2130
7Lenvatinib Mesilate Capsules214
8Dopamine Hydrochloride Injection213
9Oxytocin Injection218
10酒石酸伐尼克兰片 · No verified English name213

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

177 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Gansu Fu Ge Zang Yao Co., Ltd. romanized30270
2Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized730
3Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized530
4Sanofi-Aventis Groupe510
5Novartis Pharma Schweiz AG430
6Upjohn EESV430
7Name not romanized430
8Boehringer Ingelheim International GmbH420
9Shanghai Jia Bao Yao Yin Pharmaceuticals Technology Co., Ltd. romanized420
10Shandong An Xin Pharmaceutical Co., Ltd. romanized420

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

97 this week

AcceptedDrugApplicants
2021/10/27Import · Class 1 BI685509片 · No verified English nameJXHL2101224 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2021/10/27Import · Class 1 BI685509片 · No verified English nameJXHL2101223 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/10/27Import · Class 1 BI685509片 · No verified English nameJXHL2101222 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/10/27Import · Class 2.4 Tucatinib片 · No verified English nameJXHL2101221 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/10/27Import · Class 2.4 Tucatinib片 · No verified English nameJXHL2101220 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/10/27Generic · Class 3 Levofloxacin InjectionCYHS2101934 Jilin Si Huan Pharmaceutical Co., Ltd. romanized
2021/10/27New drug · Class 1.1 和胃解毒胶囊 · No verified English nameCXZL2101031 Changsha Xin Lin Pharmaceutical Co., Ltd. romanized
2021/10/27New drug · Class 1 首克注利单抗注射液 · No verified English nameCXSS2101042 Zhao Ke (Guangzhou) Zhong Liu Drug Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized
2021/10/27New drug · Class 1 AK112注射液 · No verified English nameCXSL2101392 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/10/27New drug · Class 1 AK117注射液 · No verified English nameCXSL2101391 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/10/27New drug · Class 2.2 注射用全氟丙烷人血白蛋白微球 · No verified English nameCXSL2101390 Xiamen Li Zhuo Pharma Co., Ltd. romanized
2021/10/27New drug · Class 2.4 泽布替尼胶囊 · No verified English nameCXHL2101615 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/10/27New drug · Class 1 SYHX2001片 · No verified English nameCXHL2101614 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2021/10/27New drug · Class 1 SYHX2001片 · No verified English nameCXHL2101613 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2021/10/27New drug · Class 1 NIP001片 · No verified English nameCXHL2101610 Zhongguo Pharmaceuticals Research Kai Fa Center Co., Ltd. romanized
2021/10/27New drug · Class 1 NIP001片 · No verified English nameCXHL2101609 Zhongguo Pharmaceuticals Research Kai Fa Center Co., Ltd. romanized
2021/10/26Import · Class 2.2 Emapalumab · No verified English nameJXSL2101120 Swedish Orphan Biovitrum AG; Sobi Pharma(Guangzhou)Co. Limited
2021/10/26Import · Class 2.4 度维利塞胶囊 · No verified English nameJXHL2101214 Secura Bio Inc.; CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY (SJZ) CO. LTD.
2021/10/26Import · Class 2.4 度维利塞胶囊 · No verified English nameJXHL2101213 Secura Bio Inc.; CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY (SJZ) CO. LTD.
2021/10/26Import · Class 2.4 紫杉醇口服溶液 · No verified English nameJXHL2101205 DAEHWA PHARMACEUTICAL CO. LTD; Shanghai RMX Biopharma Co. Ltd
2021/10/26Import · Class 2.4 紫杉醇口服溶液 · No verified English nameJXHL2101204 DAEHWA PHARMACEUTICAL CO. LTD; Shanghai RMX Biopharma Co. Ltd
2021/10/26Import · Class 2.4 紫杉醇口服溶液 · No verified English nameJXHL2101203 DAEHWA PHARMACEUTICAL CO. LTD; Shanghai RMX Biopharma Co. Ltd
2021/10/26Generic · Class 3 Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2101924 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2021/10/26Generic · Class 3 Oxytocin InjectionCYHS2101918 Chengdu Brilliant Pharmaceutical Co., Ltd.
2021/10/26Generic · Class 3 Oxytocin InjectionCYHS2101917 Chengdu Brilliant Pharmaceutical Co., Ltd.
2021/10/26Generic · Class 3 Furosemide InjectionCYHS2101908 Hangzhou Minsheng Pharmaceutical Co., Ltd
2021/10/26Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2101907 Jiangxi Yi You Pharma Co., Ltd. romanized; Jing Cheng Hui Yao Pharma Co., Ltd. romanized
2021/10/26Generic · Class 3 Torsemide InjectionCYHS2101881 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2021/10/26Generic · Class 3 Torsemide InjectionCYHS2101880 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2021/10/26New drug · Class 1 普特利单抗注射液 · No verified English nameCXSS2101041 Le Pu Bio Technology Co., Ltd. romanized; Ding Kang (Wuhan) Biopharmaceuticals Co., Ltd. romanized

67 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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