YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 278 drug applications between 20 October 2021 and 26 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 41, covering 31 drug names.

2021/10/20 – 2021/10/26

Period
2021/10/20 to 2021/10/26, 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
278
Drugs with new generic filings (by drug name, de-duplicated)
31
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

278filings, 41 of them generic

By application type

Application typeFilings
Supplement152
New drug50
Generic41
Import22
Import re-registration8
Unspecified5

By drug type

Drug typeFilings
Chemical drug181
TCM49
Therapeutic biologic43
Prophylactic biologic3
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

31 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
4Tranexamic Acid Injection2111
5Sodium Hyaluronate Eye Drops2130
6Dopamine Hydrochloride Injection213
7Oxytocin Injection218
8酒石酸伐尼克兰片 · No verified English name213
9Atorvastatin Calcium Tablets2124
10Furosemide Injection116

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

151 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. romanized530
3Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized520
4Novartis Pharma Schweiz AG430
5Upjohn EESV430
6Name not romanized430
7Shanghai Jia Bao Yao Yin Pharmaceuticals Technology Co., Ltd. romanized420
8Shandong An Xin Pharmaceutical Co., Ltd. romanized420
9Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized420
10Changchun Jin Sai Pharma 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

82 this week

AcceptedDrugApplicants
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
2021/10/26New drug · Class 1 AK104注射液 · No verified English nameCXSL2101388 Kang Fang Pharma Co., Ltd. romanized
2021/10/26New drug · Class 1 AK104注射液 · No verified English nameCXSL2101387 Kang Fang Pharma Co., Ltd. romanized
2021/10/26New drug · Class 2.2 注射用卡瑞利珠单抗 · No verified English nameCXSL2101385 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/10/26New drug · Class 1 AK117注射液 · No verified English nameCXSL2101384 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/10/26New drug · Class 1 ZG005粉针剂 · No verified English nameCXSL2101383 Name not romanized
2021/10/26New drug · Class 1 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2101381 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2021/10/26New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2101380 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2021/10/26New drug · Class 1 VT1092注射液 · No verified English nameCXSL2101377 Beijing Wei Yuan Li Kang Bio Technology Co., Ltd. romanized
2021/10/26New drug · Class 1 DXC007 · No verified English nameCXSL2101375 Hangzhou Duo Xi Bio Technology Co., Ltd. romanized
2021/10/26New drug · Class 1 重组人源化单克隆抗体MIL62注射液 · No verified English nameCXSL2101374 Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized
2021/10/26New drug · Class 1 1A46注射液 · No verified English nameCXSL2101355 Hai Zheng Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized; Chengdu En Mu Bio Technology Co., Ltd. romanized
2021/10/26New drug · Class 2.2 丁苯酞注射液 · No verified English nameCXHL2101608 Ren He Yi Kang Group Co., Ltd. romanized
2021/10/26New drug · Class 1 ZG19018片 · No verified English nameCXHL2101606 Name not romanized
2021/10/26New drug · Class 1 ZG19018片 · No verified English nameCXHL2101605 Name not romanized
2021/10/26New drug · Class 1 注射用盐酸石蒜碱硫酯 · No verified English nameCXHL2101604 Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized
2021/10/26New drug · Class 1 SYHX2001片 · No verified English nameCXHL2101603 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized

52 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.