YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 97 drug applications between 17 July 2021 and 23 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 16, covering 13 drug names.

2021/07/17 – 2021/07/23

Period
2021/07/17 to 2021/07/23, 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
97
Drugs with new generic filings (by drug name, de-duplicated)
13
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

97filings, 16 of them generic

By application type

Application typeFilings
Supplement51
New drug20
Generic16
Unspecified5
Import re-registration4
Import1

By drug type

Drug typeFilings
Chemical drug68
Therapeutic biologic13
TCM11
Biologic4
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

13 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ropivacaine hydrochloride injection215
2Iodixanol Injection210
3Eldecalcitol Soft Capsules218
4Paracetamol Tablets116
5异丙托溴铵吸入气雾剂 · No verified English name112
6注射用奥美拉唑钠(静脉滴注) · No verified English name110
7Pantoprazole Enteric-Coated Tablets111
8Eribulin Mesilate Injection110
9Levobupivacaine Hydrochloride Injection112
10Ambroxol Hydrochloride Oral Solution1146

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

63 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xian Tang Chen Pharmaceutical Co., Ltd. romanized760
2Hefei Li Fang Pharmaceutical Co., Ltd. romanized550
3Shandong Lv Ye Pharmaceutical Co., Ltd. romanized410
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized330
5Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized310
6SANOFI PASTEUR220
7Hu Lun Bei Er Song Lu Pharmaceutical Co., Ltd. romanized220
8Affamed Therapeutics (HK) Limited210
9Merck Serono Limited210
10Novo Nordisk A/S210

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

25 this week

AcceptedDrugApplicants
2021/07/21Generic · Class 3 Paracetamol TabletsCYHS2101461 Beijing Yi Ling Pharmaceuticals Technology Development Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized
2021/07/21Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2101460 Nanjing Feng Kai Si Drug Research and Development Co., Ltd. romanized; Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2021/07/21New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2101208 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2021/07/21New drug · Class 1 FTL001单抗注射液 · No verified English nameCXSL2101204 Fei Tong (Chengdu) Bio Technology Co., Ltd. romanized
2021/07/20Import · Class 2.2 阿替利珠单抗注射液 · No verified English nameJXSL2101067 F.Hoffmann-La Roche Ltd.; Roche(China)Holding Ltd.
2021/07/20Generic · Class 3 Citicoline Sodium InjectionCYHS2101456 Haikou Tian Xing Jian Drug Research Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2021/07/20New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2101206 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/07/20New drug · Class 2.1 HR011408注射液 · No verified English nameCXSL2101205 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/07/20New drug · Class 1 ZXBT-1158胶囊 · No verified English nameCXHL2101308 Dong Guan Shi Zhen Xing Bei Te Pharmaceuticals Technology Co., Ltd. romanized
2021/07/20New drug · Class 1 ZXBT-1158胶囊 · No verified English nameCXHL2101307 Dong Guan Shi Zhen Xing Bei Te Pharmaceuticals Technology Co., Ltd. romanized
2021/07/20New drug · Class 1 ZX-7101A片 · No verified English nameCXHL2101306 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2021/07/20New drug · Class 1 ZX-7101A片 · No verified English nameCXHL2101305 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2021/07/20New drug · Class 2.2 盐酸伊立替康脂质体注射液 · No verified English nameCXHL2101304 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/07/20New drug · Class 2.4 氟唑帕利胶囊 · No verified English nameCXHL2101303 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/07/20New drug · Class 2.2 丁苯酞注射液 · No verified English nameCXHL2101298 Jilin Sheng Qi Jian Bio Technology Co., Ltd. romanized
2021/07/19Generic · Class 3 Levobupivacaine Hydrochloride InjectionCYHS2101449 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2021/07/19New drug · Class 2.3 滋肾育胎丸 · No verified English nameCXZL2101019 Guangzhou Bai Yun Shan Zhong Yi Pharma Co., Ltd. romanized
2021/07/19New drug · Class 1 重组抗VEGFR2全人源单克隆抗体注射液 · No verified English nameCXSL2101203 Beijing Dong Fang Bai Tai Bio Technology Co., Ltd. romanized
2021/07/19New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2101191 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2021/07/19New drug · Class 1 注射用RC118 · No verified English nameCXSL2101189 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2021/07/19New drug · Class 2.2 依达拉奉舌下片 · No verified English nameCXHS2101030 Nanjing Bai Xin Yu Pharmaceuticals Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized
2021/07/19New drug · Class 1 LPM3770164缓释片 · No verified English nameCXHL2101302 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2021/07/19New drug · Class 1 LPM3770164缓释片 · No verified English nameCXHL2101301 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2021/07/19New drug · Class 1 LPM3770164缓释片 · No verified English nameCXHL2101300 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2021/07/19New drug · Class 1 LPM3770164缓释片 · No verified English nameCXHL2101299 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized

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.