YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 175 drug applications between 19 July 2021 and 25 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 24, covering 19 drug names.

2021/07/19 – 2021/07/25

Period
2021/07/19 to 2021/07/25, 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
175
Drugs with new generic filings (by drug name, de-duplicated)
19
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

175filings, 24 of them generic

By application type

Application typeFilings
Supplement99
New drug35
Generic24
Unspecified8
Import re-registration5
Import4

By drug type

Drug typeFilings
Chemical drug120
Therapeutic biologic28
TCM15
Prophylactic biologic8
Biologic4

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

19 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Neostigmine Methylsulfate Injection314
2Ropivacaine hydrochloride injection215
3Iodixanol Injection210
4Eldecalcitol Soft Capsules218
5Carbetocin Injection116
6Paracetamol Tablets116
7Levofloxacin Tablets117
8异丙托溴铵吸入气雾剂 · No verified English name112
9注射用奥美拉唑钠(静脉滴注) · No verified English name110
10Pantoprazole Enteric-Coated Tablets111

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

107 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hefei Li Fang Pharmaceutical Co., Ltd. romanized880
2Xian Tang Chen Pharmaceutical Co., Ltd. romanized760
3SANOFI PASTEUR430
4Guangzhou Bai Te Medical Yong Pin Co., Ltd. romanized420
5Shandong Lv Ye Pharmaceutical Co., Ltd. romanized410
6Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized410
7Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized330
8Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized330
9Novo Nordisk A/S320
10Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized320

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

47 this week

AcceptedDrugApplicants
2021/07/24Import · Class 1 PF-06863135 · No verified English nameJXSL2101069 Pfizer Inc; Pfizer Investment CO. Ltd.
2021/07/24Import · Class 2.2 Amivantamab注射液 · No verified English nameJXSL2101068 Janssen-Cilag International NV; Johnson & Johnson (China) Investment Ltd.
2021/07/24Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2101471 Chengdu Giantech Hi-technology Development Co., Ltd.; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2021/07/24Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2101470 Chengdu Giantech Hi-technology Development Co., Ltd.; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2021/07/24Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2101469 Chengdu Giantech Hi-technology Development Co., Ltd.; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2021/07/24Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2101468 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2021/07/24Generic · Class 3 Carbetocin InjectionCYHS2101453 Hui Ling Pharmaceutical (Zhongguo) Co., Ltd. romanized
2021/07/24New drug · Class 1 BA1105注射液 · No verified English nameCXSL2101212 Shandong Bo An Bio Technology Co., Ltd. romanized
2021/07/24New drug · Class 1 注射用SSGJ-705 · No verified English nameCXSL2101211 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/07/24New drug · Class 1 AK112注射液 · No verified English nameCXSL2101210 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/07/24New drug · Class 1 AK120注射液 · No verified English nameCXSL2101209 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/07/24New drug · Class 1 依鲁奥克片 · No verified English nameCXHS2101032 Qilu Pharmaceutical Co., Ltd.
2021/07/24New drug · Class 1 依鲁奥克片 · No verified English nameCXHS2101031 Qilu Pharmaceutical Co., Ltd.
2021/07/24New drug · Class 1 NB003片 · No verified English nameCXHL2101323 Ningbo Xin Wan Technology Development Co., Ltd. romanized
2021/07/24New drug · Class 1 NB003片 · No verified English nameCXHL2101322 Ningbo Xin Wan Technology Development Co., Ltd. romanized
2021/07/24New drug · Class 1 NB003片 · No verified English nameCXHL2101321 Ningbo Xin Wan Technology Development Co., Ltd. romanized
2021/07/24New drug · Class 1 苯磺酸克立福替尼片 · No verified English nameCXHL2101317 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/07/24New drug · Class 1 苯磺酸克立福替尼片 · No verified English nameCXHL2101316 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/07/24New drug · Class 1 苯磺酸克立福替尼片 · No verified English nameCXHL2101315 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/07/24New drug · Class 1 注射用BEBT-908 · No verified English nameCXHL2101314 Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized
2021/07/24New drug · Class 1 BEBT-209胶囊 · No verified English nameCXHL2101313 Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized
2021/07/24New drug · Class 1 BEBT-209胶囊 · No verified English nameCXHL2101312 Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized
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

17 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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