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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 227 drug applications between 10 February 2022 and 16 February 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 30 drug names.

2022/02/10 – 2022/02/16

Period
2022/02/10 to 2022/02/16, 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
227
Drugs with new generic filings (by drug name, de-duplicated)
30
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

227filings, 44 of them generic

By application type

Application typeFilings
Supplement138
Generic44
New drug38
Import6
Unspecified1

By drug type

Drug typeFilings
Chemical drug161
Therapeutic biologic44
TCM21
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

30 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Rosuvastatin Calcium Tablets4218
2Sodium Hyaluronate Eye Drops3330
3氧 · No verified English name2215
4Regorafenib Tablets223
5Nintedanib Esilate Soft Capsules216
6Etoricoxib Tablets218
7利奈唑胺干混悬剂 · No verified English name211
8Obeticholic Acid Tablets210
9Levofloxacin and Sodium Chloride Injection2114
10Sildenafil Citrate 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

142 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Zhuang Zu Zi Zhi Qu Hua Hong Jin Rui Pharma Co., Ltd. romanized1080
2Changchun Jin Sai Pharma Co., Ltd. romanized820
3Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized630
4Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized610
5Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized520
6Qilu Pharmaceutical Co., Ltd.433
7Hunan Ke Lun Pharmaceutical Co., Ltd. romanized420
8AstraZeneca UK Limited410
9Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized330
10UCB Pharma S.A.320

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

52 this week

AcceptedDrugApplicants
2022/02/16New drug · Class 2.3 大株红景天胶囊 · No verified English nameCXZL2200010 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2022/02/16New drug · Class 1 EVER001胶囊 · No verified English nameCXHL2200098 Yun Ding Xin Yao Pharmaceuticals Technology Co., Ltd. romanized
2022/02/16New drug · Class 1 SR750片 · No verified English nameCXHL2200095 Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized
2022/02/16New drug · Class 1 SR750片 · No verified English nameCXHL2200094 Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized
2022/02/15Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2200305 Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2022/02/15New drug · Class 2.3 金振口服液 · No verified English nameCXZL2200009 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2022/02/15New drug · Class 1 人源TH-SC01细胞注射液 · No verified English nameCXSL2200093 Jiangsu Tuo Hong Kang Heng Pharmaceuticals Co., Ltd. romanized
2022/02/15New drug · Class 1 CPD-002注射液 · No verified English nameCXSL2200092 Jiangxi Long Chang Pharma Co., Ltd. romanized
2022/02/15New drug · Class 1 注射用8MW2311 · No verified English nameCXSL2200091 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2022/02/15New drug · Class 1 SYHX2005 · No verified English nameCXHL2200097 CSPC OUYI PHARMACEUTICAL CO., LTD.
2022/02/15New drug · Class 1 SYHX2005 · No verified English nameCXHL2200096 CSPC OUYI PHARMACEUTICAL CO., LTD.
2022/02/15New drug · Class 1 XTR006注射液 · No verified English nameCXHL2200090 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized
2022/02/15New drug · Class 1 BEBT-305片 · No verified English nameCXHL2200089 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2022/02/15New drug · Class 1 BEBT-305片 · No verified English nameCXHL2200088 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2022/02/14Generic · Class 3 利奈唑胺干混悬剂 · No verified English nameCYHS2200309 Zhejiang Pu Li Pharma Co., Ltd. romanized
2022/02/14Generic · Class 3 利奈唑胺干混悬剂 · No verified English nameCYHS2200308 Zhejiang Pu Li Pharma Co., Ltd. romanized
2022/02/14Generic · Class 3 Pregabalin Extended release TabletsCYHL2200017 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2022/02/14New drug · Class 1 异体内皮祖细胞(EPCs)注射液 · No verified English nameCXSL2200090 Cheng Nuo Zai Sheng Yi Xue Technology (Zhuhai Heng Qin Xin Qu) Co., Ltd. romanized
2022/02/14New drug · Class 1 注射用重组人源化抗HER2单抗-AS269偶联物(ARX788) · No verified English nameCXSL2200080 Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized
2022/02/14New drug · Class 1 TT-01488片 · No verified English nameCXHL2200093 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2022/02/14New drug · Class 1 TT-01488片 · No verified English nameCXHL2200091 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2022/02/14New drug · Class 1 注射用聚乙二醇伊立替康 · No verified English nameCXHL2200081 Tianjin Jian Kai Technology Co., Ltd. romanized
2022/02/11Import · Class 2.4 NBTXR3 · No verified English nameJXHL2200037 Nanobiotix S.A.; Shanghai LianBio Development Co. Ltd.
2022/02/11Generic · Class 3 Oxytocin InjectionCYHS2200300 Xian Nuo Da Xin Pharmaceuticals Technology Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized
2022/02/11Generic · Class 3 Oxytocin InjectionCYHS2200299 Xian Nuo Da Xin Pharmaceuticals Technology Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized
2022/02/11Generic · Class 3 Biapenem For InjectionCYHS2200297 Shenzhen Hua Yao Nan Fang Pharmaceutical Co., Ltd. romanized
2022/02/11Generic · Class 3 lorazepam injectionCYHL2200016 Jiangsu En Hua Pharma Co., Ltd. romanized
2022/02/11New drug · Class 1 重组全人抗LAG-3单克隆抗体注射液 · No verified English nameCXSL2200089 Guangzhou Yu Heng Bio Technology Co., Ltd. romanized
2022/02/11New drug · Class 1 IBI322 · No verified English nameCXSL2200088 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/02/11New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2200087 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized

22 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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