YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 290 drug applications between 9 November 2022 and 15 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 56 drug names.

2022/11/09 – 2022/11/15

Period
2022/11/09 to 2022/11/15, 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
290
Drugs with new generic filings (by drug name, de-duplicated)
56
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

290filings, 82 of them generic

By application type

Application typeFilings
Supplement152
Generic82
New drug35
Import10
Unspecified9
Import re-registration2

By drug type

Drug typeFilings
Chemical drug218
TCM46
Therapeutic biologic25
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

56 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ibuprofen Injection538
2Palbociclib Capsules310
3Pregabalin Capsules3112
4Tranexamic Acid Injection3111
5Lidocaine Hydrochloride Injection316
6Oseltamivir Phosphate For Oral Suspension222
7Voriconazole Tablets211
8Fesoterodine Fumarate Prolonged-Release Tablets210
9Hydrocodone Bitartrate and Ibuprofen Tablets210
10Tandospirone Citrate Tablets212

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

171 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized13130
2Henan Shuang He Hua Li Pharma Co., Ltd. romanized1230
3Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized990
4Boehringer Ingelheim International GmbH610
5Hua Run San Jiu (Chen Zhou) Pharmaceutical Co., Ltd. romanized550
6UCB Pharma SA520
7Xian Sheng Pharma Co., Ltd. romanized523
8Haerbin Han Bang Medical Technology Co., Ltd. romanized510
9Jiangsu Pu Lai Pharmaceuticals Bio Technology Co., Ltd. romanized510
10Gansu Xin Min Hai Pharmaceutical Co., Ltd. romanized440

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

72 this week

AcceptedDrugApplicants
2022/11/15Import · Class 1 PF-06821497片 · No verified English nameJXHL2200336 Pfizer Inc.; Pfizer Investment CO. Ltd.
2022/11/15Import · Class 1 PF-06821497片 · No verified English nameJXHL2200335 Pfizer Inc.; Pfizer Investment CO. Ltd.
2022/11/15Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2201992 Tianjin Jin Yao Group Hubei Tian Yao Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2022/11/15Generic · Class 3 Famciclovir TabletsCYHS2201981 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2022/11/15Generic · Class 3 6-[18F]Fluoro-L-DOPA InjectionCYHL2200103 Jiangsu Hua Yi Technology Co., Ltd. romanized
2022/11/15New drug · Class 1.1 藿夏感冒颗粒 · No verified English nameCXZL2200050 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2022/11/15New drug · Class 2.2 注射用重组人TNK组织型纤溶酶原激活剂 · No verified English nameCXSS2200090 Shi Yao Group Ming Fu Le Pharma (Guangzhou) Co., Ltd. romanized
2022/11/15New drug · Class 1 BR108注射液 · No verified English nameCXSL2200573 Hai Zheng Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized
2022/11/15New drug · Class 2.2 右布洛芬缓控释双层片 · No verified English nameCXHL2200900 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized
2022/11/15New drug · Class 1 注射用顺眠肽 · No verified English nameCXHL2200899 Guangzhou Liu Shun Bio Technology Co., Ltd. romanized
2022/11/15New drug · Class 1 ZN-A-1041肠溶胶囊 · No verified English nameCXHL2200898 Suzhou Zan Rong Pharmaceuticals Technology Co., Ltd. romanized
2022/11/15New drug · Class 1 甲磺酸贝福替尼胶囊 · No verified English nameCXHL2200897 Bei Da Pharma Co., Ltd. romanized
2022/11/15New drug · Class 1 甲磺酸贝福替尼胶囊 · No verified English nameCXHL2200896 Bei Da Pharma Co., Ltd. romanized
2022/11/15New drug · Class 1 SIM0270胶囊 · No verified English nameCXHL2200895 Xian Sheng Pharma Co., Ltd. romanized
2022/11/14Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2201979 Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized
2022/11/14Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2201978 Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized
2022/11/14Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2201977 Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized
2022/11/14Generic · Class 3 Calcium Dobesilate TabletsCYHS2201974 Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized; Ningxia Kang Ya Pharma Co., Ltd. romanized
2022/11/14New drug · Class 1 SIM0270胶囊 · No verified English nameCXHL2200894 Xian Sheng Pharma Co., Ltd. romanized
2022/11/13Import · Class 2.2; 2.4 INOpulse · No verified English nameJXHL2200334 Bellerophon Pulse Technologies LLC; Baylor Biosciences Inc
2022/11/12Import · Class 1 Remternetug注射液(静脉注射) · No verified English nameJXSL2200200 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/11/12Import · Class 1 Remternetug注射液 · No verified English nameJXSL2200199 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/11/12Import · Class 1 注射用Oregovomab · No verified English nameJXSL2200198 OncoQuest Pharmaceuticals Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2022/11/12Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2201970 Shanghai Bao Long Bio Technology Co., Ltd. romanized; Shanghai Mei You Pharmaceutical Co., Ltd. romanized
2022/11/12Generic · Class 3 Ibuprofen InjectionCYHS2201969 Shandong Luo Xin Pharma Group Co., Ltd. romanized
2022/11/12Generic · Class 3 镥[177Lu]氧奥曲肽注射液 · No verified English nameCYHL2200102 Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/11/12New drug · Class 1 SM3321注射液 · No verified English nameCXSL2200572 Beijing Shuo Xing Biopharmaceuticals Technology Co., Ltd. romanized
2022/11/12New drug · Class 1 NMM肿瘤治疗性DNA疫苗裸质粒注射液 · No verified English nameCXSL2200571 Gu An Ding Tai Hai Gui Bio Technology Co., Ltd. romanized
2022/11/12New drug · Class 1 注射用IMM01 · No verified English nameCXSL2200570 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/11/12New drug · Class 1 莫非赛定利托那韦片 · No verified English nameCXHL2200893 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized

42 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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