YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 233 drug applications between 9 March 2022 and 15 March 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 33, covering 23 drug names.

2022/03/09 – 2022/03/15

Period
2022/03/09 to 2022/03/15, 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
233
Drugs with new generic filings (by drug name, de-duplicated)
23
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

233filings, 33 of them generic

By application type

Application typeFilings
Supplement123
Generic33
New drug27
Import re-registration19
Unspecified16
Import15

By drug type

Drug typeFilings
Chemical drug161
TCM33
Therapeutic biologic33
Biologic3
Prophylactic biologic3

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

23 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Paliperidone Palmitate Injection318
2Silodosin Capsules221
3Ipratropium Bromide Inhalation Solution212
4Montelukast Sodium Chewable Tablets214
5Amisulpride Injection211
6Clobazam Tablets212
7Dexmedetomidine Hydrochloride Injection210
8Alogliptin Benzoate Tablets211
9Febuxostat Tablets2112
10右佐匹克隆片 · No verified English name110

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

122 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Ze Yu Bio Co., Ltd. romanized12110
2Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized770
3Sanofi -aventis France710
4Le Tai Pharma Co., Ltd. romanized660
5Hainan Xu Wo Pharma Co., Ltd. romanized650
6Qilu Pharmaceutical Co., Ltd.633
7Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized610
8PURISYS LLC.550
9Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized440
10Beijing Xuan Sheng Pharmaceutical Co., Ltd. romanized430

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

44 this week

AcceptedDrugApplicants
2022/03/15Import · Class 1 GSK3196165 注射液 · No verified English nameJXSL2200030 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. LTD
2022/03/15Import · Class 1 GSK3196165 注射液 · No verified English nameJXSL2200029 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. LTD
2022/03/15New drug · Class 3.3 23价肺炎球菌多糖疫苗 · No verified English nameCXSS2200028 Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized
2022/03/15New drug · Class 2.2 赛帕利单抗注射液 · No verified English nameCXSS2200025 Guangzhou Yu Heng Bio Technology Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized
2022/03/15New drug · Class 2.2 HY-100209口崩片 · No verified English nameCXHL2200162 Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized
2022/03/14Import · Class 1 LY3209590注射液 · No verified English nameJXSL2200027 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/03/14Import · Class 1 AZD2936 · No verified English nameJXSL2200026 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/03/14New drug · Class 2.2 贝那鲁肽注射液 · No verified English nameCXSS2200027 Shanghai Ren Hui Biopharmaceutical Co., Ltd. romanized
2022/03/14New drug · Class 2.2 贝那鲁肽注射液 · No verified English nameCXSS2200026 Shanghai Ren Hui Biopharmaceutical Co., Ltd. romanized
2022/03/14New drug · Class 1 QX008N注射液 · No verified English nameCXSL2200127 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2022/03/14New drug · Class 1 QX008N注射液 · No verified English nameCXSL2200126 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2022/03/14New drug · Class 1 重组人GM-CSF 溶瘤II型单纯疱疹病毒(OH2)注射液(Vero 细胞) · No verified English nameCXSL2200125 Wuhan Bin Hui Bio Technology Co., Ltd. Bio Innovation Yuan Branch romanized
2022/03/14New drug · Class 2.4 奥布替尼片 · No verified English nameCXHS2200016 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2022/03/14New drug · Class 1 XZB-0004胶囊 · No verified English nameCXHL2200161 Xuan Zhu Bio Technology Co., Ltd. romanized
2022/03/14New drug · Class 1 XZB-0004胶囊 · No verified English nameCXHL2200160 Xuan Zhu Bio Technology Co., Ltd. romanized
2022/03/14New drug · Class 1 XZB-0004胶囊 · No verified English nameCXHL2200159 Xuan Zhu Bio Technology Co., Ltd. romanized
2022/03/14New drug · Class 1 XZB-0004胶囊 · No verified English nameCXHL2200158 Xuan Zhu Bio Technology Co., Ltd. romanized
2022/03/14New drug · Class 1 QLH11906片 · No verified English nameCXHL2200156 Qilu Pharmaceutical Co., Ltd.
2022/03/14New drug · Class 1 QLH11906片 · No verified English nameCXHL2200155 Qilu Pharmaceutical Co., Ltd.
2022/03/14New drug · Class 2.4 Ferumoxytol InjectionCXHL2200154 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2022/03/11Import · Class 3.1 注射用维布妥昔单抗 · No verified English nameJXSL2200028 Takeda Pharma A/S; Takeda(China) International Trading Co. Ltd
2022/03/11Import · Class 1 NNC0194-0499注射液 · No verified English nameJXSL2200025 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2022/03/11Import · Class 1 CB-5339 胶囊 · No verified English nameJXHL2200056 Cleave Therapeutics Inc.; CASI Pharmaceuticals (China) Co. Ltd.
2022/03/11Import · Class 1 CB-5339 胶囊 · No verified English nameJXHL2200055 Cleave Therapeutics Inc.; CASI Pharmaceuticals (China) Co. Ltd.
2022/03/11Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2200439 Rui Yang Pharmaceutical Co., Ltd. romanized
2022/03/11Generic · Class 3 Clobazam TabletsCYHS2200436 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/03/11Generic · Class 3 Clobazam TabletsCYHS2200435 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/03/11Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2200434 Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2022/03/11Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2200422 Sui Cheng Pharma Co., Ltd. romanized
2022/03/11Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2200421 Sui Cheng Pharma Co., Ltd. romanized

14 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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