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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 248 drug applications between 5 March 2022 and 11 March 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 39, covering 27 drug names.

2022/03/05 – 2022/03/11

Period
2022/03/05 to 2022/03/11, 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
248
Drugs with new generic filings (by drug name, de-duplicated)
27
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

248filings, 39 of them generic

By application type

Application typeFilings
Supplement133
Generic39
New drug29
Import re-registration22
Import14
Unspecified11

By drug type

Drug typeFilings
Chemical drug159
TCM46
Therapeutic biologic38
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

27 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets4123
2Silodosin Capsules221
3Montelukast Sodium Chewable Tablets214
4Tolvaptan Tablets210
5Amisulpride Injection211
6Clobazam Tablets212
7Dexmedetomidine Hydrochloride Injection210
8Arginine and Ibuprofen Granules2111
9Sugammadex Sodium Injection216
10Alogliptin Benzoate Tablets211

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

124 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized16160
2Shandong Ze Yu Bio Co., Ltd. romanized12110
3SHIN POONG Pharmaceutical Co. Ltd.820
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized810
5Le Tai Pharma Co., Ltd. romanized660
6Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized610
7Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized550
8Shandong Xin Shi Dai Pharma Co., Ltd. romanized524
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

51 this week

AcceptedDrugApplicants
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
2022/03/11New drug · Class 2.1 黄氏响声儿童喷雾剂 · No verified English nameCXZL2200014 Wuxi Ji Yu Shan He Pharmaceuticals Technology Co., Ltd. romanized; Wuxi Ji Yu Shan He Pharma Co., Ltd. romanized
2022/03/11New drug · Class 1.4 四价流感病毒亚单位疫苗 · No verified English nameCXSS2200023 Jiangsu Zhong Hui Yuan Tong Bio Technology Co., Ltd. romanized
2022/03/11New drug · Class 1 QL1706注射液 · No verified English nameCXSL2200124 Qilu Pharmaceutical Co., Ltd.
2022/03/10Generic · Class 3 右佐匹克隆片 · No verified English nameCYHS2200427 Changzhou Si Yao Pharmaceutical Co., Ltd. romanized
2022/03/10New drug · Class 2.2 丁苯酞注射液 · No verified English nameCXHL2200153 Ren He Yi Kang Group Co., Ltd. romanized
2022/03/09Generic · Class 3 Amisulpride InjectionCYHL2200024 Qilu Pharmaceutical (Hainan) Co., Ltd
2022/03/09Generic · Class 3 Amisulpride InjectionCYHL2200023 Qilu Pharmaceutical (Hainan) Co., Ltd
2022/03/09New drug · Class 1 IO-108注射液 · No verified English nameCXSL2200123 Yi Ming Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2022/03/09New drug · Class 1 SHR-1918 注射液 · No verified English nameCXSL2200122 Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/03/09New drug · Class 1 ASKG712注射液 · No verified English nameCXSL2200120 Suzhou Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized
2022/03/09New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2200152 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/03/09New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2200151 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/03/09New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2200150 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/03/09New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2200149 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/03/08Import · Class 3.1 帕博利珠单抗注射液 · No verified English nameJXSS2200010 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2022/03/08Import · Class 1 VIS649 · No verified English nameJXSL2200022 Otsuka Pharmaceutical Development & Commercialization Inc.; Otsuka Beijing Research Institute
2022/03/08Import · Class 1 VIC-1911片 · No verified English nameJXHL2200054 JS INNOPHARM LIMITED; JS InnoPharm (Suzhou) Ltd.
2022/03/08Import · Class 1 VIC-1911片 · No verified English nameJXHL2200053 JS INNOPHARM LIMITED; JS InnoPharm (Suzhou) Ltd.
2022/03/08Generic · Class 3 磷酸奥司他韦干糖浆 · No verified English nameCYHS2200416 Jiangxi Shimei Pharmaceutical Co., Ltd
2022/03/08Generic · Class 3 洛度沙胺氨丁三醇滴眼液 · No verified English nameCYHS2200415 Wuhan Xian Lu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan He Yi Pharmaceutical Co., Ltd. romanized

21 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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