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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 230 drug applications between 3 March 2022 and 9 March 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 31, covering 22 drug names.

2022/03/03 – 2022/03/09

Period
2022/03/03 to 2022/03/09, 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
230
Drugs with new generic filings (by drug name, de-duplicated)
22
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

230filings, 31 of them generic

By application type

Application typeFilings
Supplement123
New drug37
Generic31
Import re-registration18
Unspecified12
Import9

By drug type

Drug typeFilings
Chemical drug155
TCM40
Therapeutic biologic31
Biologic3
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

22 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets4123
2Drospirenone and Ethinylestradiol Tablets211
3Tolvaptan Tablets210
4Amisulpride Injection211
5Arginine and Ibuprofen Granules2111
6Sugammadex Sodium Injection216
7Alogliptin Benzoate Tablets211
8ω-3 Fish Oil Fat Emulsion Injection116
9Voglibose Tablets110
10Ritonavir Tablets110

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

118 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized23230
2Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized920
3SHIN POONG Pharmaceutical Co. Ltd.820
4N.V. Organon630
5Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized610
6Shandong Xin Shi Dai Pharma Co., Ltd. romanized524
7Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized440
8Jilin Yi Da Pharma Co., Ltd. romanized440
9Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized431
10Novo Nordisk A/S420

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
2022/03/09Generic · 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
2022/03/08New drug · Class 3.4 人凝血酶原复合物 · No verified English nameCXSS2200022 Guangdong Shuang Lin Biopharmaceutical Co., Ltd. romanized
2022/03/08New drug · Class 1 QR060127胶囊 · No verified English nameCXHL2200148 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2022/03/08New drug · Class 1 QR060127胶囊 · No verified English nameCXHL2200147 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2022/03/08New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2200144 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/03/08New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2200143 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/03/08New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2200142 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/03/08New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2200141 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/03/07Import · Class 2.2 RO7198574 · No verified English nameJXSL2200024 F.Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2022/03/07Import · Class 2.2 RO7198574 · No verified English nameJXSL2200023 F.Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2022/03/07Import · Class 1 GDC-9545 · No verified English nameJXHL2200052 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2022/03/07New drug · Class 1 ASKG712注射液 · No verified English nameCXSL2200121 Suzhou Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized
2022/03/07New drug · Class 1 MNC-168肠溶胶囊 · No verified English nameCXSL2200119 Mu En (Guangzhou) Bio Technology Co., Ltd. romanized
2022/03/07New drug · Class 1 MNC-168肠溶胶囊 · No verified English nameCXSL2200118 Mu En (Guangzhou) Bio Technology Co., Ltd. romanized
2022/03/07New drug · Class 1 MNC-168肠溶胶囊 · No verified English nameCXSL2200117 Mu En (Guangzhou) Bio Technology Co., Ltd. romanized
2022/03/07New drug · Class 1 MNC-168肠溶胶囊 · No verified English nameCXSL2200116 Mu En (Guangzhou) Bio 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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