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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 229 drug applications between 2 March 2022 and 8 March 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 32, covering 24 drug names.

2022/03/02 – 2022/03/08

Period
2022/03/02 to 2022/03/08, 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
229
Drugs with new generic filings (by drug name, de-duplicated)
24
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

229filings, 32 of them generic

By application type

Application typeFilings
Supplement126
New drug34
Generic32
Import re-registration18
Import11
Unspecified8

By drug type

Drug typeFilings
Chemical drug148
TCM50
Therapeutic biologic29
Biologic1
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

24 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets4123
2Sodium Hyaluronate Eye Drops2230
3Drospirenone and Ethinylestradiol Tablets211
4Tolvaptan Tablets210
5Arginine and Ibuprofen Granules2111
6Sugammadex Sodium Injection216
7ω-3 Fish Oil Fat Emulsion Injection116
8Voglibose Tablets110
9Ritonavir Tablets110
10Salbutamol Sulfate Inhalation Solution112

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

114 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized25250
2Jilin Yi Da Pharma Co., Ltd. romanized990
3Gui Lin Yuan Cheng Pharmaceutical Co., Ltd. romanized990
4SHIN POONG Pharmaceutical Co. Ltd.820
5N.V. Organon630
6Shandong Xin Shi Dai Pharma Co., Ltd. romanized524
7Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
8Novo Nordisk A/S420
9Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.420
10N.V.Organon410

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

49 this week

AcceptedDrugApplicants
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
2022/03/07New drug · Class 1 治疗用艾滋病核酸注射液 · No verified English nameCXSL2200115 Shenzhen Yi Ke Biopharmaceuticals Co., Ltd. romanized
2022/03/07New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2200114 Shanghai Quan Sheng Bio Technology Co., Ltd. romanized
2022/03/07New drug · Class 2.2 普拉克索透皮贴剂 · No verified English nameCXHL2200146 Guangdong Hong Shan Hu Pharma Co., Ltd. romanized
2022/03/07New drug · Class 2.1; 2.2 注射用HR18034 · No verified English nameCXHL2200145 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/03/07New drug · Class 2.2 枸橼酸莫沙必利注射液 · No verified English nameCXHL2200140 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2022/03/07New drug · Class 2.2 OT-601-C · No verified English nameCXHL2200135 Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized
2022/03/04Import · Class 1 Tremelimumab · No verified English nameJXSL2200021 MedImmune LLC; AstraZeneca Global R&D (China) Co. Ltd.
2022/03/04Generic · Class 3 Isosulfan Blue InjectionCYHS2200409 Guangdong He Bo Pharmaceutical Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2022/03/04Generic · Class 3 Citicoline Sodium InjectionCYHS2200408 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized

19 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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