YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 324 drug applications between 7 June 2022 and 13 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 40, covering 23 drug names.

2022/06/07 – 2022/06/13

Period
2022/06/07 to 2022/06/13, 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
324
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

324filings, 40 of them generic

By application type

Application typeFilings
Supplement198
New drug41
Generic40
Import27
Unspecified9
Import re-registration9

By drug type

Drug typeFilings
Chemical drug197
Therapeutic biologic72
TCM45
Biologic6
Prophylactic biologic4

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
1Atomoxetine Hydrochloride Capsules716
2Olanzapine Tablets314
3复方聚乙二醇电解质散(Ⅲ) · No verified English name221
4Olmesartan Medoxomil Tablets211
5Pravastatin Sodium Tablets212
6Pantoprazole Enteric-Coated Tablets211
7Dopamine Hydrochloride Injection213
8Oseltamivir Phosphate For Oral Suspension212
9Minoxidil Topical Solution210
10Rocuronium Bromide Injection211

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

158 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Kai Feng Pharmaceutical (Group) Co., Ltd. romanized23200
2Shanghai Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized2170
3Zhejiang Ao Tuo Kang Pharmaceuticals Technology Co., Ltd. romanized970
4Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized880
5F. Hoffmann-La Roche Ltd850
6ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.717
7Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized660
8Novo Nordisk A/S620
9Guangxi Ji Min Tang Pharma Co., Ltd. romanized550
10Jiangxi Na Fu Tang Pharmaceutical Co., Ltd. romanized540

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

74 this week

AcceptedDrugApplicants
2022/06/13Import · Class 3.1 地舒单抗注射液 · No verified English nameJXSS2200019 Amgen Europe B.V.; Amgen Manufacturing Limited; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2022/06/13Import · Class 2.2 贝伐珠单抗注射液 · No verified English nameJXSL2200084 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/06/13Import · Class 3.3 雷珠单抗注射液 · No verified English nameJXSL2200083 Samsung Bioepis NL B.V.; Shanghai Affamed Therapeutics Co. Limited
2022/06/13Import · Class 1 RO7435846片 · No verified English nameJXHL2200143 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2022/06/13Import · Class 1 RO7435846片 · No verified English nameJXHL2200142 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2022/06/13Import · Class 1 RO7435846片 · No verified English nameJXHL2200141 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2022/06/13Generic · Class 3 Venlafaxine Hydrochloride Extended Release TabletsCYHS2200865 Hainan Hui Gu Pharma Co., Ltd. romanized
2022/06/13Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2200864 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/06/13Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2200863 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/06/13Generic · Class 3 Minoxidil Topical SolutionCYHS2200862 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2022/06/13Generic · Class 3 Minoxidil Topical SolutionCYHS2200861 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2022/06/13Generic · Class 3 Ulinastatin InjectionCYHL2200049 Jiangsu Ai Di Pharma Co., Ltd. romanized
2022/06/13New drug · Class 1 托莱西单抗注射液 · No verified English nameCXSS2200059 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/06/13New drug · Class 1 TG103注射液 · No verified English nameCXSL2200262 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized
2022/06/13New drug · Class 2.2 注射用多西他赛聚合物胶束 · No verified English nameCXHL2200375 Shanxi Kang Bao Bio Zhi Pin Co., Ltd. romanized
2022/06/10Import · Class 1 CagriSema注射液 · No verified English nameJXSL2200082 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2022/06/10Import · Class 1 CagriSema注射液 · No verified English nameJXSL2200081 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2022/06/10Import · Class 1 CagriSema注射液 · No verified English nameJXSL2200080 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2022/06/10Import · Class 1 CagriSema注射液 · No verified English nameJXSL2200079 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2022/06/10Import · Class 1 CagriSema注射液 · No verified English nameJXSL2200078 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2022/06/10Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2200077 Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2022/06/10Import · Class 1 MK-4830注射液 · No verified English nameJXSL2200076 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2022/06/10Import · Class 1 BI 907828片 · No verified English nameJXHL2200139 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/06/10Import · Class 1 BI 907828片 · No verified English nameJXHL2200138 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/06/10Import · Class 1 BI 907828片 · No verified English nameJXHL2200137 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/06/10Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2200858 Yang Ling Ke Sen Biopharmaceutical Co., Ltd. romanized
2022/06/10Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2200857 Yang Ling Ke Sen Biopharmaceutical Co., Ltd. romanized
2022/06/10New drug · Class 1.1 小儿香薷颗粒 · No verified English nameCXZL2200026 Yi Li Pharmaceutical Co., Ltd. romanized
2022/06/10New drug · Class 1 ZS801注射液 · No verified English nameCXSL2200261 Sichuan Zhi Shan Wei Xin Bio Technology Co., Ltd. romanized
2022/06/10New drug · Class 1 HB0036注射液 · No verified English nameCXSL2200260 Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized

44 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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