YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 88 drug applications between 30 April 2022 and 6 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 13, covering 11 drug names.

2022/04/30 – 2022/05/06

Period
2022/04/30 to 2022/05/06, 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
88
Drugs with new generic filings (by drug name, de-duplicated)
11
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

88filings, 13 of them generic

By application type

Application typeFilings
Supplement44
Import16
Generic13
New drug12
Unspecified2
Import re-registration1

By drug type

Drug typeFilings
Chemical drug60
TCM16
Therapeutic biologic8
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

11 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Amisulpride Injection211
2Moxifloxacin Hydrochloride Eye Drops214
3Tinidazole Tablets110
4氧(液态) · No verified English name1113
5Dexrazoxane for Injection111
6Roxatidine Acetate Hydrochloride For Injection115
7Atomoxetine Hydrochloride Oral Solution110
8Ambroxol Hydrochloride Oral Solution1146
9Sitagliptin Phosphate Tablets112
10Roxithromycin Tablets112

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

54 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1UNION therapeutics A/S620
2Jilin Zhen Yuan Pharmaceutical Co., Ltd. romanized440
3Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized420
4N.V. Organon410
5Shandong Han Fang Pharmaceutical Co., Ltd. romanized330
6Pfizer Inc.320
7Beijing Lang Di Pharmaceutical Co., Ltd. romanized320
8Novo Nordisk A/S310
9Jiangsu Hao Sen Pharma Group Co., Ltd. romanized310
10Shenzhen Shi Xin Tai Pharmaceuticals Co., Ltd. romanized220

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

31 this week

AcceptedDrugApplicants
2022/05/06Import · Class 1 PF-06801591注射液 · No verified English nameJXSL2200054 Pfizer Inc.; Pfizer Investment CO. Ltd.
2022/05/06Import · Class 2.2 Somapacitan注射液 · No verified English nameJXSL2200053 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2022/05/06Import · Class 2.2 Somapacitan注射液 · No verified English nameJXSL2200052 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2022/05/06Import · Class 2.2 Somapacitan注射液 · No verified English nameJXSL2200051 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2022/05/06Import · Class 1 BMS-986166-04 胶囊 · No verified English nameJXHL2200104 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2022/05/06Import · Class 1 PF-07265807片 · No verified English nameJXHL2200103 Pfizer Inc.; Pfizer Investment CO. Ltd
2022/05/06Import · Class 1 PF-07265807片 · No verified English nameJXHL2200102 Pfizer Inc.; Pfizer Investment CO. Ltd
2022/05/06Import · Class 1 SAR443820 · No verified English nameJXHL2200101 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2022/05/06Generic · Class 3 Dexrazoxane for InjectionCYHS2200705 Yangtze River Pharmaceutical Group Co., Ltd
2022/05/06Generic · Class 3 Amisulpride InjectionCYHL2200041 Jiangsu En Hua Pharma Co., Ltd. romanized
2022/05/06Generic · Class 3 Amisulpride InjectionCYHL2200040 Jiangsu En Hua Pharma Co., Ltd. romanized
2022/05/06New drug · Class 1 注射用重组人源化抗CD70单抗-AS269偶联物(ARX305) · No verified English nameCXSL2200196 Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized
2022/05/06New drug · Class 1 注射用HRS-8427 · No verified English nameCXHL2200275 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/05/06New drug · Class 2.4 A2022注射液 · No verified English nameCXHL2200274 Beijing Pu De Kang Li Pharmaceuticals Technology Development Co., Ltd. romanized
2022/05/05Import · Class 1 Orismilast 缓释片 · No verified English nameJXHL2200100 UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd.
2022/05/05Import · Class 1 Orismilast缓释片 · No verified English nameJXHL2200099 UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd.
2022/05/05Import · Class 1 Orismilast缓释片 · No verified English nameJXHL2200098 UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd.
2022/05/05Import · Class 1 Orismilast 缓释片 · No verified English nameJXHL2200097 UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd.
2022/05/05Import · Class 1 Orismilast缓释片 · No verified English nameJXHL2200096 UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd.
2022/05/05Import · Class 1 Orismilast缓释片 · No verified English nameJXHL2200095 UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd.
2022/05/05Generic · Class 3 Tinidazole TabletsCYHS2200698 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/05/05Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2200696 Ke Bei Yuan (Beijing) Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2022/05/05New drug · Class 1.1 参味宁郁片 · No verified English nameCXZS2200005 Guangdong Si Ji Pharma Co., Ltd. romanized; Yi Li Pharmaceutical (Luo Ding) Co., Ltd. romanized
2022/05/05New drug · Class 1 GZR4 · No verified English nameCXSL2200192 Gan Li Pharma Co., Ltd. romanized
2022/05/05New drug · Class 1 培莫沙肽注射液 · No verified English nameCXHS2200022 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2022/05/05New drug · Class 1 培莫沙肽注射液 · No verified English nameCXHS2200021 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2022/05/05New drug · Class 1 培莫沙肽注射液 · No verified English nameCXHS2200020 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2022/05/05New drug · Class 2.2; 2.4 BM201注射液 · No verified English nameCXHL2200273 Suzhou Bai Mai Biopharmaceuticals Co., Ltd. romanized
2022/05/05New drug · Class 1 HS248片 · No verified English nameCXHL2200272 Han Hui Pharmaceutical Co., Ltd. romanized
2022/05/05New drug · Class 1 HS248片 · No verified English nameCXHL2200271 Han Hui Pharmaceutical Co., Ltd. romanized

1 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.