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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 342 drug applications between 12 January 2022 and 18 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 53 drug names.

2022/01/12 – 2022/01/18

Period
2022/01/12 to 2022/01/18, 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
342
Drugs with new generic filings (by drug name, de-duplicated)
53
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

342filings, 74 of them generic

By application type

Application typeFilings
Supplement191
Generic74
New drug43
Import19
Import re-registration12
Unspecified3

By drug type

Drug typeFilings
Chemical drug285
Therapeutic biologic37
TCM18
In vitro diagnostic reagent1
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

53 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Memantine Hydrochloride Sustained-release Capsules412
2Atomoxetine Hydrochloride Oral Solution330
3Urapidil Hydrochloride Injection326
4阿普米司特片 · No verified English name313
5Rivaroxaban Tablets223
6吸入用七氟烷 · No verified English name210
7Empagliflozin Tablets2118
8Lenalidomide Capsules213
9Parecoxib Sodium for Injection212
10Neostigmine Methylsulfate Injection214

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

186 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Rui Ze Pharma Co., Ltd. romanized22210
2Guangxi Kun Ze Pharma Co., Ltd. romanized2130
3Hua Run Shuang He Pharma Co., Ltd. romanized1190
4Bayer Vital GmbH920
5Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.530
6Hua Bei Pharmaceutical Group Xian Tai Pharma Co., Ltd. romanized530
7Hainan Tong Yong San Yang Pharma Co., Ltd. romanized510
8Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized510
9LES LABORATOIRES SERVIER430
10PFIZER EUROPE MA EEIG410

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

80 this week

AcceptedDrugApplicants
2022/01/18Generic · Class 3 泽布替尼胶囊 · No verified English nameCYHS2200112 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/01/18Generic · Class 3 Oxycodone And Acetaminophen TabletsCYHS2200109 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/01/18Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2200108 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2022/01/18Generic · Class 3 Memantine Hydrochloride Sustained-release CapsulesCYHS2200089 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2022/01/18Generic · Class 3 Memantine Hydrochloride Sustained-release CapsulesCYHS2200088 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2022/01/18Generic · Class 3 Memantine Hydrochloride Sustained-release CapsulesCYHS2200087 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2022/01/18Generic · Class 3 Memantine Hydrochloride Sustained-release CapsulesCYHS2200086 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2022/01/18Generic · Class 3 米诺地尔泡沫剂 · No verified English nameCYHS2200045 Zhejiang Wan Cheng Pharma Co., Ltd. romanized
2022/01/18Generic · Class 3 Bromhexine Hydrochloride Solution For InhalationCYHL2200008 Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2022/01/18New drug · Class 1 KL-A167注射液 · No verified English nameCXSL2200025 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2022/01/18New drug · Class 1 注射用SKB264 · No verified English nameCXSL2200024 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2022/01/18New drug · Class 1 SMP-100片 · No verified English nameCXHL2200032 Ke Ling Yuan Bio Technology (Shenzhen) Co., Ltd. romanized
2022/01/18New drug · Class 1 DAJH-1050766片 · No verified English nameCXHL2200031 Chengdu Di Ao Jiu Hong Pharmaceutical Factory romanized
2022/01/18New drug · Class 1 DAJH-1050766片 · No verified English nameCXHL2200030 Chengdu Di Ao Jiu Hong Pharmaceutical Factory romanized
2022/01/18New drug · Class 2.4 优替德隆注射液 · No verified English nameCXHL2200029 Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized
2022/01/18New drug · Class 2.4 优替德隆注射液 · No verified English nameCXHL2200028 Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized
2022/01/18New drug · Class 1 TQB3915片 · No verified English nameCXHL2200027 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2022/01/18New drug · Class 1 TQB3915片 · No verified English nameCXHL2200026 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2022/01/18New drug · Class 2.2 利培酮口溶膜 · No verified English nameCXHL2200015 Qilu Pharmaceutical Co., Ltd.
2022/01/18New drug · Class 2.2 利培酮口溶膜 · No verified English nameCXHL2200014 Qilu Pharmaceutical Co., Ltd.
2022/01/17Import · Class 1 VAY736注射液 · No verified English nameJXSL2200007 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/01/17Import · Class 1 RO7191863注射液 · No verified English nameJXHL2200020 F. Hoffmann-La Roche Ltd.; Roche R & D Center (China) Ltd.
2022/01/17Import · Class 1 RO7445482注射液 · No verified English nameJXHL2200019 F. Hoffmann-La Roche Ltd.; Roche R & D Center (China) Ltd.
2022/01/17Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2200101 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2022/01/17Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2200100 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2022/01/17Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2200099 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/01/17Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2200098 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/01/17Generic · Class 3 Terbutaline Sulfate InjectionCYHS2200096 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2022/01/17Generic · Class 3 Terbutaline Sulfate InjectionCYHS2200095 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2022/01/17New drug · Class 3.1 苓桂术甘颗粒 · No verified English nameCXZS2200002 Jiangsu Kang Yuan Pharma Co., Ltd. romanized

50 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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