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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 300 drug applications between 13 January 2022 and 19 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 42 drug names.

2022/01/13 – 2022/01/19

Period
2022/01/13 to 2022/01/19, 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
300
Drugs with new generic filings (by drug name, de-duplicated)
42
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

300filings, 58 of them generic

By application type

Application typeFilings
Supplement168
Generic58
New drug37
Import17
Import re-registration14
Unspecified6

By drug type

Drug typeFilings
Chemical drug238
Therapeutic biologic33
TCM23
Prophylactic biologic5
In vitro diagnostic reagent1

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

42 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Memantine Hydrochloride Sustained-release Capsules412
2阿普米司特片 · No verified English name313
3Rivaroxaban Tablets223
4Atomoxetine Hydrochloride Oral Solution220
5Diclofenac Sodium Sustained Release Tablets2110
6吸入用七氟烷 · No verified English name210
7Empagliflozin Tablets2118
8Parecoxib Sodium for Injection212
9Neostigmine Methylsulfate Injection214
10Edoxaban Tosilate Tablets219

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

176 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Rui Ze Pharma Co., Ltd. romanized22210
2Guangxi Kun Ze Pharma Co., Ltd. romanized1220
3Bayer Vital GmbH920
4Hainan Tong Yong San Yang Pharma Co., Ltd. romanized510
5Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized510
6LES LABORATOIRES SERVIER430
7Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc420
8AstraZeneca AB410
9Janssen Pharmaceuticals Inc.410
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

66 this week

AcceptedDrugApplicants
2022/01/19Import · Class 3.4 达雷妥尤单抗注射液(皮下注射) · No verified English nameJXSL2200010 Janssen Research & Development LLC; Johnson &Johnson(China)Investment Ltd.
2022/01/19Import · Class 1 MBG453 · No verified English nameJXSL2200009 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/01/19Import · Class 1 NIS793 · No verified English nameJXSL2200008 Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd
2022/01/19Import · Class 1 Pritelivir薄膜包衣片 · No verified English nameJXHL2200021 AiCuris Anti-infective Cures AG; Beijing Medpace Co.Ltd
2022/01/19New drug · Class 1 阿得贝利单抗注射液 · No verified English nameCXSS2200006 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized; Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2022/01/19New drug · Class 1 注射用BC004 · No verified English nameCXSL2200026 Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized
2022/01/19New drug · Class 1 注射用KL031322 · No verified English nameCXHL2200033 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
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.

36 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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