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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 242 drug applications between 21 February 2022 and 27 February 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 25 drug names.

2022/02/21 – 2022/02/27

Period
2022/02/21 to 2022/02/27, 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
242
Drugs with new generic filings (by drug name, de-duplicated)
25
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

242filings, 36 of them generic

By application type

Application typeFilings
Supplement137
Generic36
New drug30
Import re-registration20
Import13
Unspecified6

By drug type

Drug typeFilings
Chemical drug178
TCM38
Therapeutic biologic26

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

25 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Piracetam Injection319
2Ambroxol Hydrochloride Solution For Inhalation2210
3氧(液态) · No verified English name2213
4Rivastigmine transdermal system211
5注射用头孢呋辛钠/氯化钠注射液 · No verified English name215
6注射用头孢哌酮钠舒巴坦钠/氯化钠注射液 · No verified English name212
7Parecoxib Sodium for Injection212
8注射用阿莫西林钠克拉维酸钾(10:1) · No verified English name210
9Nitroglycerin Injection217
10Escitalopram Oxalate Tablets216

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

120 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bayer Vital GmbH1620
2Henan Nuo Mei Pharma Co., Ltd. romanized880
3Bai Ao Tai Biopharmaceutical Co., Ltd. romanized810
4Guangdong Xin Bao Pharma Technology Co., Ltd. romanized770
5Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized620
6Novo Nordisk A/S610
7Anhui Xian Gui Pharmaceuticals Technology Co., Ltd. romanized550
8Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized530
9Suzhou Rui Ming Xin Yao Research and Development Co., Ltd. romanized510
10Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized430

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
2022/02/25Import · Class 1 MK-1084片 · No verified English nameJXHL2200043 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2022/02/25Import · Class 1 MK-1084片 · No verified English nameJXHL2200042 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2022/02/25Import · Class 1 BAY 2927088片 · No verified English nameJXHL2200041 Bayer AG; Bayer Healthcare Company Ltd.
2022/02/25Import · Class 1 BAY 2927088片 · No verified English nameJXHL2200040 Bayer AG; Bayer Healthcare Company Ltd.
2022/02/25Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2200380 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2022/02/25Generic · Class 3 Nitroglycerin InjectionCYHS2200378 Qinghai Chen Fei Pharmaceutical Co., Ltd. romanized
2022/02/25Generic · Class 3 Nitroglycerin InjectionCYHS2200377 Qinghai Chen Fei Pharmaceutical Co., Ltd. romanized
2022/02/25Generic · Class 3 注射用阿莫西林钠克拉维酸钾(10:1) · No verified English nameCYHS2200376 Shenzhen Hua Run Jiu Xin Pharma Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2022/02/25Generic · Class 3 注射用阿莫西林钠克拉维酸钾(10:1) · No verified English nameCYHS2200375 Shenzhen Hua Run Jiu Xin Pharma Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2022/02/25Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2200374 Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2022/02/25Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2200373 Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2022/02/25Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2200371 Beijing Pin Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2022/02/25New drug · Class 1 艾贝格司亭α注射液 · No verified English nameCXSS2200018 Yi Yi Biopharmaceutical (Beijing) Co., Ltd. romanized
2022/02/25New drug · Class 1 斯鲁利单抗注射液 · No verified English nameCXSL2200105 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2022/02/25New drug · Class 1 HLX26单抗注射液 · No verified English nameCXSL2200104 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2022/02/25New drug · Class 1 GC301腺相关病毒注射液 · No verified English nameCXSL2200103 Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized
2022/02/25New drug · Class 1 谷美替尼片 · No verified English nameCXHS2200010 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2022/02/25New drug · Class 1 维卡格雷胶囊 · No verified English nameCXHL2200123 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2022/02/25New drug · Class 1 FCN-159片 · No verified English nameCXHL2200122 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
2022/02/25New drug · Class 1 FCN-159片 · No verified English nameCXHL2200121 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
2022/02/25New drug · Class 1 FCN-159片 · No verified English nameCXHL2200120 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
2022/02/23New drug · Class 1 GC301腺相关病毒注射液 · No verified English nameCXSL2200102 Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized
2022/02/23New drug · Class 2.2 注射用泰它西普 · No verified English nameCXSL2200101 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2022/02/23New drug · Class 2.2; 2.4 纳米炭铁混悬注射液 · No verified English nameCXHL2200119 Sichuan Ying Rui Pharmaceuticals Technology Co., Ltd. romanized
2022/02/23New drug · Class 1 JAB-6343胶囊 · No verified English nameCXHL2200118 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2022/02/23New drug · Class 1 JAB-6343胶囊 · No verified English nameCXHL2200117 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2022/02/23New drug · Class 1 HEC169096片 · No verified English nameCXHL2200111 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2022/02/23New drug · Class 1 HEC169096片 · No verified English nameCXHL2200110 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2022/02/23New drug · Class 1 HEC169096片 · No verified English nameCXHL2200109 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2022/02/21Import · Class 1 SAR443820 · No verified English nameJXHL2200039 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.

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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