YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 131 drug applications between 18 June 2021 and 24 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 20, covering 14 drug names.

2021/06/18 – 2021/06/24

Period
2021/06/18 to 2021/06/24, 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
131
Drugs with new generic filings (by drug name, de-duplicated)
14
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

131filings, 20 of them generic

By application type

Application typeFilings
Supplement73
New drug22
Generic20
Import13
Import re-registration2
Unspecified1

By drug type

Drug typeFilings
Chemical drug96
Therapeutic biologic25
TCM9
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

14 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Celecoxib Capsules415
2Pregabalin Capsules2112
3Esomeprazole Sodium for Injection211
4Valsartan Film-Coated Tablets210
5Ornidazole Injection110
6Formoterol Fumarate Inhalation Solution115
7Tofacitinib Citrate Tablets111
8泊沙康唑注射液 · No verified English name111
9Metformin Hydrochloride Extended-release Tablets1110
10Nifedipine Extended-Release Tablets110

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

80 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1The Wellcome Foundation Limited720
2Qilu Pharmaceutical Co., Ltd.530
3IPSEN PHARMA510
4Haerbin Han Bang Medical Technology Co., Ltd. romanized510
5Hangzhou Sen Ze Pharmaceuticals Technology Co., Ltd. romanized440
6Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized414
7ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.333
8Janssen Research & Development LLC310
9Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized310
10Anhui Yu Heng Bio Technology Co., Ltd. romanized310

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

38 this week

AcceptedDrugApplicants
2021/06/22Import · Class 2.2 奥妥珠单抗注射液 · No verified English nameJXSL2101044 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2021/06/22Import · Class 2.2 注射用enfortumab vedotin · No verified English nameJXSL2101043 Astellas Pharma US Inc.; Astellas Pharma China Inc.
2021/06/22Import · Class 2.2 注射用enfortumab vedotin · No verified English nameJXSL2101042 Astellas Pharma US Inc.; Astellas Pharma China Inc.
2021/06/22Generic · Class 3 Aripiprazole Oral SolutionCYHS2101331 Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized
2021/06/22Generic · Class 3 Formoterol Fumarate Inhalation SolutionCYHS2101307 Jinan Jing Sheng Technology Co., Ltd. romanized; Wei Fang Zhong Shi Pharmaceutical Co., Ltd. romanized
2021/06/22New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101150 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/06/22New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101149 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/06/22New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101148 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/06/22New drug · Class 1 注射用重组人FGF21-Fc融合蛋白 · No verified English nameCXSL2101145 An Yuan Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2021/06/22New drug · Class 1 YK-2168注射液 · No verified English nameCXHL2101218 Nanjing Da Mei Biopharmaceutical Co., Ltd. romanized
2021/06/22New drug · Class 1 YK-2168注射液 · No verified English nameCXHL2101217 Nanjing Da Mei Biopharmaceutical Co., Ltd. romanized
2021/06/22New drug · Class 2.2 HLK-6002软膏 · No verified English nameCXHL2101213 Shenzhen Shi Yao Xin Bio Technology Co., Ltd. romanized
2021/06/22New drug · Class 2.2 HLK-6002软膏 · No verified English nameCXHL2101212 Shenzhen Shi Yao Xin Bio Technology Co., Ltd. romanized
2021/06/22New drug · Class 2.2 HLK-6002软膏 · No verified English nameCXHL2101211 Shenzhen Shi Yao Xin Bio Technology Co., Ltd. romanized
2021/06/21Import · Class 1 Palovarotene胶囊 · No verified English nameJXHL2101099 IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/06/21Import · Class 1 Palovarotene胶囊 · No verified English nameJXHL2101098 IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/06/21Import · Class 1 Palovarotene胶囊 · No verified English nameJXHL2101097 IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/06/21Import · Class 1 Palovarotene胶囊 · No verified English nameJXHL2101096 IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/06/21Import · Class 1 Palovarotene胶囊 · No verified English nameJXHL2101095 IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/06/21Import · Class 1 Afuresertib片 · No verified English nameJXHL2101094 Laekna Limited; Laekna Therapeutics Shanghai Co. Ltd.
2021/06/21Import · Class 1 Afuresertib片 · No verified English nameJXHL2101093 Laekna Limited; Laekna Therapeutics Shanghai Co. Ltd.
2021/06/21Import · Class 1 Etrasimod片 · No verified English nameJXHL2101082 Arena Pharmaceuticals Inc.; Everest Medicines (China) Co. Ltd
2021/06/21Import · Class 1 Etrasimod片 · No verified English nameJXHL2101081 Arena Pharmaceuticals Inc.; Everest Medicines (China) Co. Ltd
2021/06/21Generic · Class 3 Ornidazole InjectionCYHS2101322 Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Tong Hua Jin Ma Pharma Group Co., Ltd. romanized
2021/06/21New drug · Class 1 QX004N注射液 · No verified English nameCXSL2101142 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2021/06/21New drug · Class 1 BDB-001注射液 · No verified English nameCXSL2101141 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized; Beijing De Feng Rui Bio Technology Co., Ltd. romanized
2021/06/21New drug · Class 2.4 环泊酚注射液 · No verified English nameCXHS2101025 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2021/06/21New drug · Class 1 OB756片 · No verified English nameCXHL2101216 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2021/06/21New drug · Class 1 EN002凝胶 · No verified English nameCXHL2101215 En Kang Pharma Technology (Guangzhou) Co., Ltd. romanized
2021/06/21New drug · Class 1 EN002凝胶 · No verified English nameCXHL2101214 En Kang Pharma Technology (Guangzhou) Co., Ltd. romanized

8 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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