YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 190 drug applications between 24 March 2021 and 30 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 8, covering 6 drug names.

2021/03/24 – 2021/03/30

Period
2021/03/24 to 2021/03/30, 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
190
Drugs with new generic filings (by drug name, de-duplicated)
6
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

190filings, 8 of them generic

By application type

Application typeFilings
Supplement106
New drug32
Import21
Import re-registration12
Unspecified11
Generic8

By drug type

Drug typeFilings
Chemical drug134
Therapeutic biologic32
TCM15
Prophylactic biologic8
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

6 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Celecoxib Capsules215
2酒石酸伐尼克兰片 · No verified English name213
3丙泊酚乳状注射液 · No verified English name113
4Tenofovir alafenamide Fumarate Tablets110
5Flurbiprofen Axetil Injection110
6特利加压素注射液 · No verified English name110

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

104 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hainan Sai Li Ke Pharma Co., Ltd. romanized11110
2Sichuan Kelun Pharmaceutical Co., Ltd.1140
3Fresenius Kabi Austria GmbH720
4Kyowa Kirin Co. Ltd.610
5Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized510
6Aurobindo Pharma Limited410
7Merck Europe B.V.410
8Sunovion Pharmaceuticals Inc.410
9Merck Sharp & Dohme Corp.320
10Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized320

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

47 this week

AcceptedDrugApplicants
2021/03/30Import · Class 1 Balixafortide · No verified English nameJXHL2100109 Polyphor Ltd
2021/03/30New drug · Class 1 AK104注射液 · No verified English nameCXSL2100109 Kang Fang Pharma Co., Ltd. romanized
2021/03/30New drug · Class 1 重组抗CD20人源化单克隆抗体注射液 · No verified English nameCXSL2100108 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2021/03/29Import · Class 2.4 BYL719 · No verified English nameJXHL2101001 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2021/03/29Import · Class 2.4 BYL719 · No verified English nameJXHL2101000 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2021/03/29New drug · Class 1 SH3765片 · No verified English nameCXHL2101015 Nanjing Hui Cheng Pharmaceutical Co., Ltd. romanized
2021/03/29New drug · Class 1 SH3765片 · No verified English nameCXHL2101014 Nanjing Hui Cheng Pharmaceutical Co., Ltd. romanized
2021/03/29New drug · Class 2.2 吡非尼酮双释片 · No verified English nameCXHL2101012 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized
2021/03/27New drug · Class 2.4 ZHB111注射液 · No verified English nameCXSL2100107 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2021/03/27New drug · Class 2.2 注射用西罗莫司(白蛋白结合型) · No verified English nameCXHL2101013 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2021/03/27New drug · Class 1 聚乙二醇化艾塞那肽注射液 · No verified English nameCXHL2100209 Pai Ge Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2021/03/26Generic · Class 3 Flurbiprofen Axetil InjectionCYHS2100294 YaoPharma Co., Ltd.
2021/03/26New drug · Class 2.2 注射用卡瑞利珠单抗 · No verified English nameCXSS2100032 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/03/26New drug · Class 2.2 注射用卡瑞利珠单抗 · No verified English nameCXSS2100031 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/03/26New drug · Class 1 Ociperlimab注射液 · No verified English nameCXSL2100106 Bai Ji Shen Zhou (Guangzhou) Bio Technology Co., Ltd. romanized
2021/03/26New drug · Class 1 GH35片 · No verified English nameCXHL2101011 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2021/03/26New drug · Class 1 GH35片 · No verified English nameCXHL2101010 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2021/03/26New drug · Class 2.3 磷酸盐血滤置换液 · No verified English nameCXHL2100208 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2021/03/26New drug · Class 2.3 磷酸盐血滤置换液(无钙) · No verified English nameCXHL2100207 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2021/03/26New drug · Class 1 XZP-5955 片 · No verified English nameCXHL2100206 Xuan Zhu Bio Technology Co., Ltd. romanized
2021/03/26New drug · Class 1 XZP-5955 片 · No verified English nameCXHL2100205 Xuan Zhu Bio Technology Co., Ltd. romanized
2021/03/26New drug · Class 1 XZP-5955 片 · No verified English nameCXHL2100204 Xuan Zhu Bio Technology Co., Ltd. romanized
2021/03/25Import · Class 1 Tiragolumab注射液 · No verified English nameJXSL2100042 F.Hoffmann-La Roche Ltd
2021/03/25Import · Class 1 SEP-363856片 · No verified English nameJXHL2100108 Sunovion Pharmaceuticals Inc.
2021/03/25Import · Class 1 SEP-363856片 · No verified English nameJXHL2100107 Sunovion Pharmaceuticals Inc.
2021/03/25Import · Class 1 SEP-363856片 · No verified English nameJXHL2100106 Sunovion Pharmaceuticals Inc.
2021/03/25Import · Class 1 SEP-363856片 · No verified English nameJXHL2100105 Sunovion Pharmaceuticals Inc.
2021/03/25Generic · Class 3 特利加压素注射液 · No verified English nameCYHS2100290 Shenzhen Shi Jian Xiang Biopharmaceutical Co., Ltd. romanized
2021/03/25New drug · Class 3.3 贝伐珠单抗注射液 · No verified English nameCXSL2100105 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2021/03/25New drug · Class 3.3 贝伐珠单抗注射液 · No verified English nameCXSL2100104 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized

17 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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