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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 266 drug applications between 31 August 2021 and 6 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 26, covering 18 drug names.

2021/08/31 – 2021/09/06

Period
2021/08/31 to 2021/09/06, 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
266
Drugs with new generic filings (by drug name, de-duplicated)
18
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

266filings, 26 of them generic

By application type

Application typeFilings
Supplement172
New drug42
Generic26
Import12
Unspecified11
Import re-registration3

By drug type

Drug typeFilings
Chemical drug134
TCM96
Therapeutic biologic35
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

18 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Atomoxetine Hydrochloride Oral Solution220
2Oseltamivir Phosphate Capsules2239
3Nintedanib Esilate Soft Capsules216
4Tadalafil Tablets2123
5Pregabalin Capsules2112
6Latamoxef Sodium for Injection211
7Pramipexole Dihydrochloride Prolonged-release Tablets210
8Febuxostat Tablets2112
9Bromhexine Hydrochloride Solution For Inhalation111
10头孢地尼颗粒 · No verified English name113

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

117 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Ye Zhen Tang Pharma Co., Ltd. romanized39390
2Qin Huang Dao Da En Pharma Co., Ltd. romanized29290
3Gansu Fu Ge Zang Yao Co., Ltd. romanized16160
4Dr. Falk Pharma GmbH830
5Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized660
6AstraZeneca Pharmaceuticals LP510
7Novartis Europharm Limited420
8Jiangsu Hai Hong Pharmaceutical Co., Ltd. romanized410
9Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized410
10Guo Yao Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd. romanized321

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

51 this week

AcceptedDrugApplicants
2021/09/06Generic · Class 3 头孢地尼颗粒 · No verified English nameCYHS2101687 Guo Yao Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd. romanized
2021/09/06New drug · Class 1.3 马甲子叶 · No verified English nameCXZL2101026 Sichuan Sheng Zhong Pharmaceuticals Ke College (Sichuan Sheng Zhong Yao Research Institute) romanized
2021/09/06New drug · Class 1.3 马甲子胶囊 · No verified English nameCXZL2101025 Sichuan Sheng Zhong Pharmaceuticals Ke College (Sichuan Sheng Zhong Yao Research Institute) romanized
2021/09/06New drug · Class 3.3 地舒单抗注射液 · No verified English nameCXSS2101027 Qilu Pharmaceutical Co., Ltd.
2021/09/06New drug · Class 1 舒格利单抗注射液 · No verified English nameCXSS2101026 Ji Shi Pharma (Suzhou) Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized
2021/09/06New drug · Class 1 重组抗CD20人源化单克隆抗体注射液 · No verified English nameCXSL2101308 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2021/09/06New drug · Class 1 ASC42片 · No verified English nameCXHL2101456 Gan Lai Pharmaceutical Co., Ltd. romanized
2021/09/06New drug · Class 1 ASC42片 · No verified English nameCXHL2101455 Gan Lai Pharmaceutical Co., Ltd. romanized
2021/09/06New drug · Class 1 TR64片 · No verified English nameCXHL2101450 Anhui Zhong Ke Tuo Ran Drug Ke Xue Research Co., Ltd. romanized
2021/09/03New drug · Class 3.3 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2101307 Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized
2021/09/03New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101304 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/03New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101303 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/03New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101302 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/03New drug · Class 1 TQB2916注射液 · No verified English nameCXSL2101299 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2021/09/03New drug · Class 2.2 小儿头孢呋辛酯干混悬剂(微球型) · No verified English nameCXHL2101454 Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized
2021/09/02Import · Class 2.2 Anifrolumab注射液 · No verified English nameJXSL2101106 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2021/09/02New drug · Class 3.3 利拉鲁肽注射液 · No verified English nameCXSS2101025 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized; Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2021/09/02New drug · Class 3.3 利拉鲁肽注射液 · No verified English nameCXSS2101024 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized; Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2021/09/02New drug · Class 1 TC-E202注射液 · No verified English nameCXSL2101306 Guangdong Tian Ke Ya Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/02New drug · Class 1 K1注射液 · No verified English nameCXSL2101305 Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized
2021/09/02New drug · Class 3.2 人凝血因子Ⅷ/血管性血友病因子复合物 · No verified English nameCXSL2101301 Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized
2021/09/02New drug · Class 3.2 人凝血因子Ⅷ/血管性血友病因子复合物 · No verified English nameCXSL2101300 Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized
2021/09/02New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2101296 Shanghai Lai Fu Medical Technology Co., Ltd. romanized
2021/09/02New drug · Class 1 H018片 · No verified English nameCXHL2101453 Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized
2021/09/02New drug · Class 1 HMPL-653胶囊 · No verified English nameCXHL2101452 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2021/09/02New drug · Class 1 HMPL-653胶囊 · No verified English nameCXHL2101451 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2021/09/02New drug · Class 1 AB-106胶囊 · No verified English nameCXHL2101449 Bao Yuan Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2021/09/01Generic · Class 3 Fudosteine oral solutionCYHS2101672 Suzhou Hua Jian Rui Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2021/09/01Generic · Class 3 Latamoxef Sodium for InjectionCYHS2101669 Chongqing Ji Si Rui Pharmaceutical Co., Ltd. romanized
2021/09/01Generic · Class 3 Latamoxef Sodium for InjectionCYHS2101668 Chongqing Ji Si Rui Pharmaceutical Co., Ltd. romanized

21 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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