YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 222 drug applications between 11 May 2021 and 17 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 31, covering 19 drug names.

2021/05/11 – 2021/05/17

Period
2021/05/11 to 2021/05/17, 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
222
Drugs with new generic filings (by drug name, de-duplicated)
19
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

222filings, 31 of them generic

By application type

Application typeFilings
Supplement111
New drug50
Generic31
Import24
Import re-registration4
Unspecified2

By drug type

Drug typeFilings
Chemical drug156
Therapeutic biologic43
TCM16
Prophylactic biologic5
In vitro diagnostic reagent1
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

19 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets4323
2Clindamycin Injection314
3Brexpiprazole Tablets3131
4Parecoxib Sodium for Injection222
5Osimertinib Mesylate Tablets212
6硫酸特布他林雾化吸入用溶液 · No verified English name211
7Oseltamivir Phosphate Capsules2139
8Valsartan Film-Coated Tablets210
9Salbutamol Sulfate Inhalation Solution112
10地氯雷他定口服溶液 · No verified English name1126

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
1Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.15100
2Nei Menggu Tian Qi Zhong Meng Pharmaceutical Co., Ltd. romanized870
3Qilu Pharmaceutical Co., Ltd.630
4Takeda Development Center Americas Inc.620
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
6Novartis Pharma AG520
7Shanghai Pharmaceuticals Group Co., Ltd. romanized420
8Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized420
9LTL Pharma Co. Ltd.410
10Wei Shi Pharma (Ru Gao) Co., Ltd. romanized410

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

82 this week

AcceptedDrugApplicants
2021/05/17Generic · Class 3 Brexpiprazole TabletsCYHS2101163 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2021/05/17Generic · Class 3 Brexpiprazole TabletsCYHS2101162 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2021/05/17Generic · Class 3 Brexpiprazole TabletsCYHS2101161 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2021/05/17New drug · Class 3.2 四价流感病毒裂解疫苗 · No verified English nameCXSS2101001 Hua Lan Bio Yi Miao Co., Ltd. romanized
2021/05/17New drug · Class 1 BBM-H901注射液 · No verified English nameCXSL2101082 Shanghai Xin Zhi Pharmaceuticals Technology Co., Ltd. romanized
2021/05/17New drug · Class 1 SHR-1906注射液 · No verified English nameCXSL2101081 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/05/17New drug · Class 1 SHR-1906注射液 · No verified English nameCXSL2101080 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/05/17New drug · Class 1 林普利司片 · No verified English nameCXHS2101013 Shanghai Ying Li Pharma Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2021/05/17New drug · Class 1 HRS2398片 · No verified English nameCXHL2101132 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/05/17New drug · Class 1 HRS2398片 · No verified English nameCXHL2101131 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/05/17New drug · Class 1 WXWH0240片 · No verified English nameCXHL2101130 CISEN PHARMACEUTICAL CO., LTD.
2021/05/17New drug · Class 1 WXWH0240片 · No verified English nameCXHL2101129 CISEN PHARMACEUTICAL CO., LTD.
2021/05/17New drug · Class 1 WXWH0240片 · No verified English nameCXHL2101128 CISEN PHARMACEUTICAL CO., LTD.
2021/05/14Import · Class 1 Relatlimab/Nivolumab固定剂量复方注射液 · No verified English nameJXSL2101027 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2021/05/14Import · Class 2.2 注射用维得利珠单抗 · No verified English nameJXSL2101025 Takeda Development Center Americas Inc.
2021/05/14Import · Class 1 ZN-d5片 · No verified English nameJXHL2101039 Zentera Therapeutics HK Limited; Zentera Therapeutics Shanghai Co. Ltd
2021/05/14Import · Class 1 ZN-d5片 · No verified English nameJXHL2101038 Zentera Therapeutics HK Limited; Zentera Therapeutics Shanghai Co. Ltd
2021/05/14Import · Class 1 Cotadutide注射液 · No verified English nameJXHL2101037 AstraZeneca AB; AstraZeneca Investment (China)Co. Ltd.
2021/05/14Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2101158 Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized
2021/05/14Generic · Class 3 Tofacitinib Citrate Extended Release tabletsCYHS2101133 Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2021/05/14Generic · Class 3 Clindamycin InjectionCYHS2101129 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized
2021/05/14Generic · Class 3 Clindamycin InjectionCYHS2101128 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized
2021/05/14Generic · Class 3 Clindamycin InjectionCYHS2101127 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized
2021/05/14New drug · Class 1.2 重组带状疱疹疫苗(CHO 细胞) · No verified English nameCXSL2101078 Beijing Lv Zhu Bio Technology Co., Ltd. romanized
2021/05/14New drug · Class 1.2 重组带状疱疹疫苗(CHO 细胞) · No verified English nameCXSL2101077 Beijing Lv Zhu Bio Technology Co., Ltd. romanized
2021/05/14New drug · Class 1 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2101076 Tai Zhou Han Zhong Biopharmaceuticals Co., Ltd. romanized
2021/05/14New drug · Class 1 BR102注射液 · No verified English nameCXSL2101075 Hai Zheng Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized
2021/05/14New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSL2101074 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/05/14New drug · Class 2.2 IBI310 · No verified English nameCXSL2101073 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/05/14New drug · Class 1 注射用QLS31905 · No verified English nameCXSL2101072 Qilu Pharmaceutical Co., Ltd.

52 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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