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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 223 drug applications between 9 May 2021 and 15 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 26, covering 18 drug names.

2021/05/09 – 2021/05/15

Period
2021/05/09 to 2021/05/15, 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
223
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

223filings, 26 of them generic

By application type

Application typeFilings
Supplement114
New drug44
Import28
Generic26
Import re-registration7
Unspecified4

By drug type

Drug typeFilings
Chemical drug155
Therapeutic biologic42
TCM19
Prophylactic biologic6
In vitro diagnostic reagent1

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
1Tadalafil Tablets3223
2Clindamycin Injection314
3Osimertinib Mesylate Tablets212
4硫酸特布他林雾化吸入用溶液 · No verified English name211
5Oseltamivir Phosphate Capsules2139
6Valsartan Film-Coated Tablets210
7Salbutamol Sulfate Inhalation Solution112
8地氯雷他定口服溶液 · No verified English name1126
9Olmesartan Medoxomil and Amlodipine Besylate Tablets112
10Batroxobin Injection110

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

115 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. romanized12110
3Qilu Pharmaceutical Co., Ltd.630
4Takeda Development Center Americas Inc.620
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
6Novartis Pharma AG520
7AstraZeneca AB430
8Takeda Pharma A/S420
9Shanghai Pharmaceuticals Group Co., Ltd. romanized420
10HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.420

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

78 this week

AcceptedDrugApplicants
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.
2021/05/14New drug · Class 2.2 痘苗病毒致炎兔皮提取物注射液 · No verified English nameCXSL2101064 Wei Shi Pharma (Ru Gao) Co., Ltd. romanized
2021/05/14New drug · Class 2.2 痘苗病毒致炎兔皮提取物注射液 · No verified English nameCXSL2101063 Wei Shi Pharma (Ru Gao) Co., Ltd. romanized
2021/05/14New drug · Class 2.2 痘苗病毒致炎兔皮提取物注射液 · No verified English nameCXSL2101062 Wei Shi Pharma (Ru Gao) Co., Ltd. romanized
2021/05/14New drug · Class 2.2 痘苗病毒致炎兔皮提取物注射液 · No verified English nameCXSL2101061 Wei Shi Pharma (Ru Gao) Co., Ltd. romanized
2021/05/14New drug · Class 1 6MW3211 注射液 · No verified English nameCXSL2101058 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2021/05/14New drug · Class 1 注射用TQB2825 · No verified English nameCXSL2101054 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2021/05/14New drug · Class 2.2 波生坦口崩片 · No verified English nameCXHL2101127 Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized
2021/05/14New drug · Class 2.2 波生坦口崩片 · No verified English nameCXHL2101126 Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized
2021/05/14New drug · Class 2.3 NHKC-1 · No verified English nameCXHL2101125 Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized
2021/05/14New drug · Class 2.3 NHKC-1 · No verified English nameCXHL2101124 Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized
2021/05/14New drug · Class 1 BT-101094胶囊 · No verified English nameCXHL2101123 Chengdu Hai Bo Rui Pharma Co., Ltd. romanized
2021/05/14New drug · Class 1 BT-101094胶囊 · No verified English nameCXHL2101122 Chengdu Hai Bo Rui Pharma Co., Ltd. romanized
2021/05/13Import · Class 1 巴替利单抗注射液 · No verified English nameJXSL2101016 Agenus Inc.; Betta Pharmaceuticals Co. Ltd.

48 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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