YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 243 drug applications between 12 May 2021 and 18 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 42, covering 25 drug names.

2021/05/12 – 2021/05/18

Period
2021/05/12 to 2021/05/18, 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
243
Drugs with new generic filings (by drug name, de-duplicated)
25
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

243filings, 42 of them generic

By application type

Application typeFilings
Supplement110
New drug51
Generic42
Import30
Unspecified6
Import re-registration4

By drug type

Drug typeFilings
Chemical drug174
Therapeutic biologic43
TCM18
Prophylactic biologic5
In vitro diagnostic reagent2
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

25 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets4323
2Propofol Medium And Long Chain Fat Emulsion Injection313
3Clindamycin Injection314
4Brexpiprazole Tablets3131
5阿普斯特片 · No verified English name310
6Parecoxib Sodium for Injection222
7Ambroxol Hydrochloride Injection229
8Osimertinib Mesylate Tablets212
9硫酸特布他林雾化吸入用溶液 · No verified English name211
10Oseltamivir Phosphate Capsules2139

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

138 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
3Takeda Development Center Americas Inc.620
4Novartis Pharma AG520
5Xian Li Bang Pharmaceutical Co., Ltd. romanized523
6Qilu Pharmaceutical Co., Ltd.520
7Shanghai Pharmaceuticals Group Co., Ltd. romanized420
8Shandong Luo Xin Pharma Group 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

91 this week

AcceptedDrugApplicants
2021/05/18Import · Class 3.1 注射用戈沙妥组单抗 · No verified English nameJXSS2101007 Immunomedics Inc.; BSP Pharmaceuticals S.p.A.; Everest Medicines (Suzhou) Inc.
2021/05/18Import · Class 1 MK-1026片 · No verified English nameJXHL2101041 Merck Sharp & Dohme Corp.,a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/05/18Import · Class 1 MK-1026片 · No verified English nameJXHL2101040 Merck Sharp & Dohme Corp.,a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/05/18Generic · Class 3 Succinylcholine Chloride InjectionCYHS2101170 Nanjing Jian You Sheng Hua Pharmaceutical Co., Ltd. romanized
2021/05/18Generic · Class 3 奥美拉唑碳酸氢钠干混悬剂(Ⅰ) · No verified English nameCYHS2101169 Ji Ning Hua Neng Pharmaceutical Factory Co., Ltd. romanized
2021/05/18Generic · Class 3 Chlorphenamine Maleate InjectionCYHS2101157 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2021/05/18Generic · Class 3 阿普斯特片 · No verified English nameCYHS2101156 Hua Run Shuang He Pharma Co., Ltd. romanized; Nanjing Hai Jing Pharma Co., Ltd. romanized
2021/05/18Generic · Class 3 阿普斯特片 · No verified English nameCYHS2101155 Hua Run Shuang He Pharma Co., Ltd. romanized; Nanjing Hai Jing Pharma Co., Ltd. romanized
2021/05/18Generic · Class 3 阿普斯特片 · No verified English nameCYHS2101154 Hua Run Shuang He Pharma Co., Ltd. romanized; Nanjing Hai Jing Pharma Co., Ltd. romanized
2021/05/18New drug · Class 1.1 理中消痞颗粒 · No verified English nameCXZL2101008 Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized
2021/05/18New drug 人类免疫缺陷病毒抗原抗体诊断试剂盒(酶联免疫法) · No verified English nameCXSS2101002 Shanghai Ke Hua Bio Gong Cheng Co., Ltd. romanized
2021/05/18New drug · Class 1 SI-B001双特异性抗体注射液 · No verified English nameCXSL2101084 Sichuan Bai Li Pharma Co., Ltd. romanized
2021/05/18New drug · Class 3.3 注射用重组抗IgE人源化单克隆抗体 · No verified English nameCXSL2101079 Shanghai Xie Sheng Pharmaceuticals Technology Co., Ltd. romanized
2021/05/18New drug · Class 2.3 青蒿素硫酸羟氯喹片 · No verified English nameCXHL2101121 Guangdong Xin Nan Fang Qing Hao Pharma Co., Ltd. romanized; Guangzhou Zhong Pharmaceuticals University Technology Industry Yuan Co., Ltd. romanized
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

61 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.