YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 338 drug applications between 17 December 2021 and 23 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 59, covering 40 drug names.

2021/12/17 – 2021/12/23

Period
2021/12/17 to 2021/12/23, 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
338
Drugs with new generic filings (by drug name, de-duplicated)
40
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

338filings, 59 of them generic

By application type

Application typeFilings
Supplement163
New drug76
Generic59
Unspecified14
Import13
Import re-registration13

By drug type

Drug typeFilings
Chemical drug233
Therapeutic biologic69
TCM28
In vitro diagnostic reagent4
Biologic2
Prophylactic biologic2

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

40 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Febuxostat Tablets5312
2Valsartan and Amlodipine Tablets(I)222
3Sodium Valproate Concentrated Solution for Injection210
4Nintedanib Esilate Soft Capsules216
5Eplerenone Tablets214
6Ipratropium Bromide Inhalation Solution212
7Elagolix Tablets212
8Ozagrel Sodium Injection213
9Tegafur,Gimeracil and Oteracil Potassium Capsules210
10Gemcitabine Hydrochloride for Injection211

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

189 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Anhui Shuang He Pharma Co., Ltd. romanized1230
2Boehringer Ingelheim International GmbH720
3Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized660
4Novo Nordisk A/S620
5Lv Shi Zi (Zhongguo) Bio Zhi Pin Co., Ltd. romanized620
6Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized610
7Pfizer Europe MA EEIG540
8Qilu Pharmaceutical (Hainan) Co., Ltd535
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized520
10Suzhou Hua Yi Mei Bio Technology Co., Ltd. romanized440

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

109 this week

AcceptedDrugApplicants
2021/12/23Import · Class 1 IMG-020注射液 · No verified English nameJXSL2101150 Affibody AB; Inmagene Biopharmaceuticals (Wuhan) Co. Ltd.
2021/12/23Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2102264 Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized
2021/12/23Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2102263 Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized
2021/12/23Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2102261 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2021/12/23Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2102258 Beijing Xin Mei Tai Ke Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Tian Rui Pharma Co., Ltd. romanized
2021/12/23Generic · Class 3 奥美拉唑碳酸氢钠胶囊(II) · No verified English nameCYHS2102257 Beijing Bai Ao Pharma Co., Ltd. romanized
2021/12/23Generic · Class 3 Compound Sulfamethoxazole TabletsCYHS2102256 Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized
2021/12/23Generic · Class 3 Biapenem For InjectionCYHS2102250 Shenzhen Shi Hai Bin Pharmaceutical Co., Ltd. romanized
2021/12/23Generic · Class 3 Formoterol Fumarate Inhalation SolutionCYHS2102232 Health Yuan Pharma Group Co., Ltd. romanized; Shenzhen Tai Tai Pharma Co., Ltd. romanized
2021/12/23New drug · Class 1 注射用重组人凝血因子Ⅷ-Fc融合蛋白 · No verified English nameCXSS2101084 Jiangsu Cheng Si Biopharmaceutical Co., Ltd. romanized; Ao Si Kang Bio (Nan Tong) Co., Ltd. romanized
2021/12/23New drug · Class 1 注射用重组人凝血因子Ⅷ-Fc融合蛋白 · No verified English nameCXSS2101083 Jiangsu Cheng Si Biopharmaceutical Co., Ltd. romanized; Ao Si Kang Bio (Nan Tong) Co., Ltd. romanized
2021/12/23New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSS2101072 Kang Ning Jie Rui (Jilin) Bio Technology Co., Ltd. romanized
2021/12/23New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSS2101071 Kang Ning Jie Rui (Jilin) Bio Technology Co., Ltd. romanized
2021/12/23New drug · Class 2.1 JS001sc注射液 · No verified English nameCXSL2101506 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/12/23New drug · Class 2.4 注射用BAT4306F · No verified English nameCXSL2101504 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2021/12/23New drug · Class 2.3 LJ01003 · No verified English nameCXHL2101806 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized
2021/12/23New drug · Class 2.3 LJ01003 · No verified English nameCXHL2101805 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized
2021/12/23New drug · Class 1 HTMC0435片 · No verified English nameCXHL2101804 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2021/12/23New drug · Class 1 HTMC0435片 · No verified English nameCXHL2101803 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2021/12/23New drug · Class 1 HTMC0435片 · No verified English nameCXHL2101802 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2021/12/23New drug · Class 2.2 BCM332缓释片 · No verified English nameCXHL2101801 Shanghai Bo Zhi Yan Xin Drug Technology Co., Ltd. romanized
2021/12/23New drug · Class 1 JK0002乳膏 · No verified English nameCXHL2101800 Shenzhen Jia Ke Bio Technology Co., Ltd. romanized
2021/12/23New drug · Class 1 JK0002乳膏 · No verified English nameCXHL2101799 Shenzhen Jia Ke Bio Technology Co., Ltd. romanized
2021/12/23New drug · Class 1 JK0002乳膏 · No verified English nameCXHL2101798 Shenzhen Jia Ke Bio Technology Co., Ltd. romanized
2021/12/23New drug · Class 2.2 盐酸帕洛诺司琼口颊膜 · No verified English nameCXHL2101787 Li Pin Pharma (Xiamen) Co., Ltd. romanized
2021/12/23New drug · Class 2.2 盐酸帕洛诺司琼口颊膜 · No verified English nameCXHL2101786 Li Pin Pharma (Xiamen) Co., Ltd. romanized
2021/12/22Import · Class 2.2 注射用Loncastuximab tesirine · No verified English nameJXSL2101149 ADC Therapeutics SA; Overland Pharmaceuticals (Shanghai) Co. Ltd.
2021/12/22Import · Class 1 Nipocalimab注射液 · No verified English nameJXSL2101148 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2021/12/22Import · Class 2.4 Ruxolitinib Phosphate TabletsJXHL2101281 Novartis Pharma Schweiz AG; China Novartis Institutes for BioMedical Research Co. Ltd
2021/12/22Import · Class 1 LTT462胶囊 · No verified English nameJXHL2101280 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.

79 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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