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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 284 drug applications between 27 July 2022 and 2 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 48 drug names.

2022/07/27 – 2022/08/02

Period
2022/07/27 to 2022/08/02, 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
284
Drugs with new generic filings (by drug name, de-duplicated)
48
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

284filings, 69 of them generic

By application type

Application typeFilings
Supplement161
Generic69
New drug25
Import18
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug211
TCM44
Therapeutic biologic23
Prophylactic biologic4
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

48 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Urapidil Hydrochloride Injection426
2硫酸特布他林雾化吸入用溶液 · No verified English name321
3Galantamine Hydrobromide Orally Disintegrating Tablets310
4二甲双胍恩格列净片(Ⅰ) · No verified English name227
5Sildenafil Citrate Oral Disintegrating Tablets228
6Bortezomib For Injection221
7Olopatadine Hydrochloride Eye Drops2213
8Nifuratel And Nystatin Vaginal Soft Capsules222
9Propofol Medium And Long Chain Fat Emulsion Injection213
10Paracetamol Suppositories210

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

151 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Dong Ling Pharma Technology (Liaoning) Co., Ltd. romanized47460
2Hebei Wu Luo Pharma Co., Ltd. romanized970
3Novartis Pharma AG950
4Jilin Te Yan Pharma Co., Ltd. romanized770
5Qilu Pharmaceutical Co., Ltd.664
6Hainan Tao Sheng Pharmaceuticals Technology Research Institute Co., Ltd. romanized530
7Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized424
8Hetero Labs Limited410
9Le Tai Pharma Co., Ltd. romanized330
10Zhu Zhou Qian Jin Pharma Co., Ltd. romanized330

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

58 this week

AcceptedDrugApplicants
2022/08/02Import · Class 1 JDQ443片 · No verified English nameJXHL2200225 Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd
2022/08/02Import · Class 1 JDQ443片 · No verified English nameJXHL2200224 Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd
2022/08/02Import · Class 1 TNO155 片 · No verified English nameJXHL2200223 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/08/02Import · Class 1 TNO155 胶囊 · No verified English nameJXHL2200222 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/08/02Import · Class 1 TNO155 胶囊 · No verified English nameJXHL2200221 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/08/02Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2201211 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/08/02Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2201210 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/08/02Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2201202 Hangzhou Yun Bai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/08/02Generic · Class 3 Pentoxifylline InjectionCYHS2201188 Guangdong Jun Kang Pharma Co., Ltd. romanized; Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2022/08/02New drug · Class 1 DS003冻干粉针 · No verified English nameCXSL2200349 Da Shi Pharma (Guangdong) Co., Ltd. romanized
2022/08/02New drug · Class 1 LM49片 · No verified English nameCXHL2200548 Shanxi Zhong Pharmaceuticals University romanized; Shanxi Yi Ke University romanized
2022/08/02New drug · Class 1 RAB001注射液 · No verified English nameCXHL2200547 Zhong Shan Lai Bo Rui Chen Biopharmaceuticals Co., Ltd. romanized
2022/08/01Import · Class 1 BI 1015550 片 · No verified English nameJXHL2200219 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/08/01Import · Class 1 BI 1015550 片 · No verified English nameJXHL2200218 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/08/01Generic · Class 3 Diazoxide Oral SuspensionCYHS2201199 Su Zhou Yi Fan Pharma Co., Ltd. romanized
2022/08/01Generic · Class 3 Paracetamol SuppositoriesCYHS2201185 Zhejiang Er Ying Medicines Co., Ltd. romanized; Zhejiang Jian Feng Pharma Co., Ltd. romanized
2022/08/01Generic · Class 3 Paracetamol SuppositoriesCYHS2201184 Zhejiang Er Ying Medicines Co., Ltd. romanized; Zhejiang Jian Feng Pharma Co., Ltd. romanized
2022/08/01Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2201181 Hangzhou Yun Bai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/08/01Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2201180 Hangzhou Yun Bai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/08/01New drug · Class 3.3 精蛋白锌赖脯胰岛素混合注射液(50R) · No verified English nameCXSS2200071 Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized
2022/08/01New drug · Class 3.3 精蛋白锌赖脯胰岛素混合注射液(25R) · No verified English nameCXSS2200070 Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized
2022/08/01New drug · Class 1 普那利单抗注射液 · No verified English nameCXSL2200348 Tian Jing Bio Technology (Hangzhou) Co., Ltd. romanized
2022/08/01New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2200347 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2022/08/01New drug · Class 1 HEC138671片 · No verified English nameCXHL2200546 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2022/08/01New drug · Class 1 HEC138671片 · No verified English nameCXHL2200545 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2022/07/29Import · Class 3.1 注射用艾夫糖苷酶α · No verified English nameJXSS2200029 Genzyme Corporation; Genzyme Ireland Limited; Sanofi (China) Investment Co. Ltd.
2022/07/29Import · Class 3.1 人轮状病毒减毒活疫苗 · No verified English nameJXSL2200131 GlaxoSmithKline Biologicals S.A.
2022/07/29Generic · Class 3 Ozagrel Sodium InjectionCYHS2201170 Beijing Liu Huan Pharma Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2022/07/29Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2201169 Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized; Kui Hua Pharma Group (Ji Zhou) Co., Ltd. romanized
2022/07/29Generic · Class 3 Mesalazine Enteric-coated TabletsCYHS2201167 Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized

28 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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