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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 298 drug applications between 26 July 2022 and 1 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 45 drug names.

2022/07/26 – 2022/08/01

Period
2022/07/26 to 2022/08/01, 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
298
Drugs with new generic filings (by drug name, de-duplicated)
45
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

298filings, 63 of them generic

By application type

Application typeFilings
Supplement178
Generic63
New drug32
Import14
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug211
TCM56
Therapeutic biologic25
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

45 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Urapidil Hydrochloride Injection426
2Galantamine Hydrobromide Orally Disintegrating Tablets310
3二甲双胍恩格列净片(Ⅰ) · No verified English name227
4Olopatadine Hydrochloride Eye Drops2213
5Nifuratel And Nystatin Vaginal Soft Capsules222
6Propofol Medium And Long Chain Fat Emulsion Injection213
7Paracetamol Suppositories210
8Ibuprofen Injection218
9Empagliflozin Tablets2118
10Trifluridine and Tipiracil Hydrochloride Tablets210

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

153 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Dong Ling Pharma Technology (Liaoning) Co., Ltd. romanized37360
2Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized22160
3Lanzhou Fu Ci (Rui Nuo Xin) Pharma Co., Ltd. romanized990
4Hebei Wu Luo Pharma Co., Ltd. romanized970
5Jilin Te Yan Pharma Co., Ltd. romanized770
6Qilu Pharmaceutical Co., Ltd.553
7AstraZeneca UK Limited410
8Boehringer Ingelheim International GmbH410
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

66 this week

AcceptedDrugApplicants
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
2022/07/29Generic · Class 3 维生素B12滴眼液 · No verified English nameCYHS2201153 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2022/07/29New drug · Class 1 TUL01101软膏 · No verified English nameCXHL2200544 Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized
2022/07/29New drug · Class 1 TUL01101软膏 · No verified English nameCXHL2200543 Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized
2022/07/29New drug · Class 1 TUL01101软膏 · No verified English nameCXHL2200542 Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized
2022/07/28Import · Class 3.1 ACYW群脑膜炎球菌多糖结合疫苗 · No verified English nameJXSL2200130 Sanofi Pasteur Inc.; Shenzhen Sanofi Pasteur Biological Products Co. Ltd.
2022/07/28Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2201160 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2022/07/28Generic · Class 3 Sodium cromoglicate solution for inhalationCYHS2201159 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2022/07/28New drug · Class 1 重组结核杆菌融合蛋白(EEC) · No verified English nameCXSL2200345 Chengdu Ke En Bio Technology Co., Ltd. romanized
2022/07/28New drug · Class 1 重组结核杆菌融合蛋白(EEC) · No verified English nameCXSL2200344 Chengdu Ke En Bio Technology Co., Ltd. romanized
2022/07/28New drug · Class 1 重组结核杆菌融合蛋白(EEC) · No verified English nameCXSL2200343 Chengdu Ke En Bio Technology Co., Ltd. romanized
2022/07/28New drug · Class 2.2 冻干人用狂犬病疫苗(无血清Vero细胞) · No verified English nameCXSL2200342 Ningbo Rong An Bio Pharma Co., Ltd. romanized
2022/07/28New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2200341 Shanghai Quan Sheng Bio Technology Co., Ltd. romanized

36 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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