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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 251 drug applications between 12 September 2022 and 18 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 39 drug names.

2022/09/12 – 2022/09/18

Period
2022/09/12 to 2022/09/18, 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
251
Drugs with new generic filings (by drug name, de-duplicated)
39
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

251filings, 53 of them generic

By application type

Application typeFilings
Supplement142
Generic53
New drug36
Unspecified7
Import7
Import re-registration6

By drug type

Drug typeFilings
Chemical drug183
TCM41
Therapeutic biologic27

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

39 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapagliflozin And Metformin Hydrochloride Extended-Release Tablets510
2Oseltamivir Phosphate For Oral Suspension322
3复方聚乙二醇电解质散(Ⅲ) · No verified English name221
4Nintedanib Esilate Soft Capsules216
5Indobufen Tablets216
6Tandospirone Citrate Tablets212
7Tranexamic Acid Injection2111
8Teicoplanin for Injection216
9Minoxidil Liniment2152
10Potassium Aspartate Injection213

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

147 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Jin Xing Industrial Co., Ltd. romanized1060
2Shandong Kong Sheng Tang Pharmaceutical Co., Ltd. romanized660
3Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized640
4Jiangxi Ke Rui Pharma Co., Ltd. romanized550
5Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized550
6Boehringer Ingelheim International GmbH510
7Sanofi -aventis France510
8Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized515
9Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized510
10Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical 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

68 this week

AcceptedDrugApplicants
2022/09/18New drug · Class 1 DZD9008片 · No verified English nameCXHL2200697 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2022/09/18New drug · Class 1 DZD9008片 · No verified English nameCXHL2200696 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2022/09/17Generic · Class 3 Indobufen TabletsCYHS2201555 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/09/17Generic · Class 3 Indobufen TabletsCYHS2201553 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/09/17New drug · Class 3.3 甘精胰岛素注射液 · No verified English nameCXSS2200079 Hefei Tian Mai Bio Technology Development Co., Ltd. romanized
2022/09/17New drug · Class 1 靶向 CD19 非病毒 PD1 定点整合 CAR-T 细胞注射液 · No verified English nameCXSL2200465 Shanghai Bang Yao Bio Technology Co., Ltd. romanized
2022/09/17New drug · Class 1 AP-306胶囊 · No verified English nameCXHL2200695 Shanghai Li Bang Pharmaceuticals Technology Co., Ltd. romanized
2022/09/17New drug · Class 1 AP-306胶囊 · No verified English nameCXHL2200694 Shanghai Li Bang Pharmaceuticals Technology Co., Ltd. romanized
2022/09/17New drug · Class 1 AR882胶囊 · No verified English nameCXHL2200693 Guangzhou Rui An Bo Pharmaceuticals Technology Co., Ltd. romanized
2022/09/17New drug · Class 1 AR882胶囊 · No verified English nameCXHL2200692 Guangzhou Rui An Bo Pharmaceuticals Technology Co., Ltd. romanized
2022/09/17New drug · Class 1 LNK01002胶囊 · No verified English nameCXHL2200691 Ling Ke Pharma (Hangzhou) Co., Ltd. romanized
2022/09/17New drug · Class 1 LNK01002胶囊 · No verified English nameCXHL2200690 Ling Ke Pharma (Hangzhou) Co., Ltd. romanized
2022/09/16Import · Class 1 DS-1062a · No verified English nameJXSL2200166 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2022/09/16Generic · Class 3 Piperacillin Sodium for InjectionCYHS2201550 Hainan Zhong Yue Medical Health Industry Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized
2022/09/16Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2201548 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2022/09/16Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2201547 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2022/09/16Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2201546 Zhejiang Pu Li Pharma Co., Ltd. romanized
2022/09/16Generic · Class 3 Dapagliflozin And Metformin Hydrochloride Extended-Release TabletsCYHS2201540 Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2022/09/16Generic · Class 3 Dapagliflozin And Metformin Hydrochloride Extended-Release TabletsCYHS2201539 Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2022/09/16Generic · Class 3 Dapagliflozin And Metformin Hydrochloride Extended-Release TabletsCYHS2201538 Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2022/09/16Generic · Class 3 Dapagliflozin And Metformin Hydrochloride Extended-Release TabletsCYHS2201537 Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2022/09/16Generic · Class 3 Dapagliflozin And Metformin Hydrochloride Extended-Release TabletsCYHS2201536 Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2022/09/16Generic · Class 3 Tranexamic Acid InjectionCYHS2201532 Yan Tai Lu Yin Pharma Co., Ltd. romanized
2022/09/16Generic · Class 3 Tranexamic Acid InjectionCYHS2201531 Yan Tai Lu Yin Pharma Co., Ltd. romanized
2022/09/16Generic · Class 3 Brivaracetam Solution for InjectionCYHL2200079 Jiangsu En Hua Pharma Co., Ltd. romanized
2022/09/16Generic · Class 3 Rupatadine Fumarate Oral SolutionCYHL2200078 Jiangsu Ai Li Kang Pharmaceuticals Technology Co., Ltd. romanized
2022/09/16New drug · Class 2.2 培集成干扰素α-2注射液 · No verified English nameCXSL2200464 Beijing Kai Yin Technology Co., Ltd. romanized
2022/09/16New drug · Class 3.3 达雷妥尤单抗注射液 · No verified English nameCXSL2200463 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2022/09/16New drug · Class 3.3 达雷妥尤单抗注射液 · No verified English nameCXSL2200462 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2022/09/16New drug · Class 1 舒非尼酮(SC1011)凝胶 · No verified English nameCXHL2200689 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized

38 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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