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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 363 drug applications between 1 July 2024 and 7 July 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 100, covering 73 drug names.

2024/07/01 – 2024/07/07

Period
2024/07/01 to 2024/07/07, 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
363
Drugs with new generic filings (by drug name, de-duplicated)
73
Accepted this week, now under review
5

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

363filings, 100 of them generic

By application type

Application typeFilings
Supplement182
Generic100
New drug36
Import23
Import re-registration14
Unspecified8

By drug type

Drug typeFilings
Chemical drug263
TCM48
Therapeutic biologic44
Prophylactic biologic8

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

73 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapoxetine Hydrochloride Tablets5320
2Epalrestat Tablets331
3Diquafosol Sodium Eye Drops325
4地氯雷他定口服溶液 · No verified English name3126
5Vortioxetine Hydrobromide Tablets2210
6Nicardipine Hydrochloride Injection2213
7维生素B12滴眼液 · No verified English name222
8Acetylcysteine Granules214
9Lactulose Oral Solution2134
10Tadalafil Tablets2123

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

217 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Luo Yang Hao Long Pharma Co., Ltd. romanized1780
2Janssen Research & Development LLC930
3Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized640
4AstraZeneca AB630
5Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized434
6Sanofi Winthrop Industrie420
7Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized424
8Chengdu Di Yi Pharmaceutical Co., Ltd. romanized410
9Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized410
10Suzhou Erye Pharmaceutical Co., Ltd410

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

93 this week

AcceptedDrugApplicants
2024/07/06Import · Class 1 Bleximenib片 · No verified English nameJXHL2400164 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/07/06Import · Class 1 Bleximenib片 · No verified English nameJXHL2400163 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/07/06Import · Class 1 Bleximenib片 · No verified English nameJXHL2400162 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/07/06Generic · Class 3 Pregabalin Oral SolutionCYHS2402049 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/07/06Generic · Class 3 Tebipenem Pivoxil Fine GranulesCYHL2400135 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2024/07/06Generic · Class 3 Ibuprofen and Phenylephrine Hydrochloride TabletsCYHL2400134 Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized
2024/07/06New drug · Class 1 ZL-1218注射液 · No verified English nameCXSL2400433 Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized
2024/07/06New drug · Class 3.3 注射用人生长激素 · No verified English nameCXSL2400432 Changchun Bio Zhi Pin Research Institute Co., Ltd. romanized
2024/07/06New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2400431 Fu Xing Ya Li Feng (Da Lian) Biopharmaceutical Co., Ltd. romanized
2024/07/06New drug · Class 2.2 三价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2400430 Chengdu Ou Lin Bio Technology Co., Ltd. romanized; Lanzhou Bai Ling Bio Technology Co., Ltd. romanized; Chengdu Xin Nuo Ming Bio Technology Co., Ltd. romanized
2024/07/06New drug · Class 1 SDTM001注射液 · No verified English nameCXSL2400429 Sai De Te Biopharmaceutical Co., Ltd. romanized
2024/07/06New drug · Class 1 DX1002片 · No verified English nameCXHL2400660 Guangzhou An Hao Pharmaceuticals Technology Co., Ltd. romanized
2024/07/06New drug · Class 1 DX1002片 · No verified English nameCXHL2400659 Guangzhou An Hao Pharmaceuticals Technology Co., Ltd. romanized
2024/07/05Import · Class 2.4 DS-3201b片 · No verified English nameJXHL2400161 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/07/05Import · Class 2.4 DS-3201b片 · No verified English nameJXHL2400160 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/07/05Generic · Class 3 Amoxicillin and Clavulanate Potassium TabletsCYHS2402042 Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized
2024/07/05Generic · Class 3 Ferrous Succinate TabletsCYHS2402039 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2024/07/05Generic · Class 3 Gatifloxacin Eye DropsCYHS2402038 Hainan Ying Da Run Ze Pharma Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanized
2024/07/05Generic · Class 3 Naproxen Sodium TabletsCYHS2402037 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/07/05Generic · Class 3 Naproxen Sodium TabletsCYHS2402036 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/07/05Generic · Class 3 Haloperidol TabletsCYHS2402031 Jiangsu He Chen Pharma Co., Ltd. romanized
2024/07/05New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2400428 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2024/07/05New drug · Class 1 重组抗NKG2A人源化单克隆抗体注射液 · No verified English nameCXSL2400427 Shanghai Huai Yue Bio Technology Co., Ltd. romanized
2024/07/05New drug · Class 1 CB03-154片 · No verified English nameCXHL2400658 Shanghai Zhi Meng Pharmaceuticals Technology Co., Ltd. romanized
2024/07/05New drug · Class 1 YL-13027片 · No verified English nameCXHL2400657 Shanghai Ying Li Pharma Co., Ltd. romanized
2024/07/05New drug · Class 1 YL-13027片 · No verified English nameCXHL2400656 Shanghai Ying Li Pharma Co., Ltd. romanized
2024/07/04Import · Class 1 Bleximenib胶囊 · No verified English nameJXHL2400159 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/07/04Import · Class 1 Bleximenib胶囊 · No verified English nameJXHL2400158 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/07/04Import · Class 1 Bleximenib胶囊 · No verified English nameJXHL2400157 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/07/04Import · Class 1 Dexpramipexole片 · No verified English nameJXHL2400156 Areteia Therapeutics Inc.; Parexel China Co Ltd.

63 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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