YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 367 drug applications between 29 June 2024 and 5 July 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 94, covering 69 drug names.

2024/06/29 – 2024/07/05

Period
2024/06/29 to 2024/07/05, 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
367
Drugs with new generic filings (by drug name, de-duplicated)
69
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

367filings, 94 of them generic

By application type

Application typeFilings
Supplement193
Generic94
New drug41
Import20
Import re-registration14
Unspecified5

By drug type

Drug typeFilings
Chemical drug272
TCM51
Therapeutic biologic38
Prophylactic biologic6

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

69 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Epalrestat Tablets331
2Diquafosol Sodium Eye Drops325
3Bumetanide Injection3213
4Dapoxetine Hydrochloride Tablets3220
5地氯雷他定口服溶液 · No verified English name3126
6Vortioxetine Hydrobromide Tablets2210
7维生素B12滴眼液 · No verified English name222
8维生素B6注射液 · No verified English name2210
9Lactulose Oral Solution2134
10Ipratropium Bromide Inhalation Solution212

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

209 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Luo Yang Hao Long Pharma Co., Ltd. romanized1780
2Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized10100
3Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized640
4AstraZeneca AB630
5Janssen Research & Development LLC620
6Shanxi Hua Kang Pharma Co., Ltd. romanized430
7Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized431
8Ren He Yi Kang Group Co., Ltd. romanized422
9Chengdu Di Yi Pharmaceutical Co., Ltd. romanized410
10Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized410

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

98 this week

AcceptedDrugApplicants
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.
2024/07/04Import · Class 1 Dexpramipexole片 · No verified English nameJXHL2400155 Areteia Therapeutics Inc.; Parexel China Co Ltd.
2024/07/04Generic · Class 3 Epalrestat TabletsCYHS2402025 Anhui Pioneer Pharmaceutical Co., Ltd
2024/07/04Generic · Class 3 Pentoxifylline InjectionCYHS2402024 Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Jiangxi Yin Tao Pharma Co., Ltd. romanized
2024/07/04Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2402023 Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Jiangxi Yin Tao Pharma Co., Ltd. romanized
2024/07/04Generic · Class 3 维生素K滴剂 · No verified English nameCYHS2402022 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2024/07/04Generic · Class 3 Lysine Acetylsalicylate For InjectionCYHS2402019 Guizhou Bo Lin Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2024/07/04Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2402018 Hebei Hui De Xu Sheng Pharmaceuticals Technology Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2024/07/04Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2402017 CISEN PHARMACEUTICAL CO., LTD.
2024/07/04Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2402016 CISEN PHARMACEUTICAL CO., LTD.
2024/07/04Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2402015 Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized
2024/07/04Generic · Class 3 Acetylcysteine InjectionCYHS2402010 Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized
2024/07/04Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2402009 Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2024/07/04Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2402008 Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized

68 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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