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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 329 drug applications between 17 December 2023 and 23 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 70 drug names.

2023/12/17 – 2023/12/23

Period
2023/12/17 to 2023/12/23, 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
329
Drugs with new generic filings (by drug name, de-duplicated)
70
Accepted this week, now under review
3

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

329filings, 97 of them generic

By application type

Application typeFilings
Supplement133
Generic97
New drug60
Import20
Unspecified11
Import re-registration8

By drug type

Drug typeFilings
Chemical drug227
TCM61
Therapeutic biologic34
Biologic3
Prophylactic biologic3
In vitro diagnostic reagent1

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

70 drugs with new generic filings; top 10 listed

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

207 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized770
2AstraZeneca AB730
3Guizhou Bai Ling Qi Ye Group Pharmaceutical Co., Ltd. romanized630
4Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized620
5CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD520
6Hainan Xu Wo Pharma Co., Ltd. romanized440
7Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized420
8Chengdu Brilliant Pharmaceutical Co., Ltd.420
9Patheon France410
10Guangzhou Jia Yue Pharmaceuticals 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

107 this week

AcceptedDrugApplicants
2023/12/23Import · Class 1 Aficamten片 · No verified English nameJXHL2300325 Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2023/12/23Import · Class 2.4 布地格福吸入气雾剂 · No verified English nameJXHL2300324 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2023/12/23Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2303591 Guangdong Jiang Zheng Pharma Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized
2023/12/23Generic · Class 3 Potassium Chloride InjectionCYHS2303590 Jiangxi Bo Tai Pharma Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized
2023/12/23Generic · Class 3 Potassium Chloride InjectionCYHS2303589 Jiangxi Bo Tai Pharma Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized
2023/12/23Generic · Class 3 复方聚乙二醇电解质散(II) · No verified English nameCYHS2303588 Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2023/12/23Generic · Class 3 复方聚乙二醇电解质散(II) · No verified English nameCYHS2303587 Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2023/12/23New drug · Class 1.4 24价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2300887 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized; Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized
2023/12/23New drug · Class 1.4 24价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2300886 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized; Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized
2023/12/23New drug · Class 1 FL115注射液 · No verified English nameCXSL2300885 Suzhou Fu Rong Bio Technology Co., Ltd. romanized
2023/12/23New drug · Class 1 LP-005 注射液 · No verified English nameCXSL2300884 Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2023/12/23New drug · Class 1 LP-003 注射液 · No verified English nameCXSL2300883 Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2023/12/23New drug · Class 1 LP-005 注射液 · No verified English nameCXSL2300882 Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2023/12/22Import · Class 2.2 注射用Tafasitamab · No verified English nameJXSL2300233 Incyte Biosciences Distribution B.V.; Beijing InnoCare Pharma Tech Co. Ltd.
2023/12/22Import · Class 1 DS-1062a · No verified English nameJXSL2300232 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2023/12/22Import · Class 1 Zilurgisertib片 · No verified English nameJXHL2300323 Incyte Corporation; Incyte Biosciences Shanghai Co. Ltd.
2023/12/22Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2300322 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/12/22Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2300321 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/12/22Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2300320 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2023/12/22Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2300319 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2023/12/22Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2303577 Shandong Yi Kang Pharma Co., Ltd. romanized
2023/12/22Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2303576 Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2023/12/22Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2303575 Chongqing Lai Mei Pharma Co., Ltd. romanized
2023/12/22Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2303574 Chongqing Lai Mei Pharma Co., Ltd. romanized
2023/12/22Generic · Class 3 Metoprolol Tartrate InjectionCYHS2303566 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/12/22Generic · Class 3 烟酸缓释片 · No verified English nameCYHS2303564 Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized
2023/12/22Generic · Class 3 烟酸缓释片 · No verified English nameCYHS2303563 Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized
2023/12/22Generic · Class 3 Fosaprepitant Dimeglumine for InjectionCYHL2300156 Hunan Sai Long Pharma Co., Ltd. romanized
2023/12/22New drug · Class 1 注射用BAT8010 · No verified English nameCXSL2300881 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2023/12/22New drug · Class 1 ALXN2220注射液 · No verified English nameCXSL2300880 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized

77 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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