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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 352 drug applications between 19 October 2023 and 25 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 103, covering 78 drug names.

2023/10/19 – 2023/10/25

Period
2023/10/19 to 2023/10/25, 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
352
Drugs with new generic filings (by drug name, de-duplicated)
78
Accepted this week, now under review
2

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

352filings, 103 of them generic

By application type

Application typeFilings
Supplement172
Generic103
New drug55
Import16
Unspecified3
Import re-registration3

By drug type

Drug typeFilings
Chemical drug264
TCM55
Therapeutic biologic29
Prophylactic biologic4

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

78 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Oral Solution3111
2Nicardipine Hydrochloride Injection3113
3Sodium Valproate Sustained-release Tablets(I)224
4地氯雷他定口服溶液 · No verified English name2226
5Ambroxol Hydrochloride Solution For Inhalation2110
6Candesartan Cilexetil and Hydrochlorothiazide Tablets210
7复方电解质醋酸钠葡萄糖注射液 · No verified English name2122
8Olanzapine Tablets214
9Vonoprazan Fumarate Tablets2160
10Metformin Hydrochloride And Empagliflozin Extended Release Tablets2112

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

229 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized11100
2Hainan Pu Li Pharmaceutical Co., Ltd. romanized910
3CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD544
4Shang Qiu Shi Xin Ma Bio Technology Co., Ltd. romanized440
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
6JANSSEN-CILAG NV410
7TRUEMED LTD.410
8Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized410
9Changchun Jin Sai Pharma Co., Ltd. romanized410
10Shanxi Guang Yu Yuan Guo Yao 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

114 this week

AcceptedDrugApplicants
2023/10/25Import · Class 1 BMS-986435片 · No verified English nameJXHL2300267 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2023/10/25Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2302896 Rui Yang Pharmaceutical Co., Ltd. romanized
2023/10/25Generic · Class 3 Potassium Chloride GranulesCYHS2302895 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/10/25Generic · Class 3 Calcium Acetate TabletsCYHS2302887 Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized
2023/10/25Generic · Class 3 Tolvaptan Orally Disintegrating TabletsCYHS2302886 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/10/25Generic · Class 3 Tolvaptan Orally Disintegrating TabletsCYHS2302885 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/10/25Generic · Class 3 Minoxidil LinimentCYHS2302884 Tai Kang Hai En Pharma Co., Ltd. romanized
2023/10/25Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2302883 Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2023/10/25Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2302882 Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2023/10/25New drug · Class 1 MBS314注射液 · No verified English nameCXSL2300727 Kang Yuan Bo Chuang Bio Technology (Beijing) Co., Ltd. romanized; Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized
2023/10/25New drug · Class 1 BRL03注射液 · No verified English nameCXSL2300726 Guangzhou Bai Ji Biopharmaceutical Co., Ltd. romanized
2023/10/25New drug · Class 1 注射用SC-101 · No verified English nameCXHL2301161 Tianjin Xing Lian Tai Bio Technology Co., Ltd. romanized
2023/10/25New drug · Class 2.2 SXF-100口溶膜 · No verified English nameCXHL2301160 Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized
2023/10/25New drug · Class 1 ACC017片 · No verified English nameCXHL2301159 Chengdu Ai Di Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ai Di Pharma Co., Ltd. romanized; Nanjing Ai Di Pharmaceuticals Technology Co., Ltd. romanized
2023/10/25New drug · Class 1 ACC017片 · No verified English nameCXHL2301158 Chengdu Ai Di Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ai Di Pharma Co., Ltd. romanized; Nanjing Ai Di Pharmaceuticals Technology Co., Ltd. romanized
2023/10/24Import · Class 2.3; 2.4 卡巴胆碱溴莫尼定滴眼液 · No verified English nameJXHL2300266 Visus Therapeutics Inc.; Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Co. Ltd.
2023/10/24Generic · Class 3 Atropine Sulfate InjectionCYHS2302875 Hunan Hai Shi Biopharmaceuticals Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized
2023/10/24Generic · Class 3 Torsemide InjectionCYHS2302873 Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/10/24Generic · Class 3 Torsemide InjectionCYHS2302872 Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/10/24Generic · Class 3 Celecoxib TabletsCYHS2302870 Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized
2023/10/24Generic · Class 3 Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2302866 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/10/24Generic · Class 3 Acetylcysteine Oral SolutionCYHS2302858 Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/10/24Generic · Class 3 Acetylcysteine Oral SolutionCYHS2302857 Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/10/24Generic · Class 3 Acetylcysteine Oral SolutionCYHS2302856 Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/10/24Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2302851 Sichuan Miao Ji Biopharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/10/24Generic · Class 3 Haloperidol Lactate InjectionCYHS2302850 Anhui Chang Jiang Pharma Co., Ltd. romanized
2023/10/24Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2302849 Hunan Jia Heng Pharmaceutical Co., Ltd. romanized
2023/10/24New drug · Class 1 RJMty19注射液 · No verified English nameCXSL2300725 Guangdong Rui Shun Bio Technology Co., Ltd. romanized
2023/10/24New drug · Class 1 重组人血清白蛋白注射液 · No verified English nameCXSL2300724 Shandong Jian Tong Bio Technology Co., Ltd. romanized
2023/10/24New drug · Class 1 STSA-1001注射液 · No verified English nameCXSL2300723 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized

84 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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