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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 266 drug applications between 19 April 2024 and 25 April 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 64 drug names.

2024/04/19 – 2024/04/25

Period
2024/04/19 to 2024/04/25, 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
266
Drugs with new generic filings (by drug name, de-duplicated)
64
Accepted this week, now under review
4

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

266filings, 93 of them generic

By application type

Application typeFilings
Supplement119
Generic93
New drug41
Import8
Import re-registration3
Unspecified2

By drug type

Drug typeFilings
Chemical drug166
Therapeutic biologic48
TCM47
Prophylactic biologic5

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

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride Solution For Inhalation4210
2Bupivacaine Hydrochloride Injection424
3地氯雷他定口服溶液 · No verified English name3226
4Paliperidone Palmitate Injection318
5Acetylcysteine Injection2253
6Pranoprofen Eye Drops227
7氧(液态) · No verified English name2213
8Metoclopramide Hydrochloride Injection226
9盐酸阿莫罗芬搽剂 · No verified English name2215
10Glucosamine Sulfate Capsules2251

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

164 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chen Huan Pharmaceuticals Group Co., Ltd. romanized11100
2Bristol-Myers Squibb Pharma EEIG730
3Henan Hua Feng Pharmaceutical Co., Ltd. romanized660
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
5Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized550
6Qinghai Jiu Mei Zang Yao Pharma Co., Ltd. romanized440
7Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized430
8Shijiazhuang No.4 Pharmaceutical Co., Ltd.433
9Sichuan Tian Xing Hui Pharmaceuticals Technology Co., Ltd. romanized333
10Name not romanized323

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

91 this week

AcceptedDrugApplicants
2024/04/25Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2401259 Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized
2024/04/25Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2401258 Shandong Cheng Chuang Lan Hai Pharmaceuticals Technology Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized
2024/04/25Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2401257 Shandong Cheng Chuang Lan Hai Pharmaceuticals Technology Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized
2024/04/25Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2401256 Shandong Cheng Chuang Lan Hai Pharmaceuticals Technology Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized
2024/04/25Generic · Class 3 Fudosteine oral solutionCYHS2401253 Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2024/04/25Generic · Class 3 Fudosteine oral solutionCYHS2401252 Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2024/04/25Generic · Class 3 Indobufen TabletsCYHS2401248 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/04/25Generic · Class 3 Calcium Acetate Oral SolutionCYHS2401247 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2024/04/25Generic · Class 3 Famotidine InjectionCYHS2401244 Hebei Zhi Heng Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd
2024/04/25Generic · Class 3 Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2401242 Chengdu Brilliant Pharmaceutical Co., Ltd.
2024/04/25Generic · Class 3 Doxofylline TabletsCYHS2401241 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2024/04/25Generic · Class 3 Doxofylline TabletsCYHS2401240 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2024/04/25Generic · Class 3 Acetylcysteine InjectionCYHS2401238 Sichuan Tian Xing Hui Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/04/25New drug · Class 1 CEL001注射液 · No verified English nameCXSL2400262 Guangzhou Xi Ling Bio Technology Co., Ltd. romanized
2024/04/25New drug · Class 1 BC008-1A注射液 · No verified English nameCXSL2400261 Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized
2024/04/25New drug · Class 1 HB0046注射液 · No verified English nameCXSL2400260 Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/04/25New drug · Class 2.2 注射用重组A型肉毒毒素 · No verified English nameCXSL2400259 Chongqing Yu Yan Pharmaceutical Co., Ltd. romanized
2024/04/25New drug · Class 1 达希替尼片 · No verified English nameCXHS2400036 Xuan Zhu Bio Technology Co., Ltd. romanized; Xian Sheng Pharma Co., Ltd. romanized
2024/04/25New drug · Class 1 达希替尼片 · No verified English nameCXHS2400035 Xuan Zhu Bio Technology Co., Ltd. romanized; Xian Sheng Pharma Co., Ltd. romanized
2024/04/25New drug · Class 1 艾本那肽注射液 · No verified English nameCXHS2400034 Chang Shan Kai Jie Jian Bio Drug Research and Development (Hebei) Co., Ltd. romanized; Hebei Chang Shan Sheng Hua Pharma Co., Ltd. romanized
2024/04/24Import · Class 2.2 Efgartigimod注射液 · No verified English nameJXSL2400080 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2024/04/24Import · Class 3.1 MM09舌下喷雾剂 · No verified English nameJXSL2400079 Inmunotek S.L.; Shanghai HOB Biological Medicine Co. Ltd.
2024/04/24Generic · Class 3 洛索洛芬钠细粒剂 · No verified English nameCYHS2401234 Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/04/24Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2401233 Shijiazhuang Yu Hui Pharmaceutical Co., Ltd. romanized
2024/04/24Generic · Class 3 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2401228 Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2024/04/24Generic · Class 3 Minoxidil LinimentCYHS2401225 Zhejiang Zhe Bei Pharma Co., Ltd. romanized
2024/04/24Generic · Class 3 Minoxidil LinimentCYHS2401224 Zhejiang Zhe Bei Pharma Co., Ltd. romanized
2024/04/24Generic · Class 3 Sildenafil Citrate InjectionCYHL2400079 Hefei Ke Da Bio Technology Co., Ltd. romanized
2024/04/24New drug · Class 3.1 一贯煎颗粒 · No verified English nameCXZS2400014 Shanghai Kai Bao Pharma Co., Ltd. romanized
2024/04/24New drug · Class 3.1 苓桂术甘颗粒 · No verified English nameCXZS2400013 Shanghai Kai Bao Pharma Co., Ltd. romanized

61 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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