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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 299 drug applications between 22 April 2024 and 28 April 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 64 drug names.

2024/04/22 – 2024/04/28

Period
2024/04/22 to 2024/04/28, 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
299
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

299filings, 97 of them generic

By application type

Application typeFilings
Supplement153
Generic97
New drug40
Import6
Import re-registration2
Unspecified1

By drug type

Drug typeFilings
Chemical drug205
TCM50
Therapeutic biologic37
Prophylactic biologic7

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
3Minoxidil Liniment4252
4地氯雷他定口服溶液 · No verified English name3226
5Fluvoxamine Maleate Tablets320
6Paliperidone Palmitate Injection318
7Acetylcysteine Injection2253
8氧(液态) · No verified English name2213
9Alanyl Glutamine Injection214
10Lactulose Oral Solution2134

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

169 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Di Liu Pharmaceutical Co., Ltd. romanized24230
2Chen Huan Pharmaceuticals Group Co., Ltd. romanized760
3Bristol-Myers Squibb Pharma EEIG730
4Henan Hua Feng Pharmaceutical Co., Ltd. romanized660
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
6Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized550
7Shijiazhuang No.4 Pharmaceutical Co., Ltd.544
8Beijing Foyou Pharma CO.,LTD534
9Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized510
10Zhongguo Yi Xue Ke College Yi Xue Bio Xue Research Institute 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

88 this week

AcceptedDrugApplicants
2024/04/28New drug · Class 1.4 四价流感病毒亚单位疫苗(佐剂) · No verified English nameCXSL2400267 Jiangsu Zhong Hui Yuan Tong Bio Technology Co., Ltd. romanized; Yi Hui Bio Technology (Shanghai) Co., Ltd. romanized
2024/04/27New drug · Class 1.1 百苓止咳颗粒 · No verified English nameCXZL2400021 Suzhou Zhong Yao Research Institute Co., Ltd. romanized
2024/04/27New drug · Class 1 ZHB110舌下片 · No verified English nameCXSL2400266 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2024/04/27New drug · Class 1 ZHB110舌下片 · No verified English nameCXSL2400265 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2024/04/27New drug · Class 1 HS-10370片 · No verified English nameCXHL2400420 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/04/27New drug · Class 1 TYK-01054胶囊 · No verified English nameCXHL2400419 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2024/04/27New drug · Class 1 TYK-01054胶囊 · No verified English nameCXHL2400418 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2024/04/27New drug · Class 2.2 注射用IPG · No verified English nameCXHL2400417 Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized
2024/04/26Import · Class 1 AZD8205 · No verified English nameJXSL2400082 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/04/26Import · Class 1 AZD2936 · No verified English nameJXSL2400081 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/04/26Generic · Class 3 Minoxidil LinimentCYHS2401276 Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized; Henan Tian Di Pharma Co., Ltd. romanized
2024/04/26Generic · Class 3 Minoxidil LinimentCYHS2401275 Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized; Henan Tian Di Pharma Co., Ltd. romanized
2024/04/26Generic · Class 3 Cimetidine InjectionCYHS2401262 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/04/26Generic · Class 3 Potassium Chloride Oral SolutionCYHS2401260 Sichuan Tian Xing Hui Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized
2024/04/26New drug · Class 3.3 吸附破伤风疫苗 · No verified English nameCXSS2400044 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized
2024/04/26New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400264 Chongqing Chen An Biopharmaceutical Co., Ltd. romanized
2024/04/26New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400263 Chongqing Chen An Biopharmaceutical Co., Ltd. romanized
2024/04/26New drug · Class 2.2 艾司奥美拉唑镁碳酸氢钠干混悬剂(Ⅰ) · No verified English nameCXHL2400416 Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2024/04/26New drug · Class 2.2 艾司奥美拉唑镁碳酸氢钠干混悬剂(Ⅰ) · No verified English nameCXHL2400415 Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2024/04/26New drug · Class 2.3 CP006吸入粉雾剂 · No verified English nameCXHL2400414 Shanghai Xin Huang He Pharmaceutical Co., Ltd. romanized
2024/04/26New drug · Class 1 TQB3911片 · No verified English nameCXHL2400413 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/04/26New drug · Class 1 TQB3911片 · No verified English nameCXHL2400412 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
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

58 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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