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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 345 drug applications between 26 June 2024 and 2 July 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 70 drug names.

2024/06/26 – 2024/07/02

Period
2024/06/26 to 2024/07/02, 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
345
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

345filings, 96 of them generic

By application type

Application typeFilings
Supplement189
Generic96
New drug36
Import re-registration12
Import7
Unspecified5

By drug type

Drug typeFilings
Chemical drug254
TCM58
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

70 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Bumetanide Injection4313
2Diquafosol Sodium Eye Drops325
3Calcium Folinate Injection224
4Ibuprofen Suspension2214
5Olopatadine Hydrochloride Eye Drops2213
6Penehyclidine Hydrochloride Injection222
7盐酸阿莫罗芬搽剂 · No verified English name2215
8维生素B6注射液 · No verified English name2210
9Mupirocin Ointment2230
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

202 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. romanized15150
3Hunan San Xue Pharma Co., Ltd. romanized660
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
5Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized550
6Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.434
7Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized430
8Shandong Qidu Pharmaceutical Co., Ltd.433
9Shanxi Hua Kang Pharma Co., Ltd. romanized430
10Hai Er Xue Ye Technology Chongqing Co., Ltd. romanized430

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

79 this week

AcceptedDrugApplicants
2024/07/02Import · Class 1 AMG 451 · No verified English nameJXSL2400118 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/07/02Import · Class 1 AZD0780薄膜衣片 · No verified English nameJXHL2400151 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/07/02Generic · Class 3 碳酸氢钠血滤置换液(钾4mmol/L) · No verified English nameCYHS2401981 Shanghai Feng Lin Bio Technology Co., Ltd. romanized; Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2024/07/02Generic · Class 3 Obeticholic Acid TabletsCYHS2401974 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2024/07/02Generic · Class 3 Obeticholic Acid TabletsCYHS2401973 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2024/07/02Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2401972 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2024/07/02Generic · Class 3 Vitamin K1 InjectionCYHS2401970 Hainan Hua Yi Pharma Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized
2024/07/02Generic · Class 3 Potassium Chloride GranulesCYHS2401968 Zhuo Zhou Dong Le Pharmaceutical Co., Ltd. romanized
2024/07/02Generic · Class 3 Potassium Chloride GranulesCYHS2401967 Zhuo Zhou Dong Le Pharmaceutical Co., Ltd. romanized
2024/07/02Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2401966 Zhejiang Kai Run Pharma Co., Ltd. romanized
2024/07/02Generic · Class 3 Sulpiride InjectionCYHS2401964 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/07/02Generic · Class 3 Allopurinol TabletsCYHS2401963 Jiangsu Deyuan Pharmaceutical Co.,Ltd.
2024/07/02New drug · Class 1.1 艾康片 · No verified English nameCXZL2400037 An Hua Heng Tai (Beijing) Pharmaceuticals Technology Co., Ltd. romanized
2024/07/02New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400421 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/07/02New drug · Class 1 KYS202004A注射液 · No verified English nameCXSL2400420 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2024/07/02New drug · Class 1 HX009注射液 · No verified English nameCXSL2400419 Hangzhou Han Si Biopharmaceuticals Co., Ltd. romanized
2024/07/02New drug · Class 1 JRD-018片 · No verified English nameCXHL2400648 Jing Rui Pharmaceuticals (Suzhou) Co., Ltd. romanized
2024/07/02New drug · Class 1 JRD-018片 · No verified English nameCXHL2400647 Jing Rui Pharmaceuticals (Suzhou) Co., Ltd. romanized
2024/07/02New drug · Class 2.2 吸入用PRT-068 · No verified English nameCXHL2400646 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2024/07/02New drug · Class 2.2; 2.3 LY09607 · No verified English nameCXHL2400645 Nanjing Lv Ye Pharmaceutical Co., Ltd. romanized
2024/07/02New drug · Class 1 IN10018片 · No verified English nameCXHL2400644 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2024/07/02New drug · Class 1 IN10018片 · No verified English nameCXHL2400643 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2024/06/29Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2401955 HAINAN HUALON PHARMACEUTICAL CO.,LTD; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2024/06/29Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2401954 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/06/29Generic · Class 3 Bumetanide InjectionCYHS2401952 Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized
2024/06/29Generic · Class 3 Bumetanide InjectionCYHS2401951 Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized
2024/06/29Generic · Class 3 Bumetanide InjectionCYHS2401950 Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2024/06/29Generic · Class 3 米诺地尔泡沫剂 · No verified English nameCYHL2400133 Chen Guang (Tianjin) Pharmaceutical Co., Ltd. romanized
2024/06/29New drug · Class 1.1 天川颗粒 · No verified English nameCXZL2400036 Shandong Qidu Pharmaceutical Co., Ltd.
2024/06/29New drug · Class 1 注射用IAE0972 · No verified English nameCXSL2400418 Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized

49 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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