YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 312 drug applications between 22 August 2024 and 28 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 61 drug names.

2024/08/22 – 2024/08/28

Period
2024/08/22 to 2024/08/28, 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
312
Drugs with new generic filings (by drug name, de-duplicated)
61
Accepted this week, now under review
1

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

312filings, 79 of them generic

By application type

Application typeFilings
Supplement135
Generic79
New drug48
Unspecified20
Import18
Import re-registration12

By drug type

Drug typeFilings
Chemical drug194
TCM70
Therapeutic biologic37
Biologic6
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

61 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Bumetanide Injection4213
2Riociguat Tablets314
3Vonoprazan Fumarate Tablets2260
4Nicardipine Hydrochloride Injection2213
5Dapoxetine Hydrochloride Tablets2220
6Salbutamol Sulfate injection221
7Lactulose Oral Solution2134
8Brexpiprazole Tablets2131
9Empagliflozin Tablets2118
10Loxoprofen Sodium Patches2130

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

208 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Janssen Research & Development LLC720
2Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized610
3Jilin Zhen Yuan Pharmaceutical Co., Ltd. romanized540
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
5Novo Nordisk A/S510
6Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized440
7Sichuan Kelun Pharmaceutical Co., Ltd.432
8Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized424
9Novo Nordisk Pharma AG410
10Health Pharma (Zhongguo) 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

93 this week

AcceptedDrugApplicants
2024/08/28Import · Class 3.1 替利珠单抗注射液 · No verified English nameJXSS2400070 Provention Bio Inc.; Ajinomoto Althea Inc.; Sanofi (China) Investment Co. Ltd.
2024/08/28Import · Class 1 BI 1015550 片 · No verified English nameJXHL2400210 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/28Import · Class 1 BI 1015550 片 · No verified English nameJXHL2400209 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/28Generic · Class 3 硝苯地平缓释片(Ⅱ) · No verified English nameCYHS2402802 Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized
2024/08/28Generic · Class 3 Bumetanide InjectionCYHS2402798 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized
2024/08/28Generic · Class 3 Bumetanide InjectionCYHS2402797 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized
2024/08/28Generic · Class 3 盐酸尼卡地平氯化钠注射液 · No verified English nameCYHS2402794 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2024/08/28Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2402793 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2024/08/28Generic · Class 3 Salbutamol Sulfate injectionCYHS2402792 Jewim Pharmaceutical (Shandong) Co., Ltd.
2024/08/28Generic · Class 3 Landiolol Hydrochloride for InjectionCYHL2400178 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/28Generic · Class 3 磷酸芦可替尼乳膏 · No verified English nameCYHL2400177 Chongqing Huapont Pharmaceutical Co., Ltd.
2024/08/28New drug · Class 1 乐德奇拜单抗注射液 · No verified English nameCXSL2400573 Xian Sheng Pharma Co., Ltd. romanized
2024/08/28New drug · Class 1 9MW2821 · No verified English nameCXSL2400572 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2024/08/28New drug · Class 1 DR10624注射液 · No verified English nameCXSL2400571 Zhejiang Dao Er Bio Technology Co., Ltd. romanized
2024/08/28New drug · Class 3.3 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSL2400570 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized
2024/08/28New drug · Class 1 JYP0061片 · No verified English nameCXHL2400873 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2024/08/28New drug · Class 1 JYP0061片 · No verified English nameCXHL2400872 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2024/08/28New drug · Class 1 JYP0061片 · No verified English nameCXHL2400871 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2024/08/28New drug · Class 1 西奥罗尼胶囊 · No verified English nameCXHL2400870 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized; Chengdu Wei Xin Pharma Co., Ltd. romanized
2024/08/28New drug · Class 1 西奥罗尼胶囊 · No verified English nameCXHL2400869 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized; Chengdu Wei Xin Pharma Co., Ltd. romanized
2024/08/28New drug · Class 1 AD101软膏 · No verified English nameCXHL2400868 Shenzhen Ling Yi Sheng Ming Technology Co., Ltd. romanized
2024/08/28New drug · Class 1 AD101软膏 · No verified English nameCXHL2400867 Shenzhen Ling Yi Sheng Ming Technology Co., Ltd. romanized
2024/08/28New drug · Class 1 AD101软膏 · No verified English nameCXHL2400866 Shenzhen Ling Yi Sheng Ming Technology Co., Ltd. romanized
2024/08/27Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2402789 Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized
2024/08/27Generic · Class 3 Azilsartan and Amlodipine TabletsCYHS2402787 Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized; Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized
2024/08/27Generic · Class 3 Bumetanide InjectionCYHS2402785 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2024/08/27Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2402784 Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized
2024/08/27Generic · Class 3 Bumetanide InjectionCYHS2402783 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2024/08/27Generic · Class 3 Salbutamol Sulfate injectionCYHS2402782 Henan Pu Rui Pharma Co., Ltd. romanized
2024/08/27Generic · Class 3 Metronidazole TabletsCYHS2402779 Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized

63 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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