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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 360 drug applications between 21 December 2023 and 27 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 106, covering 78 drug names.

2023/12/21 – 2023/12/27

Period
2023/12/21 to 2023/12/27, 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
360
Drugs with new generic filings (by drug name, de-duplicated)
78
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

360filings, 106 of them generic

By application type

Application typeFilings
Supplement155
Generic106
New drug60
Import21
Import re-registration11
Unspecified7

By drug type

Drug typeFilings
Chemical drug253
TCM61
Therapeutic biologic42
Prophylactic biologic3
Biologic1

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
1Vonoprazan Fumarate Tablets4260
2Levofloxacin and Sodium Chloride Injection4214
3Potassium Chloride Injection3210
4Ketorolac Tromethamine Injection324
5Telmisartan And Amlodipine Tablets2210
6Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
7Ceftazidime And Avibactam Sodium For Injection2212
8Nefopam Hydrochloride Injection223
9腺苷钴胺胶囊 · No verified English name228
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

213 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized1410
2Shenyang Hong Yao Group Co., Ltd. romanized760
3AstraZeneca AB740
4Guizhou Bai Ling Qi Ye Group Pharmaceutical Co., Ltd. romanized630
5Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized620
6Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized550
7Beijing Bu Lin Bio Technology Co., Ltd. romanized535
8Guangzhou Bai Yun Shan Tian Xin Pharmaceutical Co., Ltd. romanized530
9Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized510
10Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized444

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

121 this week

AcceptedDrugApplicants
2023/12/27Generic · Class 3 Nefopam Hydrochloride InjectionCYHS2303644 Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized
2023/12/27Generic · Class 3 Nicorandil for InjectionCYHS2303641 Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized
2023/12/27Generic · Class 3 Acetylcysteine Oral SolutionCYHS2303640 Nanjing Yi Teng Drug Research Institute Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/12/27Generic · Class 3 Potassium Chloride InjectionCYHS2303635 Fujian Xin Di Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/12/27Generic · Class 3 左羟丙哌嗪口服溶液 · No verified English nameCYHS2303634 Anhui Mao Kang Pharma Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2023/12/27Generic · Class 3 左羟丙哌嗪口服溶液 · No verified English nameCYHS2303633 Anhui Mao Kang Pharma Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2023/12/27Generic · Class 3 Gabexate Mesilate For InjectionCYHS2303631 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/12/27Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2303630 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2023/12/27Generic · Class 3 Dexmethylphenidate Hydrochloride Exended-release CapsulesCYHS2303628 Henan Zhong Shuai Pharma Co., Ltd. romanized
2023/12/27Generic · Class 3 Propafenone Hydrochloride InjectionCYHS2303627 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/12/27Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2303626 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2023/12/27Generic · Class 3 Epinephrine InjectionCYHS2303624 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/12/27Generic · Class 3 膀胱灌注用盐酸氨酮戊酸己酯及专用溶剂 · No verified English nameCYHL2300161 Guangdong Jing Guan Biopharmaceuticals Technology Co., Ltd. romanized
2023/12/27Generic · Class 3 Pregabalin Extended release TabletsCYHL2300160 Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2023/12/27New drug · Class 1.1 椒七麝凝胶贴膏 · No verified English nameCXZS2300028 Hunan Jiudian Pharmaceutical Co., Ltd
2023/12/27New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300896 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2023/12/27New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300895 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2023/12/27New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300894 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2023/12/27New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300893 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2023/12/27New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300892 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2023/12/27New drug · Class 1 LM-101注射液 · No verified English nameCXSL2300891 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/12/27New drug · Class 1 昂拉地韦片 · No verified English nameCXHS2300118 Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized; Guangdong Hua Nan Pharma Group Co., Ltd. romanized
2023/12/27New drug · Class 1 NS-041分散片 · No verified English nameCXHL2301454 Niu Ou Shen Pharmaceuticals (Shanghai) Co., Ltd. romanized
2023/12/27New drug · Class 1 NS-041分散片 · No verified English nameCXHL2301453 Niu Ou Shen Pharmaceuticals (Shanghai) Co., Ltd. romanized
2023/12/27New drug · Class 2.2 小儿泼尼松肠溶干混悬剂(微球型) · No verified English nameCXHL2301452 Wen Tao Innovation Drug Research (Beijing) Co., Ltd. romanized
2023/12/27New drug · Class 2.2 泼尼松肠溶胶囊(微球型) · No verified English nameCXHL2301451 Wen Tao Innovation Drug Research (Beijing) Co., Ltd. romanized
2023/12/27New drug · Class 2.2; 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2301450 Le Pu Pharma Co., Ltd. romanized
2023/12/27New drug · Class 2.2; 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2301449 Le Pu Pharma Co., Ltd. romanized
2023/12/26Import · Class 2.2 Benralizumab注射液 · No verified English nameJXSL2300235 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/12/26Import · Class 1 BI1569912 片 · No verified English nameJXHL2300328 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.

91 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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