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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 328 drug applications between 3 March 2023 and 9 March 2023 (data as of 14 November 2026 06:00). Of these, generic applications numbered 83, covering 56 drug names.

2023/03/03 – 2023/03/09

Period
2023/03/03 to 2023/03/09, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
328
Drugs with new generic filings (by drug name, de-duplicated)
56
Accepted this week, now under review
0

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

328filings, 83 of them generic

By application type

Application typeFilings
Supplement168
Generic83
New drug42
Import re-registration14
Unspecified12
Import9

By drug type

Drug typeFilings
Chemical drug242
TCM51
Therapeutic biologic29
Biologic3
Prophylactic biologic3

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

56 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Minoxidil Topical Solution530
2Lactulose Oral Solution4234
3Torsemide Injection421
4Dapagliflozin Tablets4284
5Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3223
6Phenylephrine Hydrochloride Injection325
7Palbociclib Capsules310
8Lidocaine and Prilocaine Cream2224
9Risperidone Orally Disintegrating Tablets210
10吸入用布地奈德混悬液 · No verified English name217

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

199 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized1090
2Shanghai Qing Ping Pharma Co., Ltd. romanized850
3Actelion Pharmaceuticals Ltd810
4Hong Xiang (Heilongjiang) Pharmaceutical Co., Ltd. romanized660
5Eurofins Analytical Science Laboratories Inc.550
6Shijiazhuang No.4 Pharmaceutical Co., Ltd.542
7Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized440
8Shi Qi Pharmaceutical (Guangdong) Co., Ltd. romanized440
9H. Lundbeck A/S420
10Novartis Pharma Schweiz AG420

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

86 this week

AcceptedDrugApplicants
2023/03/09Import · Class 1 AZD9592 · No verified English nameJXSL2300048 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/03/09Generic · Class 3 Ibuprofen InjectionCYHS2300749 Xian Han Feng Pharma Co., Ltd. romanized
2023/03/09Generic · Class 3 Baclofen Oral SolutionCYHL2300034 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2023/03/09New drug · Class 1 EXG102-031眼用注射液 · No verified English nameCXSL2300178 Hangzhou Jia Yin Bio Technology Co., Ltd. romanized
2023/03/09New drug · Class 1 盐酸阿司匹林胺喷雾剂 · No verified English nameCXHL2300290 Tai Fei Er Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2023/03/09New drug · Class 1 AXT-1003胶囊 · No verified English nameCXHL2300289 Ai Si Tuo Kang Pharmaceuticals Technology (Beijing) Co., Ltd. romanized
2023/03/09New drug · Class 1 AXT-1003胶囊 · No verified English nameCXHL2300288 Ai Si Tuo Kang Pharmaceuticals Technology (Beijing) Co., Ltd. romanized
2023/03/08Import · Class 1 Lanifibranor片 · No verified English nameJXHL2300043 Inventiva S.A.; Chia Tai Tianqing Pharmaceutical Group Co. Ltd.
2023/03/08Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300746 Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2023/03/08Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300745 Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2023/03/08Generic · Class 3 Calcium Acetate Oral SolutionCYHS2300744 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Sui Cheng Pharma Co., Ltd. romanized
2023/03/08Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2300741 Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/03/08Generic · Class 3 Minoxidil Topical SolutionCYHS2300740 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2023/03/08Generic · Class 3 Torsemide InjectionCYHS2300738 Jiangsu Rui Shi Bio Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd
2023/03/08Generic · Class 3 Torsemide InjectionCYHS2300737 Jiangsu Rui Shi Bio Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd
2023/03/08Generic · Class 3 Pregabalin Oral SolutionCYHS2300734 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2023/03/08Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300730 Shanxi Tong Da Pharma Co., Ltd. romanized
2023/03/08Generic · Class 3 丁酸氯维地平注射用乳剂 · No verified English nameCYHL2300033 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/03/08New drug · Class 3.3 地舒单抗注射液 · No verified English nameCXSS2300009 Fei Yang Bio Technology (Jilin) Co., Ltd. romanized; Kang Ning Jie Rui (Jilin) Bio Technology Co., Ltd. romanized
2023/03/08New drug · Class 3.4 人纤维蛋白原 · No verified English nameCXSS2300008 Guangdong Shuang Lin Biopharmaceutical Co., Ltd. romanized
2023/03/08New drug · Class 3.3 门冬胰岛素注射液 · No verified English nameCXSL2300177 Nanjing Han Xin Pharmaceuticals Technology Co., Ltd. romanized
2023/03/08New drug · Class 3.3 德谷门冬双胰岛素注射液 · No verified English nameCXSL2300176 Beijing SL Pharmaceutical Co., Ltd.
2023/03/08New drug · Class 1 注射用BA1202 · No verified English nameCXSL2300175 Shandong Bo An Bio Technology Co., Ltd. romanized
2023/03/08New drug · Class 1 TY-302胶囊 · No verified English nameCXHL2300285 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2023/03/08New drug · Class 1 TY-302胶囊 · No verified English nameCXHL2300284 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2023/03/08New drug · Class 2.4 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2300283 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2023/03/08New drug · Class 2.2 吸入用吡非尼酮溶液 · No verified English nameCXHL2300282 Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized
2023/03/08New drug · Class 2.2 吸入用吡非尼酮溶液 · No verified English nameCXHL2300281 Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized
2023/03/07Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2300021 Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2023/03/07Generic · Class 3 Cetirizine Hydrochloride InjectionCYHS2300724 Shandong Ke Xin Hui Yi Pharma Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized

56 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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