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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 342 drug applications between 24 February 2024 and 1 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 45 drug names.

2024/02/24 – 2024/03/01

Period
2024/02/24 to 2024/03/01, 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
342
Drugs with new generic filings (by drug name, de-duplicated)
45
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

342filings, 58 of them generic

By application type

Application typeFilings
Supplement200
Generic58
New drug53
Import17
Unspecified11
Import re-registration3

By drug type

Drug typeFilings
Chemical drug205
TCM88
Therapeutic biologic45
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

45 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Diprophylline Injection667
2Calcium Folinate Injection224
3Oseltamivir Phosphate Capsules2239
4丙泊酚乳状注射液 · No verified English name213
5Vonoprazan Fumarate Tablets2160
6Bisoprolol Fumarate Tablets216
7Enzalutamide Tablets212
8Sildenafil Citrate Tablets2112
9Fluvoxamine Maleate Tablets210
10Ezetimibe and Simvastatin Tablets114

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

181 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shijiazhuang Yu Ze Tang Pharmaceutical Co., Ltd. romanized55440
2Gansu Xin Min Hai Pharmaceutical Co., Ltd. romanized13130
3EUROAPI Germany GmbH550
4SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED542
5Dr. Falk Pharma GmbH520
6CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD520
7Myokardia Inc.510
8Guo Yao Group Guizhou Biopharmaceutical Co., Ltd. romanized420
9Shanghai Pharmaceuticals Group Co., Ltd. romanized410
10Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized410

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

90 this week

AcceptedDrugApplicants
2024/03/01Import · Class 2.4 米罗那非片 · No verified English nameJXHL2400048 AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd.
2024/03/01Import · Class 2.4 米罗那非片 · No verified English nameJXHL2400047 AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd.
2024/03/01Generic · Class 3 Diprophylline InjectionCYHS2400741 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/03/01Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2400738 Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/03/01Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2400734 Ha Yao Group Technology Center romanized
2024/03/01Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2400733 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized
2024/03/01Generic · Class 3 托吡酯口服溶液 · No verified English nameCYHS2400730 Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/03/01Generic · Class 3 Diprophylline InjectionCYHS2400728 Liaoning Hai Shen Lian Sheng Pharmaceutical Co., Ltd. romanized; Dan Dong Yi Chuang Pharma Co., Ltd. romanized
2024/03/01Generic · Class 3 Diprophylline InjectionCYHS2400727 Shandong Rui Yi Pharmaceuticals Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/03/01Generic · Class 3 Diprophylline InjectionCYHS2400726 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/03/01New drug · Class 1.1 通络健脑片 · No verified English nameCXZS2400010 Guangzhou Yue Kang Biopharmaceutical Co., Ltd. romanized
2024/03/01New drug · Class 1.1 紫花温肺止嗽颗粒 · No verified English nameCXZS2400009 Guangzhou Yue Kang Biopharmaceutical Co., Ltd. romanized
2024/03/01New drug · Class 1 注射用KKD001 · No verified English nameCXSL2400170 Shang Rao Shi Kang Ke De Bio Technology Co., Ltd. romanized
2024/03/01New drug · Class 1 RBD1016注射液 · No verified English nameCXHL2400235 Suzhou Rui Bo Bio Technology Co., Ltd. romanized
2024/03/01New drug · Class 1 HRS-5346片 · No verified English nameCXHL2400234 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2024/03/01New drug · Class 1 HRS-5346片 · No verified English nameCXHL2400233 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/03/01New drug · Class 1 TQ05105片 · No verified English nameCXHL2400232 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/03/01New drug · Class 1 TQ05105片 · No verified English nameCXHL2400231 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/02/29Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400054 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/02/29Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400053 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/02/29Import · Class 2.4 甲磺酸贝舒地尔片 · No verified English nameJXHL2400045 Kadmon Pharmaceuticals LLC; Sanofi (China) Investment Co. Ltd.
2024/02/29Generic · Class 3 Pregabalin Oral SolutionCYHS2400724 Guangdong Nan Guo Pharma Co., Ltd. romanized
2024/02/29Generic · Class 3 Dipyridamole TabletsCYHS2400718 Ben Xi Jiang Cheng Pharmaceuticals Technology Co., Ltd. romanized; Jilin Si Huan Pharmaceutical Co., Ltd. romanized
2024/02/29Generic · Class 3 Enzalutamide TabletsCYHS2400717 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/02/29Generic · Class 3 Enzalutamide TabletsCYHS2400716 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/02/29Generic · Class 3 Sodium Bicarbonate InjectionCYHS2400715 Hangzhou Minsheng Pharmaceutical Co., Ltd
2024/02/29Generic · Class 3 Methocarbamol InjectionCYHS2400714 Zhejiang AngLiKang Pharmaceutical CO.,LTD.; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2024/02/29Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2400712 Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized; Le Pu Pharmaceutical Technology Co., Ltd. romanized
2024/02/29Generic · Class 3 比拉斯汀口崩片 · No verified English nameCYHL2400048 Zhejiang Pu Li Pharma Co., Ltd. romanized
2024/02/29New drug · Class 1 注射用ILB-3101 · No verified English nameCXSL2400169 Ying Nuo Hu Pharmaceuticals (Hangzhou) Co., Ltd. romanized

60 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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