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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 296 drug applications between 23 February 2024 and 29 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 45 drug names.

2024/02/23 – 2024/02/29

Period
2024/02/23 to 2024/02/29, 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
296
Drugs with new generic filings (by drug name, de-duplicated)
45
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

296filings, 57 of them generic

By application type

Application typeFilings
Supplement165
Generic57
New drug51
Import15
Unspecified5
Import re-registration3

By drug type

Drug typeFilings
Chemical drug186
TCM67
Therapeutic biologic38
Prophylactic biologic4
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
1Potassium Phosphates Injection332
2Diprophylline Injection227
3Methocarbamol Injection223
4丙泊酚乳状注射液 · No verified English name213
5Bisoprolol Fumarate Tablets216
6Ibuprofen Suspension2114
7Enzalutamide Tablets212
8Potassium Chloride Extended Release Tablets211
9Ropivacaine hydrochloride injection215
10Benidipine Hydrochloride Tablets214

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

160 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shijiazhuang Yu Ze Tang Pharmaceutical Co., Ltd. romanized45370
2Gansu Xin Min Hai Pharmaceutical Co., Ltd. romanized13130
3SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED542
4Dr. Falk Pharma GmbH520
5Myokardia Inc.510
6Shandong Qidu Pharmaceutical Co., Ltd.432
7Shanghai Pharmaceuticals Group Co., Ltd. romanized410
8Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized410
9Shanghai Ling Tai Biopharmaceuticals Technology Co., Ltd. romanized410
10Xizang Bang Chen Pharma Group 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

86 this week

AcceptedDrugApplicants
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
2024/02/29New drug · Class 2.2 GBI268注射液 · No verified English nameCXHL2400230 Guangzhou Zhi Yao Bio Technology Co., Ltd. romanized
2024/02/29New drug · Class 2.2 BIOS2207 · No verified English nameCXHL2400229 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/02/29New drug · Class 2.2 BIOS2207 · No verified English nameCXHL2400228 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/02/29New drug · Class 1 ARG-Vx-001注射液 · No verified English nameCXHL2400227 Jin Wei Biopharmaceuticals Technology Co., Ltd. romanized
2024/02/29New drug · Class 1 TYR-Vx-001注射液 · No verified English nameCXHL2400226 Jin Wei Biopharmaceuticals Technology Co., Ltd. romanized
2024/02/28Import · Class 1 Riliprubart注射液 · No verified English nameJXSL2400052 Sanofi-aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd.
2024/02/28Import · Class 1 Riliprubart注射液 · No verified English nameJXSL2400051 Sanofi-aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd.
2024/02/28Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2400710 Zhejiang Zhe Bei Pharma Co., Ltd. romanized; Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized
2024/02/28Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2400707 Hainan Jian Tai Bio Technology Co., Ltd. romanized; Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2024/02/28New drug · Class 2.3 肾炎康复片 · No verified English nameCXZL2400012 Tianjin Tong Ren Tang Group Co., Ltd. romanized
2024/02/28New drug · Class 1 TQB2450注射液 · No verified English nameCXSS2400021 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/02/28New drug · Class 2.2 13价肺炎球菌多糖结合疫苗(CRM197,TT载体) · No verified English nameCXSS2400020 Kang Xi Nuo Bio Shareholding Company romanized
2024/02/28New drug · Class 1 PB103 异体自然杀伤(NK)细胞注射液 · No verified English nameCXSL2400168 Suzhou Mai De Tong Pharmaceuticals Technology Co., Ltd. romanized
2024/02/28New drug · Class 1 PB103 异体自然杀伤(NK)细胞注射液 · No verified English nameCXSL2400167 Suzhou Mai De Tong Pharmaceuticals Technology Co., Ltd. romanized
2024/02/28New drug · Class 1 PB103 异体自然杀伤(NK)细胞注射液 · No verified English nameCXSL2400166 Suzhou Mai De Tong Pharmaceuticals Technology Co., Ltd. romanized
2024/02/28New drug · Class 1 QX013N注射液 · No verified English nameCXSL2400165 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2024/02/28New drug · Class 1 JMT202注射液 · No verified English nameCXSL2400164 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2024/02/28New drug · Class 1 NK042细胞注射液 · No verified English nameCXSL2400163 Shanghai En Kai Xi Bao Technology 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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