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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 284 drug applications between 22 February 2024 and 28 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 40 drug names.

2024/02/22 – 2024/02/28

Period
2024/02/22 to 2024/02/28, 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
284
Drugs with new generic filings (by drug name, de-duplicated)
40
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

284filings, 50 of them generic

By application type

Application typeFilings
Supplement149
New drug60
Generic50
Import16
Import re-registration5
Unspecified4

By drug type

Drug typeFilings
Chemical drug174
TCM63
Therapeutic biologic42
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

40 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Phosphates Injection332
2Diprophylline Injection227
3丙泊酚乳状注射液 · No verified English name213
4Bisoprolol Fumarate Tablets216
5Ibuprofen Suspension2114
6Potassium Chloride Extended Release Tablets211
7Ropivacaine hydrochloride injection215
8Benidipine Hydrochloride Tablets214
9Metoprolol Tartrate Tablets213
10Sodium Valproate Sustained-release Tablets(I)114

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

145 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shijiazhuang Yu Ze Tang Pharmaceutical Co., Ltd. romanized41340
2Gansu Xin Min Hai Pharmaceutical Co., Ltd. romanized12120
3Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized820
4AstraZeneca AB720
5SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED542
6Shandong Qidu Pharmaceutical Co., Ltd.542
7Myokardia Inc.510
8Shandong Xin Shi Dai Pharma Co., Ltd. romanized432
9Shanghai Pharmaceuticals Group Co., Ltd. romanized410
10Shanghai Ling Tai Biopharmaceuticals Technology 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

94 this week

AcceptedDrugApplicants
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
2024/02/28New drug · Class 1 注射用BAT8006 · No verified English nameCXSL2400162 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/02/28New drug · Class 1 BAT1308注射液 · No verified English nameCXSL2400161 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/02/28New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHS2400018 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/02/28New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHS2400017 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/02/28New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHS2400016 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/02/28New drug · Class 2.2 阿戈美拉汀透皮贴剂 · No verified English nameCXHL2400225 Xin Wen Biopharmaceuticals Technology (Jia Shan) Co., Ltd. romanized
2024/02/28New drug · Class 1 SHR0302碱凝胶 · No verified English nameCXHL2400224 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/02/28New drug · Class 1 SHR0302碱凝胶 · No verified English nameCXHL2400223 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/02/27Import · Class 1 Lerodalcibep · No verified English nameJXSL2400050 LIB Therapeutics Inc.; Hasten Biopharmaceutic Co. Ltd.
2024/02/27Import · Class 1 Lerodalcibep · No verified English nameJXSL2400049 LIB Therapeutics Inc.; Hasten Biopharmaceutic Co. Ltd.
2024/02/27Import · Class 1 BAY 2965501口服溶液 · No verified English nameJXHL2400044 Bayer AG; Bayer Healthcare Company Ltd.
2024/02/27Generic · Class 3 Esflurbiprofen PatchesCYHL2400047 Hunan Jiudian Pharmaceutical Co., Ltd
2024/02/27New drug · Class 1.1 益智安脑颗粒 · No verified English nameCXZL2400011 Beijing Jing Shi Nao Li Technology Co., Ltd. romanized
2024/02/27New drug · Class 1.1 灵香片 · No verified English nameCXZL2400010 Zhejiang Zuo Li Pharma Co., Ltd. romanized
2024/02/27New drug · Class 1 注射用BGB-A3055 · No verified English nameCXSL2400160 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2024/02/27New drug · Class 1 注射用BL-B16D1 · No verified English nameCXSL2400159 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2024/02/27New drug · Class 1 SPH7485片 · No verified English nameCXHL2400222 Shanghai Pharmaceuticals Group Co., Ltd. romanized

64 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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