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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 382 drug applications between 6 February 2024 and 12 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 111, covering 86 drug names.

2024/02/06 – 2024/02/12

Period
2024/02/06 to 2024/02/12, 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
382
Drugs with new generic filings (by drug name, de-duplicated)
86
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

382filings, 111 of them generic

By application type

Application typeFilings
Supplement152
Generic111
New drug78
Import21
Unspecified11
Import re-registration9

By drug type

Drug typeFilings
Chemical drug286
Therapeutic biologic52
TCM35
Prophylactic biologic5
Biologic4

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

86 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets5270
2Oseltamivir Phosphate Capsules3139
3Fusidic Acid Cream2215
4洛索洛芬钠凝胶贴膏 · No verified English name229
5Mecobalamin Tablets2216
6Magnesium Sulfate Injection227
7Tacrolimus Capsules212
8Tacrolimus Ointment216
9Tadalafil Tablets2123
10Diclofenac Sodium Sustained Release Tablets2110

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

230 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized1190
2Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized920
3Hebei Bian Que Pharmaceutical Co., Ltd. romanized770
4Shandong Xin Shi Dai Pharma Co., Ltd. romanized655
5Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized646
6Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized610
7Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized610
8CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD530
9AbbVie Inc.510
10Suzhou Te Rui Pharma Co., Ltd. romanized510

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

137 this week

AcceptedDrugApplicants
2024/02/10Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2400606 Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2024/02/09Import · Class 1 SGN-B6A · No verified English nameJXSL2400043 Seagen Inc.; IQVIA RDS (Shanghai) Co. Ltd
2024/02/09Generic · Class 3 Ebastine Oral SolutionCYHS2400603 Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2024/02/09New drug · Class 1 TQB3107片 · No verified English nameCXHL2400193 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/02/09New drug · Class 1 TQB3107片 · No verified English nameCXHL2400192 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/02/09New drug · Class 1 TQG3926片 · No verified English nameCXHL2400191 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/02/09New drug · Class 1 TQG3926片 · No verified English nameCXHL2400190 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/02/08Import · Class 3.1 注射用德曲妥珠单抗 · No verified English nameJXSS2400013 Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2024/02/08Import · Class 3.1 塔奎妥单抗注射液 · No verified English nameJXSS2400012 Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.
2024/02/08Import · Class 3.1 塔奎妥单抗注射液 · No verified English nameJXSS2400011 Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.
2024/02/08Import · Class 1 镥[177Lu]Lu-NeoB注射液 · No verified English nameJXHL2400032 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/02/08Import · Class 1 用于制备放射性药物[68Ga]Ga-NeoB注射液的药盒 · No verified English nameJXHL2400031 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/02/08Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2400602 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/02/08Generic · Class 3 Diphenhydramine Hydrochloride InjectionCYHS2400599 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2024/02/08Generic · Class 3 Diphenhydramine Hydrochloride InjectionCYHS2400598 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2024/02/08Generic · Class 3 Fexofenadine Hydrochloride Oral SuspensionCYHS2400592 Haerbin Kui Hua Pharma Co., Ltd. romanized; Kui Hua Pharma Group Chongqing Xiao Kui Hua Er Tong Pharmaceutical Co., Ltd. romanized
2024/02/08Generic · Class 3 Piracetam InjectionCYHS2400580 Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized
2024/02/08Generic · Class 3 Memantine Hydrochloride OD TabletsCYHS2400578 Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized; Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized
2024/02/08Generic · Class 3 Memantine Hydrochloride OD TabletsCYHS2400577 Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized; Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized
2024/02/08Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2400570 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/02/08Generic · Class 3 Sodium Bicarbonate InjectionCYHS2400568 Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/02/08Generic · Class 3 Acetylcysteine InjectionCYHS2400567 Zhong Run Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2024/02/08Generic · Class 3 Pimavanserin Tartrate CapsulesCYHL2400037 Hua Zhong Pharma Co., Ltd. romanized
2024/02/08New drug · Class 1 夫那奇珠单抗注射液 · No verified English nameCXSS2400019 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/02/08New drug · Class 1 夫那奇珠单抗注射液 · No verified English nameCXSS2400018 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/02/08New drug · Class 1 夫那奇珠单抗注射液 · No verified English nameCXSS2400017 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/02/08New drug · Class 1 M108单抗注射液 · No verified English nameCXSL2400118 Ming Ji Biopharmaceutical (Beijing) Co., Ltd. romanized
2024/02/08New drug · Class 1 RJK002注射液 · No verified English nameCXSL2400117 Shanghai Rui Ji Kang Biopharmaceuticals Co., Ltd. romanized
2024/02/08New drug · Class 1 MSCohi-O镜片 · No verified English nameCXSL2400116 Guangdong Pu Luo Kai Rong Biopharmaceuticals Technology Co., Ltd. romanized
2024/02/08New drug · Class 1 MSCohi-O镜片 · No verified English nameCXSL2400115 Guangdong Pu Luo Kai Rong Biopharmaceuticals Technology Co., Ltd. romanized

107 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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