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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 586 drug applications between 2 February 2024 and 8 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 182, covering 136 drug names.

2024/02/02 – 2024/02/08

Period
2024/02/02 to 2024/02/08, 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
586
Drugs with new generic filings (by drug name, de-duplicated)
136
Accepted this week, now under review
8

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

586filings, 182 of them generic

By application type

Application typeFilings
Supplement235
Generic182
New drug109
Import33
Unspecified16
Import re-registration11

By drug type

Drug typeFilings
Chemical drug432
Therapeutic biologic84
TCM58
Biologic6
Prophylactic biologic6

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

136 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets5270
2Urapidil Hydrochloride Injection426
3Diprophylline Injection337
4Tadalafil Tablets3223
5Vonoprazan Fumarate Tablets3260
6Diphenhydramine Hydrochloride Injection329
7LevomilnacipranHydrochloride Extended-release Capsules316
8Oseltamivir Phosphate Capsules3139
9Acetylcysteine Injection2253
10Lidocaine and Prilocaine Cream2224

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

345 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
3Shandong Xin Shi Dai Pharma Co., Ltd. romanized867
4Hebei Bian Que Pharmaceutical Co., Ltd. romanized770
5Shijiazhuang No.4 Pharmaceutical Co., Ltd.775
6Sichuan Yi Ke Cao Pharma Co., Ltd. romanized660
7Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized646
8Jiangsu En Hua Pharma Co., Ltd. romanized634
9AbbVie Inc.620
10Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized610

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

207 this week

AcceptedDrugApplicants
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
2024/02/08New drug · Class 1 MSCohi-O镜片 · No verified English nameCXSL2400114 Guangdong Pu Luo Kai Rong Biopharmaceuticals Technology Co., Ltd. romanized
2024/02/08New drug · Class 1 SHR-2106注射液 · No verified English nameCXSL2400113 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/02/08New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2400112 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2024/02/08New drug · Class 1 异体人源脂肪间充质干细胞注射液 · No verified English nameCXSL2400111 Jiangsu De Kang Bio Technology Co., Ltd. romanized
2024/02/08New drug · Class 1 注射用TQB2102 · No verified English nameCXSL2400110 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/02/08New drug · Class 1 玛赛洛沙韦片 · No verified English nameCXHS2400011 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2024/02/08New drug · Class 2.2 CB275舌下膜 · No verified English nameCXHL2400189 Hangzhou Cheng Bang Pharmaceuticals Technology Co., Ltd. romanized

177 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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