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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 371 drug applications between 4 November 2023 and 10 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 103, covering 69 drug names.

2023/11/04 – 2023/11/10

Period
2023/11/04 to 2023/11/10, 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
371
Drugs with new generic filings (by drug name, de-duplicated)
69
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

371filings, 103 of them generic

By application type

Application typeFilings
Supplement178
Generic103
New drug60
Import12
Unspecified11
Import re-registration7

By drug type

Drug typeFilings
Chemical drug245
TCM90
Therapeutic biologic34
Biologic2

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

69 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Norepinephrine Bitartrate Injection639
2Vonoprazan Fumarate Tablets4260
3Ibuprofen Injection328
4Potassium Chloride Oral Solution3211
5中/长链脂肪乳注射液(C6~24) · No verified English name310
6Piracetam Injection319
7Potassium Phosphates Injection222
8氧 · No verified English name2215
9Famotidine Injection228
10Oseltamivir Phosphate For Oral Suspension222

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

221 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized17170
2Jiangsu Hao Sen Pharma Group Co., Ltd. romanized1030
3Shijiazhuang No.4 Pharmaceutical Co., Ltd.832
4Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized640
5ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.646
6Sanofi Winthrop Industrie620
7Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized530
8Kyowa Kirin Co. Ltd.520
9Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized440
10Guangxi Hong Ji Pharma Group Co., Ltd. romanized440

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

123 this week

AcceptedDrugApplicants
2023/11/10Import · Class 2.3 马昔腾坦他达拉非片 · No verified English nameJXHL2300281 Actelion Pharmaceuticals Ltd; Johnson & Johnson (China) Investment Ltd.
2023/11/10Import · Class 1 LNP023胶囊 · No verified English nameJXHL2300280 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/11/10Generic · Class 3 Potassium Chloride Oral SolutionCYHS2303094 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2023/11/10Generic · Class 3 Sodium Acetate Ringer's InjectionCYHS2303093 Zhejiang Kang Ji Er Pharma Co., Ltd. romanized
2023/11/10Generic · Class 3 Paracetamol and Ibuprofen TabletsCYHS2303092 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized
2023/11/10Generic · Class 3 Vitamin K1 InjectionCYHS2303088 Hainan Brilliant Pharmaceutical Co., Ltd.
2023/11/10Generic · Class 3 Vitamin K1 InjectionCYHS2303087 Hainan Brilliant Pharmaceutical Co., Ltd.
2023/11/10Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2303085 Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized
2023/11/10Generic · Class 3 Ibuprofen InjectionCYHL2300136 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2023/11/10New drug · Class 3.4 人凝血酶原复合物 · No verified English nameCXSS2300087 Guo Yao Group Lanzhou Biopharmaceutical Co., Ltd. romanized
2023/11/10New drug · Class 1 重组抗IL-1β人源化单克隆抗体注射液 · No verified English nameCXSL2300773 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2023/11/10New drug · Class 1 BR115注射液 · No verified English nameCXSL2300772 Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized; Hai Zheng Biopharmaceutical Co., Ltd. romanized; Chengdu En Mu Bio Technology Co., Ltd. romanized
2023/11/10New drug · Class 1 注射用AMT-116 · No verified English nameCXSL2300771 Pu Zhong Fa Xian Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/11/10New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300770 Shenzhen Shi Yin Guan Bio Technology Co., Ltd. romanized
2023/11/10New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300769 Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized
2023/11/10New drug · Class 2.3 HR20031片(Ⅱ) · No verified English nameCXHS2300100 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/11/10New drug · Class 2.3 HR20031片(Ⅰ) · No verified English nameCXHS2300099 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/11/10New drug · Class 2.4 盐酸右美托咪定鼻喷剂 · No verified English nameCXHL2301255 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2023/11/10New drug · Class 1 HRS-7535片 · No verified English nameCXHL2301254 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/11/10New drug · Class 1 HRS-7535片 · No verified English nameCXHL2301253 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/11/09Import · Class 1 BI 1810631 片 · No verified English nameJXHL2300279 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2023/11/09Import · Class 1 MK-5684片 · No verified English nameJXHL2300278 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2023/11/09Import · Class 1 MK-5684片 · No verified English nameJXHL2300277 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2023/11/09Generic · Class 3 Calcium Acetate TabletsCYHS2303084 Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized
2023/11/09Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2303080 Chongqing Zhong Chuang Ke Pharmaceuticals Co., Ltd. romanized; Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2023/11/09Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2303079 Chongqing Zhong Chuang Ke Pharmaceuticals Co., Ltd. romanized; Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2023/11/09Generic · Class 3 多种微量元素注射液(I) · No verified English nameCYHS2303078 Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2023/11/09Generic · Class 3 多种微量元素注射液(I) · No verified English nameCYHS2303077 Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2023/11/09Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2303076 Liaoning Min Kang Pharmaceutical Co., Ltd. romanized
2023/11/09Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2303075 Liaoning Min Kang Pharmaceutical Co., Ltd. romanized

93 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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