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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 363 drug applications between 3 November 2023 and 9 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 70 drug names.

2023/11/03 – 2023/11/09

Period
2023/11/03 to 2023/11/09, 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
363
Drugs with new generic filings (by drug name, de-duplicated)
70
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

363filings, 101 of them generic

By application type

Application typeFilings
Supplement173
Generic101
New drug61
Import12
Unspecified8
Import re-registration8

By drug type

Drug typeFilings
Chemical drug238
TCM88
Therapeutic biologic35
Biologic1
Prophylactic 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

70 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Norepinephrine Bitartrate Injection639
2Vonoprazan Fumarate Tablets4260
3中/长链脂肪乳注射液(C6~24) · No verified English name310
4Piracetam Injection319
5Potassium Phosphates Injection222
6氧 · No verified English name2215
7Potassium Chloride Injection2210
8Famotidine Injection228
9Oseltamivir Phosphate For Oral Suspension222
10Carbazochrome Sodium Sulfonate Injection211

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

212 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized19190
2Jiangsu Hao Sen Pharma Group Co., Ltd. romanized1030
3Shijiazhuang No.4 Pharmaceutical Co., Ltd.832
4ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.757
5Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized640
6Sanofi Winthrop Industrie620
7Kyowa Kirin Co. Ltd.520
8Guangxi Hong Ji Pharma Group Co., Ltd. romanized440
9Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized440
10Jiangsu Xin Li Yuan Biopharmaceutical Co., Ltd. romanized430

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

120 this week

AcceptedDrugApplicants
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
2023/11/09Generic · Class 3 Minoxidil LinimentCYHS2303072 Guangzhou Kang Yao Shi Pharmaceuticals Technology Co., Ltd. romanized; Hunan Wu Zhou Tong Pharma Co., Ltd. romanized
2023/11/09Generic · Class 3 Potassium Chloride Oral SolutionCYHS2303071 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2023/11/09Generic · Class 3 Potassium Chloride Oral SolutionCYHS2303070 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2023/11/09Generic · Class 3 Torsemide InjectionCYHS2303068 Hubei Heng Di Pharma Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2023/11/09Generic · Class 3 Torsemide InjectionCYHS2303067 Hubei Heng Di Pharma Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2023/11/09Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2303066 Chengdu Xu Yang Yong Jian Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2023/11/09Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2303065 Chengdu Xu Yang Yong Jian Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2023/11/09Generic · Class 3 Acetylcysteine InjectionCYHS2303064 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized
2023/11/09Generic · Class 3 Ibuprofen InjectionCYHS2303063 Shaanxi Li Cai Pharma Co., Ltd. romanized; Guangdong Da Zhong Pharmaceutical Co., Ltd. romanized
2023/11/09Generic · Class 3 Ibuprofen InjectionCYHS2303062 Shaanxi Li Cai Pharma Co., Ltd. romanized; Guangdong Da Zhong Pharmaceutical Co., Ltd. romanized
2023/11/09New drug · Class 2.1 注射用左奥拉西坦 · No verified English nameCXHS2300098 Nanjing Bo De Biopharmaceutical Co., Ltd. romanized; Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized
2023/11/09New drug · Class 1 CMS-D001片 · No verified English nameCXHL2301252 Hainan Kang Zhe Mei Li Technology Co., Ltd. romanized
2023/11/09New drug · Class 1 CMS-D001片 · No verified English nameCXHL2301251 Hainan Kang Zhe Mei Li Technology Co., Ltd. romanized
2023/11/09New drug · Class 1 CMS-D001片 · No verified English nameCXHL2301250 Hainan Kang Zhe Mei Li Technology Co., Ltd. romanized
2023/11/09New drug · Class 1 DA414颗粒 · No verified English nameCXHL2301249 Chengdu Di Ao Jiu Hong Pharmaceutical Factory romanized
2023/11/09New drug · Class 1 DA414颗粒 · No verified English nameCXHL2301248 Chengdu Di Ao Jiu Hong Pharmaceutical Factory romanized
2023/11/09New drug · Class 1 BGB-15025片 · No verified English nameCXHL2301247 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/11/08Import · Class 3.1 帕博利珠单抗注射液 · No verified English nameJXSS2300083 Merck Sharp & Dohme LLC; MSD Ireland(Carlow); MSD R&D (China) Co. Ltd.
2023/11/08Import · Class 1 Lebrikizumab注射液 · No verified English nameJXSL2300191 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/11/08Import · Class 1 BAY 2433334片 · No verified English nameJXHL2300276 Bayer AG; Bayer Healthcare Company Ltd.

90 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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