YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 359 drug applications between 8 November 2023 and 14 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 60 drug names.

2023/11/08 – 2023/11/14

Period
2023/11/08 to 2023/11/14, 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
359
Drugs with new generic filings (by drug name, de-duplicated)
60
Accepted this week, now under review
1

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

359filings, 95 of them generic

By application type

Application typeFilings
Supplement182
Generic95
New drug51
Import14
Import re-registration9
Unspecified8

By drug type

Drug typeFilings
Chemical drug257
TCM71
Therapeutic biologic29
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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Granules634
2Norepinephrine Bitartrate Injection639
3Ibuprofen Injection328
4Potassium Chloride Oral Solution3211
5Minoxidil Liniment3252
6Piracetam Injection319
7Neostigmine Methylsulfate Injection314
8Oseltamivir Phosphate For Oral Suspension222
9Acipimox Capsules222
10Ethyl Iosapentate Capsules2127

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

204 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Shuang Yan Pharma Co., Ltd. romanized26250
2Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized1140
3Jiangsu Hao Sen Pharma Group Co., Ltd. romanized1030
4Jiu Hua Hua Yuan Pharma Co., Ltd. romanized880
5Sanofi Winthrop Industrie730
6Shijiazhuang No.4 Pharmaceutical Co., Ltd.721
7ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.545
8Merck Sharp & Dohme LLC520
9Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized440
10Hebei Wan Bang Fu Lin Pharma 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

116 this week

AcceptedDrugApplicants
2023/11/14Import · Class 3.1 注射用利纳西普(暂定) · No verified English nameJXSS2300084 Kiniksa Pharmaceuticals (UK),Ltd.; Jubilant HollisterStier LLC; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICALS CO. LTD
2023/11/14Import · Class 1 Alnuctamab注射液 · No verified English nameJXSL2300195 Celgene International II Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd.
2023/11/14Import · Class 1 Alnuctamab注射液 · No verified English nameJXSL2300194 Celgene International II Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd.
2023/11/14Import · Class 1 RO7538483注射液 · No verified English nameJXSL2300193 F. Hoffmann -La Roche Ltd; Roche (China) Holding Ltd
2023/11/14Generic · Class 3 Potassium Chloride GranulesCYHS2303127 Hebei San He Shi Chuang Bio Technology Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2023/11/14Generic · Class 3 Potassium Chloride GranulesCYHS2303126 Hebei San He Shi Chuang Bio Technology Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2023/11/14Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2303121 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/11/14Generic · Class 3 布地奈德福莫特罗吸入气雾剂 · No verified English nameCYHS2303119 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2023/11/14Generic · Class 3 Potassium Chloride GranulesCYHS2303118 Chi Feng Gu De Pharma Co., Ltd. romanized; Zhejiang Nord Pharmaceutical Co., Ltd
2023/11/14Generic · Class 3 Potassium Chloride GranulesCYHS2303117 Chi Feng Gu De Pharma Co., Ltd. romanized; Zhejiang Nord Pharmaceutical Co., Ltd
2023/11/14Generic · Class 3 Minoxidil LinimentCYHS2303116 Guangdong Pei Jie Drug Research Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd.
2023/11/14Generic · Class 3 Minoxidil LinimentCYHS2303115 Guangdong Pei Jie Drug Research Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd.
2023/11/14Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2303113 Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Sui Cheng Pharma Co., Ltd. romanized
2023/11/14Generic · Class 3 Pirfenidone TabletsCYHL2300137 Chengdu Brilliant Pharmaceutical Co., Ltd.
2023/11/14New drug · Class 1 SCTC21C注射液 · No verified English nameCXSL2300778 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2023/11/14New drug · Class 1.4 十五价重组人乳头瘤病毒疫苗(汉逊酵母) · No verified English nameCXSL2300777 Chongqing Bo Wei Bai Tai Biopharmaceutical Co., Ltd. romanized; Shanghai Bo Wei Bio Technology Co., Ltd. romanized
2023/11/14New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300776 Beijing Bei Lai Bio Technology Co., Ltd. romanized; Beijing Bei Lai Pharma Co., Ltd. romanized
2023/11/14New drug · Class 1 注射用LN005 · No verified English nameCXHL2301265 Shanghai Hui Yong Pharmaceutical Co., Ltd. romanized
2023/11/14New drug · Class 1 RGT-419B胶囊 · No verified English nameCXHL2301264 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2023/11/14New drug · Class 1 RGT-419B胶囊 · No verified English nameCXHL2301263 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2023/11/13Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2303109 Hangzhou Minsheng Pharmaceutical Co., Ltd
2023/11/13Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2303108 Hangzhou Minsheng Pharmaceutical Co., Ltd
2023/11/13Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2303107 Hangzhou Minsheng Pharmaceutical Co., Ltd
2023/11/13Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2303106 Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/11/13Generic · Class 3 Diphenhydramine Hydrochloride TabletsCYHS2303105 Changchun Hai Yue Pharma Co., Ltd. romanized
2023/11/11Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2300192 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2023/11/11Generic · Class 3 Potassium Chloride GranulesCYHS2303100 Shanxi Huang Cheng Xiang Fu Pharma Co., Ltd. romanized
2023/11/11Generic · Class 3 Potassium Chloride GranulesCYHS2303099 Shanxi Huang Cheng Xiang Fu Pharma Co., Ltd. romanized
2023/11/11New drug · Class 1 ZS805注射液 · No verified English nameCXSL2300775 Sichuan Zhi Shan Wei Xin Bio Technology Co., Ltd. romanized
2023/11/11New drug · Class 1 注射用MK-2870 · No verified English nameCXSL2300774 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized

86 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.