YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 318 drug applications between 23 November 2023 and 29 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 61 drug names.

2023/11/23 – 2023/11/29

Period
2023/11/23 to 2023/11/29, 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
318
Drugs with new generic filings (by drug name, de-duplicated)
61
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

318filings, 85 of them generic

By application type

Application typeFilings
Supplement153
Generic85
New drug45
Import22
Unspecified7
Import re-registration6

By drug type

Drug typeFilings
Chemical drug212
TCM50
Therapeutic biologic46
Prophylactic biologic7
Biologic3

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

61 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Granules424
2Roxadustat Capsules4217
3Tadalafil Tablets3123
4Latamoxef Sodium for Injection311
5Acetylcysteine Injection2253
6Tafluprost Eye Drops223
7Cytarabine for Injection222
8Moxifloxacin Hydrochloride Eye Drops224
9Torsemide Injection211
10Sildenafil Citrate Tablets2112

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

203 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Jin Xin Kang Da Pharmaceuticals Technology Co., Ltd. romanized1090
2Jiangsu Hao Sen Pharma Group Co., Ltd. romanized720
3CSL Behring GmbH710
4Shanxi Shuang Yan Pharma Co., Ltd. romanized540
5Chongqing Xi Er An Pharma Co., Ltd. romanized540
6Merck Sharp & Dohme LLC510
7Novo Nordisk A/S510
8Shandong Er Ye Pharmaceutical Co., Ltd. romanized510
9Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized440
10Qilu Pharmaceutical (Hainan) Co., Ltd422

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

104 this week

AcceptedDrugApplicants
2023/11/29Generic · Class 3 Acetylcysteine InjectionCYHS2303299 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2023/11/29Generic · Class 3 Salbutamol Sulfate injectionCYHS2303298 Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/11/29Generic · Class 3 Gatifloxacin Eye DropsCYHS2303293 Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanized
2023/11/29Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2303292 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/11/29Generic · Class 3 Rupatadine Fumarate Oral SolutionCYHL2300145 Zhejiang Xiong Di Pharma Co., Ltd. romanized
2023/11/29New drug · Class 1 注射用SHR-A1811 · No verified English nameCXSL2300823 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/11/29New drug · Class 1 QLP3119注射液 · No verified English nameCXSL2300822 Qilu Pharmaceutical Co., Ltd.
2023/11/29New drug · Class 1 BAOMAI001注射液 · No verified English nameCXSL2300821 Beijing Zhong Wei Yi Zheng Technology Co., Ltd. romanized
2023/11/29New drug · Class 2.2 注射用紫杉醇聚合物胶束 · No verified English nameCXHL2301315 Shanxi Kang Bao Bio Zhi Pin Co., Ltd. romanized
2023/11/28Import · Class 3.1 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300214 CSL Behring GmbH; PAREXEL China Co. Ltd.
2023/11/28Import · Class 3.1 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300213 CSL Behring GmbH; PAREXEL China Co. Ltd.
2023/11/28Import · Class 3.1 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300212 CSL Behring GmbH; PAREXEL China Co. Ltd.
2023/11/28Import · Class 3.1 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300211 CSL Behring GmbH; PAREXEL China Co. Ltd.
2023/11/28Import · Class 3.1 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300210 CSL Behring GmbH; PAREXEL China Co. Ltd.
2023/11/28Import · Class 3.1 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300209 CSL Behring GmbH; PAREXEL China Co. Ltd.
2023/11/28Import · Class 3.1 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300208 CSL Behring GmbH; PAREXEL China Co. Ltd.
2023/11/28Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2303288 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2023/11/28Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2303287 Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized
2023/11/28Generic · Class 3 Biapenem For InjectionCYHS2303286 Jiangsu Rui Shi Bio Technology Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized
2023/11/28Generic · Class 3 Acetylcysteine InjectionCYHS2303285 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/11/28Generic · Class 3 Diprophylline InjectionCYHS2303282 Wuhan Hua Er Bio Technology Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized
2023/11/28Generic · Class 3 吗替麦考酚酯干混悬剂 · No verified English nameCYHS2303280 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2023/11/28Generic · Class 3 Acetylcysteine Oral SolutionCYHS2303279 Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/11/28Generic · Class 3 Magnesium Sulfate InjectionCYHS2303278 Jiangxi Bo Tai Pharma Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized
2023/11/28Generic · Class 3 Ketotifen Fumarate Oral SolutionCYHS2303277 Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/11/28Generic · Class 3 Amisulpride InjectionCYHS2303270 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/11/28Generic · Class 3 Amisulpride InjectionCYHS2303269 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/11/28Generic · Class 3 Relugolix TabletsCYHL2300144 Jiangxi Shan Xiang Pharma Co., Ltd. romanized
2023/11/28New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300820 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2023/11/28New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300819 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized

74 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.