YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 328 drug applications between 22 October 2023 and 28 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 69 drug names.

2023/10/22 – 2023/10/28

Period
2023/10/22 to 2023/10/28, 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
328
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

328filings, 90 of them generic

By application type

Application typeFilings
Supplement167
Generic90
New drug52
Unspecified8
Import6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug235
TCM55
Therapeutic biologic31
Biologic4
Prophylactic 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

69 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Oral Solution3111
2Piracetam Injection319
3Nicardipine Hydrochloride Injection3113
4Sodium Valproate Sustained-release Tablets(I)224
5Betamethasone Sodium Phosphate Injection215
6Vonoprazan Fumarate Tablets2160
7Metformin Hydrochloride And Empagliflozin Extended Release Tablets2112
8Tolvaptan Orally Disintegrating Tablets215
9Torsemide Injection211
10Lacosamide Tablets210

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

182 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Shuang Yan Pharma Co., Ltd. romanized2890
2Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized17160
3Hebei Yu Zhi Lin Pharma Co., Ltd. romanized880
4CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD844
5Jin He Zang Yao Co., Ltd. romanized760
6Haerbin Han Bang Medical Technology Co., Ltd. romanized510
7Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized510
8Li Bang Pharma (Shanghai) Co., Ltd. romanized510
9Takeda Manufacturing Austria AG410
10Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized410

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

96 this week

AcceptedDrugApplicants
2023/10/28Generic · Class 3 Piracetam InjectionCYHS2302936 Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized
2023/10/28Generic · Class 3 Piracetam InjectionCYHS2302935 Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized
2023/10/28Generic · Class 3 Piracetam InjectionCYHS2302934 Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized
2023/10/28Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2302933 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/10/28Generic · Class 3 Peramivir InjectionCYHS2302932 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2023/10/28Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2302929 Shanghai Bao Long Bio Technology Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized
2023/10/28Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2302928 Jiangsu Shen Long Pharma Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2023/10/28Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2302927 Jiangsu Shen Long Pharma Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2023/10/28New drug · Class 1 TJ033721注射液 · No verified English nameCXSL2300739 Tian Jing Bio Technology (Shanghai) Co., Ltd. romanized
2023/10/28New drug · Class 1 ZT002注射液 · No verified English nameCXSL2300738 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized
2023/10/28New drug · Class 1 AK112注射液 · No verified English nameCXSL2300737 Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized
2023/10/28New drug · Class 1 AK130注射液 · No verified English nameCXSL2300736 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2023/10/28New drug · Class 1 注射用BGB-A3055 · No verified English nameCXSL2300735 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2023/10/28New drug · Class 1 注射用GRK-006 · No verified English nameCXHL2301182 Hui An Kai (Xiamen) Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Ge Lan Ke Pharmaceuticals Technology Co., Ltd. romanized; Quan Zhou Hai Chuang Pharmaceuticals Technology Co., Ltd. romanized
2023/10/28New drug · Class 1 TQG3020片 · No verified English nameCXHL2301181 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/10/28New drug · Class 1 TQG3020片 · No verified English nameCXHL2301180 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/10/28New drug · Class 1 TQG3020片 · No verified English nameCXHL2301179 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/10/28New drug · Class 1 TQG3020片 · No verified English nameCXHL2301178 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/10/28New drug · Class 1 SIM0501片 · No verified English nameCXHL2301177 Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized
2023/10/28New drug · Class 1 SIM0501片 · No verified English nameCXHL2301176 Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized
2023/10/28New drug · Class 1 TQH3906胶囊 · No verified English nameCXHL2301175 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/10/28New drug · Class 1 TQH3906胶囊 · No verified English nameCXHL2301174 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/10/27Import · Class 1 DS-6000a · No verified English nameJXSL2300189 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2023/10/27Generic · Class 3 盐酸拉贝洛尔氯化钠注射液 · No verified English nameCYHS2302925 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/10/27Generic · Class 3 Milrinone InjectionCYHS2302916 Hubei Heng Di Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2023/10/27Generic · Class 3 Milrinone InjectionCYHS2302915 Hubei Heng Di Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2023/10/27New drug · Class 2.2 卡度尼利单抗注射液 · No verified English nameCXSL2300734 Kang Fang Pharma Co., Ltd. romanized
2023/10/27New drug · Class 1 AK127注射液 · No verified English nameCXSL2300733 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2023/10/27New drug · Class 2.2 HJE-219 · No verified English nameCXHL2301173 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/10/27New drug · Class 1 AND019·MSA胶囊 · No verified English nameCXHL2301172 Hangzhou An Dao Pharma Co., Ltd. romanized

66 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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