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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 339 drug applications between 25 October 2023 and 31 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 61 drug names.

2023/10/25 – 2023/10/31

Period
2023/10/25 to 2023/10/31, 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
339
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

339filings, 80 of them generic

By application type

Application typeFilings
Supplement174
Generic80
New drug55
Import re-registration11
Unspecified10
Import9

By drug type

Drug typeFilings
Chemical drug227
TCM61
Therapeutic biologic40
Biologic7
Prophylactic biologic4

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
1Piracetam Injection429
2Nicardipine Hydrochloride Injection4213
3Betamethasone Sodium Phosphate Injection215
4Procaterol Hydrochloride Solution for Inhalation212
5Doxofylline Tablets212
6Vonoprazan Fumarate Tablets2160
7Metformin Hydrochloride And Empagliflozin Extended Release Tablets2112
8Tolvaptan Orally Disintegrating Tablets215
9Lacosamide Tablets210
10Trifluridine and Tipiracil Hydrochloride 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

188 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Shuang Yan Pharma Co., Ltd. romanized2890
2Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized19180
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
9Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized434
10Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized420

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
2023/10/31Import · Class 1 Donanemab注射液 · No verified English nameJXSS2300082 Eli Lilly and Company; Lilly France; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/10/31Import · Class 3.1 罗泽利昔珠单抗注射液 · No verified English nameJXSS2300081 UCB Inc.; Vetter Pharma-Fertigung GmbH & Co. KG; UCB Trading (Shanghai) Co. Ltd
2023/10/31Import · Class 2.4 卡巴胆碱滴眼液 · No verified English nameJXHL2300269 Visus Therapeutics Inc.; Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Co. Ltd.
2023/10/31Import · Class 2.4 Sotorasib 片 · No verified English nameJXHL2300268 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2023/10/31Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2302956 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/10/31Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2302955 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/10/31Generic · Class 3 Potassium Chloride Oral SolutionCYHS2302952 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2023/10/31Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302950 Nanjing Chuang Di Bio Technology Co., Ltd. romanized; Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2023/10/31Generic · Class 3 Diprophylline InjectionCYHS2302949 Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized
2023/10/31Generic · Class 3 Calcium Acetate CapsulesCYHS2302948 Niu Ha Bo Pharma Co., Ltd. romanized
2023/10/31Generic · Class 3 Doxofylline TabletsCYHS2302945 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/10/31Generic · Class 3 Doxofylline TabletsCYHS2302944 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/10/31Generic · Class 3 Piracetam InjectionCYHS2302943 Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/10/31New drug · Class 1 JYB1904注射液 · No verified English nameCXSL2300745 Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized
2023/10/31New drug · Class 1 TX103嵌合抗原受体T细胞注射液 · No verified English nameCXSL2300744 Fuzhou Tuo Xin Tian Cheng Bio Technology Co., Ltd. romanized
2023/10/31New drug · Class 1 HC006注射液 · No verified English nameCXSL2300743 Shanghai Hong Cheng Pharma Co., Ltd. romanized
2023/10/31New drug · Class 1 YS001胶囊 · No verified English nameCXHL2301194 Suzhou Ze Run Xin Yao Research and Development Co., Ltd. romanized
2023/10/31New drug · Class 1 YS001胶囊 · No verified English nameCXHL2301193 Suzhou Ze Run Xin Yao Research and Development Co., Ltd. romanized
2023/10/31New drug · Class 1 YS001胶囊 · No verified English nameCXHL2301192 Suzhou Ze Run Xin Yao Research and Development Co., Ltd. romanized
2023/10/31New drug · Class 2.2 LPC-022口溶膜 · No verified English nameCXHL2301191 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/10/31New drug · Class 2.3 盐酸左沙丁胺醇异丙托吸入溶液 · No verified English nameCXHL2301190 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2023/10/31New drug · Class 2.2 PDX-06 · No verified English nameCXHL2301189 Hunan Jiudian Pharmaceutical Co., Ltd
2023/10/31New drug · Class 1 FZ008-145胶囊 · No verified English nameCXHL2301188 Guangzhou Fei Mi Zi Technology Co., Ltd. romanized
2023/10/31New drug · Class 1 FZ008-145胶囊 · No verified English nameCXHL2301187 Guangzhou Fei Mi Zi Technology Co., Ltd. romanized
2023/10/31New drug · Class 1 FZ008-145胶囊 · No verified English nameCXHL2301186 Guangzhou Fei Mi Zi Technology Co., Ltd. romanized
2023/10/31New drug · Class 1 YH001胶囊 · No verified English nameCXHL2301185 Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized
2023/10/31New drug · Class 1 YH001胶囊 · No verified English nameCXHL2301184 Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized
2023/10/30New drug · Class 1 TQB2928注射液 · No verified English nameCXSL2300742 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/10/30New drug · Class 1 注射用MK-2870 · No verified English nameCXSL2300741 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2023/10/30New drug · Class 1 BT02单克隆抗体注射液 · No verified English nameCXSL2300740 Shanghai Bai Quan Bio Technology 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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