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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 339 drug applications between 26 October 2023 and 1 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 52 drug names.

2023/10/26 – 2023/11/01

Period
2023/10/26 to 2023/11/01, 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)
52
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, 68 of them generic

By application type

Application typeFilings
Supplement179
Generic68
New drug63
Unspecified11
Import re-registration10
Import8

By drug type

Drug typeFilings
Chemical drug224
TCM64
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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Piracetam Injection429
2Perindopril tert-Butylamine Tablets315
3腺苷钴胺胶囊 · No verified English name228
4Betamethasone Sodium Phosphate Injection215
5Procaterol Hydrochloride Solution for Inhalation212
6Doxofylline Tablets212
7Lacosamide Tablets210
8Trifluridine and Tipiracil Hydrochloride Tablets210
9Potassium Chloride Granules214
10注射用头孢唑肟钠 · No verified English name214

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

178 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Shuang Yan Pharma Co., Ltd. romanized2890
2Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized21200
3Hebei Yu Zhi Lin Pharma Co., Ltd. romanized880
4Jin He Zang Yao Co., Ltd. romanized760
5Janssen-Cilag International NV740
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

100 this week

AcceptedDrugApplicants
2023/11/01Generic · Class 3 Metaraminol Tartrate InjectionCYHS2302971 Hong He Pharmaceutical Co., Ltd. romanized; Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized
2023/11/01Generic · Class 3 Potassium Chloride GranulesCYHS2302961 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2023/11/01Generic · Class 3 Potassium Chloride GranulesCYHS2302960 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2023/11/01Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2302959 Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized
2023/11/01Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2300132 Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized
2023/11/01New drug · Class 1.1 松针正脑颗粒 · No verified English nameCXZL2300067 Shenzhen Li Fu Bio Technology Co., Ltd. romanized
2023/11/01New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300747 Shenzhen Shi Yin Guan Bio Technology Co., Ltd. romanized
2023/11/01New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2300746 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/11/01New drug · Class 1 GRK-008片 · No verified English nameCXHL2301205 Hui An Kai (Xiamen) Pharmaceuticals Technology Co., Ltd. romanized; Quan Zhou Hai Chuang Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Ge Lan Ke Pharmaceuticals Technology Co., Ltd. romanized
2023/11/01New drug · Class 2.2 LPC-007口溶膜 · No verified English nameCXHL2301204 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/11/01New drug · Class 2.2 奥曲肽长效注射液 · No verified English nameCXHL2301203 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2023/11/01New drug · Class 2.2 奥曲肽长效注射液 · No verified English nameCXHL2301202 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2023/11/01New drug · Class 1 HRS-1167片 · No verified English nameCXHL2301201 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/11/01New drug · Class 1 HRS-1167片 · No verified English nameCXHL2301200 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/11/01New drug · Class 1 HRS-1167片 · No verified English nameCXHL2301199 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/11/01New drug · Class 1 CSCJC3456片 · No verified English nameCXHL2301198 Chang Shan Kai Jie Jian Bio Drug Research and Development (Hebei) Co., Ltd. romanized; Hebei Chang Shan Sheng Hua Pharma Co., Ltd. romanized
2023/11/01New drug · Class 1 CSCJC3456片 · No verified English nameCXHL2301197 Chang Shan Kai Jie Jian Bio Drug Research and Development (Hebei) Co., Ltd. romanized; Hebei Chang Shan Sheng Hua Pharma Co., Ltd. romanized
2023/11/01New drug · Class 1 MY004567片 · No verified English nameCXHL2301196 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/11/01New drug · Class 1 MY004567片 · No verified English nameCXHL2301195 Wuhan Lang Lai Technology Development Co., Ltd. romanized
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

70 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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