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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 331 drug applications between 1 November 2023 and 7 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 59 drug names.

2023/11/01 – 2023/11/07

Period
2023/11/01 to 2023/11/07, 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
331
Drugs with new generic filings (by drug name, de-duplicated)
59
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

331filings, 80 of them generic

By application type

Application typeFilings
Supplement166
Generic80
New drug61
Import re-registration12
Import7
Unspecified5

By drug type

Drug typeFilings
Chemical drug208
TCM82
Therapeutic biologic39
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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Potassium Chloride Granules424
3Minoxidil Liniment3252
4中/长链脂肪乳注射液(C6~24) · No verified English name310
5Perindopril tert-Butylamine Tablets315
6Potassium Phosphates Injection222
7Potassium Chloride Injection2210
8Carbazochrome Sodium Sulfonate Injection211
9Orlistat Capsules218
10Olmesartan Medoxomil Tablets211

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

198 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized19190
2Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized640
3Guangdong Tuan Li Pharmaceutical Co., Ltd. romanized550
4Janssen-Cilag International NV520
5Merck Sharp & Dohme B.V.510
6Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized510
7Sichuan Kelun Pharmaceutical Co., Ltd.424
8Wuhan Lang Lai Technology Development Co., Ltd. romanized420
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
10AstraZeneca AB410

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

101 this week

AcceptedDrugApplicants
2023/11/07Import · Class 1 AZD5305 · No verified English nameJXHL2300275 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/11/07Import · Class 1 AZD5305 · No verified English nameJXHL2300274 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/11/07Import · Class 1 AZD5305 · No verified English nameJXHL2300273 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/11/07Import · Class 1 AZD5305 · No verified English nameJXHL2300272 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/11/07Generic · Class 3 Folic Acid TabletsCYHS2303033 Shenyang Tian Bang Pharma Co., Ltd. romanized
2023/11/07Generic · Class 3 Potassium Chloride GranulesCYHS2303029 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized
2023/11/07Generic · Class 3 Potassium Chloride GranulesCYHS2303028 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized
2023/11/07Generic · Class 3 Desonide OintmentCYHS2303027 Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized
2023/11/07Generic · Class 3 米诺地尔泡沫剂 · No verified English nameCYHS2303026 Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized; Ji Ning Wei Min Pharmaceutical Co., Ltd. romanized
2023/11/07Generic · Class 3 Famotidine InjectionCYHS2303025 Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2023/11/07Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2303024 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2023/11/07Generic · Class 3 Naproxen Sodium TabletsCYHS2303023 Changchun Hai Yue Pharma Co., Ltd. romanized
2023/11/07Generic · Class 3 Potassium Chloride InjectionCYHS2303022 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/11/07New drug · Class 1 AZD0901 · No verified English nameCXSL2300767 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized
2023/11/07New drug · Class 1 注射用SHR-A1921 · No verified English nameCXSL2300766 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/11/07New drug · Class 1 AZD0901 · No verified English nameCXSL2300765 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized
2023/11/07New drug · Class 1 注射用JMKX003142 · No verified English nameCXHL2301229 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/11/07New drug · Class 1 ND-003片 · No verified English nameCXHL2301228 Shenzhen Shi Xin Yue Bio Technology Co., Ltd. romanized; Shenzhen Shi Xiao Fen Zi Xin Yao Innovation Center Co., Ltd. romanized
2023/11/07New drug · Class 1 ND-003片 · No verified English nameCXHL2301227 Shenzhen Shi Xin Yue Bio Technology Co., Ltd. romanized; Shenzhen Shi Xiao Fen Zi Xin Yao Innovation Center Co., Ltd. romanized
2023/11/07New drug · Class 2.2 阿哌沙班胃滞留缓释胶囊 · No verified English nameCXHL2301226 Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized
2023/11/07New drug · Class 1 ABP1019A片 · No verified English nameCXHL2301225 Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized
2023/11/07New drug · Class 1 ABP1019A片 · No verified English nameCXHL2301224 Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized
2023/11/06Generic · Class 3 Potassium Phosphates InjectionCYHS2303010 Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/11/06New drug · Class 1 QR056240CR片 · No verified English nameCXHL2301223 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/11/06New drug · Class 1 QR056240CR片 · No verified English nameCXHL2301222 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/11/06New drug · Class 1 BGB-43395片 · No verified English nameCXHL2301221 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/11/06New drug · Class 1 BGB-43395片 · No verified English nameCXHL2301220 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/11/06New drug · Class 1 BGB-43395片 · No verified English nameCXHL2301219 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/11/04Generic · Class 3 Potassium Phosphates InjectionCYHS2303008 Chengdu Giantech Hi-technology Development Co., Ltd.; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/11/04Generic · Class 3 富马酸酮替芬滴眼液 · No verified English nameCYHS2303005 Chengdu Hui De Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized

71 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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