YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 204 drug applications between 27 April 2023 and 3 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 26 drug names.

2023/04/27 – 2023/05/03

Period
2023/04/27 to 2023/05/03, 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
204
Drugs with new generic filings (by drug name, de-duplicated)
26
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

204filings, 35 of them generic

By application type

Application typeFilings
Supplement117
Generic35
New drug34
Import13
Unspecified3
Import re-registration2

By drug type

Drug typeFilings
Chemical drug138
TCM35
Therapeutic biologic25
Prophylactic biologic4
Biologic2

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

26 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Duloxetine Hydrochloride Enteric Capsules314
2Ipratropium Bromide Inhalation Solution212
3Topiroxostat Tablets210
4Trifluridine and Tipiracil Hydrochloride Tablets210
5氢化可的松缓释片 · No verified English name210
6苯磺酸左氨氯地平片 · No verified English name2145
7Norepinephrine Bitartrate Injection219
8阿伐替尼片 · No verified English name210
9Sodium Valproate Sustained-release Tablets(I)111
10吸入用布地奈德混悬液 · No verified English name117

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

111 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized30170
2Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized1090
3Guo Xin (Heilongjiang) Pharmaceutical Co., Ltd. romanized770
4Sichuan He Li Xin Jian Pharma Co., Ltd. romanized640
5CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD520
6Janssen-Cilag AG410
7Merck Sharp & Dohme LLC410
8Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized330
9Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized310
10Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.313

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

54 this week

AcceptedDrugApplicants
2023/04/29Import · Class 1 MK-6024注射液 · No verified English nameJXSL2300085 Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd.
2023/04/29Import · Class 1 MK-6024注射液 · No verified English nameJXSL2300084 Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd.
2023/04/29Import · Class 1 MK-6024注射液 · No verified English nameJXSL2300083 Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd.
2023/04/29Import · Class 1 MK-6024注射液 · No verified English nameJXSL2300082 Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd.
2023/04/29Import · Class 1 BBP-398胶囊 · No verified English nameJXHL2300102 LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd.
2023/04/29Import · Class 1 BBP-398胶囊 · No verified English nameJXHL2300101 LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd.
2023/04/29Import · Class 1 AMG 890 · No verified English nameJXHL2300100 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2023/04/29Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2301203 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2023/04/29Generic · Class 3 头孢丙烯干混悬剂 · No verified English nameCYHS2301198 Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized
2023/04/29Generic · Class 3 Pentoxifylline InjectionCYHS2301197 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/04/29Generic · Class 3 Mepivacaine Hydrochloride InjectionCYHS2301195 Jinan Chen Xin Pharmaceuticals Technology Co., Ltd. romanized; CISEN PHARMACEUTICAL CO., LTD.
2023/04/29New drug · Class 3.3 水痘减毒活疫苗 · No verified English nameCXSL2300299 Zhong Yi An Ke Bio Technology Co., Ltd. romanized; Liaoning Mao Kang Yuan Bio Technology Co., Ltd. romanized
2023/04/29New drug · Class 1 重组抗PEAR1人源化单克隆抗体雾化吸入溶液 · No verified English nameCXSL2300298 Shanghai Xun Yao Bio Technology Co., Ltd. romanized
2023/04/29New drug · Class 2.4 Levoleucovorin for InjectionCXHL2300453 Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized
2023/04/29New drug · Class 2.4 Levoleucovorin for InjectionCXHL2300452 Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized
2023/04/29New drug · Class 1 PG-011凝胶 · No verified English nameCXHL2300451 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2023/04/29New drug · Class 1 PG-011凝胶 · No verified English nameCXHL2300450 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2023/04/29New drug · Class 1 BPYT-01胶囊 · No verified English nameCXHL2300449 Bai Ji You Tang (Guangdong) Pharmaceuticals Technology Co., Ltd. romanized
2023/04/29New drug · Class 1 TQB3454片 · No verified English nameCXHL2300448 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/04/29New drug · Class 1 BPYT-01胶囊 · No verified English nameCXHL2300447 Bai Ji You Tang (Guangdong) Pharmaceuticals Technology Co., Ltd. romanized
2023/04/29New drug · Class 1 TQB3454片 · No verified English nameCXHL2300446 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/04/28Import · Class 2.2 TV-44749 · No verified English nameJXHL2300099 Teva Branded Pharmaceutical Products R&D Inc.
2023/04/28Generic · Class 3 氢化可的松缓释片 · No verified English nameCYHL2300068 Jin Yao Pharma Co., Ltd. romanized
2023/04/28Generic · Class 3 氢化可的松缓释片 · No verified English nameCYHL2300067 Jin Yao Pharma Co., Ltd. romanized
2023/04/28New drug · Class 3.1 芍药甘草颗粒 · No verified English nameCXZS2300010 Shen Wei Pharma Group Co., Ltd. romanized
2023/04/28New drug · Class 1 SNP201注射液 · No verified English nameCXSL2300297 Sai Shen (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/04/28New drug · Class 2.2 注射用重组改构人肿瘤坏死因子 · No verified English nameCXSL2300296 Shanghai Wei Ke Biopharmaceutical Co., Ltd. romanized
2023/04/28New drug · Class 1 JY016注射液 · No verified English nameCXSL2300295 Beijing Dong Fang Bai Tai Bio Technology Co., Ltd. romanized; Beijing Jing Yi Tai Xiang Technology Development Co., Ltd. romanized
2023/04/28New drug · Class 1 VGM-R02b · No verified English nameCXSL2300294 Shanghai Tian Ze Yun Tai Biopharmaceuticals Co., Ltd. romanized
2023/04/28New drug · Class 1 QB0208-1胶囊 · No verified English nameCXHL2300445 Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized

24 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.